NO vioxx lawsuit

Document Sample
NO vioxx lawsuit Powered By Docstoc
					             NO. 10-0006
                       In the Supreme Court of Texas
            _________________________________________

CAROL A. ERNST, INDIVIDUALLY AND AS REPRESENTATIVE OF THE
            ESTATE OF ROBERT CHARLES ERNST,
                                    Petitioner,

                                            v.

                       MERCK & CO., INC.,
                                         Respondent.
            _________________________________________

                O N R EVIEW F RO M      F O U RTEEN TH C OURT O F A PPEALS
                                     TH E
                                   H O U STO N , T EXAS
                                 N O . 14-06-00835-CV
            _________________________________________

              PETITIONER’S BRIEF ON THE MERITS

            _________________________________________

 T HE H OLMAN L AW F IRM, P.C.                   T HE L ANIER L AW F IRM
 David W. Holman                                 W. Mark Lanier
 Texas Bar No. 09902500                          Texas Bar No. 11934600
 24 Greenway Plaza, Suite 2000                   Kevin P. Parker
 Houston, Texas 77046                            Texas Bar No. 15494020
 Telephone 713.400.4840                          Ken S. Soh
 Facsimile   713.400.4841                        Texas Bar No. 00794670
                                                 Dara G. Hegar
 S ANFORD B ARLOW, LLP                           Texas Bar No. 24007280
 Shelly A. Sanford                               6810 FM 1960 West
 Texas Bar No. 00784904                          Houston, Texas 77069
 1500 McGowen, Suite 250                         Telephone 713.659.5200
 Houston, Texas 77004                            Facsimile     713.659.2204
 Telephone 713.524.6677
 Facsimile    713.524.6611

             Counsel for Carol A. Ernst, Individually and as
            Representative of the Estate of Robert Charles Ernst
                            IDENTITY OF PARTIES AND COUNSEL

Petitioner

         Carol A. Ernst, Individually and as
         Representative of the Estate of Robert Charles Ernst

                                    Appellate Counsel
         David W. Holman                       W. Mark Lanier
         T HE H OLMAN L AW F IRM, P.C.         Kevin P. Parker
         24 Greenway Plaza, Suite 2000         Kenneth S. Soh
         Houston, Texas 77046                  Dara G. Hegar
         Telephone 713.400.4840                T HE L ANIER L AW F IRM
         Facsimile    713.400.4841             6810 FM 1960 West
                                               Houston, Texas 77069
         Shelly A. Sanford                     Telephone 713.659.5200
         S ANFORD B ARLOW, LLP                 Facsimile     713.659.2204
         1500 McGowen, Suite 250
         Houston, Texas 77004
         Telephone 713.524.6677
         Facsimile    713.524.6611

                                       Trial Counsel
         W. Mark Lanier                         Shelly A. Sanford
         Kevin P. Parker                        S ANFORD B ARLOW, LLP
         Kenneth S. Soh                         1500 McGowen, Suite 250
         Dara G. Hegar                          Houston, Texas 77004
         T HE L ANIER L AW F IRM                Telephone 713.524.6677
         6810 FM 1960 West                      Facsimile    713.524.6611
         Houston, Texas 77069
         Telephone 713.659.5200
         Facsimile     713.659.2204

         Benedict P. Morelli
         B ENEDICT P. M ORELLI & A SSOCIATES
         950 Third Avenue, 10th Floor
         New York, New York 10022
         Telephone 212.751.9800
         Facsimile    212.751.0046




Petitioner’s Brief on the Merits                                            i
                             Identity of Parties and Counsel (continued)

Respondent

         Merck & Co., Inc.

                                   Appellate Counsel
         Katherine D. Mackillop               Of Counsel:
         F ULBRIGHT & J AWORSKI, LLP          Walter E. Dellinger III
         1301 McKinney, Suite 5100            John H. Beisner
         Houston, Texas 77010                 Charles C. Lifland
         Telephone 713.651.5151               O’M ELVENY & M YERS LLP
         Facsimile    713.651.5246            1625 Eye Street, N.W.
                                              Washington, D.C. 20006
                                              Telephone 202.383.5300
                                              Facsimile     202.383.5414

                                     Trial Counsel
         Gerry Lorry                          Richard L. Josephson
         Julie Harbin                         Travis Sales
         F ULBRIGHT & J AWORSKI, LLP          B AKER B OTTS, L.L.P.
         1301 McKinney, Suite 5100            910 Louisiana Street
         Houston, Texas 77010                 Houston, Texas 77002-4995
         Telephone 713.651.5151               Telephone 713.229.1460
         Facsimile    713.651.5246            Facsimile    713.229.7760

         Jonathan B. Skidmore                        Douglas R. Marvin
         Joe W. Tomaselli, Jr.                       David C. Kiernan
         F ULBRIGHT & J AWORSKI L.L.P.               W ILLIAMS & C ONNOLLY, L.L.P.
         2200 Ross Avenue, Suite 2800                725 12th Street, N.W.
         Dallas, Texas 75201-2784                    Washington, D.C. 20005-5901
         Telephone 214.855.8000                      Telephone 202.434.5000
         Facsimile     214.855.8200                  Facsimile    202.434.5029

         Joseph D. Piorkowski, Jr.                   Theodore V.H. Mayer
         L AW O FFICE OF J OSEPH P IORKOWSKI         Seth D. Rothman
         910 Seventh Street NW, Suite 800            H UGHES H UBBARD & R EED LLP
         Washington, D.C. 20006                      One Battery Park Plaza
         Telephone 202.223.5530                      New York, New York 10004-1482
         Facsimile     202.293.3596                  Telephone 212.837.6000
                                                     Facsimile    212.422.4726



Petitioner’s Brief on the Merits                                                     ii
                                             TABLE OF CONTENTS

                                                                                                                             Page

IDENTITY OF PARTIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

INDEX OF AUTHORITIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

STATEMENT OF THE CASE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

ISSUES PRESENTED.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

STATEMENT OF JURISDICTION .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

STATEMENT OF FACTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

SUMMARY OF ARGUMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

ARGUMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

         I.        The Court of Appeals Misapplied The No Evidence Standard Of
                   Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

                   A.        The court of appeals failed to consider legally sufficient
                             evidence that Vioxx caused Mr. Ernst’s death. . . . . . . . . . . . . . . . . 19

                             1.        Dr. David Egilman.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .         21
                             2.        Dr. Benedict Lucchesi. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .          27
                             4.        Dr. Maria Araneta. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .        31
                             5.        Dr. Thomas Wheeler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .            31
                             6.        Dr. Nancy Santanello.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .          32

                   B.        Merck’s “no clot on autopsy,” “no evidence of MI,” and
                             “arrhythmias have other causes” theories do not trump Mrs.
                             Ernst’s causation evidence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

                             1.        The “no clot found on autopsy” theory is not dispositive. . . 33




Petitioner’s Brief on the Merits                                                                                                  iii
                                          Table of Contents (continued)

                                                                                                                          Page

                              2.        The “no physical evidence of myocardial infarction”
                                        theory is not dispositive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
                              3.        The “arrhythmias can occur from other causes” theory is
                                        without merit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

                    C.        The court of appeals created a new and unworkable standard of
                              review for differential diagnosis.. . . . . . . . . . . . . . . . . . . . . . . . . . . 39

                    D.        The court of appeals resolved conflicting evidence and
                              inferences against the judgment. . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

                              1.        Expert opinion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   43
                              2.        Dissolving of clot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .     44
                              3.        Atherosclerosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .    46
                              4.        Unclear whether Naproxen helped. . . . . . . . . . . . . . . . . . . .                  46

          II.       Alternatively, the Court of Appeals Violated Mrs. Ernst’s
                    Constitutional Rights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

CONCLUSION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

CERTIFICATE OF SERVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

APPENDIX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53




Petitioner’s Brief on the Merits                                                                                                iv
                                        INDEX OF AUTHORITIES

Cases                                                                                                          Page(s)

ACS Investors, Inc. v. McLaughlin,
      943 S.W.2d 426 (Tex. 1997).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Alamo Nat’l Bank v. Kraus,
      616 S.W.2d 908 (Tex. 1981).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Brandt v. Surber,
      194 S.W.3d 108 (Tex. App.—Corpus Christi 2006, pet. denied).. . . . . . . . . . . . . 44

Breazeale v. State,
      655 S.W.2d 230 (Tex. App.—Houston [14th Dist.] 1983) . . . . . . . . . . . . . . . . . . 48

Browning-Ferris, Inc. v. Reyna,
     865 S.W.2d 925 (Tex. 1993) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Bunton v. Bentley,
      153 S.W.3d 50 (Tex. 2004) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Choate v. San Antonio & A.P. Ry. Co.,
      91 Tex. 406, 44 S.W. 69 (1898). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

City of Keller v. Wilson,
       168 S.W.3d 802 (Tex. 2005).. . . . . . . . . . . . . . . . . . . . . . . 18-20, 27, 39, 42, 43, 48

Coastal Tankships, U.S.A., Inc. v. Anderson,
      87 S.W.3d 591 (Tex. App.—Houston [1st Dist.] 2002, pet. denied). . . . . . . . . . . 40

Del Lago Partners, Inc. v. Smith,
      307 S.W.3d 762 (Tex. 2010).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Duncan v. Louisiana,
     391 U.S. 145 (1968). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Ford Motor Co. v. Ledesma,
      242 S.W.3d 32 (Tex. 2007).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Golden Eagle Archery, Inc. v. Jackson,
      116 S.W.3d 757 (Tex. 2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42


Petitioner’s Brief on the Merits                                                                                        v
                                       Index of Authorities (continued)

Cases                                                                                                              Page(s)

Hurlbut v. Gulf Atlantic Life Ins. Co.,
      749 S.W.2d 762 (Tex. 1987) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

In re Phenylpropanolamine (PPA),
       2003 WL 22417238 (N.J. Super. 2003) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Jackson v. Axelrad,
      221 S.W.3d 650 (Tex. 2007).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43, 45

Kalina v. Burns,
      No. 14-08-00589-CV, 2009 WL 2176313 (Tex. App.—Houston [14th Dist.]
      2009, pet. denied). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Lassiter v. Dep’t of Social Services,
       452 U.S. 18 (1981) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Lucas v. United States,
      757 S.W.2d 687 (Tex. 1988) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47, 49

McGalliard v. Kuhlmann,
     722 S.W.2d 694 (Tex. 1986) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Merck & Co., Inc. v. Ernst,
      296 S.W.3d 81 (Tex. App.—Houston [14th Dist] 2009, pet. filed). . . . . . . . passim

Merck & Co., Inc. v. Garza,
      277 S.W.3d 430 (Tex. App.—San Antonio 2008, pet. granted).. . . . . . . . . . . . . . . 5

Merrell Dow Pharm., Inc. v. Havner,
      953 S.W.2d 706 (Tex. 1997).. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 6, 20, 21, 32, 40

Minnesota Min. & Mfg. Co. v. Atterbury,
      978 S.W.2d 183 (Tex. App.—Texarkana 1998, pet. denied). . . . . . . . . . . . . . . . . . 5

Owens-Corning Fiberglas Corp. v. Malone,
     972 S.W.2d 35 (Tex. 1998).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15




Petitioner’s Brief on the Merits                                                                                           vi
                                         Index of Authorities (continued)
Cases                                                                                                                   Page(s)

Pointer v. Texas,
      380 U.S. 400 (1965). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Pool v. Ford Motor Co.,
       715 S.W.2d 629 (Tex. 1986) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Praytor v. Ford Motor Co.,
      97 S.W.3d 237 (Tex. App.—Houston [14 Dist.] 2002, no pet.). . . . . . . . . . . . . . . 40

Scaife v. Astrazeneca LP,
       No. 06C-04-218SER, 2009 WL 1610575 (Del. Super. 2009) . . . . . . . . . . . . . . . . 42

Speiser v. Randall,
       357 U.S. 513 (1958). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Walker v. Sauvinet,
      92 U.S. 90 (1875). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Zandi v. Wyeth,
      No. A08-1455, 2009 WL 2151141 (Minn. App. 2009) . . . . . . . . . . . . . . . . . . . . . 42




Statutes, Rules and Regulations

T EX. C IV. P RAC. & R EM. C ODE § 41.008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

T EX. C IV. P RAC. & R EM. C ODE § 71.004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

T EX. C IV. P RAC. & R EM. C ODE § 71.021. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

T EX. G OV’T C ODE § 22.001. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

T EX. R. A PP. P. 49.9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49




Petitioner’s Brief on the Merits                                                                                                vii
                                        Index of Authorities (continued)

Other Authorities                                                                                                     Page(s)

Bombardier, Claire, M.D., et al.,
     Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in
     Patients with Rheumatoid Arthritis, N EW E NGLAND J OURNAL OF M EDICINE,
     November 23, 2000.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Bresalier, Robert S., M.D.,
       Cardiovascular Events Associated with Rofecoxib In a Colorectal Adenoma
       Chemoprevention Trial, N EW E NGLAND J OURNAL OF M EDICINE. . . . . . . . . . . . . . . 5

Calvert, Robert W.,
      “No Evidence” & “Insufficient Evidence” Points of Error, 38 T EX. L. R EV .
      361 (1960).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

D ECLARATION OF INDEPENDENCE (1776). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Editorial, Big Pharma’s buddies, H OUSTON C HRONICLE, May 31, 2008. . . . . . . . . . . . . 16

Egilman, David, et al.,
      What we have learnt from Vioxx, BMJ [British Medical Journal],
      2007:334:120 (2 April, 2007). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Hotze, Steven, “No justice for common man with GOP judges,”
       Houston Community Newspapers, June 19, 2008. . . . . . . . . . . . . . . . . . . . . . . . . 16

Juni, Peter,
       Risk of cardiovascular events and rofecoxib: cumulative meta-analysis,
       www.thelancet.com, November 5, 2004.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Wolfram, Charles,
      The Constitutional History of the Seventh Amendment,
      57 M INN. L. R EV. 639 (1973). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50




Petitioner’s Brief on the Merits                                                                                            viii
                                   STATEMENT OF THE CASE

Nature of the case:                   This is a wrongful death action brought by Carol Ernst
                                      against Merck & Co., Inc. (“Merck”), the manufacturer
                                      of the drug Vioxx—the drug that Mrs. Ernst alleged
                                      caused the death of Mr. Ernst.

Trial court:                          23rd Judicial District Court, Brazoria County, Texas, the
                                      Honorable Ben Harbin presiding

Trial court disposition:              Jury trial was held from July 5, 2005 to August 17, 2005.
                                      The jury reached a verdict on August 19, 2005, finding
                                      all issues in favor of Mrs. Ernst and awarding actual
                                      damages of $22,450,000, together with $229,000,000 in
                                      exemplary damages. See Appendix D.

                                      The trial court reduced the exemplary damages to
                                      $1,600,000, but otherwise entered judgment on the jury
                                      verdict. See Appendix E. The trial court denied Merck’s
                                      post-judgment motions. Merck filed a notice of appeal
                                      and Mrs. Ernst filed a cross-notice of appeal.

Court of appeals disposition:         On May 28, 2008, a panel of the Fourteenth Court of
                                      Appeals (Hedges, C.J., joined by Anderson, J. and
                                      Brown, J.) issued an Opinion that reversed and rendered
                                      judgment. See Appendix B. Mrs. Ernst filed a Motion
                                      for Rehearing En Banc.

                                      After waiting over a year, on June 4, 2009, the same
                                      panel issued a Substitute Opinion, which was an entirely
                                      new opinion, that again reversed and rendered judgment
                                      but for different reasons. See Merck & Co., Inc. v. Ernst,
                                      296 S.W.3d 81 (Tex. App.—Houston [14th Dist] 2009,
                                      pet. filed) (Appendix A). This time, the panel found no
                                      evidence that Vioxx caused Mr. Ernst’s death. Mrs.
                                      Ernst filed a second Motion for Rehearing En Banc.

                                      On November 19, 2009, the First Court denied Mrs.
                                      Ernst’s motion for rehearing, with a vote of 3-3. The
                                      only Justices who voted to deny rehearing en banc were
                                      the authors of the Substitute Opinion. See Appendix C.



Petitioner’s Brief on the Merits                                                             ix
                                      ISSUES PRESENTED

1.       Sufficiency of evidence

         After a month long trial, the jury found Merck guilty of marketing defect, design

defect and negligence for causing the death of Bob Ernst. Most of the testimony at trial

concerned whether Vioxx was a cause of Mr. Ernst’s death. Testimony was presented

through renowned medical experts, documents and cross-examination. On appeal, the court

of appeals disregarded all of that evidence and held that Mrs. Ernst presented no evidence

that Vioxx was a cause of Bob Ernst’s death. Specifically, the court of appeals failed to

consider evidence presented, created a new standard for review of differential diagnosis

evidence, disregarded evidence that favored the judgment, and resolved conflicting evidence

against the judgment.

         •        Did the court of appeals improperly apply the standard for no evidence review
                  by disregarding evidence favorable to the judgment and resolving conflicts in
                  the evidence and inferences against the judgment?

         •        Did the court of appeals erroneously create an improper standard for review
                  of differential diagnosis evidence, by disregarding evidence of exclusion of
                  risk factors?

         •        Are the jury findings supported by legally sufficient evidence of specific
                  causation?

2.       Constitutional rights

         •        Did the court of appeals, by disregarding evidence in the record contrary to the
                  standard of review, and by substituting itself for the jury, violate Mrs. Ernst’s
                  rights under the Texas and United States Constitution to procedural due
                  process and to the right to trial by jury?




Petitioner’s Brief on the Merits                                                                 x
                                   STATEMENT OF JURISDICTION

         This Court has jurisdiction because the court of appeals held differently from a prior

decision of another court of appeals or of this Court. See T EX. G OV’T C ODE § 22.001(a)(2).

This Court also has jurisdiction because the proper application of the standard of review for

no evidence is a recurring issue of substantial importance to Texas jurisprudence. Id. at §

22.001(a)(6).




Petitioner’s Brief on the Merits                                                             xi
                                                    NO. 10-0006


                                      In the Supreme Court of Texas
                         _________________________________________

     CAROL A. ERNST, INDIVIDUALLY AND AS REPRESENTATIVE OF THE
                 ESTATE OF ROBERT CHARLES ERNST,

                                                                         Petitioner,

                                                           v.

                                            MERCK & CO., INC.,

                                                      Respondent.
                         _________________________________________

                               O N R EVIEW F RO M      F O U RTEEN TH C OURT O F A PPEALS
                                                    TH E
                                                  H O U STO N , T EXAS
                                                N O . 14-06-00835-CV
                         _________________________________________

                           PETITIONER’S BRIEF ON THE MERITS
                         _________________________________________

TO THE HONORABLE JUSTICES OF THE SUPREME COURT OF TEXAS:

         Petitioner, Carol Ernst, Individually and as Representative of the Estate of Robert

Charles Ernst, files this brief on the merits in support of her request that the Court grant

review, reverse the judgment of the court of appeals, and remand to that court for

consideration of unaddressed points.




Petitioner’s Brief on the Merits                                                            xii
                                   STATEMENT OF FACTS

1.       The Ernst family

         The case concerns the death of Bob Ernst, who died from a sudden cardiac death at

the age of 59, eight months after being given a daily prescription of Vioxx.

         Bob was a “fitness nut.” (40 RR 40). He ran five or six times a week, he went to the

fitness center daily, he rode a bike 10 or 12 miles a day (Id.). He competed in marathons and

triatholons (Id.). He ate chicken, fish, a lot of vegetarian meals, no soda, no chips, no fried

foods (40 RR 49). Every one of his tests—cholesterol, blood pressure, weight—showed him

to be in safe range (21 RR 65-66). He had not smoked in 15 to 20 years, which made him,

in the view of one of the doctors, like a nonsmoker (21 RR 66). He was not a drinker (40 RR

47). He presented none of the classic risks for causing heart attacks (21 RR 64-66; 22 RR

68-71; 36 RR 106-109, 140).

         He met his wife, Carol, about four years earlier (40 RR 52). They were an older

couple when they met, he was 55, she was 52 (41 RR 19). In Carol’s daughter’s view, Bob

was Carol’s soulmate (38 RR 30). The two dated about three years before they were married

(40 RR 52). They waited to get married until her children left the house (40 RR 51). They

were married just short of a year when Bob died (38 RR 19).

         The couple did everything together, riding bikes, rollerblading, camping (9 RR 30; 38

RR 21; 40 RR 41, 55, 56). They went to a kite festival in Washington State (40 RR 55).

Eight days before Bob’s death, the two went on a 65 mile bicycle ride outside of Tyler,

Texas, a bike ride dubbed “The Beauty and the Beast,” because of a huge hill at the end



Petitioner’s Brief on the Merits                                                             1
known as the “Beast.” (40 RR 42; 41 RR 91).

2.       Bob Ernst is prescribed Vioxx

         In September, 2000, Bob Ernst experienced pain in his hands (40 RR 42). He went

to Dr. Brent Wallace, who wrote Bob a prescription for Vioxx, one 25-mg. tablet per day (40

RR 45, 57). Vioxx is a drug manufactured and marketed by Merck & Co., Inc. (“Merck”).

Vioxx is an NSAID, a non-steroidal anti-inflammatory and painkiller, in the same class as

aspirin, Motrin, Advil and Aleve (20 RR 121-22).          Bob Ernst    took Vioxx daily, as

prescribed, until his sudden death on May 6, 2001 (40 RR 61).

3.       Vioxx

         Merck is a pharmaceutical company, headquartered in New Jersey. Merck developed

Vioxx as a COX-2 painkiller, which was intended to alleviate pain while not causing the

gastrointestinal problems that were common with other painkillers, like Aleve (Naproxen).

In 1999, when Merck was readying Vioxx for production, Merck faced extreme financial

pressure because the patents on five of Merck’s most popular drugs were going to expire in

2000 (46 RR 127). Merck saw Vioxx as “a major driver of growth.” (46 RR 129).

         The story of this case is a story of corporate irresponsibility—of Merck’s efforts to

rush Vioxx to market before all testing was done, and to sell at all costs, while concealing

risks and minimizing patient safety. The jury heard evidence that Merck knew about

significant cardiovascular risks of Vioxx, yet sold Vioxx anyway, without providing adequate

warnings.




Petitioner’s Brief on the Merits                                                            2
4.        Merck’s knowledge of cardiovascular risks

          In 1992, Merck published the 16th edition of the Merck Manual, which is a the largest

selling medical text in the world. In that version of the Manual, there was a Chapter 285,

which discussed the body’s “mechanism” for stopping the clotting of blood (50 RR 26-27).

The Merck Manual is published by the Merck Research Labs, the same division that did the

science for Vioxx.1 When clotting occurs, the body releases an enzyme called prostacyclin,

which thins and reduces the clotting. Unfortunately, as Merck’s corporate representative

admitted at trial, Vioxx decreases prostacyclin by 50 percent (17 RR 79-80; see also 21 RR

72; 36 RR 60). If prostacyclin is decreased, a platelet aggregation can occur and a clot can

form, which can stop the flow of blood to the heart, which causes an “acute ischemic event”

which causes a sudden cardiac death (22 RR 64, 66-67).2

          That mechanism was understood in 1997 when Merck scientists were exchanging

emails about the design of a protocol for a Vioxx trial. One Merck scientist recommended

that subjects of the Vioxx study be allowed to use aspirin because, without COX-1 inhibition,

“you will get more thrombotic3 events and kill [the] drug.” (PX 856). In response, another

Merck scientist confessed that “the possibility of increased CV [cardiovascular ] events is

of great concern.” (PX 856).

          In February, 1998, Merck’s Research Lab Epidemiology Department released an


1
 It does not seem coincidental that in 1999, when Merck issued the 17th edition of the Merck Manual, and when Vioxx
was its best-selling drug, the chapter explaining the “mechanism” was deleted from the publication (9 RR 74-75; 39 CR
7233).

2
    “Ischemia means no blood flow.” (36 RR 73).

3
    A “thrombus” is a clot (22 RR 87).

Petitioner’s Brief on the Merits                                                                                   3
analysis on the incidence of significant adverse cardiovascular events in a Merck clinical trial

involving Vioxx (PX 793). That analysis considered three groups: one was given a 125-mg.

dose of Vioxx; one was given a 25-mg. dose, and one was given a placebo, or sugar pill. The

125-mg. group had 4 cardiovascular events; the 25-mg. group had 3 cardiovascular events;

the placebo group had none (PX 793).

         In May, 1998, before it started to sell Vioxx, Merck’s scientific advisors met (PX

524). The scientific advisors warned Merck of the possibility that Vioxx could increase heart

attacks or ischemic ventricular fibrillation (a life threatening arrhythmia) by removing the

prostacyclin from the bloodstream. (Id. at pp. 12-13). Thus, before Merck began selling

Vioxx, their scientists knew that it could cause adverse cardiovascular events.

5.       Studies confirmed the cardiovascular risks of Vioxx

         The record is rife with numerous peer reviewed studies and clinical trials that

confirmed the statistically significant cardiovascular risks of Vioxx, which eventually caused

Vioxx to be removed from the market in 2004.

         The peer-reviewed VIGOR study, an 8,000 patient study, showed a 2.38 relative risk

of cardiovascular events, and a 4.0 relative risk for myocardial infarction. See Claire

Bombardier, M.D., et al., Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and

Naproxen in Patients with Rheumatoid Arthritis, N EW E NGLAND J OURNAL OF M EDICINE,

November 23, 2000. (DHX 13).4




4
  Merck tried to downplay those findings, by saying that they were only against Naproxen and at double Mr. Ernst’s
dose. However, the 4.0 relative risk for myocardial infarction is significant, because that is the most likely cause of Bob
Ernst’s sudden death.

Petitioner’s Brief on the Merits                                                                                         4
         The peer-reviewed APPROVe study showed a combined endpoint relative risk of

1.92, but for cardiovascular events—which is, by definition, what killed Bob Ernst—the

APPROVe study showed a statistically significant 2.8 relative risk, with a 95% confidence

level. See Robert S. Bresalier, M.D., Cardiovascular Events Associated with Rofecoxib In

a Colorectal Adenoma Chemoprevention Trial, N EW E NGLAND J OURNAL OF M EDICINE.

(DHX 14).

         The record also included, among other studies, the Juni meta-analysis, which was an

analysis of 18 controlled trials, 11 observational studies and 126 reports of observational

studies of the cardiovascular risks of Vioxx. See Peter Juni, Risk of cardiovascular events

and rofecoxib: cumulative meta-analysis, www.thelancet.com, November 5, 2004. (DHX 15;

PX 1726).5 The Juni meta-analysis focused just on the risks of heart attacks and sudden

death from Vioxx (29 RR 118). That meta-analysis found a combined relative risk of 2.30,

with a relative risk of 2.24 one year later. The authors of that meta-analysis concluded that

there was there was no evidence that Vioxx’s “cardiovascular toxicity is dose dependent.”

