LEVIN FISHBEIN SEDRAN BERMAN BY ARNOLD LEVIN ESQUIRE by sanmelody

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									LEVIN, FISHBEIN, SEDRAN & BERMAN
BY:    ARNOLD LEVIN, ESQUIRE
ATTORNEY I.D. NO.:     02280
DANIEL C. LEVIN, ESQUIRE
ATTORNEY I.D. NO.:     80013
510 Walnut Street
Suite 500
Philadelphia, PA 19106
(215) 592-1500

              IN THE COURT OF COMMON PLEAS - CIVIL TRIAL DIVISION
                            PHILADELPHIA COUNTY


 JERRY EUGENE LEWIS, ARTHUR CONNORS,
 NAOMI CARROLL, DIANE JACOBS, MILTON
 ANGERT, LORRAINE FOWLER, OCTAVIO
 QUINCHIA , TERRI FLOWERS AND LENORE                      AUGUST TERM, 2001
 DEL BUONO for themselves and all others
 similarly situated,
                                                          NO. 002353
                                Plaintiffs,
         v.

 BAYER AG, ET AL

                                Defendants.




                   PLAINTIFFS? MOTION FOR CLASS CERTIFICATION



       Pursuant to Rule 1702 of the Pennsylvania Rules of Civil Procedure, Plaintiffs, through

counsel, move this Court for certification of the following Classes:
CLASS I -- All persons in the Commonwealth of Pennsylvania, or their
estates, administrators or other legal representatives, heirs or
beneficiaries, who were prescribed and ingested the drug, Baycol, also
known as cerivastatin. This class seeks, among other relief, medical
monitoring benefits for inter alia, testing for CoQ10 depletion, elevated
CK levels and a chest x-ray to determine to what extent they may
suffer from latent injury or may develop injury in the future in order
to provide timely appropriate medical care. Incidental to the Court-
supervised monitoring program, plaintiffs seek to obtain
epidemiological research benefits for scientists to further understand
the effects of Baycol and other equitable relief including restitution for
the cost of the drug. Excluded from this class are all persons and
entities with claims for personal injury. Also excluded from this class
are the defendants, any entities in which the defendants have a
controlling interest, and all of their legal representatives, heirs, and
successors.



CLASS II -- All persons in the United States, its possessions and
territories, or their estates, administrators or other legal
representatives, heirs or beneficiaries, who were prescribed and
ingested the drug, Baycol, also known as cerivastatin. This class seeks,
among other relief, medical monitoring benefits for inter alia, testing
for CoQ10 depletion, elevated CK levels and a chest x-ray to determine
to what extent they may suffer from latent injury or may develop
injury in the future in order to provide timely appropriate medical
care. Incidental to the Court-supervised monitoring program,
plaintiffs seek to obtain epidemiological research benefits for scientists
to further understand the effects of Baycol and other equitable relief
including restitution for the cost of the drug. Excluded from this class
are all persons and entities with claims for personal injury. Also
excluded from this class are the defendants, any entities in which the
defendants have a controlling interest, and all of their legal
representatives, heirs, and successors.

CLASS III -- All persons in the United States, its possessions and
territories, or their estates, administrators or other legal


                                    2
             representatives, heirs or beneficiaries, who were prescribed and
             ingested the drug, Baycol, also known as cerivastatin, who now suffer
             from personal injury. This class represents all individuals who have
             suffered pain, swelling, debilitation, and other medical injuries.
             Included in this class are spouses and others entitled to loss of
             consortium, as well as dependents and others entitled to recover under
             the Wrongful Death or Survival statutes. This class seeks damages for
             personal injury, wrongful death, loss of consortium, etc.

             CLASS IV ? All persons in the Commonwealth of Pennsylvania, its
             possessions and territories, or their estates, administrators or other
             legal representatives, heirs or beneficiaries, who were prescribed and
             ingested the drug, Baycol, also known as cerivastatin, who now suffer
             from personal injury. This class represents all individuals who have
             suffered pain, swelling, debilitation, and other medical injuries.
             Included in this class are spouses and others entitled to loss of
             consortium, as well as dependents and others entitled to recover under
             the Wrongful Death or Survival statutes. This class seeks damages for
             personal injury, wrongful death, loss of consortium, etc.

     The grounds for this motion and the relief requested are set forth in the attached
memorandum of law.