(PX 1726, at 2025). The study further concluded “Our cumulative meta-analysis of RCTs

indicates that an increased risk of myocardial infarction was evident from 2000 onwards. At

the end of 2000, the effect was both substantiated and unlikely to be a chance finding.” Id.6


5
   In the Garza appeal, the court of appeals noted that Merck conceded that clinical trials are “the best type of
epidemiological evidence” and are “much more powerful than an epidemiology study.” See Merck & Co., Inc. v. Garza,
277 S.W .3d 430, 435 (Tex. App.— San Antonio 2008, pet. granted).

6
   Because there is no “litmus test” that each study must show more than double the risk, all of this evidence was
sufficient to prove general causation under Havner. See Merrell Dow Pharm., Inc. v. Havner, 953 S.W .2d 706, 718
(Tex. 1997) (“W e do not hold, however, that a relative risk of more than 2.0 was a litmus test or that a single
epidemiological test is legally sufficient evidence of causation. Other factors must be considered.”); Minnesota Min.
& Mfg. Co. v. Atterbury, 978 S.W .2d 183, 198 (Tex. App.—Texarkana 1998, pet. denied)(“There is no requirement in
a toxic tort case that a party must have reliable epidemiological evidence of a relative risk of 2.0 or greater.”). The trial

Petitioner’s Brief on the Merits                                                                                           5
5.       Merck’s sell “at all costs” philosophy

         There is evidence in the record that although Merck’s own scientists, among others,

raised significant concerns of the cardiovascular risks of Vioxx, Merck proceeded to sell it

anyway, as aggressively as possible, playing down adverse risks, fighting truthful warnings,

providing false or misleading information to doctors, training its salesmen to avoid a

discussion of the known risks, and so forth. The evidence was sufficient for the jury to find

Merck liable for marketing defect, design defect and negligence.

         A.       Rigging testing

         Armed with the knowledge of the potential danger of cardiovascular events, Merck

did its testing in a way designed to avoid reports of that danger. The same scientist who

expressed “great concern” about “the possibility of increased CV events”recommended a

method to hide this truth to ensure greater sales. Incredibly, he wrote: “What about the idea

of excluding high risk CV patients from this study? . . . This may decrease the CV rate so that

a difference between the two groups would not be evident.” (PX 856). And, equally

incredible, Merck approved those recommendations. In the most important Vioxx study, the

evidence showed that the Merck scientists deliberately excluded high-risk CV patients.

         In VIGOR, Merck did the following: (1) loaded up with people under 55, who were

less likely to have a heart attack; (2) eliminated from the test anyone who had had a heart




court is to”make a determination of reliability from all the evidence” and explore carefully the evidence “in a given
context.” Havner, 953 S.W .2d at 719-20. It is noted that the court of appeals found sufficient evidence of general
causation. Merck v. Ernst, 296 S.W .3d 96 n.7. Thus, the question raised on the present appeal is whether there was any
probative evidence of specific causation.

Petitioner’s Brief on the Merits                                                                                     6
attack;7 (3) eliminated from the testing anyone who took aspirin daily (because they were

more likely to be concerned about heart attacks);8 and (4) loaded up on more women than

men (because women are less likely to have a heart attack than men).9

           Surprisingly, Merck’s efforts to rig the testing did not prevent the anticipated results.

As Merck’s head scientist, Ed Scolnick, stated, upon first reviewing the VIGOR results,

“[t]he CV events are clearly there.” (PX 1636). Later, Scolnick conceded in an internal email

that he was “in minor agony” over the results and that the adverse results were “mechanism-

based as we worried it was.” (PX 154).                         Scolnick’s concession “as we worried it

was”revealed Merck’s prior knowledge about the cardiovascular risks of Vioxx.

           B.       “The CV events are clearly there”

           Despite Scolnick’s truth that “[t]he CV events are clearly there,” Merck intentionally

obscured that truth. After the VIGOR results came out—a study that showed a five-fold

increase in adverse cardiovascular events over Naproxen—the Merck team tried to figure out

a way to spin it so that the safety risks would not affect burgeoning sales. Instead of putting

a halt on the sales of the drug until the adverse heart results could be analyzed, Merck tried

to neutralize the results.

           To play down the cardiovascular risks of Vioxx, the Merck scientists decided to play

up the cardiovascular benefits of Naproxen—not that Vioxx hurts your heart, but that


7
    Dr. Reicin said that was limited to anyone who had a heart attack within a year of the test (50 RR 41).

8
  One Merck scientist expressed concern that if subjects were not allowed to use aspirin (which provided COX-1
inhibition— Vioxx did not) “you will get more thrombotic events and kill [the] drug.” (PX 856)

9
 This test was extremely loaded up with women. Out of the 4,000 test subjects who took Vioxx, 3,200 were female and
800 were men (50 RR 45).

Petitioner’s Brief on the Merits                                                                                 7
Naproxen helps your heart. Merck tried to portray Naproxen as a wonder drug, that it was

better than aspirin to prevent heart attacks. Merck touted the fact that the study showed less

gastrointestinal (“GI”) bleeds with Naproxen, but the study also showed that more people

died from GI bleeds taking Vioxx than taking Naproxen (20 RR 128-29).

         Within days after receiving the VIGOR results, Merck issued a press release which

said nothing about the adverse cardiovascular results for Vioxx, but which touted

“significantly fewer thromboembolic events were observed in patients taking naproxen . . .

which is consistent with naproxen’s ability to block platelet aggregation.” (DX 125). Merck

tried to get a world-renowned expert, Carlos Patrono, to sign off on that fiction, but he

refused to do so—providing Merck with multiple reasons why the VIGOR results could not

be explained by the benefits of Naproxen (PX 2023). The FDA sent Merck a warning letter

saying that Merck’s explanation of the VIGOR results were “simply incomprehensible” in

light of available data (23 CR 4169); see also PX 953 (FDA memo concluding “This

hypothesis is not supported by any prospective placebo-controlled trials with naproxen.”).

         Merck’s promotional campaign said that Vioxx does not increase the risk of heart

attacks, and (maintaining the fiction) that the VIGOR finding “is consistent with Naproxen’s

ability to block platelet aggregation like aspirin.” (11 RR 45). Finally owning up to the

VIGOR results at trial, Merck’s corporate representative, Dr. Santanello, admitted that Vioxx

can cause heart attacks (11 RR 46).10

         Although Merck recognized the need for a CV outcome study, it did not do one until


10
    A later meta-analysis of reported trials and literature concluded that “the cardioprotective effect of naproxen was small
. . . and could not have explained the findings of the VIGOR trial.” (PX 1726).

Petitioner’s Brief on the Merits                                                                                           8
2004, and the results led to the withdrawal of Vioxx from the market (19 RR 125, 126-27).

           C.       Change the label

           The FDA recommended a label that warned of the cardiovascular risks of Vioxx. The

proposed black box warning would read in part: “NSAIDs11 may cause an increased risk of

serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be

fatal.” (DX 373 at 133-16).12 Merck calculated that if they had to change the label by

October, as recommended by the FDA, instead of by January, it would cost Merck $229

million (PX 2002). Merck’s efforts to put off the label change were successful. Merck was

able to delay the label change until the following April, 2002.

           D.       Targeting the doctors

           Merck prepared a “coffin nail hit list” of doctors it wanted to target to prescribe Vioxx

(PX 658). One of the doctors so targeted was Bob Ernst’s own doctor, Dr. Wallace (39 RR

59-60). Even though it was illegal for Merck to pay Dr. Wallace to write a prescription,

Merck offered to pay Dr. Wallace to let their sales rep watch him write a prescription,

ostensibly as an educational exercise (39 RR 65). Merck took Dr. Wallace to dinners where

a speaker touted how safe Vioxx was (39 RR 57).

           And, the promotional materials were intentionally designed to mislead the doctors

about the safety of the drug. Dr. Wallace, Dr. Egilman, and other doctors received a letter

in which Merck told them that the “rate of cardiovascular events was .4 to .5.” (PX 648; PX




11
     “NSAIDs” are non-steroidal anti-inflammatory drugs, which includes Vioxx.

12
     Available at http://www.fda.gov/cder/drug/infopage/cox2/nsaidrxtemplate.pdf.

Petitioner’s Brief on the Merits                                                                  9
1668). But, the truth was that the results were some 20 times what Merck told the doctor.

The real figure from the original VIGOR data was that out of every 1,000 patients, 146

suffered a cardiovascular event (21 RR 21). Even Dr. Santanello, Merck’s corporate

representative, said of the letter sent to the doctors, “Perhaps it’s not very precise, sir.” (13

RR 104). The figure was false.

         The CV card provided to the sales representatives for communication of CV risks with

the doctors said that NSAIDs and Naproxen are 8 times more harmful on cardiovascular

mortality than Vioxx (PX 75). Based on the results of the VIGOR study, that was also false.

         For those doctors who would not go along with the Merck program—those who were

speaking out about the health risks of Vioxx—Merck set about to harass and intimidate them.

On January 9, 2001, Dr. James Fries, Professor of Medicine at Stanford, wrote to the CEO

of Merck to complain about a consistent pattern of intimidation by Merck of doctors and

investigators who showed an anti-Merck and anti-Vioxx bias (PX 747A). Dr. Fries reported

that he received a call on Saturday night at home by Merck’s Dr. Sherwood who advised him

of a Stanford investigator with an anti-Merck bias. Id. Dr. Sherwood threatened Dr. Fries

and Stanford with “consequences.” Id. Dr. Fries referred to this in his letter as “Merck

damage control by intimidation.” Id. Dr. Fries also reported his knowledge of eight people

who were so intimidated (listed by name). Id.

         E.       Training salesmen to “dodge” the risks

         In a further effort to hide the known cardiovascular risks of Vioxx, Merck trained its

sales representatives to “dodge” questions about safety. In a training exercise called “Dodge



Petitioner’s Brief on the Merits                                                              10
Ball,” sales reps are given cards that represent “obstacles.”        Each card presents an

obstacle—such as “I am concerned about the cardiovascular effects of Vioxx” (PX 79,

Obstacle #4)—and then presents in bold letters, the word: “DODGE!”

         The object of the exercise is to either give the answer that Merck wants to be given

or to “dodge” the question. One wins the game if one dodges all the safety questions (See

11 RR 51-52).

         Merck also disseminated to its sales representatives a “CV card” to provide approved

information to use to talk to doctors (PX 75). The card did not contain the mortality data

from the VIGOR study (14 RR 18). In fact, Merck instructed its sales representatives not to

tell physicians about the VIGOR study (14 RR 120-21).

6.       Dr. Wallace’s testimony

         Dr. Wallace, Ernst’s treating physician, testified in detail about the pressure Merck

put on him to sell Vioxx ( 39 RR 56-70). He wrote 12.70 percent of his prescriptions for

Vioxx; Merck’s goal was to get him to write over 50 percent of his prescriptions for Vioxx

(PX 649; PX 658A). Merck told Dr. Wallace that Vioxx was safe and Merck misrepresented

the risks of adverse cardiovascular events (39 RR 56-57). Dr. Wallace testified that if Merck

had told him the truth, he would not have written all those prescriptions for Vioxx (39 RR

17).

7.       Carol Ernst’s testimony

         Carol Ernst testified that if Bob “had known that there was a heart attack risk with

Vioxx, he never would have taken it.” (40 RR 49). Carol Ernst showed the package insert



Petitioner’s Brief on the Merits                                                           11
that Bob Ernst received with his prescription of Vioxx, which provided no information that

Vioxx might cause a five-fold increase in the risks of heart attacks (40 RR 48; PX 1772).

8.       Bob Ernst’s death

         On May 6, 2001, Bob Ernst died suddenly (40 RR 61). Carol’s daughter and her son-

in-law performed CPR on him until the ER people arrived. The autopsy report, done by Dr.

Maria Araneta, listed the cause of death as “[c]ardiac arr[h]ythmia secondary to coronary

atherosclerosis.” (DX 480).        In the autopsy, Bob Ernst was discovered to have

atherosclerosis, which is a buildup of plaque on the walls of his arteries (33 RR 40, 43). In

the view of the coroner, his atherosclerosis showed 50-75 percent occlusion, but that

atherosclerosis could not have caused his death, because that requires at least 80-90 percent

occlusion (30 RR 79; 33 RR 87).

9.       Lawsuit

         On May 24, 2002, Mrs. Carol Ernst, individually and as representative of the estate

of Bob Ernst, filed a wrongful death and survival action against Merck, and others. (1 CR

25); see T EX. C IV. P RAC. & R EM. C ODE §§ 71.004 (wrongful death), 71.021 (survival). Mrs.

Ernst alleged causes of action against Merck for negligence, strict product liability

(marketing defect and design defect), misrepresentation, breach of warranty, conspiracy, and

fraud.

         The development and discovery of the case took three years.

10.      Trial

         Trial lasted for five weeks, from July 11, 2005 to August, 2005. An enormous amount



Petitioner’s Brief on the Merits                                                          12
of evidence was presented by the parties and considered by the jury. The Plaintiffs presented

ten live witnesses, including an expert economist, four expert medical witnesses—Dr. David

Egilman, Dr. Isaac Weiner, Dr. Maria Araneta, and Dr. Benedict Lucchesi—and Merck’s

corporate representative—Dr. Nancy Santanello—who also provided expert testimony. The

Defendant presented five live witnesses, including three expert medical witnesses—Dr. Allan

Nies, Dr. Thomas Wheeler, and Dr. Craig Pratt. The parties presented over 500 exhibits,

many highly technical medical studies and reports, which occupy 43 volumes of the record.

The reporter’s record alone takes up 102 volumes, and the clerk’s record is 42 volumes.

         At the time, this was one of the most closely watched and highly publicized trials in

the nation. Although there were thousands of similar lawsuits filed against Merck, this was

the first Vioxx lawsuit in the nation to go to trial.

11.      Dr. Araneta’s testimony

         During trial, an issue arose that Merck raised in the court of appeals as one of its

issues on appeal—the trial court’s admission of the testimony of Dr. Maria Araneta, the

forensic pathologist who did Bob Ernst’s autopsy.

         In its opening, Merck’s counsel focused on Dr. Araneta, and he told the jury to look

only to the conclusions in Dr. Araneta’s autopsy report, and then he proceeded to misinterpret

those conclusions (30 RR 87-92; PX 1365-L). Merck framed much of its defense based on

its interpretation of Dr. Araneta’s autopsy report (23 RR 196, 209).

         Because of that significant focus and misinterpretation, Plaintiff’s counsel attempted

to locate Dr. Araneta and could not do so. He testified that he had to hire an investigator to



Petitioner’s Brief on the Merits                                                            13
find the location of the coroner, Dr. Maria Araneta, who left the United States. The

investigator determined, in the middle of trial, that Dr. Araneta was in Abu Dhabi, United

Arab Emirates (23 RR 187). Upon getting information about where she was, Plaintiff’s

counsel immediately listed her and proceeded to let the defendants know in writing (Id.).

None of that testimony was controverted (23 RR 190-91). For her part, Dr. Araneta testified

that she had been in Abu Dhabi since February 5, 2005 (the Ernst trial began on July 11,

2005) and had not been back to the United States since (APX 1365 P, at 15, 16).

         Merck had no reason to be surprised by Dr. Araneta’s testimony because it listed her

on its witness list (PX 1365 O, at 8). Merck had contacted the coroner’s office on many

occasions and had been in email communication with Dr. Araneta (23 RR 195, 208; APX

1365-P, at ARN-9, 10). However, to prevent unfair prejudice to Merck, the trial court

granted a postponement of trial to allow the parties to take the deposition of Dr. Araneta. (23

RR 196; 35 CR 6646). The trial court, at Merck’s urging, also precluded Dr. Araneta from

testifying live, allowing her testimony to be put on at trial only by deposition (30 RR 95-96).

         As the Court will see, Dr. Araneta provided the only independent expert testimony at

trial, independent expert testimony that rebutted most of Merck’s defense.

12.      Verdict

         On August 19, 2005, the jury rendered its verdict. It found: (1) that Merck was liable

for a marketing defect that was a producing cause of the death of Bob Ernst; (2) that Merck

was liable for a design defect that was a producing cause of the death of Bob Ernst; and (3)

that Merck was liable for negligence that was a proximate cause of the death of Bob Ernst.



Petitioner’s Brief on the Merits                                                            14
The jury found damages for Carol Ernst as follows: (1) pecuniary loss in the past: $100,000;

(2) pecuniary loss in the future: $350,000; (3) loss of companionship and society in the past:

$2 million; (4) loss of companionship and society in the future: $10 million; (5) mental

anguish in the past: $2 million; and (6) mental anguish in the future: $10 million. See Charge

of Court, attached as Appendix D.

         The jury also found, unanimously, that there was clear and convincing evidence that

the harm to Bob Ernst resulted from malice. The jury also found, unanimously, with proper

Kraus instructions,13 that Merck was liable for exemplary damages in the amount of $229

million.

13.      Final judgment

         Mrs.     Ernst moved for judgment on the jury verdict, and argued that limiting

exemplary damages as set forth in T EX. C IV. P RAC. & R EM. C ODE § 41.008 was

unconstitutional (37 CR 6869). On June 23, 2006, the trial court entered Final Judgment

which rendered judgment on the actual damages found by the jury against Merck, together

with prejudgment and postjudgment interest, but reduced the amount of exemplary damages,

per § 41.008 to $1,650,000. Thus, the Final Judgment entered in favor of Carol Ernst against

Merck was for $26,100,000.000, plus prejudgment interest of $1,248,534.25, plus court costs

and post-judgment interest.

         The trial court denied Merck’s motions for new trial or for remittitur, and for




13
   See Owens-Corning Fiberglas Corp. v. Malone, 972 S.W .2d 35, 39 (Tex. 1998) (calling T EX . C IV . P RAC . & R EM .
C O D E § 41.011 the “statutory adoption” of the Kraus factors); see Alamo Nat’l Bank v. Kraus, 616 S.W .2d 908, 910
(Tex. 1981).

Petitioner’s Brief on the Merits                                                                                  15
judgment notwithstanding the verdict. On September 19, 2006, Merck filed its notice of

appeal. On October 2, 2006, Mrs. Ernst filed her notice of cross-appeal.

14.      Appeal

         The process of appeal to the Fourteenth Court of Appeals involved the issuance of two

separate and distinct panel opinions, and a contentious order on motion for rehearing en banc.

         a.       The first Opinion

         In its first Opinion, on the Fourteenth Court of Appeals (Hedges, C.J., joined by

Anderson, J. and Brown, J.), found sufficient evidence of general causation, but held that,

despite all the evidence that was presented throughout the five week trial, there was no

evidence that Vioxx caused Mr. Ernst’s death because a clot was not found during the

autopsy—even though the purpose of the autopsy was not to find a clot. See Opinion of May

29, 2008, attached as Appendix B. The court reversed and rendered a take nothing judgment.

         That Opinion’s apparent jury nullification triggered public scrutiny.14 Mrs. Ernst filed

a Motion for Rehearing En Banc.15

         b.       The Substitute Opinion

         The panel waited over a year to issue another Opinion—perhaps enough time for the

public scrutiny to die down. On June 4, 2009, the panel withdrew its earlier Opinion, denied

the motion for rehearing as moot, and issued its Substitute Opinion. See Substitute Opinion,


14
  See Editorial, “Big Pharma’s buddies,” H O U STO N C H RO N IC LE , May 31, 2008; Hotze, Steven , No justice for common
man with GOP judges, H O USTO N C OM M U N ITY N EW SPAPERS , June 19, 2008.

15
   In her Motion for Rehearing en Banc, Mrs. Ernst also argued that the court of appeals’ disregard of the evidence in
the record, contrary to the proper standard of review, unconstitutionally invaded the province of the jury and denied her
right to due process and her right to trial by jury. See Ernst’s Motion for Rehearing En Banc (filed August 11, 2008),
at 18-20.

Petitioner’s Brief on the Merits                                                                                     16
Merck v. Ernst, 296 S.W.3d 81, attached as Appendix A. Although that Opinion went into

more detail with regard to the evidence, it appeared as a reweighing of the evidence, in which

the court of appeals ignored evidence that Vioxx caused Mr. Ernst’s death, created a new and

unworkable standard of review for differential diagnosis, disregarded evidence favorable to

the judgment, and resolved conflicting evidence and inferences against the judgment. In any

event, the result was the same.                Despite all the unchallenged expert testimony and

documentary evidence presented throughout the five week trial, the panel found not even a

scintilla of evidence that Vioxx caused Bob Ernst’s death. The panel found no evidence of

specific causation and again reversed and rendered a take nothing verdict. Because of that

holding, the panel did not reach Merck’s other issues or Mrs. Ernst’s issue.

         Mrs. Ernst filed another Motion for Rehearing En Banc.16

         c.       The vote on motion for rehearing

         As an indication of the opinions of the other justices of the Fourteenth Court of

Appeals on the quality of the Substitute Opinion, the court of appeals split 3 to 3 on granting

motion for rehearing en banc, with only the original panel members voting to deny the

motion for rehearing en banc. See Order (November 19, 2009); attached as Appendix C.

Justices Yates, Frost and Seymore would grant en banc review; Justices Boyce and Sullivan

recused; and Justice Guzman had recently departed for this Court. Because it was a 3 to 3

tie, the Substitute Opinion was not reheard.




16
  In this second M otion for Rehearing En Banc, Mrs. Ernst again complained about the court of appeals’ denial of her
constitutional rights to due process and trial by jury. See Motion for Rehearing En Banc (filed September 2, 2009), at
14-15.

Petitioner’s Brief on the Merits                                                                                  17
                                   SUMMARY OF ARGUMENT

         The court of appeals found no evidence of specific causation—that is, no evidence

that Bob Ernst died from a thrombotic cardiovascular event, which is harm caused by Vioxx.

In reaching that conclusion, the court of appeals improperly applied the no evidence standard

of review by failing to consider legally sufficient evidence, adopting a new standard of

review for differential diagnosis, disregarding favorable evidence, and resolving conflicts in

the evidence and inferences against the verdict. The court of appeals’ opinion not only sets

bad precedent, but also represents such a distortion of the proper standard of review that it

cries out to be corrected. This Court should grant review of this important case.

                                        ARGUMENT

I.       The Court of Appeals Misapplied The No Evidence Standard Of Review

         The standard of review for no evidence, or legal insufficiency of the evidence, is

“improperly applied” if the court of appeals fails to affirm jury verdicts that are supported

by evidence. See City of Keller v. Wilson, 168 S.W.3d 802, 823 (Tex. 2005). “The final test

for legal sufficiency must always be whether the evidence at trial would enable reasonable

and fair-minded people to reach the verdict under review.” Id. at 827. The reviewing court

is required to credit evidence favorable to the verdict if the jury could do so, and is required

to reject evidence contrary to the verdict unless the jury could not do so. Id.

         This was over a month long trial in which the bulk of the evidence presented went to

one issue—that is, whether Vioxx was a cause of the death of Bob Ernst. Volumes of

evidence were presented on that one issue. Yet, the Fourteenth Court of Appeals, in its



Petitioner’s Brief on the Merits                                                             18
Substitute Opinion, found no evidence that Vioxx caused the death of Bob Ernst. In other

words, the Fourteenth Court of Appeals disregarded all of the scientific evidence that Mrs.

Ernst presented to the jury. The only way that the court of appeals could reach that result was

by an improper application of the no evidence standard of review.

         Specifically, the court of appeals: (1) failed to consider legally sufficient evidence that

Vioxx caused Mr. Ernst’s death; (2) created a new and unworkable standard of review for

differential diagnosis; and (3) resolved conflicting evidence and inferences against the

judgment. Because the court of appeals improperly applied the no evidence standard of

review, this Court should grant this petition and correct that recurring and important error.

         A.       The court of appeals failed to consider legally sufficient evidence that
                  Vioxx caused Mr. Ernst’s death

         For as long as any of us can remember, Texas jurisprudence has required that for a “no

evidence” point to be sustained, the record must disclose (a) a complete absence of evidence

of a vital fact; (b) the court is barred by rules of law or of evidence from giving weight to the

only evidence offered to prove a vital fact; (c) the evidence offered to prove a vital fact is no

more than a mere scintilla; or (d) the evidence establishes conclusively the opposite of the

vital fact. See City of Keller, 168 S.W.3d at 810 (quoting Robert W. Calvert, “No Evidence”

and “Insufficient Evidence” Points of Error, 38 T EX. L. R EV. 361, 362-63 (1960)). Neither

(a), (b) or (d) apply here. It appears that the court of appeals below relied on (c)—that the

evidence offered to prove a vital fact was no more than a scintilla.

         The opposite proposition is also true. That is, if there is more than a scintilla of

evidence, the court of appeals has no choice but to overrule the no evidence point and affirm


Petitioner’s Brief on the Merits                                                                 19
the jury verdict. See ACS Investors, Inc. v. McLaughlin, 943 S.W.2d 426, 430 (Tex. 1997)

(“Any evidence of probative force supporting a finding requires us to uphold the jury

verdict.”). Because of Texas’ historic respect for jury verdicts, the no evidence standard of

review requires the reviewing court to “consider the evidence in the light most favorable to

the verdict, and indulge every inference that would support it.” City of Keller, 168 S.W.3d

at 822. “A reviewing court cannot substitute its judgment for that of the trier-of-fact, so long

as the evidence falls within this zone of reasonable disagreement.” Id. at 822.

         Which brings us to our case.    In a toxic tort case, a plaintiff proves causation by

proving both general causation and specific causation. See Merrill Dow Pharm. v. Havner,

953 S.W.2d at 714. General causation is whether the substance is capable of causing injury,

and specific causation is whether the substance did cause injury to the particular individual.

Id. Here, the court of appeals found sufficient evidence of general causation. Merck v. Ernst,

296 S.W.3d 96 n.7. Thus, the question that confronted the court of appeals was whether

there was sufficient evidence that Vioxx was a cause of the death of Bob Ernst.

         Despite over a month of documentary and expert testimony, the court of appeals held

that there was no evidence that Vioxx caused the death of Bob Ernst. Specifically, the court

of appeals held that Mrs. Ernst was required to present evidence that Bob Ernst suffered a

“thrombocardiovascular event” (the injury caused by Vioxx), and the court of appeals

concluded that there is “no evidence that Mr. Ernst suffered a thrombotic cardiovascular

event, i.e., a myocardial infarction triggered by a blood clot.” Id. at 100 .

         There are literally volumes of evidence, both from Mrs. Ernst’s experts and from



Petitioner’s Brief on the Merits                                                             20
Merck’s experts, on which the jury could find that Bob Ernst died from a thrombotic

cardiovascular event. The only way that the court of appeals could find no evidence was to

fail to consider that evidence.

         However, before we begin that journey, it is also important to understand Mrs. Ernst’s

burden of proof. Mrs. Ernst was not required to prove conclusively, or even clearly and

convincingly, that Vioxx caused Bob Ernst’s death. Rather, Mrs. Ernst was only required to

prove that it was “more likely than not” that Vioxx caused Bob Ernst’s death. Havner, 953

S.W.2d at 717.

         And, Mrs. Ernst was not required to prove that Vioxx was the only cause, or the sole

cause, of Bob Ernst’s death. Rather, Mrs. Ernst met her burden of proof if she proved that

Vioxx was a contributing cause, or one of the causes, of Bob Ernst’s death. See Del Lago

Partners, Inc. v. Smith, 307 S.W.3d 762, 774 (Tex. 2010) (“There may be more than one

proximate cause of an event.”); Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 45 (Tex. 2007)

(“We agree with Ledesma that the second part of the court’s definition, recognizing that there

may be more than one producing cause of an event, is correct.”).

         Against that backdrop, we will review the evidence that the court of appeals held was

no evidence that Vioxx caused Bob Ernst’s death.

         1.       Dr. David Egilman

         Dr. David Egilman is a medical doctor who is board certified in internal medicine and

preventative medicine (20 RR 79). He was trained in epidemiology in a three year program

with the National Institute of Health (20 RR 81). He also has a Masters of Public Health



Petitioner’s Brief on the Merits                                                            21
from Harvard (20 RR 89). He worked as a medical officer for the Center for Disease Control

(20 RR 81). He testified twice before Congress on research ethics (20 RR 80). He has

authored 20-25 peer-reviewed publications, including a peer reviewed article on Vioxx, and

50 other publications (20 RR 89-96); see also David Egilman, M.D., et al., What we have

learnt from Vioxx, BMJ [British Medical Journal], 2007:334:120-123 (2 April, 2007). In his

testimony on July 22, 28 and 29, Dr. Egilman presented critical testimony on arrhythmia,

ischemia, clots, thrombolysis, and other issues central to the case.

         Dr. Egilman walked the jury through a college lecture on how Vioxx causes heart

attacks. Platelets cause the blood to clot (21 RR 70). Just as if one cuts an arm and the

platelets cause a thrombus, or clot, to close up the wound, the same thing can happen to the

heart (Id.). A heart attack occurs when “the supply of oxygen is not enough to feed the work

of the heart.” (21 RR 70-71). It’s “basically a supply and demand problem.” (21 RR 71).

         When a platelet senses a cut that it needs to clot, it activates a COX-1 enzyme (Id.).

The body has another enzyme that senses when the cut is clotted, because otherwise “you’d

just clot your whole body off.” (21 RR 72). The body’s mechanism says, “Okay, fixed. We

can stop now.” (Id.). That enzyme is prostacyclin, the enzyme that says “stop the clotting.”

(Id.). This would be the “brake mechanism.” (21 RR 73).

         When a platelet hits plaque and senses that it is a cut, it begins the clotting process (21

RR 72-73). The brake mechanism says, “Whoa. We don’t want a clot in our heart. Knock

it off.” (21 RR 73-74). In a normal person, prostacyclin gets activated and the clotting

process stops (21 RR 74).



Petitioner’s Brief on the Merits                                                                 22
         However, as admitted by Merck, Vioxx reduces prostacyclin by half (17 RR 79-80;

see also 21 RR 72; 36 RR 60). Or, as Dr. Egilman said, “VIOXX cuts the brakes, so that

VIOXX—with a—with the VIOXX, there’s nothing that says to that clot, ‘stop.’” (21 RR

74). In such a case, the clot forms up and your heart starves (Id.). And, it does not have to

be “ fully clotted off. You just need an imbalance.” (Id.).

         If the heart gets short of oxygen, it can throw off an irregular beat (Id.). “And that’s

what happens: 90 percent of heart attacks die because of irregular beats called arrhythmias.

It doesn’t have to clot it off all the way, just have to have that imbalance.” (Id.). Dr. Egilman

explained that the reason that hospitals use defibrillators, and measure heart rates, and use

lidocaine with heart attacks is to stop the arrhythmia, because “[t]hat’s what kills you most.”

(21 RR 75).

         After Dr. Egilman provided his analysis and his review of the scientific studies, he

was asked for his opinion on whether Vioxx was a cause of Bob Ernst’s heart attack:

         Q.       Okay. Dr. Egilman, based upon your analysis and the studies, scientific
                  liability—I mean, scientific plausibility, the epidemiology, all of the
                  different things that you’ve looked at, do you have an opinion, based
                  upon reasonable medical probability, as to whether or not VIOXX was
                  a cause of Bob Ernst having a heart attack?

         A.       Yes, sir.

         Q.       And what is your opinion, sir?

         A.       That his taking VIOXX caused and contributed to and/or contributed
                  to his heart attack.
(21 RR 76).

         Later on in his testimony, Dr. Egilman confirmed that opinion. Dr. Egilman said: “he



Petitioner’s Brief on the Merits                                                              23
took the VIOXX pill. The VIOXX got into his blood. It was in his blood at the time he had

the heart attack. It prevented the blood thinner from unclogging a clot or from prevented it

from plaquing, and that he had a heart attack because of not enough oxygen getting by when

he had a clot.” (30 RR 20-21). He also said that he believed, in reasonable medical

probability, that Vioxx was a cause of the death of Bob Ernst (30 RR 21-22). Rather than

base this opinion on speculation, Dr. Egilman walked through every “medical fact” that

supported his opinion that Vioxx was a cause of the death of Bob Ernst (30 RR 22).

         Dr. Egilman proceeded to list the medical facts that he relied on to support his

opinion. First, it is a medical fact that Vioxx was in Bob Ernst’s bloodstream (30 RR 22).

Second, it is a medical fact that Vioxx prevents the production of prostacyclin, and that

Vioxx drops prostacyclin levels (30 RR 22-23). “The Vioxx got into his blood. It was in his

blood at the time he had his heart attack. It prevented the blood thinner from unclogging a

clot or prevented it from plaquing, and that he had a heart attack because of not enough

oxygen getting by when he had a clot.” (30 RR 22, 23-35).

         Third, it is a medical fact that prostacyclin stops clotting in the body (30 RR 24).

Fourth, it is a medical fact that Bob Ernst died of heart problems (Id.). Fifth, it is a medical

fact that the very heart problems that caused Bob Ernst’s death are included as adverse events

in the VIOXX studies (Id.) Sixth, it is a medical fact that the main problems in the studies

were myocardial infarction and sudden cardiac death (30 RR 25-27). Seventh, it is a medical

fact that Bob Ernst died of an arrhythmia (30 RR 27). Eighth, it is a medical fact, as Merck

says in the Merck Manual, that 90 percent of the time, arrhythmias are associated with heart



Petitioner’s Brief on the Merits                                                             24
attacks, and the main cause of death by heart attacks is arrhythmia (Id.).

         Dr. Egilman was asked whether the fact that a clot was not found during the autopsy

submarined his position. He replied:

         Most of the time when you have a heart attack, you don’t have a clot, full clot
         found. You don’t need to completely close the artery in the first place to have
         a heart attack, because a heart attack is caused by an imbalance; that is, not
         enough oxygen to the amount of work that the heart is doing.

(30 RR 28).

         Dr. Egilman was asked whether the fact that Bob Ernst had atherosclerosis

submarined his position. He replied:

         A.       No. The more risk factors you have, the higher your total risk when you
                  take VIOXX. So if you treat sicker people or people who are more
                  likely to have heart attacks, then you get a higher rate of risk from
                  adding VIOXX to that baseline rate. That’s absolute risk.

         Q.       If you have atherosclerosis, are you saying it increases the risk of
                  VIOXX causing a heart attack?

         A.       Yes. For example, if you had 12-year-olds or 13-year-olds who don’t
                  have atherosclerosis, unlikely to get a heart attack from VIOXX. Very,
                  very, very rare. Take 67 year-olds, whatever their baseline risk is, you
                  more or less double it.

(30 RR 29).

         Dr. Egilman was then asked about another medical fact—differential diagnosis. He

stated that it is a medical fact that doctors are taught to diagnose problems using differential

diagnosis (30 RR 28). He explained differential diagnosis as follows:

         If you put down all the possible causes and then you do something called rule-
         outs, you say -- you might start with five or ten and say, okay, is it let’s say you
         see a spot on the lung. So you put down, could be TB, could be cancer, could
         be a fungal infection, could be pneumonia, could be a clot from the leg. And


Petitioner’s Brief on the Merits                                                                25
          then you go down and try to figure out each one, and you rule them out one at
          a time. The one you’re left with is the most likely diagnosis.

(30 RR 30-31).

          Dr. Egilman testified that it is a medical fact that, as the American Heart Association

and Harvard have said, there are risk factors that cause a person to be more likely to have

a heart attack (30 RR 30). Vioxx is a risk factor for causing heart attacks (30 RR 31). Other

risk factors include hypertension, diabetes, gender, obesity, lack of exercise, age, overweight,

high cholesterol, high blood pressure, smoking, and family history (21 RR 61-66; 30 RR 31-

33).

          Dr. Egilman reviewed and excluded all of the most likely risks for causing a heart

attack, except for gender and Vioxx. Bob Ernst’s family history was not a risk because his

parents lived into their 90s (30 RR 32). As a medical fact, his weight was normal (30 RR

33). He was not in the high risk age group (Id.). Lack of exercise was not a risk because he

was “amazingly fit.” (Id.). “He’s in probably the top half of one percent of exercisers.” (21

RR 66). Smoking was not a factor because he had stopped smoking long before he had his

heart attack and his “risk from smoking pretty much is back to a non-smoker level.” (30 RR

33). Gender: “He’s got the risk, given the two choices.” (Id.). He did not have diabetes (Id.).

His blood pressure was normal to low (Id.).

          After review of all of those medical facts, including differential diagnosis, Dr.

Egilman was again asked for his opinion on whether Vioxx was a cause of Bob Ernst’s heart

attack:




Petitioner’s Brief on the Merits                                                              26
         Q.       Doctor, all of those medical facts that are on the board, what conclusion
                  do they draw you to?

         A.       [by Dr. Egilman] On a more likely than not basis, VIOXX caused or
                  contributed to Mr. Ernst’s death.

(30 RR 34-35).

         Incredibly, despite that evidence, the court of appeals found not even a scintilla of

evidence that Vioxx was a cause of the death of Bob Ernst. And, even more incredibly, the

court of appeals, in its Substitute Opinion, failed to even mention Dr. Egilman’s three days

of testimony in its review of “Ernst’s evidence.” See Merck v. Ernst, 296 S.W.3d at 90-93.

As an example of the factual errors in the court of appeals’ opinion, the court of appeals said

that Ernst presented three experts who testified that Vioxx was a cause of Bob Ernst’s

death—Dr. Lucchesi, Dr. Araneta, and Dr. Weiner—when, in fact, Mrs. Ernst presented four

experts: Dr. Lucchesi, Dr. Araneta, Dr. Weiner, and Dr. Egilman.

         Dr. Egilman gave his medical opinion based on reliable methodologies, and his

testimony was some evidence that “would enable reasonable and fair-minded people to reach

the verdict under review.” City of Keller, 168 S.W.3d at 827. The court of appeals failed to

follow the proper standard of no evidence review because it failed to consider the causation

testimony of Dr. Egilman. This Court should grant the petition to ensure that the proper

standard of review is followed.

          2.      Dr. Benedict Lucchesi

         In addition to Dr. Egilman, Mrs. Ernst presented two other retained experts who gave

testimony from which the jury could determine that Vioxx was a cause of the death of Bob



Petitioner’s Brief on the Merits                                                              27
Ernst—Dr. Benedict Lucchesi and Dr. Issac Weiner. Mrs. Ernst also presented the testimony

of the independent forensic pathologist who conducted Bob Ernst’s autopsy—Dr. Maria

Araneta—who not only rebutted Merck’s misinterpretation of the autopsy, but also testified,

in medical probability, that Bob Ernst’s death was caused by an acute ischemic event.

Although we will not review the testimony of each of those expert witnesses with the detail

devoted to Dr. Egilman, the record references to the testimony of each of those experts is

noted, and each of those experts gave well supported reasons for their opinions.

         Dr. Benedict Lucchesi, Ph.D., M.D., is a Professor of Pharmacology at the University

of Michigan and is a world renowned authority on clots and coronary arteries (36 RR 11).

Dr. Lucchesi has been researching arrhythmias and clots since the 1950s and he has written

over 480 articles on the subject (36 RR 12). He has spent his life as a medical scientist,

researcher and pharmacologist (36 RR 18). Since 1978, he has taught a course to senior

medical students and faculty on COX-2 inhibitors (36 RR 44-45).

         As with Dr. Egilman, Dr. Lucchesi walked the jury through a lengthy college lecture

that explained in detail the mechanisms by which Vioxx caused Mr. Ernst’s death (36 RR 48-

99). Dr. Lucchesi testified that Bob Ernst died of a sudden cardiac death (which Merck’s

experts admitted was a “thrombotic cardiovascular event”) (36 RR33; see 11 RR 35, 78-79,

159-160; 27 RR 35 [Dr. Santanello]). Dr. Lucchesi explained that a heart does not fibrillate

spontaneously, and “[h]earts don’t fibrillate on their own.” (36 RR 106). Dr. Lucchesi

performed a differential diagnosis where he reviewed and excluded all other possible causes

of arrhythmia, including genetic defect, a previous myocardial infarction, a hypertrophied



Petitioner’s Brief on the Merits                                                          28
heart, electrocution, valvular defects, leaving him with Vioxx as a cause of the arrhythmia

that caused Bob Ernst’s death (36 RR 106-109, 140). After his extended analysis of the heart

processes and the documentation, Dr. Lucchesi presented his opinion on causation:

         A.       [by Dr. Lucchesi] Well, I reviewed . . . the Ernst documents very
                  carefully. And my final conclusion, based on reasonable medical
                  probability, is that he died of an arrhythmia, precipitated by an transient
                  ischemic event leading to ventricular fibrillation.

         Q.       Was VIOXX a cause in that process?

         A.       In view of the fact that he was taking VIOXX and in view of the fact
                  that I know that VIOXX blocks COX-2 and in view of the fact that he
                  had underlying vascular disease, which makes him a candidate, along
                  with VIOXX, for such a serious event, my only conclusion would be
                  that VIOXX contributed significantly to this.

                  And that’s beyond any probability. The probability is in favor of
                  VIOXX having contributed to this. And he’s not the only one, because
                  there are many other instances where we’ve seen similar cases.

(36 RR 99-100).

         Remarkably, the court of appeals also found that Dr. Lucchesi’s testimony was not

even a scintilla of evidence that Vioxx was a cause of Bob Ernst’s death. Because all of Dr.

Lucchesi’s testimony was focused on the determination of the cause of Bob Ernst’s death,

the only way that the court of appeals could reach that no evidence conclusion would be to

ignore Dr. Lucchesi’s testimony entirely.

         3.       Dr. Isaac Weiner

         Dr. Isaac Weiner is a practicing cardiologist, who has spent his life treating patients

with heart problems and treating and studying arrhythmia (22 RR 8). He was the Director

of Electrophysiology at Mt. Sinai Hospital, studying arrhythmia, and is a clinical professor


Petitioner’s Brief on the Merits                                                                29
at UCLA teaching the study of arrhythmia (22 RR 24-25). He is board certified in internal

medicine, has a certificate of special competency in cardiac pacing, and is a diplomat of the

American Board of Internal Medicine in Clinical Cardiac Electrophysiology, which is a

separate specialization for arrhythmia specialists (22 RR 25-29). He is a peer reviewer for

the American College of Cardiology, the American Heart Journal and the Journal of

Arrhythmia (22 RR 30). He has authored a number of papers and textbooks dealing with

arrhythmia and myocardial infarction (22 RR 32).

         Dr. Weiner spent a great deal of time explaining to the jury how the heart worked,

how heart attacks are caused by arrhythmia, and how Vioxx can cause a heart attack (22

RR35-72). He reviewed the treating doctor’s reports, the coroner’s report, the VIGOR and

APPROVe studies, and other information (22 RR 58-59). Dr. Weiner explained to the jury

the basis for his opinion, including an explanation why Merck’s theories were incorrect (22

RR 58-72). Dr. Weiner also walked the jury through a differential diagnosis that reviewed

and excluded the Harvard and AMA risk factors for causing heart attacks, and he concluded:

         Q.       All right. Other than VIOXX and the fact that he was a man older than
                  40 or something, can you think of any other risk factors that you see for
                  this man?

         A.       [by Dr. Weiner] No.

         Q.       As a man who specializes and spent your entire life dealing with this
                  problem, can you find any other risk factors for Bob Ernst that explain
                  why he had a heart attack?

         A.       He doesn’t have much in the way of risk, other risk factors.

(22 RR 72).



Petitioner’s Brief on the Merits                                                              30
         Dr. Weiner presented his opinion: “And I think to a reasonable medical probability

VIOXX was a significant contributing factor in causing this event.” (22 RR 59-60). Dr.

Weiner then walked the jury through the basis of his opinion, including what he reviewed

and the differential diagnosis. He concluded:

         Q.       In conclusion, based upon your practice, all of your review of the
                  records and everything you have done and looked at, do you believe
                  VIOXX was a significant contributing factor in causing his heart attack
                  or sudden cardiac death or whatever we’re going to call it?

         A.       Well, I would call it sudden cardiac death, and I would answer yes.

(22 RR 72).

         Remarkably, again, the court of appeals considered Dr. Weiner’s testimony “no

evidence” that Vioxx was a cause of Bob Ernst’s death.

         4.       Dr. Maria Araneta

         In addition to Mrs. Ernst’s retained experts, the coroner who performed Mr. Ernst’s

autopsy, Dr. Marie Araneta—who was the only expert not retained by either party—testified

that Bob Ernst died from a thrombotic cardiovascular event. Dr. Araneta testified that in

reasonable medical probability, Mr. Ernst’s arrhythmia was caused by an “acute ischemic

event.” (33 RR 145). Dr. Araneta’s final diagnosis was “a cardiac arrhythmia secondary to

acute ischemic event on a background of atherosclerosis. Acute ischemic event would be an

MI [myocardial infarction].” (33 RR 144-145).

         5.       Dr. Thomas Wheeler

         Not only did Mrs. Ernst’s experts and the doctors present at Bob Ernst’s death testify

that Bob Ernst suffered a thrombotic cardiovascular event (or a heart attack caused by a clot),


Petitioner’s Brief on the Merits                                                            31
but also Merck’s expert’s testimony, when viewed in the light most favorable to the jury

verdict, supports the finding that Bob Ernst died of a thrombotic cardiovascular event.

Merck’s expert, Dr. Thomas Wheeler, admitted that Bob Ernst presented the “classic

textbook complication” of a myocardial infarction, that myocardial infarctions cause

numerous sudden deaths like Ernst’s, that Mr. Ernst died from sudden cardiac death, and that

“more than likely” the cause of Mr. Ernst’s heart attack “was some sort of regional ischemia

. . .” (44 RR 101-02, 133-34, 138; 46 RR 102).

         6.       Dr. Nancy Santanello

         Merck’s corporate representative, Dr. Nancy Santanello, admitted that the very heart

problems that caused Mr. Ernst’s death are listed as adverse events in the Vioxx studies (30

RR 24-25). Significantly, Dr. Santanello conceded in numerous places in the record that

Bob Ernst suffered a sudden cardiac death, which she acknowledged was a thrombotic

cardiovascular event (11 RR 35, 78-79, 159-160; 27 RR 35).

         The court of appeals’ failure to consider any of this evidence as probative on the

question of whether Bob Ernst died of a thrombotic cardiovascular event is an egregious

misapplication of the no evidence standard of review. The court of appeals appears to have

required Mrs. Ernst to prove causation beyond a reasonable doubt. But, that is not her

burden. As this Court recognized in Havner, Mrs. Ernst was only required to present

evidence that it was “more likely than not.” See Havner, 953 S.W.2d at 715. Mrs. Ernst

presented that evidence. The Court should grant review to correct the court of appeal’s

improper application of the standard of review and provide guidance to courts and litigants



Petitioner’s Brief on the Merits                                                          32
on this important and recurring issue.

         B.       Merck’s “no clot on autopsy,” “no evidence of MI,” and “arrhythmias
                  have other causes” theories do not trump Mrs. Ernst’s causation evidence

         In its response to the petition for review, Merck continued to sing the refrain that

despite all the causation evidence presented above, the failure to find a clot on autopsy

trumps all the other evidence and “defeats Plaintiff’s claim.” This is a little like a killer

saying that because you didn’t find a bullet, there is no evidence that the victim died of a

gunshot wound.

         Merck’s theories ignore evidence that should have been considered by the court of

appeals under the proper standard of no evidence review. When all the evidence is

considered, Merck’s theories are seen to be without substance. The resolution of the

conflicts in the evidence was for the jury, not the court of appeals. Because clarification of

the proper standard of review of medical causation is important to the jurisprudence of

Texas, this Court should grant this petition for review.

         1.       The “no clot found on autopsy” theory is not dispositive

         Merck appeared to convince the court of appeals that the failure to find a clot on the

autopsy meant that there was no evidence that Bob Ernst’s heart attack was caused by a

clot—despite the fact that both Dr. Nancy Santanello, Merck’s corporate representative, and

Dr. Thomas Wheeler, Merck’s expert, admitted at various places in the record that Bob Ernst

died of a thrombotic cardiovascular event (11 RR 35, 78-79, 159-160; 27 RR 35; 44 RR 101-

02, 133-34, 138; 46 RR 102). In fact, the only explanation for Bob Ernst’s sudden cardiac

death, after all the other risk factors and causes were excluded, was that he died of a


Petitioner’s Brief on the Merits                                                            33
thrombus, or clot.

         There is no scientific support for Merck’s sort of “magic bullet” theory, that if one

does not find the clot on autopsy, one cannot diagnose the cause of death. Not a single

scientific article or scientist, other than Merck’s experts, has ever taken the position that one

is unable to diagnose an ischemic event that causes a sudden cardiac death if one does not

find a clot during the autopsy. In fact, the overwhelming evidence on this record was that,

for a variety of reasons, clots that cause ischemic events are usually not found on autopsy.

         Merck’s position was not shared by Dr. Maria Araneta, the forensic pathologist who

performed the autopsy. In fact, when asked directly why she did not find a clot on autopsy,

the coroner, Dr. Araneta, testified that the purpose of the autopsy is not to find clots or do a

detailed dissection of the heart, but to rule out foul play (33 RR 84, 147). Dr. Isaac Weiner

also explained that “The clinical autopsy is done to exclude poisoning, to exclude foul play,

to get a rough idea of the cause of death.” (22 RR 65). Dr. Weiner contrasted an autopsy,

whose purpose is not to find the clot, with scientific pathological studies. And, Dr. Weiner

presented evidence and explained that even in controlled scientific studies of sudden cardiac

death (which is how Bob Ernst died), clots are not found 25 percent of the time (22 RR 64-

65; PX 1689). Merck’s expert, Dr. Wheeler, conceded on cross-examination that even in

clinical settings, at least 45 percent of the time a clot is not found (44 RR 38).

         Dr. Araneta, the only expert experienced in performing autopsies, testified that clots

are rarely found on autopsy (33 RR 88). Dr. Araneta’s testimony could not be clearer, but

its message was apparently lost on Merck: “Like I said, I seldom was able to see clots where



Petitioner’s Brief on the Merits                                                              34
I did my own autopsies; but I just saw the end result.” (33 RR 76). “But like I told you, I see

most of the time the clot is not there. But I see evidence of what the clot has done.” (33 RR

128). She testified that just because she did not see a clot on autopsy “doesn’t mean it wasn’t

there.” (33 RR 147).

         There was much testimony about why a clot may not appear on autopsy. For example,

Dr. Lucchesi, one of the world’s leading authorities on the subject, when asked about the

heart being “clogged up” by a thrombus, or clot, said:”Well, I wouldn’t go so far as even

saying clogged up by a thrombus. A thrombus could have been a small group of platelets

which could have moved downstream to obstruct a small vessel, and you would not identify

it as a thrombus” or find it on autopsy (36 RR 111).

         Other scientific testimony was presented to the jury that clots are often not found

because: (1) the clot may be too small to be seen (36 RR 73); (2) the clot could be in a

location not dissected in an autopsy (36 RR 89-90); (3) the clot could have dissolved (36 RR

85-86);17 and (4) the clot could move away (26 RR 92; 36 RR 91).

         Certainly, the fact that a clot was not found on autopsy (even though that was not the

purpose of the autopsy) is a good fact for Merck, and it allowed Merck to argue that the death

did not happen as all of Ernst’s experts said it did. However, that fact only went to the

weight of the evidence. It was the province of the jury to weigh that piece of evidence on the



17
    Merck continues to parrot the testimony of its expert, Dr. Pratt, who testified that the process of fibrinolysis
(dissolving of clots) takes 24 to 48 hours and ends after the patient dies. Dr. Pratt admitted he had no scientific support
for that opinion (52 RR 65). On the other hand, Dr. Lucchesi, who has worked with clots for over five decades,
explained that the process of dissolving of clots continues after death (36 RR 85-86). The Merck Manual, which Dr.
Pratt discounts, supports Dr. Lucchesi’s opinion (52 RR 66). Merck’s other expert, Dr. W heeler, testified that the
number of clots that dissolve is likely to be large (44 RR 134).

Petitioner’s Brief on the Merits                                                                                       35
scales of all the evidence. It was not the province of the court of appeals to reweigh the

evidence. See Pool v. Ford Motor Co., 715 S.W.2d 629, 633-634 (Tex. 1986) (holding courts

of appeals are not free to reweigh the evidence, even if a different result may seem more reasonable).

Because the “no clot on autopsy” fact is not dispositive and does not trump all the other

evidence, the court of appeals erred in giving that fact more weight than the other evidence

presented.

         2.       The “no physical evidence of myocardial infarction” theory is not
                  dispositive

         In addition to relying on the “no clot found on autopsy” theory, Merck also claimed

in its response to the petition for review that there can be no evidence of causation because

there was no physical evidence of a myocardial infarction. That argument is misleading

because, as Merck later admitted in its response, when a person dies of sudden cardiac death,

like Mr. Ernst, there will not be physical evidence of a myocardial infarction. See Merck’s

Response to Petition for Review, at 12. It is undisputed that the color changes in the heart

that show a myocardial infarction do not appear for 12 to 18 hours after death, and that

although one could see changes with electro microscopy after 6 hours, electro microscopy

is not done on autopsy (33 RR 44-45, 60-61). “Sudden cardiac death is, by definition, not

a myocardial infarction. It is what doctors term the condition when someone dies of a heart

attack before their heart muscle has a chance to deteriorate. It is only when a person survives

long enough for muscle deterioration that it is called myocardial infarction. That is why

Merck always included ‘sudden cardiac death’ and ‘myocardial infarction’ in their studies

as two sides of the same coin—i.e, ischemic heart events (‘commonly called ‘heart attacks.’).


Petitioner’s Brief on the Merits                                                                   36
Thus, with a sudden death, as here, ‘you would not see a myocardial infarction.’” (33 RR 44;

see also 22 RR 77). “[T]he autopsy is not a useful way of . . . ruling in or ruling out

myocardial infarction.” (22 RR 81).

         But, the fact that one cannot see physical signs of an MI in an autopsy does not mean

that a sudden cardiac death did not occur. Merck’s expert, Dr. Thomas Wheeler, admitted

that Bob Ernst presented the “classic textbook complication” of a myocardial infarction (44

RR 138). Dr. Wheeler explained that myocardial infarctions are “often associated with

thrombus formation on coronary arteries” and are responsible for numerous sudden deaths,

like Bob Ernst’s death (44 RR 133-34). Dr. Wheeler admitted that Ernst died from sudden

cardiac death caused by ventricular fibrillation (44 RR 101-102). And, Dr. Wheeler agreed

that “although acute MI is often the underlying precipitant of ventricular fibrillation in

cardiac arrest, 50 percent of victims have no evidence of MI.” (44 RR 103-04).

         Further, the coroner, Dr. Araneta, testified, in reasonable medical probability, that Mr.

Ernst suffered “an acute ischemic event,” and that the acute ischemic event “would be an

MI.” (33 RR 145).

         Both the court of appeals, and Merck in its response to the petition for review, take

the position that Dr. Araneta, testified “[c]ontrary to her report . . . .” See Opinion, at 10.

That is wrong. In response to Merck’s question on this very point, Dr. Araneta testified, “No,

I’m not changing my opinion. I’m just explaining it further. There’s no place in the death

certificate to say more likely than not MI secondary to arrhythmia.” (33 RR 64). She further

testified that her opinion was not inconsistent with what she wrote in her report (33 RR 44-



Petitioner’s Brief on the Merits                                                               37
45).

         But, even if Dr. Araneta did testify contrary to her report, as Merck contends, that

would go only to her credibility and the weight of the evidence. It certainly would not allow

the court of appeals to invade the province of the jury and disregard all of Dr. Araneta’s other

testimony.

         As this review reveals, the fact that there was no physical evidence of a myocardial

infarction is not evidence of anything, because with a sudden cardiac death, as Merck admits,

there never is such evidence. That fact also does not prove or disprove anything. And, that

fact certainly does not trump all of the causation evidence that was presented to the jury.

         3.       The “arrhythmias can occur from other causes” theory is without merit

         Another theory that Merck espouses in its response to the petition for review is that

arrhythmias can occur from other causes and, therefore, Merck says, the fact that Ernst died

of an arrhythmia cannot be considered in the causation analysis. In that argument, Merck

conveniently ignores the testimony at trial of Dr. Lucchesi, the world renowned expert on

arrhythmia, who has written some 480 peer-reviewed papers on the subject, and who

performed a differential diagnosis of the causes of Bob Ernst’s arrhythmia (36 RR 87-90,

106-110). In his analysis, Dr. Benedict Lucchesi considered and ruled out the “other causes”

of arrhythmia, such as genetic defects, earlier myocardial infarctions, hypertrophied heart,

electrocution, valvular defects, coronary artery disease, and spontaneous arrhythmia, and

reached the conclusion that the most likely cause was ischemia caused by Vioxx (Id.).

         Further, on two separate occasions, Merck’s expert, Dr. Wheeler, walked through this



Petitioner’s Brief on the Merits                                                             38
same differential diagnosis, and conceded that none of the “other causes” of arrhythmia, as

listed in the Merck Manual and a textbook, were present, and he concluded that the only

likely cause was myocardial infarction (44 RR 98-117, 131-34; 45 RR 80-85).

         Thus, as with Merck’s other theories, they are a good fodder for argument, but they

certainly do not trump all of the causation evidence that was presented to and considered by

the jury. The standard of review is not what is more reasonable in the view of the court of

appeals, but it is only whether there is any probative evidence that “would enable reasonable

and fair-minded people to reach the verdict under review.” City of Keller, 168 S.W.3d at 827.

The court of appeals misapplied the standard of no evidence review by failing to consider

legally sufficient evidence. Because there is legally sufficient evidence from which the jury

could determine that it was more likely than not that Vioxx was a cause of Bob Ernst’s death,

this Court should reverse the court of appeals’ judgment and remand to the court of appeals

for consideration of Merck’s and Mrs. Ernst’s unaddressed points of error.

         C.       The court of appeals created a new and unworkable standard of review
                  for differential diagnosis

         Another reason to grant review is to correct the court of appeals’ misapplication of

the differential diagnosis evidence. As we have discussed, not only did Mrs. Ernst’s experts

testify that it was more likely than not that Vioxx caused Mr. Ernst’s death, but also the

experts went a step further. The experts conducted a differential diagnosis (30 RR 30).

         In a differential diagnosis, a doctor puts down all the possible causes, and then rules

them out, one by one, until he figures out which one is the most likely diagnosis (Id.).

Differential diagnosis is the generally accepted methodology that doctors use to determine


Petitioner’s Brief on the Merits                                                             39
the cause of a medical problem or death (30 RR 31). It is a “medical fact” that doctors are

trained to diagnose the causes of a medical problem through use of differential diagnosis

(Id.). Merck’s expert, Dr. Thomas Wheeler, stated that he “always” uses differential

diagnosis to come up with the “most likely” cause of a medical problem (44 RR 131).

Moreover, that analytical framework was approved in Havner: “[t]o raise a fact issue on

causation . . . if there are other plausible causes of the injury or condition that could be

negated, the plaintiff must offer evidence excluding those causes with reasonable certainty.”

Havner, 953 S.W.2d at 720.

         Not only this Court in Havner, but also other courts have held that differential

diagnosis is not “junk science” and is itself some evidence of causation. See Praytor v. Ford

Motor Co., 97 S.W.3d 237, 244-245 (Tex. App.—Houston [14 Dist.] 2002, no pet.)

(“Differential diagnosis, or differential etiology, is a standard scientific technique of

identifying the cause of a medical problem by eliminating the likely causes until the most

probable one is isolated.”). It “has widespread acceptance in the medical community, has

been subject to peer review, and does not frequently lead to incorrect results.” Id. (quoting

Brown v. Southeastern Penn. Transp. Auth. (In re Paoli R.R. Yard PCB Litig.), 35 F.3d 717,

758 (3d Cir.1994)); see also Coastal Tankships, U.S.A., Inc. v. Anderson, 87 S.W.3d 591,

604 (Tex. App.—Houston [1st Dist.] 2002, pet. denied).

         In painstaking detail in this record, each of Mrs. Ernst’s medical experts conducted

a differential diagnosis, in which they reviewed and excluded with reasonable certainty the

American Medical Association and Harvard risk factors for causing a heart attack, to which



Petitioner’s Brief on the Merits                                                          40
was added the Vioxx factor, and they concluded that the only relevant risk factors for Bob

Ernst were age, gender and Vioxx. (21 RR 61-66; 22 RR 62-71; 30 RR 31-33; 36 RR100-

108). Further, Dr. Nancy Santanello, Merck’s corporate representative, walked through the

same risk factors and came to the same results, results leaving only age, gender and Vioxx

as the most likely risk factors (17 RR 68-77). This led the experts to conclude, under this

accepted methodology, within reasonable medical probability, that Vioxx was a contributing

cause of Mr. Ernst’s heart attack (22 RR 72; 30 RR 22; 31 RR 35; 36 RR 99).

         Without any citation to authority, the court of appeals created a new and unworkable

standard of review for evidence of differential diagnosis. The court of appeals held that the

evidence should not be considered because it was an “exclusion of risk factors” and not an

“exclusion of causes.” Merck v. Ernst, 296 S.W.3d at 99.

         First, that holding is just plain wrong factually. The differential diagnosis evidence

was not limited to an exclusion of risk factors, but also included an exclusion of potential

causes. The court of appeals wholly overlooked the testimony of Dr. Benedict Lucchesi, the

renowned expert on arrhythmia, who also performed a differential diagnosis of the causes

of Bob Ernst’s arrhythmia (36 RR 87-90, 106-110). In that analysis, Dr. Lucchesi ruled out

genetic defects, earlier myocardial infarctions, hypertrophied heart, electrocution, valvular

defects, coronary artery disease, and spontaneous arrhythmia to reach the conclusion that the

most likely cause of the arrhythmia was ischemia caused by Vioxx (Id.). Further, Merck’s

own expert, Dr. Wheeler, conducted a differential diagnosis using the Merck Manual and a

textbook he used to teach his students.         He also ruled out all the listed causes of



Petitioner’s Brief on the Merits                                                            41
arrhythmia—hemolysis, chronic ventricular fibrillation, hypothermia, vasoactive drugs,

shock, electrolyte imbalances—and he concluded that the only likely cause was myocardial

infarction (44 RR 98-117, 131-34; 45 RR 80-85). However, Dr. Wheeler tried to explain that

all away by saying that both the Merck Manual and the textbook that he used to teach his

students were wrong (44 RR 109; 45 RR 67, 71).

         Second, the new standard is wrong legally. Numerous courts define differential

diagnosis as the exclusion of risk factors as potential causes. See, e.g, Zandi v. Wyeth, No.

A08-1455, 2009 WL 2151141, at *8 (Minn. App. 2009) (holding that a doctor’s differential

diagnosis was not reliable because he failed to eliminate risk factors as potential causes);

Scaife v. Astrazeneca LP, No. 06C-04-218SER, 2009 WL 1610575, at *15 (Del. Super.

2009) (holding that both Kansas and Delaware recognize differential diagnosis as a valid

methodology which attempts to rule out “other known risk factors as the cause.”); In re

Phenylpropanolamine (PPA), 2003 WL 22417238, at *20 (N.J. Super. 2003) (in a mass tort

drug case, the court finds that differential diagnosis is a valid methodology and defines it as

“a process by which different possible causes or risk factors for a disease are systematically

considered, tested for and ruled in or ruled out.”).

         This Court should grant review to correct the court of appeals’ improper standard of

review of differential diagnosis evidence.

         D.       The court of appeals resolved conflicting evidence and inferences against
                  the judgment

         It is within the province of the jury to resolve conflicts in the evidence. See City of

Keller, 168 S.W.3d at 819-20; Golden Eagle Archery, Inc. v. Jackson, 116 S.W.3d 757, 761


Petitioner’s Brief on the Merits                                                             42
(Tex. 2003) (jury remains sole judge of witnesses’ credibility and weight to be given their

testimony); McGalliard v. Kuhlmann, 722 S.W.2d 694, 697 (Tex. 1986) (jury can choose to

believe one witness over other witnesses or resolve inconsistencies in their testimony). This

Court requires appellate courts to presume that jurors decided all conflicts in favor of the

verdict. Jackson v. Axelrad, 221 S.W.3d 650, 653 (Tex. 2007). That presumption ensures

that the appellate court “did not substitute its own judgment for that of the jury.” Id.

         Moreover, where a court of appeals is faced with conflicting testimony and

documentary evidence, as here, the court of appeals is required to resolve all doubts and

inferences in favor of the jury verdict. See City of Keller, 168 S.W.3d at 819-20.

         In this case, the court of appeals erred by adopting Merck’s expert’s testimony instead

of the conflicting testimony of Ernst’s experts, testimony that supported the verdict.

Although there are numerous examples of the court of appeals’ resolution of the conflicts

and inferences in favor of Merck, a few examples should suffice to demonstrate how far

afield the court of appeals strayed from the proper standard of no evidence review.

         1.       Expert opinion

         The court of appeals’ Substitute Opinion embraced the opinions of Merck’s expert,

Dr. Wheeler, and discredited the opinions of all the other experts, including Dr. Lucchesi,

Dr. Weiner, Dr. Egilman, and even Dr. Araneta, the independent pathologist who performed

the autopsy.

         Dr. Wheeler, whose “niche” is prostate treatment, and who has never written an article

on pathology of heart disease, or on arrhythmia, or on clots (44 RR 70-71), admitted that he



Petitioner’s Brief on the Merits                                                             43
disagreed with the opinions of: (1) the ER doctor who first treated Mr. Ernst; (2) Dr. Araneta,

who performed Mr. Ernst’s autopsy; (3) Dr. Weiner, who is an electrophysiology cardiologist

(an arrhythmia specialist); (4) Dr. Lucchesi, a leading authority on arrhythmia and clots; (5)

a pathology textbook that he uses to teach his students; and (6) the Merck Manual (44 RR

109; 45 RR 55-71).

         When the medical experts are highly qualified with extensive experience, and base

their opinions on objective data, as here, it is the province of the jury to determine the value

of their conflicting expert testimony. Brandt v. Surber, 194 S.W.3d 108, 132-133 (Tex.

App.—Corpus Christi 2006, pet. denied). The jury is the sole judge of the credibility of

witnesses and the weight to be given to their testimony, and the jury is free to credit or

disregard the testimony of experts. Kalina v. Burns, No. 14-08-00589-CV, 2009 WL

2176313, at *3 (Tex. App.—Houston [14th Dist.] 2009, pet. denied). Because the expert

testimony was in conflict, the court of appeals should not have invaded the province of the

jury, but should have sided with the evidence that supported the verdict.

         2.       Dissolving of clot

         In its review of legal sufficiency, the court of appeals stated: “Contrary to Dr.

Araneta’s and Dr. Lucchesi’s testimony, Dr. Pratt testified that the possibility of a clot

dissolving on its own was not a viable hypothesis because the natural process of fibrinolysis

takes 24 to 48 hours and only continues while the patient is alive.” See Merck v. Ernst, 296

S.W.3d at 97. Needless to say, because the testimony on this issue was conflicting, the panel

should have adopted the testimony of Drs. Araneta and Lucchesi which supported the verdict.



Petitioner’s Brief on the Merits                                                             44
See Jackson, 221 S.W.3d at 653.

         But, there are other reasons why the court of appeals should not have accepted Dr.

Pratt’s testimony over Dr. Lucchesi.      Dr. Pratt admitted that he is not an expert on

clots—whereas, Dr. Lucchesi is one of the world’s foremost authorities on clots (Compare

52 RR 62 with 36 RR 11-13). More importantly, Dr. Pratt admitted on cross-examination

that his “24 to 48 hour” opinion was not supported by a single study (52 RR 65). Rather, the

opinion is based on “my practice experience over 27 years.” (Id.). The court of appeals also

ignored the other evidence that supported Dr. Lucchesi’s analysis, such as the Merck Manual

itself which stated that “spontaneous thrombolysis” (dissolving of the clot) occurs in two-

thirds of patients within 24 hours (52 RR 66). To this, Dr. Pratt replied, “I never rely on the

Merck Manual for information on cardiology.” (Id.). Referencing a learned treatise, Merck’s

own expert, Dr. Wheeler, testified that the number of clots that dissolve is likely to be large

(44 RR 134).

         Dr. Lucchesi explained directly how the process of dissolving of clots occurs, and

explained that because the enzymes do not die immediately, the dissolving can happen even

after death (36 RR 85-86). Dr. Lucchesi directly rebutted Dr. Pratt’s “24 to 48 hour” opinion

(54 RR 93). Dr. Weiner, whom the panel does not mention in this regard, testified in detail

about the “fibrinolytic system” and why Merck’s argument about “once a clot, always a clot”

made no sense (22 RR 67). Dr. Araneta also described the process of fibrinolysis, by which

clots dissolve (33 RR 63).

         The court of appeals erred in choosing one medical expert’s opinion over others.



Petitioner’s Brief on the Merits                                                            45
Because the testimony was conflicting, the resolution of this issue was a question for the jury.

         3.       Atherosclerosis

         The court of appeals also states “no expert ruled out atherosclerosis as a cause of

Ernst’s arrhythmia.” See Opinion, at 17.         That is incorrect.     In discussing Ernst’s

atherosclerosis, Dr. Lucchesi testified that Ernst was “athletically remarkable,” without any

symptoms of severe coronary heart disease, “[s]o something else had to superimpose upon

that to make his disease worse.” (36 RR 139-40; see also 100) (emphasis added).

         Moreover, the other experts presented extensive testimony to show that

atherosclerosis, alone, was not the cause of Bob Ernst’s death ((21 RR 76; 22 RR 72; 36 RR

99-100; 44 RR 89-92, 139; 45 RR 71, 76-77). For his part, Dr. Wheeler conceded that

something besides atherosclerosis must “trigger” the 50 to 75 percent occlusion to reach the

90 percent threshold, but he thought, instead of an ischemia, or clot, it could be “a

nightmare.” (45 RR 76-77). Dr. Wheeler admitted that he had no evidence to support his

“nightmare” supposition (45 RR 77).

         Once again, the court of appeals erred in crediting Merck’s experts and discrediting

Ernst’s experts. The weight to be given to the testimony of each expert is a matter committed

to the jury.

         4.       Unclear whether Naproxen helped

         In discussing Merck’s knowledge, the Opinion states that after the VIGOR trial,

Merck did not immediately remove Vioxx from the market “because it was unclear whether

Vioxx lead to thromboembolic events, or whether Naproxen helped prevent such events.” See



Petitioner’s Brief on the Merits                                                             46
Opinion, at 3. That is wrong. There was clear evidence that Merck knew that Vioxx caused

an increase in the adverse cardiovascular events, and that Merck fabricated the Naproxen

issue.

         As discussed in the Statement of Facts, the evidence showed that well before the

VIGOR trials, the Merck scientists knew that Vioxx could cause cardiovascular events, and

that Merck tried to spin the cardiovascular events found in the VIGOR trial as showing

Naproxen helped, rather than that Vioxx hurt, and that the FDA even sent Merck a warning

for those “incomprehensible” and misleading statements about Naproxen (See, e.g., PX 524,

856; 16 RR 113-15; PX 1636; PX 2023; DX 125; (23 CR 4169); see also PX 953 (FDA

memo concluding “This hypothesis is not supported by any prospective placebo-controlled

trials with naproxen.”).

         Based on that evidence, the court of appeals erred in resolving that evidence in favor

of Merck and contrary to the verdict. This Court should grant review to correct the court of

appeals’ wholesale misapplication of the proper standard of no evidence review.

II.      Alternatively, the Court of Appeals Violated Mrs. Ernst’s Constitutional Rights

         In addition to legal and practical reasons why this Court should grant the petition for

review, there are also constitutional reasons.18

         “Both the federal and state due process clauses originated as a guarantee of procedural

fairness.” Lucas v. United States, 757 S.W.2d 687, 711 (Tex. 1988). While States have



18
    These constitutional complaints were preserved in the motion for rehearing and raised as error in the petition for
review. See Bunton v. Bentley, 153 S.W .3d 50, 53 (Tex. 2004) (“A complaint that arises from the court of appeals’
judgment itself, however, may be raised either in a motion for rehearing in the court of appeals or in a petition for review
in this Court.”); T EX . R. A PP . P. 49.9.

Petitioner’s Brief on the Merits                                                                                        47
substantial authority “to regulate procedures under which its laws are carried out, including

the burden of producing evidence and the burden of persuasion,” that authority does not

embrace actions that “offend[s] some principle of justice so rooted in the traditions and

conscience of our people as to be ranked as fundamental.” See Speiser v. Randall, 357 U.S.

513, 523 (1958); see also Lassiter v. Dep’t of Social Services, 452 U.S. at 33 (holding that

the Fourteenth Amendment “imposes on the States the standards necessary to ensure that

judicial proceedings are fundamentally fair.”).

         A fundamental principle of justice is this Court’s standard of review of jury trials. See

City of Keller, 168 S.W.3d at 810; see also Robert W. Calvert, “No Evidence” &

“Insufficient Evidence” Points of Error, 38 T EX. L. R EV. 361 (1960). Where the court of

appeals, as here, has utterly disregarded evidence in the record, contrary to the traditional

standard of review, and substituted itself for the jury, the court of appeals has

unconstitutionally invaded the province of the jury and denied the plaintiff’s rights to due

process. As Chief Justice Rueben R. Gaines wrote long ago: “It is contrary to the genius of

our institutions, as well as to the letter and spirit of every constitution ever adopted in this

State, to suppose that it was ever intended to substitute the judgment of the appellate courts

upon the facts of a case in place of that of the jury, and to make the determination of these

courts final.” Choate v. San Antonio & A.P. Ry. Co., 91 Tex. 406, 410, 44 S.W. 69, 70

(1898).

         Further, Mrs. Ernst was guaranteed a fundamental right to trial by jury under Art. I,

§ 15 of the Texas Constitution. See Breazeale v. State, 655 S.W.2d 230, 232 (Tex.



Petitioner’s Brief on the Merits                                                               48
App.—Houston [14th Dist.] 1983)(“Trial by jury is a fundamental right guaranteed by the

Sixth and Fourteenth Amendments to the United States Constitution. Additionally, the right

is embodied in T EX. C ONST. art. I, § 15 . . .”), rev’d on other grounds, 683 S.W.2d 446 (Tex.

Crim. App. 1984); Browning-Ferris, Inc. v. Reyna, 865 S.W.2d 925, 927 (Tex. 1993)

(acknowledging trial by jury as a fundamental right); Lucas v. United States, 757 S.W.2d

687, 692 (Tex. 1988) (same). The Seventh Amendment to the United States Constitution

also guarantees a right to trial by jury, but it has not yet been applied to States. See Walker

v. Sauvinet, 92 (2 Otto) U.S. 90 (1875). Under the criteria set forth in Duncan v. Louisiana,

the Seventh Amendment’s civil jury right should be applied to States because it is a

“fundamental principle[] of liberty and justice,” which is “basic in our system of

jurisprudence,” and “a fundamental right, essential to a fair trial.” 391 U.S. 145, 148-49

(1968); see also Pointer v. Texas, 380 U.S. 400, 403 (1965).

         As Justice Robertson once argued in dissent:

         I believe that the ordinary citizen of Texas would be outraged to learn that this
         is how our system of justice operates. Our Texas Constitution guarantees that
         “the right of trial by jury shall remain inviolate.” T EX. C ONST. art. I, § 15. This
         valuable right is fundamental to our entire system of jurisprudence. It is a right
         premised on the dignity of the ordinary citizen in whom our society entrusts
         the power to decide the facts of litigated disputes.
         If two out of three judges sitting on an appellate panel can reweigh the
         evidence and undo the work of a jury who listened in person to all the
         evidence, then it can no longer be said that the right of trial by jury is
         “inviolate.” Instead, that right is debased and diminished.

Hurlbut v. Gulf Atlantic Life Ins. Co., 749 S.W.2d 762, 769 (Tex. 1987) (Robertson, J., dissenting)

         Under either the Texas constitutional right or the Seventh Amendment, Mrs. Ernst’s

right to trial by jury was violated when the jury’s authority to determine the facts was usurped

Petitioner’s Brief on the Merits                                                                 49
and the standard of review was ignored. One of the grievances of colonial America was the

Crown’s use of bench trials to avoid decisions by juries. See Charles Wolfram, The

Constitutional History of the Seventh Amendment, 57 M INN. L. R EV. 639, 654 n. 47 (1973).

Our Declaration of Independence decries the Crown’s laws “depriving us, in many cases, of

the benefits of Trial by Jury.” D ECLARATION OF INDEPENDENCE [¶ 3] (1776). The court of

appeals should not be allowed to deprive Mrs. Ernst of the benefits of trial by jury here.

         Thus, if this Court does not reverse the court of appeals’ judgment because of its

misapplication of the standard of no evidence review, this Court should reverse the court of

appeals’ judgment because it violates Mrs. Ernst’s fundamental rights of due process and trial

by jury, under both the Texas and United States Constitutions.

                                      CONCLUSION

         Petitioner, Carol Ernst, Individually and as Representative of the Estate of Robert

Charles Ernst, requests that the Court grant her petition for review, reverse the judgment of

the court of appeals, and remand to that court for consideration of unaddressed points.

                                           Respectfully submitted,

                                           T HE H OLMAN L AW F IRM, P.C.




                                              s/David W. Holman
                                           David W. Holman
                                           Texas Bar No. 09902500
                                           24 Greenway Plaza, Suite 2000
                                           Houston, Texas 77046
                                           Telephone 713.400.4840
                                           Facsimile    713.400.4841



Petitioner’s Brief on the Merits                                                             50
                                   T HE L ANIER L AW F IRM
                                   W. Mark Lanier
                                   Texas Bar No. 11934600
                                   Kevin P. Parker
                                   Texas Bar No. 15494020
                                   Ken S. Soh
                                   Texas Bar No. 00794670
                                   Dara G. Hegar
                                   Texas Bar No. 24007280
                                   6810 FM 1960 West
                                   Houston, Texas 77069
                                   Telephone 713.659.5200
                                   Facsimile     713.659.2204

                                   S ANFORD B ARLOW, LLP

                                   Shelly A. Sanford
                                   Texas Bar No. 00784904
                                   1500 McGowen, Suite 250
                                   Houston, Texas 77004
                                   Telephone 713.524.6677
                                   Facsimile    713.524.6611

                                   Attorneys for Carol A. Ernst, Individually
                                   and as Representative of the Estate of
                                   Robert Charles Ernst




Petitioner’s Brief on the Merits                                                51
                                   CERTIFICATE OF SERVICE

         I certify that on December 21, 2010, a copy of the foregoing document was forwarded

to the following via electronic mail and Certified Mail–Return Receipt Requested:

                                   Ms. Katherine D. Mackillop
                                  F ULBRIGHT & J AWORSKI, LLP
                                   1301 McKinney, Suite 5100
                                      Houston, Texas 77010
                        Telephone 713.651.5151    Facsimile 713.651.5246

                                    Mr. Walter E. Dellinger III
                                        Mr. John H. Beisner
                                      Mr. Charles C. Lifland
                                    O’MELVENY & M YERS LLP
                                       1625 Eye Street, N.W.
                                     Washington, D.C. 20006
                         Telephone 202.383.5300 Facsimile 202.383.5414
                                  Attorneys for Merck & Co., Inc.




                                                      s/David W. Holman
                                                   David W. Holman




Petitioner’s Brief on the Merits                                                         52
                                              APPENDIX

Tab                                Document

A                          Opinion (June 4, 2009)

B                          Opinion (May 29, 2008)

C                          Order on Motion for Rehearing En Banc on the Second Opinion

D                          Charge of the Court

E                          Final Judgment




Petitioner’s Brief on the Merits                                                         53
                 NO. 10-0006




    PETITIONER’S BRIEF ON THE MERITS

______________________________________________




           APPENDIX A

    Opinion (June 4, 2009)
                               MERCK & CO., INC. v. ERNST                                     Tex.   81
                        Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

  Another statute that deals with fire-               a felony of the second degree; he faced a
arms, regulating the carrying of concealed            twenty-year sentence for any violation of
handguns, gave ‘‘convicted’’ a special defi-          the conditions of supervision. He also
nition that included deferred adjudication:           pleaded guilty to several other felony of-
   ‘‘ ‘Convicted’ means an adjudication of            fenses, with the agreement that the sen-
   guilt or, except as provided in Section            tences in those cases, like the sentence in
   411.1711, an order of deferred adjudica-           this case, would run concurrently with the
   tion entered against a person by a court           twenty-year sentence.
   of competent jurisdiction whether or not             Given the unsettled state of the law
   the imposition of the sentence is subse-           regarding the possession of firearm stat-
   quently probated and the person is dis-            ute, and the agreement for concurrent sen-
   charged from community supervision.                tencing in that case and other cases, we do
   The term does not include an adjudica-             not think that counsel’s advice to plead
   tion of guilt or an order of deferred              guilty to the firearm offense can be called
   adjudication that has been subsequently:           ineffective assistance.
       (A) expunged; or
                                                           Relief is denied.
       (B) pardoned under the authority of a
       state or federal official.’’ 7
                                                        KELLER, P.J., concurred in the
A related statute created an exemption                judgment.
from the status of being ‘‘convicted’’ for


                                                                       ,
some persons who were on deferred adju-
dication.8
  Whether a person who is on deferred
adjudication has been ‘‘convicted’’ as that
term is used in the Unlawful Possession of
                                                             MERCK & CO., INC., Appellant,
Firearm statute need not be resolved to-
day. The claim before us is that the appli-                                      v.
cant was denied effective assistance of               Carol A. ERNST, Individually and as
counsel when his attorney allowed him to                Personal Representative of the Estate
plead guilty without raising this question              of Robert Charles Ernst, Deceased,
in the trial court. We think that this may              Appellee.
not be called ineffective assistance. For
one thing, as we have explained, the issue                          No. 14–06–00835–CV.
of the proper construction of the statute                        Court of Appeals of Texas,
was unresolved and remains unclear. In                             Houston (14th Dist.).
such circumstances, counsel usually may
not be held to have rendered ineffective                                 June 4, 2009.
assistance.9                                                   Rehearing En Banc Overruled
  For another, the circumstances of the                               Nov. 19, 2009.
case must be taken into account. The                  Background: Widow filed personal-injury
applicant was on deferred adjudication for            and wrongful-death suit against pharma-

7.   GOV’T CODE § 411.171.                            9.     See Ex parte Chandler, 182 S.W.3d 350, 358
                                                           (Tex.Cr.App.2005); Ex parte Welch, 981
8.   Id., § 411.1711.                                      S.W.2d 183, 184 (Tex.Cr.App.1998) (‘‘[W]e
                                                           will not find counsel ineffective where the
                                                           claimed error is based upon unsettled law’’).
82   Tex.          296 SOUTH WESTERN REPORTER, 3d SERIES


ceutical company, alleging that ingestion of     dence conclusively establishes the opposite
its non-steroidal anti-inflammatory drug         of a vital fact.
caused husband’s death. Following jury
                                                 5. Products Liability O147
trial, the 23rd District Court, Brazoria
                                                      Causation in toxic tort cases is dis-
County, Ben Hardin, J., entered judgment
                                                 cussed in terms of general and specific
for widow. Company appealed.
                                                 causation; ‘‘general causation’’ describes
Holding: The Court of Appeals, Adele             whether a substance is capable of causing
Hedges, C.J., withdrawing its earlier opin-      a particular injury or condition in the gen-
ion, and substituting therefor, held that        eral population, while ‘‘specific causation’’
there was no evidence that husband’s car-        describes whether a substance caused a
diac death was caused by a blood clot            particular individual’s injury.
triggered by the drug.                                See publication Words and Phrases
Reversed.                                           for other judicial constructions and
                                                    definitions.

                                                 6. Products Liability O390
1. Evidence O597
                                                      To survive a legal sufficiency review
     The test for legal sufficiency is wheth-    of a toxic tort case, a claimant must do
er the evidence at trial would enable rea-       more than simply introduce into evidence
sonable and fair-minded people to reach          epidemiological studies that show a sub-
the verdict under review.                        stantially elevated risk; a claimant must
2. Appeal and Error O930(1)                      show that he or she is similar to those in
                                                 the studies.
     Legal-sufficiency review in the proper
light must credit favorable evidence if rea-     7. Products Liability O390
sonable jurors could, and disregard con-              There was no evidence in widow’s
trary evidence unless reasonable jurors          wrongful-death suit that her husband’s
could not.                                       sudden cardiac death was caused by a
                                                 blood clot triggered by pharmaceutical
3. Appeal and Error O930(1), 996
                                                 company’s non-steroidal anti-inflammatory
     Although the reviewing court must           drug, as required to support jury’s finding
consider evidence in the light most favor-       that company’s alleged negligence proxi-
able to the judgment, and indulge every          mately caused husband’s death; although
reasonable inference that would support it,      the epidemiological evidence supported the
if the evidence permits only one inference,      conclusion that use of the drug at a certain
neither jurors nor the reviewing court may       dose and duration was associated with in-
disregard it.                                    creased risk of thrombotic cardiovascular
4. Appeal and Error O1001(1, 3)                  events, such as a myocardial infarction
                                                 triggered by a blood clot, no blood clot was
     The Court of Appeals sustains a legal-
                                                 found on autopsy, and experts’ speculation
sufficiency challenge when the record dis-
                                                 that a clot ‘‘could have’’ existed, but ‘‘could
closes one of the following situations: (1)
                                                 have’’ dissolved, been dislodged, or frag-
complete absence of evidence establishing
                                                 mented gave rise to nothing more than
a vital fact; (2) the court is barred by rules
                                                 conjecture.
of law or of evidence from giving weight to
the only evidence of a vital fact; (3) the       8. Appeal and Error O1001(1)
evidence offered to prove a vital fact is no          In claims supported by only meager
more than a mere scintilla; or (4) the evi-      circumstantial evidence, the evidence does
                              MERCK & CO., INC. v. ERNST                                Tex.   83
                       Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

not rise above a scintilla and will not over-        13. Evidence O54
come a legal-sufficiency challenge if jurors              Facts from which an inference may
would have to guess whether a vital fact             properly be drawn must be established by
exists.                                              direct evidence, not by other inferences.

9. Appeal and Error O930(1)
     On a legal-sufficiency challenge, when
the circumstantial evidence of a vital fact is
                                                       Katherine D. Mackillop, Houston, TX,
meager, the Court of Appeals must consid-
                                                     for appellants.
er not just favorable but all the circum-
stantial evidence, and competing infer-               W. Mark Lanier and David W. Holman,
ences as well.                                       Houston, TX, for appellees.

10. Evidence O555.5, 571(9)                           Panel consists of Chief Justice
      To be considered reliable circumstan-          HEDGES and Justices ANDERSON and
tial evidence of causation, an expert’s opin-        BROWN.
ion must be independently evaluated to
                                                                SUBSTITUTE OPINION
determine whether the opinion is reliable;
an expert’s bare opinion will not suffice to            ADELE HEDGES, Chief Justice.
support a jury’s verdict, and the substance             Appellee’s motion for rehearing en banc
of the testimony must be considered.                 is denied as moot. The opinion of May 29,
11. Evidence O555.2                                  2008, is withdrawn and the following is
                                                     substituted therefor.
      Factors to which a reviewing court
should look in determining the reliability              Merck & Co., Inc. (‘‘Merck’’), appeals
of scientific testimony are: (1) the extent to       from a jury verdict in a personal-injury
which the theory has been or can be test-            and wrongful-death suit filed by Carol
ed; (2) the extent to which the technique            Ernst in which she alleged that ingestion
relies upon the subjective interpretation of         of Vioxx caused the sudden cardiac death
the expert; (3) whether the theory has               of her husband, Bob Ernst. Merck raises
been subjected to peer review and/or pub-            four issues in which it challenges the legal
lication; (4) the technique’s potential rate         and factual sufficiency of the evidence to
of error; (5) whether the underlying theory          support the jury’s verdict on causation,
or technique has been generally accepted             strict liability, negligence, malice, and
as valid by the relevant scientific communi-         damages. Merck further contends that
ty; (6) the nonjudicial uses that have been          the trial court erred in instructing the jury
made of the theory or technique; and (7)             and in admitting certain evidence. Find-
any other factor that is helpful to deter-           ing the evidence to be legally insufficient
mine the reliability of the scientific evi-          on the issue of causation, we reverse the
dence.                                               trial court’s judgment and render judg-
                                                     ment that appellee take nothing.
12. Evidence O555.5, 571(9)
     Causation opinions by an expert wit-                             I.   BACKGROUND
ness based on possibility, speculation, and            Vioxx, known generically as rofecoxib,
surmise are no evidence; expert opinions             belongs to a general class of pain relievers
must be supported by facts in evidence,              known as non-steroidal anti-inflammatory
not conjecture.                                      drugs (‘‘NSAIDs’’). NSAIDs work by in-
84   Tex.          296 SOUTH WESTERN REPORTER, 3d SERIES


hibiting cyclooxygenase (‘‘COX’’), an en-            A.   Development and Marketing
zyme that stimulates synthesis of prosta-                        of Vioxx
glandins, which are chemicals produced in
the body that promote certain effects.             On November 23, 1998, Merck submit-
Traditional NSAIDs, such as Advil (ibu-         ted a new drug application for Vioxx to the
profen), Aleve (naproxen), and Voltaren         Food and Drug Administration (‘‘FDA’’)
(diclofenac), have been longstanding treat-     and requested an expedited review of its
ment options for patients needing relief        application. Six months later, on May 20,
from chronic or acute inflammation and          1999, the FDA approved Vioxx as safe and
pain associated with osteoarthritis, rheu-      effective for treatment of osteoarthritic
matoid arthritis, and other musculoskeletal     pain, menstrual pain, and acute pain based
conditions. This relief, however, has his-      on the data and label supplied by Merck.
torically come with significant adverse side
effects. Specifically, traditional, NSAIDs      1.   Clinical Trials
greatly increase the risk of gastrointestinal
perforations, ulcers, and bleeds (‘‘PUBs’’).       Vioxx was subjected to a number of
This risk is further increased when high        studies and tests both before and after its
doses are ingested, which is often neces-       initial approval. Dr. Nancy Santanello is a
sary to remedy chronic or acute inflamma-       physician researcher and the executive di-
tion and pain.                                  rector of the epidemiology group at Merck
                                                Research Labs (‘‘MRL’’), a division of
   In the early 1990s, scientists discovered
                                                Merck that researches and develops new
that the COX enzyme had two forms—
                                                medications. She supervised the clinical
COX–1 and COX–2—each of which ap-
                                                trials and epidemiology studies of Vioxx
peared to have several distinct functions.
                                                until it was removed from the market in
Scientists believed that COX–1 affected
                                                September 2004. Dr. Santanello testified
the synthesis or production of prostaglan-
                                                that in developing a new drug, Merck con-
dins responsible for protection of the stom-
                                                ducts three phases of clinical trials. In
ach lining, whereas COX–2 mediated the
                                                Phase One, the drug is tested on healthy
synthesis or production of prostaglandins
                                                individuals to determine how well it is
responsible for pain and inflammation.
This belief led scientists to hypothesize       absorbed and tolerated. In Phase Two,
that ‘‘selective’’ NSAIDs designed to inhi-     the drug is tested on individuals who have
bit COX–2, but not COX–1, could offer the       the disease that the drug is designed to
same pain relief as non-selective NSAIDs        prevent or treat; in the case of Vioxx, it
with a reduced risk of fatal or debilitating    was tested on patients with osteoarthritis.
PUBs. In addition, scientists believed that     In Phase Three, large clinical trials are
such drugs might also prove beneficial for      conducted to test the safety of the drug.
the prevention or treatment of other condi-     The FDA requires at least two trials with
tions, such as Alzheimer’s disease and cer-     consistent results in Phase Three before it
tain cancers where evidence suggests that       will approve a new drug. There were 54
inflammation may play a causative role.         clinical trials conducted for Vioxx prior to
In light of these scientific developments,      its approval by the FDA. These clinical
pharmaceutical companies began develop-         trials showed no statistically significant
ing new drugs known as ‘‘COX–2 inhibi-          difference in cardiovascular events be-
tors’’ or ‘‘coxibs.’’ Merck developed a         tween Vioxx and a placebo, or between
COX–2 inhibitor and named it Vioxx.             Vioxx and traditional NSAIDs.
                                 MERCK & CO., INC. v. ERNST                                 Tex.   85
                          Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

   Dr. Santanello testified that Dr. Garret             thromboembolic events to monitor their
Fitzgerald, a researcher at MRL, con-                   clinical trials to determine whether pa-
ducted Phase One research into the renal                tients taking Vioxx experienced an in-
effects of Vioxx. In measuring urinary                  crease in those events. Dr. Santanello
output of patients taking Vioxx, Dr. Fitz-              testified that even after the FDA had ap-
gerald found a decrease in prostaglandin                proved Vioxx for treatment of osteoarthri-
metabolites, indicating the possibility of              tis, acute pain and menstrual pain, Merck
an imbalance of prostacyclin and throm-                 continued to study Vioxx for the treatment
boxane. Dr. Fitzgerald theorized that                   of other conditions.
Vioxx creates an imbalance between
thromboxane and prostacyclin in the blood
vessels. Thromboxane promotes platelet                  2.     VIGOR Trial
aggregation, vessel constriction, and pro-                 In March of 2000, Merck received the
liferation of smooth muscle cells. Prosta-              preliminary results of the Vioxx Gastroin-
cyclin, by contrast, opposes the action of              testinal Outcomes Research (‘‘VIGOR’’)
thromboxane inhibiting platelet aggrega-
                                                        study. VIGOR was an 8,000–patient trial
tion, facilitating vasodilation, and prevent-
                                                        designed to assess the relative incidence of
ing proliferation of smooth muscle cells.
                                                        gastrointestinal PUBs in rheumatoid ar-
In blocking COX–2, Vioxx also blocks
                                                        thritis patients treated with Vioxx as com-
prostacyclin; therefore, Dr. Fitzgerald hy-
                                                        pared to those treated with the drug na-
pothesized, the inhibition of COX–2 pro-
                                                        proxen. The VIGOR trial was conducted
motes an imbalance of prostacyclin and
                                                        with a 50–milligram dose of Vioxx, twice
thromboxane in the blood vessels, leading
to the formation of blood clots. In 1998,               the approved dosage for osteoarthritis.
Merck made the FDA advisory board                       The results of the VIGOR trial revealed
aware of the Fitzgerald hypothesis. The                 that, after nine months of daily 50–milli-
FDA concluded that while the hypothesis                 gram doses, of the 4,000 patients taking
was a theoretical concern, there was no                 Vioxx, 20 had suffered a thromboembolic
evidence that it was true.                              event; of the 4,000 patients taking Na-
                                                        proxen, four had suffered a thromboem-
   Dr. Santanello also testified that Merck
                                                        bolic event. Merck did not immediately
recognized the concerns raised by the Fitz-
gerald hypothesis and conducted several                 remove Vioxx from the market after re-
studies designed to determine whether                   ceiving these results because it was un-
Vioxx had a biochemical effect on the car-              clear whether Vioxx lead to the thrombo-
diovascular system. As a result of Dr.                  embolic events, or whether Naproxen had
Fitzgerald’s hypothesis, Merck created a                helped prevent such events. While VIG-
‘‘Standard Operating Procedure for the                  OR demonstrated that patients taking
Surveillance Monitoring and Adjudication                Vioxx suffered fewer serious gastrointesti-
of Acute Thromboembolic Vascular Events                 nal PUBs than patients taking Naproxen,
in Clinical Trials of COX–2 Specific Inhibi-            it also showed that patients on Vioxx suf-
tors.’’ As part of the standard operating               fered a statistically significant increase of
procedure, Merck assembled groups of in-                serious cardiovascular thrombotic events 1
dependent physicians with expertise in                  compared to patients taking Naproxen.

1.     ‘‘Cardiovascular thrombotic events’’ are              tions caused by blood clots.
     events such as strokes and myocardial infarc-
86    Tex.          296 SOUTH WESTERN REPORTER, 3d SERIES


3.   Additional Clinical Trials                   Searle, to put a COX–2 inhibitor on the
   At the time of the VIGOR trial, two            market. In marketing Vioxx, Merck de-
studies were simultaneously conducted on          cided to distribute more free samples of
Alzheimer’s patients to determine if Vioxx        Vioxx than they had distributed for any
could treat the inflammation associated           previous drugs. In one year, Merck spent
with Alzheimer’s disease. Those studies           over $300 million to market Vioxx. In
differed from the VIGOR trial in that the         2002, Merck sold two and a half billion
control group was taking a placebo, not           dollars worth of Vioxx, its second best
Naproxen. In those studies, half the pa-          selling drug.
tients took 25 milligrams of Vioxx, and the          Ernst introduced into evidence an email
other half took a placebo. The results of         sent from a stock analyst in which Merck’s
those studies showed that fewer thrombo-          Vioxx studies were analyzed. The analyst
embolic events had occurred in the pa-            stated that in looking specifically at arthri-
tients taking Vioxx than in those taking a        tis patients, the analysis revealed that
placebo. As a result of those studies,            Vioxx-treated patients experienced a high-
Merck determined that the VIGOR results           er incidence of cardiovascular events com-
were caused by Naproxen’s alleged car-
                                                  pared to patients given a placebo in both
dioprotective effect. In a press release
                                                  rheumatoid arthritis and osteoarthritis
dated March 27, 2000, Merck released the
                                                  studies. The analyst further expressed
results of the VIGOR study stating that
                                                  suspicion of Merck’s explanation that Na-
patients on Vioxx had a lower incidence of
                                                  proxen was cardioprotective. In the email,
serious gastrointestinal events and that pa-
                                                  the analyst stated that the FDA had con-
tients on Naproxen had a lower incidence
                                                  cluded that the heterogeneity of the stud-
of serious thromboembolic events. The
                                                  ies included in Merck’s meta-analysis ob-
press release explained the higher inci-
                                                  scured relevant facts. Edward Scolnick,
dence of thromboembolic events was due
                                                  Merck’s lead scientist, forwarded the ana-
to Naproxen’s cardioprotective effect.
                                                  lyst’s email to David Anstice. In the mes-
4.   Merck’s Marketing and Distribution           sage to Anstice, Scolnick stated, ‘‘David, if
     of Vioxx                                     he says this I will boil him in oil at the
                                                  meeting. I have never seen any analyst
   David Anstice is president of Merck’s
                                                  provide data analysis on his own. I think
Human Health Division for Canada, Latin
                                                  merck [sic] should do something about
America, Japan, Australia, and New Zea-
                                                  him.’’
land. Until December 2002, he was presi-
dent of the Human Health Division for the            Ernst questioned Dr. Santanello about
Americas. In that position, he was re-            several marketing issues surrounding
sponsible for sales and marketing activi-         Vioxx and warning letters issued by the
ties. He testified that in the late 1990’s,       FDA. First, Ernst asked Dr. Santanello
sales of Pepcid were a significant source of      about a warning letter written by Thomas
revenue for Merck. The patent was due             W. Abrams, director of the Drug Market-
to expire in either 2000 or 2001, and Merck       ing, Advertising, and Communications divi-
was looking to drugs like Vioxx to maintain       sion of the FDA to Raymond V. Gilmartin,
that level of revenue. Merck engaged in           President and Chief Executive Officer of
what Anstice described as a ‘‘race’’ with         Merck. The letter stated that it was writ-
Searle Pharmaceuticals,2 later Pfizer             ten in response to a promotional campaign

2.   Searle Pharmaceuticals developed Celebrex.
                                  MERCK & CO., INC. v. ERNST                                      Tex.   87
                           Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

for Vioxx that ‘‘minimizes the potentially               also referred to audio conferences being
serious cardiovascular findings that were                given by a physician. The letter noted
observed in the [VIGOR] study, and thus,                 that Merck had misrepresented the num-
misrepresents the safety profile for Vioxx.’’            ber of heart attacks suffered by study
The letter requested that Merck take im-                 participants who were taking Vioxx. The
mediate corrective action including ‘‘ceas-              FDA further stated that Merck’s sugges-
ing all violative promotional activities, and            tion that COX–2 inhibitors have an overall
the dissemination of violative promotional               safety profile that is superior to other
materials for Vioxx,’’ and issuing a ‘‘Dear              NSAIDs is misleading. In response,
Healthcare provider’’ letter to correct false            Merck terminated its relationship with the
or misleading impressions or information.                physician and requested that he not pro-
The FDA’s letter stated that there were                  duce further conferences. Merck also dis-
no adequate and well-controlled studies of               seminated a letter to health care providers
Naproxen supporting Merck’s claim of car-                explaining that the statements made by
dio-protection. The FDA warned Merck                     the physician were not accurate. The
not to minimize the risks associated with                FDA reviewed Merck’s corrective actions
Vioxx use and to correct the misrepresen-
                                                         and determined that the matter had been
tation in the medical community. Dr. San-
                                                         ‘‘satisfactorily resolved.’’
tanello testified that Merck took the alle-
gations seriously and acted upon them.3                    In a letter dated July 16, 1999, the
   Dr. Santanello further testified about a              FDA’s Division of Drug Marketing, Ad-
second letter sent by the FDA to Merck.                  vertising, and Communications asked
In that letter, dated December 15, 1999,                 Merck to immediately cease certain broad-
the FDA addressed two ‘‘homemade pro-                    cast advertisements for Fosamax, and a
motional pieces,’’ entitled ‘‘Ten Reasons                print advertisement for Vioxx. The Vioxx
Why Vioxx is Better than Celebrex,’’ and                 advertisement represented an X-ray im-
‘‘Vioxx vs. Celebrex Poem.’’ In the letter,              age of a hand with superimposed red
the FDA warned that the promotional ma-                  markings at the joints. The FDA stated
terials misrepresented the safety profile                that the advertisement should cease imme-
for Vioxx and were lacking in fair balance.              diately because it failed to (1) provide ade-
The FDA stated that the ‘‘homemade’’ pro-                quate information regarding the product’s
motional pieces misrepresented the gas-                  usage, (2) include risk information, and (3)
trointestinal safety profile of Vioxx and                present a brief summary of necessary in-
improperly represented that Vioxx was                    formation related to side effects, contrain-
more effective than Celebrex.4 The letter                dications, and effectiveness, or provide ad-

3.     On June 16, 1998, one year prior to the           4.      One of the homemade promotional pieces
     approval of Vioxx, Merck received a warning              addressed in the letter was a poem designed
     letter from the FDA stating that Merck had               to tout the superiority of Vioxx over Celebrex.
     engaged in ‘‘a continuing pattern and practice           In its warning letter, the FDA stated that the
     of widespread corporate behavior to avoid                poem ‘‘makes a broad superiority claim com-
     compliance with the regulations concerning               paring Vioxx not only to the class of NSAIDS,
     the disclosure of risk information.’’ The let-           of which it is a member, but to all analgesic
     ter referred to ‘‘promotional materials for a            and anti-inflammatory therapies available for
     variety of products,’’ and stated that those             the management of pain.’’ The FDA de-
                                                              scribed this ‘‘global superiority claim’’ as
     materials suggested ‘‘a corporate policy to-
                                                              ‘‘false or misleading.’’ Merck agreed that the
     ward minimizing the presentations of [risk]
                                                              homemade promotional piece was wrong and
     disclosures.’’
                                                              removed it from distribution.
88      Tex.           296 SOUTH WESTERN REPORTER, 3d SERIES


equate provision for the dissemination of            pression of data by Merck and a consistent
full product labeling in connection with the         pattern of intimidation of investigators by
broadcast advertisement.        Ernst also           Merck staff.’’ 5
questioned Dr. Santanello about a warning              The jury also viewed three television
letter Merck received concerning pro-                advertisements for Vioxx, none of which
motional materials for drugs other than
                                                     warned of the cardiovascular risks of tak-
Vioxx. In it, the FDA warned Merck
                                                     ing Vioxx. Dr. Santanello testified that
about issuing a press release that was
                                                     the advertisements were approved by the
false or misleading with regard to the car-
                                                     FDA and, at the time the advertisements
diovascular safety profile of Vioxx. The
                                                     were published, Merck believed the VIG-
FDA described Merck’s description of
                                                     OR results were skewed by the cardio-
Vioxx’s favorable cardiovascular safety
                                                     protective effects of Naproxen. Ernst in-
profile as ‘‘simply incomprehensible.’’
                                                     troduced evidence of a brochure used in
   Ernst introduced into evidence a letter           Merck’s sales training sessions. The bro-
dated January 22, 2001, addressed to the             chure is entitled, ‘‘Dodge Ball Vioxx,’’ and
president of Merck and written by Dr.                contains the word ‘‘DODGE!’’ written on
James Fries, a professor of medicine at              the front page. The brochure addresses
the Stanford University Medical Center.              several objections physicians may have to
Dr. Fries was a principal investigator for a         using Vioxx including, ‘‘I am concerned
National Institute of Health (‘‘NIH’’) fund-         about the cardiovascular effects of Vioxx.’’
ed data bank called Arthritis, Rheumatism,           Dr. Santanello testified it was her under-
and Aging Medical Information System                 standing that the marketing department
(‘‘ARAMIS’’). The organization worked                used this brochure as a game to teach the
toward reducing the frequency of serious             salespeople how to answer questions for
gastrointestinal events from traditional             physicians. She stated that despite its
NSAIDs and believed that the COX–2 in-               name, the technique had ‘‘nothing to do
hibitors were the ‘‘best approach toward             with dodging questions.’’
better drug safety in this area.’’ Dr. Fries
received a telephone call from Dr. Louis                Ernst also showed a sales instruction
Sherwood of Merck expressing concern                 video in which sales representatives were
over lectures given by Dr. Gurkirpal Singh           instructed that if physicians asked whether
of ARAMIS, which were reported to be                 Vioxx caused heart attacks, the represen-
‘‘anti-Merck and specifically anti-Vioxx.’’          tatives were to answer, ‘‘[t]hat is not true.’’
Dr. Fries wrote, ‘‘Dr. Sherwood suggested            Sales representatives were encouraged to
that if this continued Dr. Singh would               tell physicians that their friends and family
‘flame out’ and there would be conse-                members continued to take Vioxx even
quences for myself and for Stanford.’’ Dr.           after negative news articles were publish-
Fries wrote to express his concerns about            ed in the New York Times and the Journal
underemphasized drug toxicity problems               of the American Medical Association.
with Vioxx, especially at the 50–milligram             Ernst further questioned Dr. Santanello
dose. He also expressed concern that                 about a document used by the marketing
Merck was engaging in ‘‘damage control               department to track physicians who pre-
by intimidation.’’ The letter further ex-            scribed anti-inflammatory drugs. The
pressed concern with the issue of ‘‘sup-             document listed physicians nationwide and

5.     The trial court admitted the letter for the     not for the truth of the matters contained
     limited purpose of showing notice to Merck,       therein.
                             MERCK & CO., INC. v. ERNST                               Tex.   89
                      Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

the sales representatives assigned to those         cardiovascular events. Dr. Santanello ex-
physicians. The intent was to ‘‘neutralize’’        plained that serious cardiovascular events
the physicians through various tactics in-          included heart attacks and strokes, while
cluding awarding grant money to physi-              all cardiovascular events encompassed
cians if they agreed to prescribe Vioxx             high blood pressure, congestive heart fail-
instead of other anti-inflammatories.               ure, and other events not necessarily in-
Sales representatives received bonuses              volving a thrombus, or blood clot.
tied to the physicians’ prescription rates
                                                       On September 15, 2000, Dr. Wallace pre-
for Vioxx. Dr. Santanello explained that
the term ‘‘neutralize’’ referred to the rep-        scribed a daily 25–milligram dose of Vioxx
resentatives’ intent to educate the physi-          to Bob Ernst to alleviate tendinitis pain in
cians on Vioxx so they could be fair and            Ernst’s hands. On May 6, 2001, approxi-
balanced. She further explained that it             mately one hour after Ernst went to bed,
was common for physicians to request fi-            appellee noticed that he was unconscious
nancial support for their research from a           and was having trouble breathing. Appel-
number of different industries.                     lee called emergency medical personnel
                                                    and began cardiopulmonary resuscitation
       B.   Dr. Wallace Prescribes                  (‘‘CPR’’). Ernst never regained conscious-
            Vioxx to Mr. Ernst                      ness and was pronounced dead shortly af-
   Dr. Santanello testified that Merck sub-         ter arriving in the emergency room. An
scribes to a service that tracks every pre-         autopsy was performed the following
scription a physician writes so it can target       morning, and the report listed his death as
physicians who are prescribing drugs oth-           cardiac arrhythmia secondary to coronary
er than those sold by Merck. Dr. Brent              atherosclerosis.
Wallace, the physician who prescribed                 On September 23, 2004, an external
Vioxx for Ernst, was on Merck’s list of             safety board monitoring the results of a
high NSAID prescribers who ‘‘should be              separate long-term study entitled Adeno-
detailed on Vioxx first.’’ By August of             matous Polyp Prevention on Vioxx (‘‘AP-
2000, Dr. Wallace’s new prescription share          PROVe’’), which was designed to assess
for Vioxx was up to 45.9 percent. Dr.               whether Vioxx could help prevent the re-
Santanello’s testimony was unclear as to            currence of precancerous colon polyps, in-
what percentage Dr. Wallace had been                formed Merck that the interim data from
writing prior to being targeted. On April           this study also showed a significantly in-
18, 2001, Merck sent a letter to Dr. Wal-           creased rate of cardiovascular events in
lace explaining the results of the VIGOR            the Vioxx arm as compared to the placebo
study. Attached to the letter was the full          arm of the study. One week later, on
VIGOR report as published in the New                September 30, 2004, Merck voluntarily
England Journal of Medicine. The letter             withdrew Vioxx from the market.
stated that as of February 2000, the rate
of cardiovascular events in the VIGOR
                                                            C.    Trial Court Proceedings
study was .4 percent. In the subsequent
final analysis, which included all events              Appellee, Carol Ernst, sued Merck al-
after the February 2000 cut-off date, the           leging that the ingestion of Vioxx caused
rate of cardiovascular events was .5 per-           the death of her husband. Ernst’s suit
cent. The VIGOR study reported the .4               was tried to a jury, which found that the
and .5 percent rates referred to serious            design and marketing of Vioxx was defec-
thrombolic cardiovascular events, not all           tive, that Merck’s negligence proximately
90   Tex.            296 SOUTH WESTERN REPORTER, 3d SERIES


caused Ernst’s death, and that the harm to      ther jurors nor the reviewing court may
Ernst resulted from malice attributable to      disregard it. Id. at 822. We sustain a
Merck. The jury awarded a total of              legal-sufficiency challenge when the record
$24,450,000 in compensatory damages and         discloses one of the following situations:
assessed $229,000,000 in exemplary dam-         (1) complete absence of evidence establish-
ages. Pursuant to section 41.008 of the         ing a vital fact; (2) the court is barred by
Texas Civil Practice and Remedies Code,         rules of law or of evidence from giving
the trial court reduced the assessment of       weight to the only evidence of a vital fact;
exemplary damages and entered judgment          (3) the evidence offered to prove a vital
for appellee in the sum of $26,100,000.         fact is no more than a mere scintilla; or (4)
From that judgment, Merck appeals.              the evidence conclusively establishes the
  Merck raises four issues in which it chal-    opposite of a vital fact. Id. at 810.
lenges the legal and factual sufficiency of        A thrombotic cardiovascular event is a
the evidence to support the jury’s verdict      myocardial infarction or sudden cardiac
on causation, strict liability, negligence,     death triggered by a thrombus, or blood
malice, and damages. Merck further con-         clot. The autopsy report reflected that
tends that the trial court erred in instruct-   Ernst suffered mild to severe atherosclero-
ing the jury and in admitting certain evi-      sis in the left anterior artery and left
dence.                                          circumflex coronary arteries and listed the
                                                cause of death as ‘‘cardiac arr[h]ythmia
               II.   ANALYSIS
                                                secondary to coronary atherosclerosis.’’
   In its first issue, Merck argues that        Both parties’ experts testified that the
appellee failed to present legally sufficient   usual cause of a myocardial infarction is a
evidence of specific causation. At trial,       blood clot formed in response to a rupture
Ernst alleged that Mr. Ernst’s death was        or fissure of atherosclerotic plaque in the
caused by a blood clot triggered by Vioxx.      inner lining of the artery. It is undisputed
The trial court excluded all evidence of        that no blood clot or fissure of atheroscler-
non-thrombotic causes of Ernst’s death.         otic plaque was found during the autopsy.
Merck argues that Ernst failed to present
competent evidence of the existence of a                  A.   Ernst’s Evidence
clot.
                                                   Admitting that there is no direct evi-
   [1–4] The test for legal sufficiency         dence of a blood clot, Ernst contends that
‘‘must always be whether the evidence at        there is sufficient circumstantial evidence
trial would enable reasonable and fair-         to support the jury’s verdict. Prior to
minded people to reach the verdict under        trial, the court held a hearing on several
review.’’ City of Keller v. Wilson, 168         pretrial motions including Merck’s motion
S.W.3d 802, 827 (Tex.2005). Legal-suffi-        to exclude evidence based on Merrell Dow
ciency review in the proper light must          Pharm. v. Havner, 953 S.W.2d 706 (Tex.
credit favorable evidence if reasonable ju-     1997). No evidence was introduced at the
rors could, and disregard contrary evi-         hearing, but the court heard arguments of
dence unless reasonable jurors could not.       counsel. Merck’s counsel explained sever-
Id. Although the reviewing court must con-      al medical terms that would be used at
sider evidence in the light most favorable      trial beginning with ‘‘atherosclerosis,’’
to the judgment, and indulge every reason-      which is the disease that involves deposi-
able inference that would support it, if the    tion of plaque on the walls of the arteries,
evidence permits only one inference, nei-       sometimes referred to as ‘‘hardening of the
                             MERCK & CO., INC. v. ERNST                               Tex.   91
                      Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

arteries.’’ When atherosclerosis becomes            that acts as a natural pacemaker for the
advanced, a piece of plaque can rupture,            heart. The heart uses electrical signals to
and the body responds by forming a                  ensure that it beats correctly. If the elec-
‘‘thrombus,’’ or ‘‘blood clot,’’ around the         trical system is interrupted, an arrhythmia
plaque. If that clot breaks away, it will           occurs. If the arteries in the heart are
often block, or occlude, a blood vessel lead-       blocked, the heart will not get enough
ing to a ‘‘myocardial infarction,’’ commonly        oxygen and will suffer abnormal rhythm.
known as a heart attack. Counsel further            A thrombus, or blood clot, can block an
explained that ‘‘cardiac arrythmia’’ is ‘‘es-       artery causing a lack of oxygen, or ische-
sentially an electrical problem with the            mia, to the heart. An ‘‘acute ischemic
heart.’’ Finally, the term ‘‘sudden cardiac         event’’ occurs when the heart suddenly
death’’ refers to the death of an individual        does not get enough blood.
usually within a certain period of time               In Dr. Weiner’s opinion, Ernst’s ar-
after the onset of symptoms. Sudden car-            rhythmia was ‘‘caused by ischemia, by in-
diac death encompasses both myocardial              adequate blood flow to the heart.’’ Be-
infarction and cardiac arrythmia.                   cause Ernst died suddenly after the onset
   After hearing arguments of counsel, the          of symptoms, no reliable test could be
court permitted Ernst’s expert testimony            performed to determine whether he suf-
on causation, but excluded all evidence of          fered a myocardial infarction. Dr. Weiner
non-thrombotic causes of Mr. Ernst’s                admitted that the medical examiner, in
death. The circumstantial evidence on               conducting the autopsy, found no evidence
which Ernst relies is the testimony that a          of recent or remote infarction or a throm-
clot could have been present, then could            bus. The cause of Ernst’s arrhythmia ac-
have disappeared through various means              cording to the autopsy report is coronary
prior to autopsy. Appellee presented the            atherosclerosis. The most common predis-
testimony of three experts who testified            posing factor to sudden cardiac death is
that Vioxx caused Ernst’s death: Dr. Isaac          coronary atherosclerosis. In explaining
Wiener, Dr. Maria Araneta, and Dr. Bene-            how Vioxx contributed to Ernst’s death,
dict Lucchesi.                                      Dr. Wiener testified:
                                                      [I]schemic ventricular fibrillation, sud-
Dr. Isaac Wiener
                                                      den cardiac death, the most common
   Dr. Isaac Wiener is a practicing cardiol-          thing that causes sudden cardiac death,
ogist who specializes in cardiac arrhythmia           that causes someone to just keel over
and testified that cardiac arrhythmia re-             the way Mr. Ernst, unfortunately, did is
fers to rhythm abnormalities that occur in            ventricular fibrillation, which is an ab-
the electrical system of the heart. He is a           normal heart rhythm related to blockag-
clinical professor of medicine at the Uni-            es in his artery. And that’s what he
versity of California at Los Angeles. He              had. And does the only time it hap-
conducts peer review for the Journal of the           pen[s] is to people taking Vioxx? No.
American College of Cardiology, the                   Unfortunately it happens to people not
American Heart Journal, and the Journal               taking Vioxx. But the evidence sug-
of Arrhythmias. and has published several             gests that Vioxx makes it significantly
articles on cardiac arrhythmia.                       more common.
   Dr. Wiener explained for the jury how
the heart works as a pumping muscle to              Dr. Maria Araneta
circulate blood throughout the body. He               Dr. Maria Araneta, the assistant medical
further explained the electrical system             examiner who performed the autopsy, tes-
92    Tex.            296 SOUTH WESTERN REPORTER, 3d SERIES


tified that Ernst’s left coronary arteries     testified that he has an undergraduate de-
were 50– to 75–percent blocked by calci-       gree in pharmacology, a master’s in physi-
fied plaque. She did not find a blood clot     ology and a doctorate in pharmacology and
when she performed the autopsy on              has researched arrhythmia since the
Ernst’s body. She did not see evidence of      1950’s. He participated on the team that
a myocardial infarction, or heart attack,      invented the first pacemaker, another
because Ernst died within an hour of ini-      team that invented the nitroglycerin patch,
tially showing symptoms. To affirmatively      and another team that invented the first
diagnose a myocardial infarction, the phy-     beta-blocker.
sician must observe either death of the
heart muscle tissue or the presence of            Dr. Lucchesi testified as follows: Ernst
cardiac enzymes. To observe either death       had atheromatous plaque formed on the
of the tissue or the presence of cardiac       inside walls of his arteries. This is com-
enzymes, the individual must have lived six    mon among people 59–years–old as Ernst
to eighteen hours after suffering the myo-     was because as individuals age, cholesterol
cardial infarction.6                           causes build-up of plaque in the arteries.
  The most likely cause of Ernst’s ar-         Relying on the theories behind the Fitz-
rhythmia, Dr. Araneta testified, was an        gerald Hypothesis, Dr. Lucchesi testified
acute ischemic event. As the potential         that when COX–2 is inhibited as with
cause of such an event, she said, ‘‘Some-      Vioxx, blood platelets can aggregate
thing blocked that artery that was already     around an area in the artery where plaque
narrowed, either a clot, a fissure, block or   has formed. By disturbing the balance of
ruptured atheroma, none of which I saw,        prostacyclin and thromboxane in the blood,
but it—these things could be dissolved.’’      ‘‘the potential for the platelets to aggre-
According to Dr. Araneta, the clot could       gate’’ is increased. Vioxx can be taken by
have spontaneously dissolved, been dis-        many people without difficulty, but should
lodged through vigorous CPR, or could          not be taken by patients with underlying
have been too small to detect on autopsy.
                                               cardiovascular disease.
Not only did she not see a clot, but she
observed no rupturing or fissuring of the         Dr. Lucchesi admitted that Ernst did
atherosclerotic plaque in the coronary ar-     not suffer a myocardial infarction, but
teries. In fact, the plaque in Ernst’s ar-     speculated that he could have suffered re-
teries was intact and so hard that the         perfusion injury when a blood clot, which
arteries had to be de-calcified before they    was never found, dissolved. Reperfusion
could be sectioned for autopsy. If she         injury occurs when the heart has been
attempted to section the arteries prior to     ischemic and blood flow suddenly returns
de-calcification, her knife would have been    to the heart. Microemboli, which are
broken due to the hardness of the arteries.    small blood clots that move, can cause
Contrary to her report, at trial Dr. Arane-    reperfusion because the flow of blood to
ta was ‘‘leaning towards more likely than      the heart is intermittent. Prior to his
not’’ that Ernst suffered a myocardial in-     death, when Ernst said he was not feeling
farction.                                      well, he was most likely suffering from
Dr. Benedict Lucchesi                          microemboli. Dr. Lucchesi’s reperfusion
  Dr. Lucchesi is a professor of pharma-       theory is based on a study performed on
cology at the University of Michigan and       animals and published in Circulation Jour-

6.   All experts agreed on this conclusion.
                              MERCK & CO., INC. v. ERNST                                   Tex.   93
                       Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

nal, which states that ‘‘the causal involve-         along with Vioxx, for such a serious event,
ment of microemboli in death from malig-             my only conclusion would be that Vioxx
nant arrhythmias and/or cardiac failure              contributed significantly to this.’’
remains unclear.’’ Dr. Lucchesi admitted                Dr. Lucchesi did not rule out coronary
there was no evidence of microemboli in              atherosclerosis as the cause of Ernst’s ar-
Ernst’s autopsy, but stated that, ‘‘[O]ne of         rhythmia. Ernst argues that because Mr.
the possibilities why a clot could not be            Ernst’s atherosclerosis was ‘‘asymptomat-
found is because the efforts to administer           ic,’’ it was ruled out as a cause of his death.
CPR could have dislodged that clot and               In that regard, Dr. Lucchesi testified that
sent it somewhere, elsewhere, where it               Mr. Ernst ‘‘had a normal-looking heart
could not be localized and observed.’’ He            except for the disease within the coronary
admitted that he is not aware of any case            arteries, which are asymptomatic.’’ He
reports that suggest that CPR can dis-               further explained that the term ‘‘asymp-
lodge a clot.                                        tomatic’’ refers to the fact that Ernst was
   He opined that Ernst ‘‘died of an ar-             able to continue vigorous exercise and an
rhythmia, precipitated by a transient is-            active lifestyle in spite of moderate to se-
chemic event leading to ventricular fibril-          verely clogged arteries.
lation.’’   Dr. Lucchesi explained that
                                                                  B.    Merck’s Evidence
ischemia is a lack of blood flow. Most
likely, because Ernst was taking Vioxx, he             In support of its contention that there
died due to a temporary interruption of              was no evidence Ernst suffered a throm-
blood flow based on platelet aggregation             botic event, Merck presented the testimo-
due to the inhibition of COX–2. Although             ny of Dr. Thomas Wheeler and Dr. Craig
there was no evidence that the temporary             Pratt.
interruption of blood flow was due to a              Dr. Thomas Wheeler
clot, Dr. Lucchesi testified that blood clots           At the time of trial, Dr. Wheeler was the
can naturally dissolve through the process           interim chairman of the pathology depart-
of fibrinolysis. Although all experts testi-         ment at the Baylor College of Medicine.
fied that the process of fibrinolysis ends at        He testified that autopsies are performed
death, Dr. Lucchesi testified that when an           to determine the cause of death, and, in
individual dies, all his blood clots, and            some cases, the manner of death. In de-
then, over a period of time, the blood               termining the cause of death when sudden
turns to liquid again.                               cardiac death occurs, the medical examiner
   Ernst had the most severe atherosclero-           first rules out all causes other than the
sis in the anterior descending coronary              heart. When those causes have been ruled
artery. He also showed moderate to se-               out, the physician focuses on a careful
vere calcific atherosclerosis in the left cir-       examination of the heart. Approximately
cumflex coronary artery. ‘‘Mr. Ernst’s               85 percent of individuals who die from
demise was caused by an arrhythmia initi-            sudden cardiac death have severe athero-
ated by ischemia.’’ Ernst had coronary               sclerosis. At least half of the people who
disease, but was able to continue vigorous           have severe atherosclerosis do not experi-
exercise because the coronary arteries               ence symptoms. In some of those people,
have a ‘‘tremendous reserve capacity.’’              death is the first symptom of the disease.
Because Vioxx blocks COX–2 and ‘‘in view               During life, risk factors for heart disease
of the fact that he had underlying vascular          play a role in helping a physician deter-
disease, which makes him a candidate,                mine whether a patient needs to have a
94   Tex.         296 SOUTH WESTERN REPORTER, 3d SERIES


risk assessment, but, for an autopsy, risk     cracks and ruptures causing the contents
factors mean nothing. In an autopsy the        of the plaque, i.e., cholesterol and other
physician can see the cause of death such      material, to get into the bloodstream,
that risk factors do not come into play.       which causes the clot to begin to form.
Myocardial infarctions are diagnosed by        Calcific plaque, the type that was in
determining a patient’s symptoms, meas-        Ernst’s arteries, is least likely to rupture
uring cardiac enzymes, or measuring elec-      or fissure to initiate a blood clot. One
trical impulses in the heart through an        would ordinarily not expect a blood clot to
electrocardiogram. None of those tests is      form, but if a clot were to form around
effective after death.                         such plaque, there would be evidence, even
   In reviewing Dr. Araneta’s autopsy re-      if the clot dissolved or moved, of a rupture
port, Dr. Wheeler reviewed the microscop-      and a hemorrhage into the plaque at the
ic slides of tissue taken from the organs at   point of rupture or fissure.
the time of the autopsy. In his opinion,          Because Dr. Araneta cut the arteries in
the autopsy was thoroughly performed in a      such thin sections, the fact that she did not
professional manner. He agreed with Dr.        find a clot essentially rules out the possi-
Araneta’s finding that the cause of death      bility of a clot’s having caused Ernst’s
was cardiac arrhythmia secondary to coro-      death. The clot could not have dissolved
nary atherosclerosis. Fatal arrhythmias        after death. The scenario described by
can and do occur without a myocardial          Dr. Lucchesi in which all of the blood in
infarction. According to the autopsy,          the body clots and then dissolves could
Ernst’s arrhythmia was caused by severe        only occur if the body had not been pre-
atherosclerosis. Ernst’s heart showed          served as Ernst’s body was at the funeral
signs of prior ischemic episodes. Dr.          home. If a clot were there, it would not
Wheeler saw no evidence of plaque rup-         have dissolved, but would have been pre-
ture or fissure, which is necessary for a      served.
thrombus to form. In conducting the au-           Dr. Wheeler testified that the possibility
topsy, Dr. Araneta made slices of the ar-      of paramedics breaking up a clot through
teries that were one to two millimeters        CPR is ‘‘a preposterous notion.’’ There is
thick, which is the best way for a patholo-    no support in scientific or medical litera-
gist to find a clot. Despite a thorough        ture for such a theory. He has neither
examination of very thin slices of Ernst’s     independently learned of CPR dislodging
coronary arteries, Dr. Araneta did not find    or fragmenting a clot, nor has he read any
a blood clot. If a clot had been present,      anecdotal case reports supporting the the-
she would have been able to see it.            ory. After hearing Dr. Araneta’s and Dr.
  It is not at all uncommon to find on         Lucchesi’s testimony, he researched the
autopsy severe atherosclerosis, but no clot    possibility of CPR’s dislodging a clot and
or myocardial infarction. With the degree      found no scientific or medical support for
of atherosclerosis Ernst experienced in        the theory. Even if CPR could theoreti-
two coronary arteries, he was susceptible      cally have dislodged a clot, it could not
to an arrhythmia at any time. The artery       have dislodged a clot in Ernst’s arteries
in which Ernst experienced severe athero-      because the calcified plaque made his ar-
sclerosis is the one most associated with      teries too hard to succumb to pressure
sudden death. The plaque had been build-       from CPR compressions. In other words,
ing up in Ernst’s arteries for decades.        if Dr. Araneta’s knife could not cut the
Blood clots form in arteries when plaque       arteries, they could not have succumbed to
                              MERCK & CO., INC. v. ERNST                                Tex.   95
                       Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

pressure of CPR compressions to the de-              fibrillation, which is the type of arrhythmia
gree that a possible blood clot could have           that caused Ernst’s death. The experts
been dislodged. Not only is there no sci-            agree that cardiac arrhythmia can occur
entific support for the theory, but Dr.              without a blood clot. With regard to cardi-
Wheeler opined, ‘‘I don’t think it makes             ac risk factors, Dr. Pratt testified, ‘‘Risk
sense from an anatomic standpoint as                 factors are something that matter when
well.’’                                              someone is alive. Once we know at autop-
  As to the theory of the clot breaking              sy they have moderate to severe athero-
into small pieces, a blood clot is not brittle,      sclerosis, then whether or not they were
but is supple, like a piece of bubble gum,           identified adequately in life really doesn’t
making it almost impossible to break into            matter.’’
small pieces. Further, Dr. Wheeler exam-
ined Dr. Araneta’s slides, and, if the clot             Within reasonable medical probability,
had broken into several tiny pieces, he              Ernst died of ventricular fibrillation
would have been able to see them under               brought on by moderate to severe athero-
the microscope. Dr. Wheeler re-examined              sclerosis. The atherosclerosis led to an
the small arteries in the heart after hear-          ischemia, which triggered the life-threat-
ing plaintiff’s experts’ testimony, and,             ening arrhythmia. The paramedics found
again did not see evidence of a clot. Not            evidence of very broad ventricular tachy-
only was there no clot, but there was no             cardia and ventricular fibrillation. There
rupture or fissure of the atherosclerotic            is no evidence at all that Ernst had a
plaque necessary to formation of a clot.             myocardial infarction. Patients who die
Dr. Wheeler opined that Ernst’s death was            within one hour of the onset of symptoms
caused by severe atherosclerosis, which led          are much more likely to have ventricular
to a fatal arrhythmia.                               fibrillation due to ischemia, not due to
Dr. Craig Pratt                                      myocardial infarction. ‘‘[T]he number-one
   Dr. Craig Pratt is the director of the            primary driver of his arrhythmia event
coronary care unit at Methodist Hospital, a          was his severe underlying atherosclerosis.’’
professor of medicine at Baylor College of           It is ‘‘impossible to imagine’’ that the
Medicine, and the director of research at            body’s natural clot-dissolving system,
the DeBakey Heart Center. He testified               which ordinarily takes 24 to 48 hours to
that ischemia is an imbalance in the heart           dissolve a clot, would have impacted
muscle that results from a significant               Ernst’s situation. Vioxx did not play a
blockage in one of the coronary arteries.            role in Ernst’s death.
Atherosclerosis is a process in which
blockage builds up on the inside of arter-
                                                       C.   Legal Sufficiency of the Evidence
ies, frequently leading to ischemia. Clot-
                                                               on Specific Causation
busting drugs are very effective, but usual-
ly take 60 to 90 minutes to dissolve, or                [5, 6] Causation in toxic tort cases is
lyse, a clot.                                        discussed in terms of general and specific
  Ernst had moderate to severe stenosis              causation. Havner, 953 S.W.2d at 714.
in two of his coronary arteries. The ex-             General causation describes whether a
tent of the blockage in Ernst’s arteries             substance is capable of causing a particular
was not known until after his death. Ath-            injury or condition in the general popula-
erosclerosis in the coronary arteries is the         tion, while specific causation describes
most common foundation for ventricular               whether a substance caused a particular
96      Tex.          296 SOUTH WESTERN REPORTER, 3d SERIES


individual’s injury.7 Id. In many cases, as         that ‘‘[ventricular fibrillation] by itself [is]
in this case, it is impossible to present           not a clotting problem.’’
direct evidence that the substance caused              Ernst further relies on the testimony of
a litigant’s injury. Id. at 715. Proving            Dr. Egilman, who testified that Vioxx was
one type of causation does not necessarily          a contributing cause to Ernst’s death. In
prove the other, and both are needed for a          explaining how Vioxx contributed to
plaintiff in a toxic-tort suit to prevail.          Ernst’s death, Dr. Egilman explained,
Coastal Tankships U.S.A., Inc. v.                   ‘‘The Vioxx got into his blood. It was in
Anderson, 87 S.W.3d 591, 602 (Tex.App.-             his blood at the time he had his heart
Houston [1st Dist.] 2002, pet. denied).             attack. It prevented the blood thinner
‘‘[T]o survive a legal sufficiency review, a        from unclogging a clot or prevented it
claimant must do more than simply intro-            from plaquing, and that he had a heart
duce into evidence epidemiological studies          attack because of not enough oxygen get-
that show a substantially elevated risk. A          ting by when he had a clot.’’ Dr. Egil-
claimant must show that he or she is simi-          man’s testimony assumes that (1) a clot
lar to those in the studies.’’ Havner, 953          was found, and (2) Mr. Ernst suffered a
S.W.2d at 720. In the case of Vioxx, the            heart attack, or myocardial infarction. Be-
claimant must show he suffered the injury           cause there was no evidence of clot or
Vioxx is alleged to cause, i.e., a thrombolic       myocardial infarction, Dr. Egilman’s con-
cardiosvascular event. Further, if there            clusion is based on a false assumption.
are other plausible causes of the injury or            Another of Ernst’s experts, Dr. Weiner,
conditions that could be negated, the plain-        testified that Vioxx was a ‘‘significant con-
tiff must offer evidence excluding those            tributing factor’’ in Ernst’s death. Dr.
causes with reasonable certainty. Id.               Weiner’s testimony was based on the fact
                                                    that, in his opinion, Ernst ‘‘had a cardiac
   [7] Each expert who testified on the             arrest. And this is part of the spectrum of
issue of specific causation testified that          acute ischemic events—in other words,
Ernst’s death was caused by an ‘‘acute              events where suddenly the heart doesn’t
ischemic event.’’ In reciting her experts’          get enough blood.’’ Dr. Weiner also testi-
testimony as evidence of causation, Ernst           fied that Ernst’s arrhythmia was caused
equates an ‘‘acute ischemic event’’ with a          by ischemia, or an inadequate blood flow to
‘‘clot.’’ The two terms are not equivalent.         the heart. Dr. Weiner’s opinion assumes,
Ernst’s own expert, Dr. Weiner, defined             without evidence, that the inadequate
an acute ischemic event as ‘‘events where           blood flow was caused by a clot. Further,
suddenly the heart doesn’t get enough               Dr. Weiner admitted that he could not
blood.’’ There are several possible causes          testify with certainty that Ernst suffered a
of ischemia; not all are caused by blood            myocardial infarction. He also admitted
clots. Even Ernst’s experts testified that          that the autopsy report contained no evi-
arrhythmias can occur without thrombotic            dence of a clot.
causes. Dr. Weiner testified that, ‘‘Ar-               [8, 9] Ernst also relies on circumstan-
rhythmias can occur completely unrelated            tial evidence that a clot could have been
to heart attacks.’’ Dr. Araneta testified           present, then could have disappeared

7.     There is some evidence that Vioxx use at a     considering the appropriate standard of re-
     certain dose and duration is associated with     view, we conclude there is some evidence to
     an increased risk of thrombotic cardiovascu-     support a finding of general causation.
     lar events. After reviewing the evidence and
                              MERCK & CO., INC. v. ERNST                                Tex.   97
                       Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

through various means prior to the autop-               [10–12] To be considered reliable cir-
sy. In claims supported by only meager               cumstantial evidence of causation, an ex-
circumstantial evidence, the evidence does           pert’s opinion must be independently eval-
not rise above a scintilla if jurors would           uated to determine whether the opinion is
have to guess whether a vital fact exists.           reliable. Havner, 953 S.W.2d at 713–14.
City of Keller, 168 S.W.3d at 813. When              An expert’s bare opinion will not suffice to
the circumstances are equally consistent             support a jury’s verdict. Id. at 711. The
with either of two facts, neither fact may           substance of the testimony must be con-
be inferred. Id. When the circumstantial             sidered. Id. Factors to which a reviewing
evidence of a vital fact is meager, we must          court should look in determining the relia-
consider not just favorable but all the cir-         bility of scientific testimony are: (1) the
cumstantial evidence, and competing infer-           extent to which the theory has been or
ences as well. Id. at 814. Therefore, we             can be tested; (2) the extent to which the
address the circumstantial evidence that             technique relies upon the subjective inter-
although a clot was not found, it could have         pretation of the expert; (3) whether the
existed, then disappeared.                           theory has been subjected to peer review
   First, Dr. Araneta opined that a clot             and/or publication; (4) the technique’s po-
could have naturally dissolved through a             tential rate of error; (5) whether the un-
process called fibrinolysis. However, Dr.            derlying theory or technique has been
Araneta admitted that she would not ex-              generally accepted as valid by the rele-
pect a clot to naturally dissolve after              vant scientific community; (6) the nonju-
death. Dr. Lucchesi explained that certain           dicial uses that have been made of the
types of clots could naturally move                  theory or technique; and (7) any other
through the blood vessels, but did not               factor that is helpful to determine the reli-
specify how quickly this process could take          ability of the scientific evidence. Id. at
place in the body. Contrary to Dr. Arane-            714 (citing E.I. duPont de Nemours and
ta’s and Dr. Lucchesi’s testimony, Dr.               Co. v. Robinson, 923 S.W.2d 549, 557
Pratt testified that the possibility of a clot       (Tex.1995)). Causation opinions based on
dissolving on its own was not a viable               possibility, speculation, and surmise are
hypothesis because the natural process of            no evidence. Havner, 953 S.W.2d at 711–
fibrinolysis takes 24 to 48 hours and only           12. Expert opinions must be supported
continues while the patient is alive.                by facts in evidence, not conjecture.
                                                     Marathon Corp. v. Pitzner, 106 S.W.3d
   Next, Dr. Araneta and Dr. Lucchesi
                                                     724, 729 (Tex.2003).
speculated that vigorous CPR could have
dislodged a blood clot or caused it to frag-            Dr. Araneta’s and Dr. Lucchesi’s opin-
ment into such small pieces that it could            ions are not supported by scientifically re-
not be detected on autopsy. Dr. Araneta              liable facts in evidence. Ernst’s experts
testified that emboli could have been dis-           postulate that Mr. Ernst suffered a throm-
lodged and fragmented into such small                botic cardiovascular event, but at the time
pieces that she could not have seen them             of his death, less than one hour later, the
on her microscope. She described this                thrombus had been dislodged and frag-
theory as a ‘‘guess,’’ her ‘‘estimate,’’ and a       mented into such small pieces that it could
‘‘possibility.’’ Dr. Lucchesi admitted that          not be seen under a microscope. Because
he was aware of no published literature              there is no evidence that a clot existed and
suggesting that CPR could dislodge or                was dislodged, the experts’ opinions are
move clots.                                          mere speculation. Moreover, we cannot
98   Tex.          296 SOUTH WESTERN REPORTER, 3d SERIES


disregard Dr. Wheeler’s uncontroverted           statement, appellee seems to imply that
testimony that there is no support in scien-     sudden cardiac death is always the result
tific or medical literature for such a theo-     of a myocardial infarction. Appellee’s own
ry. We also cannot disregard Dr. Wheel-          expert, Dr. Weiner, explained that sudden
er’s uncontroverted testimony that Mr.           cardiac death is a general term meaning
Ernst’s atherosclerosis would have pre-          simply that a person died within six hours
vented the arteries from succumbing to           of the onset of symptoms. Death can re-
CPR compressions. Dr. Araneta testified          sult from arrhythmia, myocardial infarc-
that Mr. Ernst’s arteries were so hardened       tion, or other means related to the heart.
by atherosclerosis that they had to be           Ernst cites Merck’s expert, Dr. Wheeler,
soaked in acid before she could slice them       as stating that sudden cardiac death is
for examination. Dr. Wheeler explained           cardiac arrest. Dr. Wheeler’s testimony,
that if Mr. Ernst’s arteries were so hard        however, is no evidence that Ernst suf-
that they would have broken Dr. Araneta’s        fered a thrombotic event or even that he
knife, the arteries could not have suc-          suffered a myocardial infarction. In the
cumbed to the pressure of CPR compres-           testimony referred to, appellee’s attorney
sions to the degree that a possible blood        recited the Merck manual definition of car-
clot could have been dislodged.                  diac arrest as ‘‘absent or inadequate ven-
                                                 tricular contraction[.]’’    Dr. Wheeler
   Appellee points to Dr. Araneta’s testi-
                                                 agreed with that definition of cardiac ar-
mony that she rarely finds a clot on autop-
                                                 rest and explained that it encompassed
sy; therefore, appellee argues, the failure
                                                 many cardiac events, not just myocardial
to find a clot does not rule out the possibil-
                                                 infarction. He also agreed that some doc-
ity of a myocardial infarction. Dr. Arane-
                                                 tors use the terms ‘‘cardiac arrest’’ and
ta’s testimony, however, referred to cases
                                                 ‘‘sudden cardiac death’’ interchangeably.
in which the autopsy revealed pathological
                                                 He did not testify, however, that Ernst
evidence of myocardial infarction, i.e., dead
                                                 suffered a myocardial infarction triggered
or obviously infarcted muscle tissue. Ev-
                                                 by a blood clot.
ery expert agreed that Ernst died too
suddenly for his heart muscle tissue to                 D.   Differential Diagnosis
show signs of death. Moreover, the trial
                                                    Appellee argues that she introduced
court excluded any evidence that ingestion
                                                 some evidence of specific causation based
of Vioxx is associated with non-thrombotic
                                                 on the process of differential diagnosis. A
cardiovascular events because the theory
                                                 differential diagnosis is a clinical process
was not supported by scientifically reliable     whereby a doctor determines which of sev-
evidence. Ernst directs our attention to         eral potential diseases or injuries might
Dr. Araneta’s and Dr. Lucchesi’s opinions        have caused the patient’s symptoms by
that ‘‘something’’ triggered the ischemic        ruling out possible causes. Coastal Tank-
event suffered by Mr. Ernst. However,            ships, 87 S.W.3d at 604. In a differential
there is no competent evidence that a            diagnosis, a doctor compares a patient’s
blood clot triggered by Vioxx ingestion was      symptoms to symptoms associated with
the ‘‘something’’ causing his death.             known diseases, conducts physical exami-
   Ernst argues in her motion for rehear-        nations of the patient, collects data on the
ing that ‘‘[t]he statement that there is no      patient’s history and illness, and then ana-
direct evidence of a myocardial infarction       lyzes that data until reaching a final diag-
is misleading because Mr. Ernst died of a        nosis and makes a decision on how to
sudden cardiac death.’’ By making this           properly treat the patient’s injury or ill-
                              MERCK & CO., INC. v. ERNST                                  Tex.   99
                       Cite as 296 S.W.3d 81 (Tex.App.—Houston [14th Dist.] 2009)

ness. Id. In the case of an autopsy, unlike          mony that risk factors have no application
a differential diagnosis, the medical exam-          after death. Once an autopsy is per-
iner is not confined in her analysis to              formed, risk factors are not used to rule
observable outward symptoms; she is able             out potential causes of death.
to examine and test vital organs.                       Further, no expert ruled out atheroscle-
   Appellee contends that the failure to             rosis as a cause of Ernst’s arrhythmia. If
find a blood clot does not defeat causation,         there are other plausible causes of the
arguing that Dr. Lucchesi ruled out all              injury or condition that could be negated,
non-thrombotic causes of Ernst’s arrhyth-            the plaintiff must offer evidence excluding
mia through the use of differential diagno-          those causes with reasonable certainty.
sis. Dr. Lucchesi testified that Ernst was           Havner, 953 S.W.2d at 720. As part of her
under 65 years old, exercised regularly,             burden on specific causation, Ernst was
had not smoked for more than 15 years,               required to offer evidence excluding other
and did not have a family history of heart           causes of Mr. Ernst’s death with reason-
disease. Ernst contends that by ruling out           able certainty. Id. Ernst contends that
other potential risk factors for sudden car-         Dr. Lucchesi ruled out atherosclerosis as a
diac death, the evidence is legally sufficient       cause of Ernst’s death because he testified
to show that Mr. Ernst suffered a myocar-            that his atherosclerosis was ‘‘asymptomat-
dial infarction triggered by a blood clot.           ic.’’ However, Dr. Lucchesi and several
Dr. Lucchesi’s testimony that Ernst did              other experts explained that the term
not exhibit risk factors for cardiovascular          ‘‘asymptomatic’’ referred to Mr. Ernst’s
disease does not reasonably support the              ability to vigorously exercise and continue
conclusion that he suffered a thrombotic             his daily routine without suffering symp-
cardiovascular event.                                toms of atherosclerosis such as fatigue,
   Appellee misapprehends the nature of              shortness of breath, and chest pain.
differential diagnosis. This diagnostic pro-
cess does not contemplate the consider-                               III.   CONCLUSION
ation of risk factors; it is a consideration            [13] The epidemiological evidence sup-
of symptoms and potential causes. In argu-           ports the conclusion that Vioxx use at a
ing that there is some evidence through              certain dose and duration is associated
the use of differential diagnosis, Ernst ar-         with an increased risk of thrombotic car-
gues that her medical experts excluded all           diovascular events. The experts’ specula-
other risk factors for heart attack except           tion that a clot ‘‘could have’’ existed, but
the ‘‘Vioxx factor.’’ A differential diagno-         ‘‘could have’’ dissolved, been dislodged, or
sis requires the exclusion of the likely             fragmented gives rise to nothing more
causes until the most probable one is iso-           than conjecture. Facts from which an in-
lated. Praytor v. Ford Motor Co., 97                 ference may properly be drawn must be
S.W.3d 237, 244–45 (Tex.App.-Houston                 established by direct evidence, not by oth-
[14th Dist.] 2002, no pet.). Appellee ar-            er inferences. Entex v. Gonzalez, 94
gues ‘‘the experts were able to exclude all          S.W.3d 1, 8 (Tex.App.-Houston [14th Dist.]
risk factors for heart attacks except two—           2002, pet. denied) (‘‘a vital fact may not be
his gender and his daily intake of Vioxx.’’          established by piling inference upon infer-
The exclusion of risk factors, however,              ence’’). Crediting all favorable evidence
does not equate to the exclusion of causes.          that reasonable jurors could believe and
Further, we cannot ignore Dr. Pratt’s and            disregarding all contrary evidence except
Dr. Wheeler’s uncontradicted expert testi-           that which they could not ignore, we find
100      Tex.          296 SOUTH WESTERN REPORTER, 3d SERIES


no evidence that Mr. Ernst suffered a               and deeds were void insofar as they pur-
thrombotic cardiovascular event, i.e., a            ported to cover the royalty interest in the
myocardial infarction triggered by a blood          land. Record title owner appealed.
clot. Accordingly, Ernst failed to show             Holdings: The Court of Appeals, Charles
that the ingestion of Vioxx caused her              Seymore, J., held that:
husband’s death. Merck’s first issue is
sustained.8                                         (1) possibility of reverter under a mineral
                                                        lease was never severed from the sur-
  The judgment of the trial court is re-                face estate, which was sold at a tax
versed and judgment is rendered that ap-                foreclosure sale;
pellee take nothing.
                                                    (2) mineral rights and royalty interest in
                                                        land were not subject to foreclosure

                  ,                                     and thus not covered by sheriff’s deed;
                                                    (3) possibility of reverter in mineral estate
                                                        went to the purchaser of surface estate
                                                        at tax foreclosure sale;
                                                    (4) statute providing that challenger of tax
Pat POUNDS, Alvin Community College                     sale must first deposit into registry of
  District, Alvin Independent School                    court amount equal to delinquent taxes
  District, The City of Alvin, The City of              did not apply to owners of royalty in-
  Manvel, and Brazoria County, Appel-                   terest;
  lants,
                                                    (5) three-year limitations period for ac-
                         v.                             tions relating to property sold for taxes
        Megan L. JURGENS and Judy                       did not preclude appellees’ royalty
          Piper Leahy, Appellees.                       owners challenge to foreclosure;
                                                    (6) claim by owners of royalty interest
                No. 14–07–00830–CV.
                                                        challenging tax foreclosure sale was
           Court of Appeals of Texas,                   not governed by one year limitations
             Houston (14th Dist.).                      period; and
                   June 18, 2009.                   (7) limitation period for challenges to tax
                                                        sale applied to bar challenge by owner
         Rehearing En Banc Overruled
                                                        of royalty to sale of surface estate
                Nov. 19, 2009.
                                                        along with its possibility of reverter.
Background: Oil and gas company depos-
                                                    Affirmed as modified.
ited royalties relating to a parcel of land in
the Circuit Court’s registry, and inter-
pleaded the record title owner under a tax
deed and the alleged owners of the royalty          1. Judgment O181(2)
interest, each of whom answered and filed                On a traditional motion for summary
claims against the other. The 239th Dis-            judgment, the movant must show there is
trict Court, Brazoria County, Patrick Ed-           no genuine issue of material fact and he is
ward Sebesta, J., ruled that the tax sale           entitled to judgment as a matter of law.

8.    Because Merck’s first issue is dispositive,     the issues raised in appellee’s cross-appeal.
     we need not address its remaining issues or
                 NO. 10-0006




    PETITIONER’S BRIEF ON THE MERITS

______________________________________________




           APPENDIX B

    Opinion (May 29, 2008)
Texas Judiciary Online - HTML Opinion                                                      Page 1 of 8



    Send this document to a colleague                                            Close This Window




Reversed and Rendered and Opinion filed May 29, 2008.

                                                In The

                              Fourteenth Court of Appeals
                                            ____________

                                        NO. 14-06-00835-CV
                                          ____________

                                  MERCK & CO., INC., Appellant

                                                  V.

  CAROL A. ERNST, INDIVIDUALLY AND AS PERSONAL REPRESENTATIVE OF THE
           ESTATE OF ROBERT CHARLES ERNST, DECEASED, Appellee


                              On Appeal from the 23rd District Court
                                     Brazoria County, Texas
                               Trial Court Cause No. 19961*BH02


                                           OPINION


      Merck & Co., Inc., appeals from a jury verdict in a personal-injury and wrongful-death suit
filed by Carol Ernst in which she alleged that ingestion of Vioxx caused the sudden cardiac death of
her husband, Bob Ernst. Merck raises four issues in which it challenges the legal and factual
sufficiency of the evidence to support the jury=s verdict on causation, strict liability, negligence,
malice, and damages. Merck further contends that the trial court erred in instructing the jury and in
admitting certain evidence. Finding the evidence to be legally insufficient on the issue of causation,
we reverse the trial court=s judgment and render judgment that appellee take nothing.

                                          BACKGROUND

      Vioxx, known generically as rofecoxib, belongs to a general class of pain relievers known as
non-steroidal anti-inflammatory drugs (ANSAIDs@). NSAIDs work by inhibiting cyclooxygenase
(ACOX@), an enzyme that stimulates synthesis of prostaglandins, which are chemicals produced in the
body that promote certain effects. Traditional NSAIDs, such as Advil (ibuprofen), Aleve (naproxen),
and Voltaren (diclofenac), have been longstanding treatment options for patients needing relief from



http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567               6/2/2008
Texas Judiciary Online - HTML Opinion                                                        Page 2 of 8




      chronic or acute inflammation and pain associated with osteoarthritis, rheumatoid arthritis, and
other musculoskeletal conditions. This relief, however, has historically come with significant adverse
side effects. Specifically, traditional, or non-selective, NSAIDs greatly increase the risk of
gastrointestinal perforations, ulcers, and bleeds (APUBs@). This risk is further increased when high
doses are ingested, which is often necessary to remedy chronic or acute inflammation and pain.

      In the early 1990s, scientists discovered that the COX enzyme had two formsCCOX-1 and
COX-2Ceach of which appeared to have several distinct functions. Scientists believed that COX-1
affected the synthesis or production of prostaglandins responsible for protection of the stomach lining,
whereas COX-2 mediated the synthesis or production of prostaglandins responsible for pain and
inflammation. This belief led scientists to hypothesize that Aselective@ NSAIDs designed to inhibit
COX-2, but not COX-1, could offer the same pain relief as non-selective NSAIDs with a reduced risk
of fatal or debilitating PUBs. In addition, scientists believed that such drugs might also prove
beneficial for the prevention or treatment of other conditions, such as Alzheimer=s disease and certain
cancers where evidence suggests that inflammation may play a causative role. In light of these
scientific developments, pharmaceutical companies began developing new drugs known as ACOX-2
inhibitors@ or Acoxibs.@ Merck developed a COX-2 inhibitor and named it Vioxx.


      On November 23, 1998, Merck submitted a new drug application for Vioxx to the Food and
Drug Administration (AFDA@) and requested an expedited review of its application. Six months later,
on May 20, 1999, the FDA approved Vioxx as safe and effective for treatment of osteoarthritic pain,
menstrual pain, and acute pain based on the data and label supplied by Merck.

      Vioxx was subjected to a number of studies and tests both before and after its initial approval.
In March of 2000, Merck received the preliminary results of the Vioxx Gastrointestinal Outcomes
Research (AVIGOR@) study. VIGOR was an 8,000-patient trial designed to assess the relative
incidence of gastrointestinal PUBs in rheumatoid arthritis patients treated with Vioxx as compared to
those treated with the drug naproxen. While VIGOR demonstrated that patients taking Vioxx suffered
fewer serious gastrointestinal PUBs than patients taking naproxen, it also showed that patients on
Vioxx suffered a statistically significant increase of serious cardiovascular thrombotic events
                                      [1]
compared to patients taking naproxen.
     At the time of the VIGOR trial, two studies were being conducted on the effects of Vioxx on
Alzheimer=s patients. Those studies differed from the VIGOR trial in that the control group was taking
a placebo, not naproxen. After receiving the VIGOR results, Merck requested that the blind controls
be removed from those studies so that the scientists at Merck could investigate whether the patients
who were taking Vioxx in the Alzheimer=s studies experienced similar risks of cardiovascular




http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567                 6/2/2008
Texas Judiciary Online - HTML Opinion                                                         Page 3 of 8



       thrombotic events. The results of both of the Alzheimer=s studies revealed that patients taking
                                                                            [2]
Vioxx did not suffer a greater risk for cardiovascular thrombotic events.

       In light of the new data obtained in the VIGOR study, Merck submitted a proposed label change
for Vioxx to the FDA in June of 2000. After approximately 18 months of negotiation with Merck over
the content and organization of a new Vioxx label, the FDA approved a revised label on April 11,
2002. The new label incorporated the VIGOR data and noted that such data Ashould be taken into
consideration and caution should be exercised when Vioxx is used in patients with a medical history of
ischemic heart disease.@

       On September 23, 2004, an external safety board monitoring the results of a separate long-term
study entitled Adenomatous Polyp Prevention on Vioxx (AAPPROVe@), which was designed to assess
whether Vioxx could help prevent the recurrence of precancerous colon polyps, informed Merck that
the interim data from this study also showed a significantly increased rate of cardiovascular events in
                                                                [3]
the Vioxx arm as compared to the placebo arm of the study.            One week later, on September 30,
2004, Merck voluntarily withdrew Vioxx from the market.

       On September 15, 2000, Dr. Brent Wallace prescribed a daily 25-milligram dose of Vioxx to
Bob Ernst to alleviate tendinitis pain in Ernst=s hands. On May 6, 2001, approximately one hour after
Ernst went to bed, appellee noticed that he was unconscious and was having trouble breathing.
Appellee called emergency medical personnel and began cardiopulmonary resuscitation (ACPR@).
Ernst never regained consciousness and was pronounced dead shortly after arriving in the emergency
room. An autopsy was performed the following morning, and the report listed his death as cardiac
arrhythmia secondary to coronary atherosclerosis.


       Appellee sued Merck alleging that the ingestion of Vioxx caused the death of her husband.
Appellee=s suit was tried to a jury, which found that the design and marketing of Vioxx was defective,
that Merck=s negligence proximately caused Ernst=s death, and that the harm to Ernst resulted from
malice attributable to Merck. The jury awarded a total of $24,450,000 in compensatory damages and
assessed $229,000,000 in exemplary damages. Pursuant to section 41.008 of the Texas Civil Practice
and Remedies Code, the trial court reduced the assessment of exemplary damages and entered
judgment for appellee in the sum of $26,100,000. From that judgment, Merck appeals.

                                             CAUSATION

       In its first issue, Merck argues that appellee failed to present legally sufficient evidence of
causation. At trial, appellee alleged that Ernst=s death was caused by a blood clot triggered by Vioxx.
Merck first argues that appellee failed to present competent evidence of the existence of such a clot.



http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567                  6/2/2008
Texas Judiciary Online - HTML Opinion                                                          Page 4 of 8




       The test for legal sufficiency Amust always be whether the evidence at trial would enable
reasonable and fair-minded people to reach the verdict under review.@ City of Keller v. Wilson, 168
S.W.3d 802, 827 (Tex. 2005). Legal-sufficiency review in the proper light must credit favorable
evidence if reasonable jurors could, and disregard contrary evidence unless reasonable jurors could
not. Id. Although the reviewing court must consider evidence in the light most favorable to the
judgment, and indulge every reasonable inference that would support it, if the evidence permits only
one inference, neither jurors nor the reviewing court may disregard it. Id. at 822. We sustain a legal-
sufficiency challenge when the record discloses one of the following situations: (1) complete absence
of evidence establishing a vital fact; (2) the court is barred by rules of law or of evidence from giving
weight to the only evidence of a vital fact; (3) the evidence offered to prove a vital fact is no more than
a mere scintilla; or (4) the evidence conclusively establishes the opposite of a vital fact. Id. at 810.
     A thrombotic cardiovascular event is a myocardial infarction or sudden cardiac death triggered by
a thrombus, or blood clot. The autopsy report reflected that Ernst suffered mild to severe
atherosclerosis in the left anterior artery and left circumflex coronary arteries and listed the cause of
death as Acardiac arr[h]ythmia secondary to coronary atherosclerosis.@ Both parties= experts testified
that the usual cause of a myocardial infarction is a blood clot formed in response to a rupture or fissure
of atherosclerotic plaque in the inner lining of the artery. It is undisputed that no blood clot or fissure
of atherosclerotic plaque was found during the autopsy.

       Appellee=s theory of liability is that Vioxx increases the risk of thrombotic cardiovascular
events. A key component of this theory is what has become known as the Fitzgerald hypothesis,
which was first posited by Garret Fitzgerald, a researcher at Merck Research Laboratories. Toward the
end of 1997, Merck was studying the renal effects of Vioxx. In measuring urinary output of patients
taking Vioxx, Fitzgerald found a decrease in prostaglandin metabolites, indicating the possibility of an
imbalance of prostacyclin and thromboxane. Fitzgerald theorized that Vioxx creates an imbalance
between thromboxane and prostacylcin in the blood vessels. Thromboxane promotes platelet
aggregation, vessel constriction, and proliferation of smooth muscle cells. Prostacyclin, by contrast,
opposes the action of thromboxane inhibiting platelet aggregation, facilitating vasodilation, and
preventing proliferation of smooth muscle cells. In blocking COX-2, Vioxx also blocks prostacyclin;
therefore, Fitzgerald hypothesized, the inhibition of COX-2 promotes an imbalance of prostacyclin and
                                                                             [4]
thromboxane in the blood vessels, leading to the formation of blood clots. Appellee claims that this
mechanism ultimately led to the formation of a blood clot in Ernst=s coronary artery, causing his
sudden death.


       Appellee presented the testimony of three experts who testified that Vioxx caused Ernst=s




http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567                    6/2/2008
Texas Judiciary Online - HTML Opinion                                                            Page 5 of 8




       death. Dr. Benedict Lucchesi, a professor of pharmacology at the University of Michigan,
testified as follows: He has performed extensive research on COX-2 inhibitors, including Vioxx. He
testified extensively about the Fitzgerald hypothesis and the mechanism by which Vioxx can cause
thrombotic cardiovascular events. Ernst Adied of an arrhythmia, precipitated by a transient ischemic
event leading to ventricular fibrillation.@ An Aischemic event@ is an event that decreases the amount of
oxygen delivered to the heart. Dr. Lucchesi testified that Ernst most likely died when a blood clot
dissolved in the artery; he could have, however, suffered from very small clots that moved toward
smaller capillaries after causing the arrhythmia. No microemboli, or small blood clots, were found
during the autopsy.

       Dr. Isaac Weiner, a board-certified cardiologist, testified as follows: Vioxx was a significant
contributing factor in causing Ernst=s death because a thrombus, or blood clot, could have formed on
the underlying blockage in Ernst=s arteries and blocked blood flow to the heart. Dr. Weiner opined that
a blood clot might have dissolved through fibrinolysis. Vioxx does not affect the electrical impulses of
the heart directly, but leads to blockages in the arteries, which cause cardiovascular events.


       Dr. Maria Araneta, the assistant medical examiner who performed the autopsy, testified as
follows: Ernst=s left coronary arteries were 50- to 75-percent blocked by calcified plaque. She did not
find a blood clot when she performed the autopsy on Ernst=s body. She did not see evidence of a
myocardial infarction, or heart attack, because Ernst died within an hour of initially showing
symptoms. To affirmatively diagnose a myocardial infarction, the physician must observe either death
of the heart muscle tissue or the presence of cardiac enzymes. To observe either death of the tissue or
the presence of cardiac enzymes, the individual must have lived six to eighteen hours after suffering
                          [5]
the myocardial infarction.   The most likely cause of Ernst=s arrhythmia, Dr. Araneta testified, was an
acute ischemic event. As the potential cause of such an event, she said, ASomething blocked that artery
that was already narrowed, either a clot, a fissure, block or ruptured atheroma, none of which I saw,
but it B these things could be dissolved.@ According to Dr. Araneta, the clot could have spontaneously
dissolved, been dislodged through vigorous CPR, or could have been too small to detect on autopsy.
Not only did she not see a clot, but she observed no rupturing or fissuring of the atherosclerotic plaque
in the coronary arteries. In fact, the plaque in Ernst=s arteries was intact and so hard that the arteries
had to be de-calcified before they could be sectioned for autopsy. Contrary to her report, at trial Dr.
Araneta was Aleaning towards more likely than not@ that Ernst suffered a myocardial infarction.

       Admitting that there is no direct evidence of a blood clot or myocardial infarction, appellee
contends that there is sufficient circumstantial evidence to support the jury=s verdict. The
circumstantial evidence on which appellee relies is the testimony that a clot could have been present,
but could have disappeared through various means prior to the autopsy. In claims supported by only



http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567                     6/2/2008
Texas Judiciary Online - HTML Opinion                                                         Page 6 of 8




         meager circumstantial evidence, the evidence does not rise above a scintilla if jurors would have
to guess whether a vital fact exists. City of Keller, 168 S.W.3d at 813. When the circumstances are
equally consistent with either of two facts, neither fact may be inferred. Id. When the circumstantial
evidence of a vital fact is meager, we must consider not just favorable but all the circumstantial
evidence, and competing inferences as well. Id. at 814. Therefore, we address the circumstantial
evidence that although a clot was not found, it could have disappeared.

         First, Dr. Araneta opined that a clot could have naturally dissolved through a process called
fibrinolysis. However, Dr. Araneta admitted that she would not expect a clot to naturally dissolve after
death. Dr. Lucchesi explained that certain types of clots could naturally move through the blood
vessels, but did not specify how quickly this process could take place in the body. Dr. Craig Pratt,
director of the coronary care unit at Methodist Hospital and a professor of medicine at Baylor College
of Medicine, testified that the possibility of a clot dissolving on its own was not a viable hypothesis
because the natural process of fibrinolysis takes 24 to 48 hours and only continues while the patient is
alive. Further, clot-busting drugs, which are administered to accelerate this natural process, usually
take at least an hour to dissolve a clot.


         Next, Dr. Araneta and Dr. Lucchesi speculated that vigorous CPR could have dislodged a blood
clot or caused it to fragment into such small pieces that it could not be detected on autopsy. Dr.
Araneta testified that emboli could have been dislodged and fragmented into such small pieces that she
could not have seen them on her microscope. She described this theory as a Aguess,@ her Aestimate,@
and a Apossibility.@ Dr. Lucchesi admitted that he was aware of no published literature suggesting that
CPR could dislodge or move clots.

         An expert=s bare opinion will not suffice to support a jury=s verdict. Merrell Dow Pharm. v.
Havner, 953 S.W.2d 706, 711 (Tex. 1997). The substance of the testimony must be considered. Id.
Factors to which a reviewing court should look in determining the reliability of scientific testimony are:
(1) the extent to which the theory has been or can be tested; (2) the extent to which the technique relies
upon the subjective interpretation of the expert; (3) whether the theory has been subjected to peer
review and/or publication; (4) the technique=s potential rate of error; (5) whether the underlying theory
or technique has been generally accepted as valid by the relevant scientific community; (6) the
nonjudicial uses that have been made of the theory or technique; and (7) any other factor that is helpful
to determine the reliability of the scientific evidence. Id. at 714 (citing E.I. duPont de Nemours and
Co. v. Robinson, 923 S.W.2d 549, 557 (Tex. 1995)). Causation opinions based on possibility,
speculation, and surmise are no evidence. Havner, 953 S.W.2d at 711B12. Expert opinions must be
supported by facts in evidence, not conjecture. Marathon Corp. v. Pitzner, 106 S.W.3d 724, 729 (Tex.
2003).



http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567                   6/2/2008
Texas Judiciary Online - HTML Opinion                                                        Page 7 of 8




       Dr. Araneta=s and Dr. Lucchesi=s opinions are not supported by scientifically reliable facts in
evidence. Appellee=s experts postulate that Ernst suffered a thrombotic cardiovascular event, but at the
time of his death, less than one hour later, the thrombus had been dislodged and fragmented into such
small pieces that it could not be seen on a microscope. Because there is no proof that a clot existed
and was dislodged, the experts= opinions are mere speculation. Moreover, we cannot disregard Dr.
Thomas Wheeler=s uncontroverted testimony that there is no support in scientific or medical literature
                   [6]
for such a theory.     Dr. Wheeler conceded that he had neither independently learned of CPR
dislodging or fragmenting a clot, nor had he read any anecdotal case reports supporting the theory. He
further testified that after hearing Dr. Araneta=s and Dr. Lucchesi=s testimony, he researched the
possibility of CPR=s dislodging a clot and found no scientific or medical support for the theory. Dr.
Wheeler explained that if a clot had been fragmented by CPR, the anatomy of the heart would not have
permitted the fragments to travel down toward smaller capillaries, but would have pushed the
fragments to a position in the coronary artery where they could have been detected.

       Appellee contends that the failure to find a blood clot does not defeat causation, arguing that
Dr. Lucchesi ruled out all non-thrombotic causes of Ernst=s arrhythmia. Dr. Lucchesi testified that
Ernst was under 65 years old, exercised regularly, had not smoked for more than 15 years, and did not
have a family history of heart disease. Appellee contends that by ruling out other potential causes of
sudden cardiac death, the evidence is legally sufficient to show Ernst suffered a myocardial infarction
triggered by a blood clot. Dr. Lucchesi=s testimony that Ernst did not exhibit risk factors for
cardiovascular disease does not support the reasonable conclusion that Ernst suffered a thrombotic
cardiovascular event.


       Appellee points to Dr. Araneta=s testimony that she rarely finds a clot on autopsy; therefore,
appellee argues the failure to find a clot does not rule out the possibility of a myocardial infarction.
Dr. Araneta=s testimony, however, referred to cases in which the autopsy revealed pathological
evidence of myocardial infarction, i.e., dead or obviously infarcted muscle tissue. Every expert agreed
that Ernst died too suddenly for his heart muscle tissue to show signs of death. Moreover, the trial
court excluded any evidence that ingestion of Vioxx is associated with non-thrombotic cardiovascular
events because the theory was not supported by scientifically reliable evidence. The reliable expert
testimony supports the theory that Vioxx causes cardiovascular events by causing blood clots, which
lead to myocardial infarction or sudden cardiac death. See Merck & Co. v. Garza, 04-07-00234-CV
2008 WL 2037350 at *2 (Tex. App.CSan Antonio May 14, 2008, no pet. h.) (not released for
publication) (recognizing expert testimony that Athe formation of clots is the type of problem caused
by Vioxx@). Appellee directs our attention to Dr. Araneta=s and Dr. Lucchesi=s opinions that




http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567                  6/2/2008
Texas Judiciary Online - HTML Opinion                                                                       Page 8 of 8



        Asomething@ triggered the ischemic event suffered by Ernst. However, there is no competent
evidence that a blood clot triggered by Vioxx ingestion was the Asomething@ causing his death.

        The epidemiological evidence supports the conclusion that Vioxx use at a certain dose and
duration is associated with an increased risk of thrombotic cardiovascular events. The experts=
speculation that a clot Acould have@ existed, but Acould have@ dissolved, been dislodged, or fragmented
gives rise to nothing more than conjecture. Crediting all favorable evidence that reasonable jurors
could believe and disregarding all contrary evidence except that which they could not ignore, we find
no evidence that Ernst suffered a thrombotic cardiovascular event, i.e., a myocardial infarction
triggered by a blood clot. Accordingly, appellee failed to show that the ingestion of Vioxx caused her
                                                          [7]
husband=s death. Merck=s first issue is sustained.
      The judgment of the trial court is reversed and judgment is rendered that appellee take nothing.



                                                   /s/   Adele Hedges
                                                         Chief Justice


Judgment rendered and Opinion filed May 29, 2008.
Panel consists of Chief Justice Hedges and Justices Anderson and Brown.



        [1]
              Claire Bombardier, et al., Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in
Patients with Rheumatoid Arthritis, 343 New Eng. J. Med. 1520 (Nov. 23, 2000).


        [2]
            S.A. Reines, et. al., Rofecoxib No effect on Alzheimer=s Disease in a 1-year, Randomized, Blinded, Controlled
Study, 70 Neurology 66 (Sept. 16, 2003); Leon J. Thal, et. al., A Randomized, Double-Blind, Study of Rofecoxib in
Patients with Mild Cognitive Impairment, Neuropsychopharmacology (2005).

        [3]
          Robert S. Bresalier, et. al., Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma
Chemoprevention Trial, 352 New Eng. J. Med. 1092 (Mar. 17, 2005).

        [4]
              In 1998, Merck made the FDA advisory board aware of the Fitzgerald hypothesis. The FDA concluded that
while the hypothesis was a theoretical concern, there was no evidence that it was true.

        [5]
              All experts agreed on this conclusion.

        [6]
              Dr. Wheeler is the head of pathology at Baylor College of Medicine.

        [7]
             Because Merck=s first issue is dispositive, we need not address its remaining issues or the issues raised in
appellee=s cross-appeal.




http://www.14thcoa.courts.state.tx.us/opinions/htmlopinion.asp?OpinionId=84567                                 6/2/2008
                       NO. 10-0006




          PETITIONER’S BRIEF ON THE MERITS

      ______________________________________________




                 APPENDIX C

Order on Motion for Rehearing En Banc on
          the Second Opinion
           FOURTEENTH COURT OF APPEALS
           1307 San Jacinto, 11t h Floor
           HouS ton, Texas 77002

                                                                                Thl.lr~ay .     tlo v e.mer l!I, 2009


           RE :   Case No.   14 + 06~00B3S-CV                                                   $ 00.28'
Style:     Merck & Co . , Inc.                                .E
    v.     Carol A. Ernst, Individually and aB Representative of the Estate of Robert
         Charles Ernst, DeceaBed

     PleaBe be adviBed that on this date, the Court OVERRULED motion for en banc
consideration in the above cause (Yates, J.       FroBt, J . and Seymore. J. would grant en
banc review . ) (Boyce, J . and Sullivan, J . , recused . )


T. C. Case W 19961 · BH02                                                        ChriBtopher A. Prine, Clerk
                                     DAVID W. HOLMAN
                                     THE HOLMAN LAW FIRM            PC
                                     24 GREENWAY PLAZA
                                     SUITE 2000
                                     HOUSTON TX 77046



                                                                                         ,1
                               11",11",111 " •• 1, ,1 ... ,1 ,I" 1,1 .. 1,1" III ,.,11. 1 .11
                                                     .11 .1                          II
                 NO. 10-0006




    PETITIONER’S BRIEF ON THE MERITS

______________________________________________




           APPENDIX D

      Charge of the Court
                          •                                             •
                                    CAUSE NO. 19961*BH02

CAROL A. ERNST                                   §
                                                 §
v.                                               §
                                                  §
MERCK & CO. INC.                                 §


                                  CHARGE OF THE COURT

LADIES AND GENTLEMEN OF THE JURY:

        This case is submitted to you by asking questions about the facts, which you must decide
from the evidence you have heard in this trial. You are the sole judges of the credibi lity of the
witnesses and the weight to be given their testimony. but in matters oflaw. you must be governed
by the instructions in this charge. In discharging your responsibility on this jury, you will observe
all the instructions which have previously been given you. I shall now give you additional
instructions which you should carefully and strictly follow during your deliberations.

        ).     Do not let bias, prejudice or·sympathy play any part in your deliberations.

       2.       In arriving at your answers, consider only the evidence introduced here under oath
       and such exhibits. if any, as have been introduced for your consideration under the rulings
       of the court. that is, what you have seen and heard in this courtroom, together with the la\-V
       as given you by the court. In your deliberdtions, you will not consider or discuss anything
       that is not represented by the evidence in this case.

       3.     Since every answer that is required by the charge is important, no juror should stale
       or consider that any required answer is not important.

                                                                   li.
       4. .... _y9):~_must not 9~~i9.e who YQl,IJhin}(~h9.t!]qwin,.. mUh~n tryJo ~!,werJhe...9uestioJ!L
       accordingly. Simply answer the questions, and do not discuss nor concern yourselves with
       the.effect of your answers.

       5.       You will not decide the answer to a question by lot or by drawing straws. or by any
       other method of chance. Do not return a quotient verdict. A quotient verdict means that the
       jurors agree to abide by the result to be reached by adding together each juror's figures and
       dividing by the number ofjurors to get an average. Do not do any trading on your answers;
       that is, one juror should not agree to answer a certain question one way if others will agree
       to answer another question another way.




                                                 -1-
                                              EXHIBIT
                                        j        A
                         •                                               •
         6.       You may render your verdict upon the vote often or more members of the jury. The
         same ten or more of you must agree upon all of the answers made and to the entire verdict.
         You will not, therefore, enter into an agreement to be bound by a majority or any other vote
         of less than ten jurors. If the verdict and all ofthe answers therein are reached by unanimous
         agreement, the presiding j uror shall sign the verdict for the entire jury. If any juror disagrees
         as to any answer made by the verdict.. those jurors who 3b1Tf!e to all findings shall each sign
         the verdict.

         These instructions are given you because your conduct is subject to review the same a'ithat
 of the witnesses, parties. attorneys and the judge. (f it should be found that you have disregarded any
 of these instructions, it will be jury misconduct and it may require another trial by another jury; then
 all of our time will have been wasted.

       The presiding juror or any other who observes a violation of tbe court's instructions shall
 immediately warn the one who is violating the same and caution the juror not to do so again.

        When words are used in this charge in a sense that varies from the meaning commonly
 understood, you are, given a proper legal definition. which you are bound to accept in place of any
 other meaning.

        Answer "Yes" or "No" to all questions unless otherwise instructed. A "Yes" answer must
 be based on a preponderance ofthe evidence unless otherwise instructed. If you do not find that a
 preponderance of the evidence supports a "Yes" answer, then answer "No".

         The lenn "preponderance of the evidence';' means the greater weight and degree of credible
  evidence admitted in this case. Whenever a question requires an answer other than "Yes" or "No."
. your answer must be based on a preponderance oftbe evidence unless otherwise instructed.

                                            DEFINITIONS

       "Negligence" means failure to use ordinary care, that is. failing to do that which a person of
ordinary prudence would have done under the same or similar circumstances or doing that which a
person of ordinary prudence would not have done under the same or similar circumstance-so

       "Ordinary care" means that degree of care that would be used by a person of ordinary
prudence under the same or similar circumstances.

        "Proximate cause" means that cause which, in a natural and continuous sequence. produces
an event, and without which cause such event would not have occurred .. In order to be a proximate
cause, the act or omission complained of must be such that a person using ordinary care would have
foreseen that the event, or some similar event, might reasonably result therefrom. There may be
more than one proximate cause of an event.


                                                   -2-




                                                                                                        006R02
                       •                                            •
       "Producing cause" means an efficient, exciting, or contributing cause that, in a natural
sequence. produces the i(\jury. There may be more than one producing cause.

         A fact may be established by "direct evidence" or by "circumstantial evidence" or both. A
fact is estabHshedby direct evidence when proved by documentary evidence or by witnesses who
saw the act done or heard the words spoken. A fact is established by -circumstantial evidence when
it may be fairly and reasonably inferred from other facts proved.

        During trial1t was permissible for you to take notes. You may carry those notes to the jury
room for your personal use during deliberation on the court' s charge. You may not share these notes
with other jurors. Your personal recollection of the evidence takes precedence over any notes you
have taken. A juror may not rely on the notes of another juror. If you disagree about the evidence,
the presiding juror may apply to the court and have the court reporter's notes reud to the jury.




                                               ·3·
                        •                                            •
Question No. _1_

       Was there a defect in the marketing of VIOXX® at the time it left the possession of Merck
& Co., Inc. that was a producing cause of the death of Bob Ernst?

        A "marketing defect" with respect to the product means the failure to give adequate warnings
of the product's dangers that were known or by the application of reasonably developed human skill
and foresight should have been known or failure to give adequate instructions to avoid such dangers,
which failure rendered the product unreasonably dangerous as marketed.

        "Adequate" warnings and instructions mean warnings and instructions given in a form that
could reasonably be expected to catch the attention of a reasonably prudent physician in the
circumstances of the product's use; and the content of the warnings and instructions must be
comprehensible to the average physician and must convey a fair indication of the nature and extent
of the danger and how to avoid it to the mind of a reasonably prudent physician.

       An "unreasonably dangerous" product is one that is dangerous to an extent beyond that which
would be contemplated by the ordinary physician with the ordinary knowledge common to the
medical community as to the product's characteristics.

Answer "Yes" or "No."

         ·'~q...I'J2~A'-'...!~_ _ _ _ _ __
Answer: _~




                                               -4-
                         e·                                            e
Question No. l

       Was there a design defect in VIOXX® at the time it left the possession of Merck & Co .. Inc.
that was a producing cause of the death of Boh Ernst?

       A "design defect" is a condition of the product that renders it unreasonably dangerous as
       desib'Tled, taking into consideration the utility of the product and the risk involved in its usc.
       For a design defect to exist there must have been a safer alternative design.

       "Safer alternative design" means a product design other than the one actually used that in
       reasonably probability --

                 (1) would have prevented or significantly reduced the risk of the death in question
                 without substantially impairing the product's utility and

              (2) was economically and technologically feasible at the time the produclleft the
              control of Merck & Co., Inc. by the application ofexisting or reasonably achievable
              scientific knowledge.

Answer "Yes" or "No."

Answer:   l~ Q4..1




                                                 -5-




                                                                                                    . · tC' . J.:>
                                                                                                      O
                                                                                                    Ot. v Rf r -
                         •                                        •
Question No. _3_


        Did the negligence, if any, of Merck & Co., Inc. proximateJy cause the death of Bob Ernst?

Answer "Yes" or "No."

Answer: _7-'-t~jltL/<.Io£.-_ _ __




                                              -6-
                       •                                            •
      If you have answered "Yes" to Questions 1, 2 or 3, then answer the following question.
Otherwise, do not answer the following question.


Question No.4.

        What sum of money, if paid now in cash, would fairly and reasonably compensate Carol
Ernst for her damages, if any. resulting from the death of Bob Ernst?

        Consider the elements of damages listed below and none other. Consider each element
separately. Do not award any sum of money on any element if you have otherwise. under some
other element, awarded a sum of money for the same loss. That is, do not compensate twice for the
same loss, if any. Do not include interest on any amount of damages you find.

       Answer separately, in dollars and cents, for damages, ifany.

       a.     Pecuniary loss sustained in the past.

              "Pecuniary loss" means the loss of the care, maintenance, support, services,.advice,
              counsel. and reasonable contributions of a pecuniary value that Carol Ernst. in
              reasonable probability, would have received from Bob Ernst had he lived.

      Answer:     Jt   /00) 000. ~'O

      b.      Pecuniary ]oss that, in reasonable probability, will be sustained in the future.

      Answer:     -1.3 5'0) 000. •',
      c.      Loss of companionship and society sustained in the past.

             "Loss of companionship and society" means the loss of the positive benefits flowing
             from the love, comfort, companionship. and society that Carol Ernst, in reasonably
             probability, would have received from Bob Ernst, had he lived.

      Answer: _   .1   QL ~~

      d.     Loss of companionship and society that in reasonable probability. will be sustained
             in the future.




                                              -7-




                                                                                                 006F~O'I'
                      •                                            •
       e.      Mental anguish sustained in the past.

               "Mental anguish" means the emotional pain; tonnent. and suffering experienced by
               Carol Ernst because of the death of Bob Ernst.



       f·      Mental anguish that, in reasonable probability, will be sustained in the future.

       Answer:   .1   . ~~
                      J~

       In detennining damages for elements c, d. e and f, you may consider the relationship between
Carol Ernst and Bob Ernst, their living arrangements, any extended absences from one another, the
hannony of their family relations. and their common interests and activities.




                                               -8-
                        •                                            •
       If you have answered '·Yes'· to Questions I, 2 or 3 and you have inserted a sum of money
in answer to Question 4, then answer the following question. Otherwise. do not answer the
following question.

Question No.5

       Do you find by clear and convincing evidence that the hann to Bob Ernst resulted from
malice attributable to Merck & Co., Inc.?

          "Clear and convincing evidence" means the measure or degree of proof that produces a jirm
          belief or conviction of the truth of the allegations sought to be established.

          "Malice" means an act or omission by Merck & Co., Inc.,

                 (a) which when viewed objectively from the standpoint of Merck & Co. lnc. at the
                 time ofits occurrence involves an extreme degree ofrisk, considering the probability
                 and magnitude of the potentia) hann to others; and

                (b) of which Merck & Co., Inc. had actual subjective awareness of the risk involved.
                but nevertheless proceeded with conscious indifference to the rights. safety or
                welfare of others.

         In answering this question. you may consider only the conduct of the following; (1) a vice-
principal of Merck & Co., Inc.; or (2) a director, officer, employee or agent of Merck & Co .. Inc who
was employed in a managerial capacity and was acting in the scope ofthat managerial capacity. 1\
"vice-principal" of a corporation is a person who has the authority to hire, discharge and direct
employees or who has the authority to manage the entire corporation or a department or division of
its buisness.

Answer "Yes" or "No."

Answer:     '-?/g,v




                                                -9-
                            •                                             •
       If you have answered "yes" to Question No.5, then answer Question No.6. Otherwise. do
not answer Question No.6.


       Question No.6

       What sum of money, if any, should be assessed against Merck & Co .. Inc. and awarded to
Carol Ernst as exemplary damages for the death of Bob Ernst?

      "Exemplary damages" means any damages awarded as a penalty or by way of punishment.
Exemplary damages includes punitive damages.

        In determining the amount of exemplary damages, you shall consider evidence. if any,
relating to --

        a.       the nature of the wrong;

        b.           thl;! character of the conduct involved;

        c.           the degree of cUlpability of Merck & Co., Inc.~

        d.           the situation and sensibilities of the parties concerned:

        e.           the extent to which such conduct offends a public sense ofjustice and propriety; and

        [.           the net worth of Merck & Co., Inc.

       Answer in dollars and cents, ifany.

                             -     . .AI!'   .
       $     ·. jj     "U9~·




                                                       ';10-
                        •                                              •
        After you retire to the jury room, you will select your own presiding juror• and then you will
deliberate upon your answers to the questions asked.

       It is the duty of the presiding juror·

        1.     to preside during your deliberations.

       2.      to see that your deliberations are conducted in an orderly manner and in accordance
               with the instructions in this charge.

        3.     to write out and hand to the bailiffany communications concerning the case that you
               desire to have delivered to the judge,

       4.      to vote on the questions,

       5.      to write your answers to the questions in the spaces provided, and

       6.      to certify to your verdict in the space provided for the presiding juror's signature or
               to obtain the signatures of all the jurors who agree with the verdict ifyour verdict is
               less than unanimous.

        You should not discuss the case with anyone, not even with other members of the jury, unless
you are all present and assembled in the jury room. Should anyone attempt to talk to you about the
case before the verdict is returned, whether at the courthouse, at your home, or elsewhere, please
inform the judge ofthis fact.

         When you have answered all the questions you are required to answer under the instructions
of the judge and your presiding juror has placed your answers in the spaces provided and signed the ·
verdict as presidingjuror or obtained the signatures, you will infonn the baiJiffat the door of the jury
room that you have reached a verdict. and then you win .return into the court with your verdict.




                                                        JUDGE PRESIDING
                                                                  e-l1-Q.S




                                                 -11·
                        •                                          •
                                            Certificate

       We, the jury. have answered the above and foregoing questions as herein indicated. and
herewith return same into court as our verdict.

                        (To be signed by the pTesiding,iuror if unanimous)




                                                      PRESIDING JUROR




                                                    -\2-
                 NO. 10-0006




    PETITIONER’S BRIEF ON THE MERITS

______________________________________________




           APPENDIX E

          Final Judgment
                               •                                          •
                                         CAUSE NO. 19961·BH02

 ~ CAROL A. ERNST et. aI.                          §       IN THE DISTRICT COURT OF /:'

If   VS.
     MERCK & CO., INC.
                                                   §
                                                   §
                                                   §
                                                   §
                                                                                 ~t
                                                           BRAZORIA COUNTY, TEXAS ~,o'c"
                                                                                        I(

                                                           23rd JUDICIAL DISTRICT CIl"'IHIrI.,.
                                                                                                   _l
                                                                                                  '" W
                                                                                                   .1_
                                                                                                                    oco_{.
                                                                                                                          '"
                                                                                                                               1$ b
                                                                                                             ~J ln~·~·'-.......'
                                                                                       81' .      . "C:·'tti-Y'           ut/6
                                                                                                  Cf         I)~l:fyf:-
                                                                                                             ~~.
                                           FINAL JUDGMENT                                               .    ~Co.,li.
                                                                                                                  o~ e.tofs
                                                                                                                                'II,."
            On July 11, 2005, this case was called for trial. Plaintiff Carol Ernst appeared through her

     attorney and announced ready for trial. Defendant Merck & Co., Inc. appeared through its attorney

     and announced ready for trial.

            After a jury was impaneled and sworn, it heard evidence and arguments of counsel. In

     response to the jury charge, the jury made findings that the Court received, filed, and entered of

     record. The questions submitted to the jury and the jury's findings are attached as Exhibit A and

     incorporated by reference.

            The court hereby renders judgment for Plaintiff as follows:

            1.      The Court orders that Plaintiff recover from Defendant the sum of $26,100,000.00.

     The Court awards pre-judgment interest on damages sustained in the past ($4,100,000.00) at the

     annual rate of7.5 percent simple interest in the total sum of$1,248,534.25. The Court also awards

     court costs and post-judgment interest on the total amount of the judgment at the annual rate of 7.5

     percent compounded annually.

            2.      This is a suit for personal injury and prejudgment interest is governed by Texas

     Finance Code section 304.1 01 et seq. Prejudgment interest began accruing the date the lawsuit was

     filed against Defendant which was May 24, 2002, and stopped accruing on the day before the

     judgment was rendered which was June 14, 2006.




                                                                                                            0075:t6
                         •                                           •
       3.     The amount of prejudgment interest earned under Texas Finance Code Section

304.104 is not reduced under Section 304.105 because defendant did not make a written settlement

offer that complied with Section 304.106.

       4.     This judgment is final, disposes of all claims and all parties and is appealable.

       5.     The court orders execution to issue for this judgment.



Signed on   ~__ t   .:l,:!.   ,2006


                                                     The Honorable Ben Hardin




                                                                                             007517

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:33
posted:8/14/2012
language:Unknown
pages:114