Dated:                                      Respectfully submitted,

                                            LEVIN, FISHBEIN, SEDRAN & BERMAN




                                            _______________________________________
                                            Arnold Levin, Esquire, 02280
                                            Daniel C. Levin, Esquire, 80013
                                            510 Walnut Street, Suite 500
                                            Philadelphia, PA 19106

                                            Richard S. Lewis, Esquire


                                               3
COHEN, MILSTEIN, HAUSFELD & TOLL, P.L.L.C.
1100 New York Avenue, N.W.
West Tower - Suite 500
Washington, D.C. 20005

Neil D. Overholtz, Esquire
LEVIN, PAPANTONIO, THOMAS, MITCHELL,
EICHSNER & PROCTOR, P.A.
P.O. Box 12308
316 South Baylen Street
Pensacola, FL 32501

Lee B. Balefsky, Esquire
GREITZER & LOCKS
1500 Walnut Street, 20th Floor
Philadelphia, PA 19102




   4
James J. McHugh, Esquire
BEASLEY, CASEY & ERBSTEIN
1125 Walnut Street
Philadelphia, PA 19107

Sol H. Weiss, Esquire
ANAPOL , SCHWARTZ, WEISS,
COHAN, FELDMAN & SMALLEY, P.C.
1900 Delancey Place
Philadelphia, PA 19103

Michael Coren, Esquire
LEVY, ANGSTREICH, FINNEY, BALDANTE,
RUBENSTEIN & COREN, PC
1616 Walnut Street, 18th Floor
Philadelphia, PA 19103

Stephen A. Sheller, Esquire
SHELLER, LUDWIG & BADEY
1528 Walnut Street
3rd Floor
Philadelphia, PA 19102

Russell D. Henkin, Esquire
Berger & Montague, P.C.
1622 Locust Street
Philadelphia, PA 19103

Bernard M. Gross, Esquire
1515 Locust Street, 2nd Floor
Philadelphia, PA 19103

Robert Gibson, Esquire
LAW OFFICES OF ROBERT GIBSON
319 West Front Street
Media, PA 19063

Robert Sink, Esquire
LAW OFFICES OF ROBERT SINK
1417 Crosby Drive
Fort Washington, PA 19034

Michael Lombardi, Esquire
LOMBARDI AND LOMBARDI
1862 Oak Tree Road
P.O. Box 2065
Edison, NJ 08818
Kenneth Jacobson, Esquire

   5
22 West Front Street
Media, PA 19063

Mark C. Rifkin, Esquire
FELDMAN & RIFKIN
Jenkintown Plaza, LLP 230
101 Greenwood Avenue
Jenkintown, PA 19046

Dianne M. Nast, Esquire
RODA & NAST, P.C.
801 Estelle Drive
Lancaster, PA 17601

Elizabeth J. Cabraser, Esquire
LIEFF, CABRASER, HEIMANN & BERNSTEIN
Embarcadero Center West
275 Battery Street, 30th Fl.
San Francisco, CA 94111

Steven Fineman, Esquire
LIEFF, CABRASER, HEIMANN & BERNSTEIN
780 Third Avenue, 48th Floor
New York, NY 10017-2024

Samuel L. Davis, Esquire
DAVIS, SAPERSTEIN & SOLOMON
375 Cedar Lane
Teaneck, NJ 07666

Counsel for Plaintiffs




   6
LEVIN, FISHBEIN, SEDRAN & BERMAN
BY:    ARNOLD LEVIN, ESQUIRE
ATTORNEY I.D. NO.:     02280
DANIEL C. LEVIN, ESQUIRE
ATTORNEY I.D. NO.:     80013
510 Walnut Street
Suite 500
Philadelphia, PA 19106
(215) 592-1500

             IN THE COURT OF COMMON PLEAS - CIVIL TRIAL DIVISION
                           PHILADELPHIA COUNTY

 JERRY EUGENE LEWIS, ARTHUR CONNORS,
 NAOMI CARROLL, DIANE JACOBS, MILTON
 ANGERT, LORRAINE FOWLER, OCTAVIO
 QUINCHIA , TERRI FLOWERS AND LENORE                    AUGUST TERM, 2001
 DEL BUONO for themselves and all others
 similarly situated,
                                                        NO. 002353
                               Plaintiffs,
        v.

 BAYER AG, ET AL



                               Defendants.

                MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS?
                     MOTION FOR CLASS CERTIFICATION

I.     INTRODUCTION

       Defendants Bayer AG, Bayer Corporation, Glaxo Smithkline and Glaxo Smithkline, PLC

(?Defendants?) manufactured, promoted, marketed, sold and distributed Baycol, also referred to as

cerivastatin. Defendants marketed Baycol to consumers as safe and efficacious for the lowering of

cholesterol levels. Baycol was not safe. Baycol, which was primarily marketed in the .4 mg and
.8 mg strength, exposed its users to Rhabdomyolysis, life-threatening kidney disease, congestive heart

failure, severe myalgia and myopathy and other adverse medical conditions. Despite overwhelming

data from their own clinical and animal studies showing the drug has a propensity to cause serious

injury, Defendants aggressively promoted the drug as being safe and effective. As a result, it was

placed on the formularies of managed care and health maintenance organizations, and was

prescribed by thousands of unsuspecting physicians to their patients. Defendants knew of or should

have known of these adverse risks, yet they never warned patients and their physicians of these risks.

Ultimately, Defendants could not ignore the mounting numbers of Baycol users injured as a result of

their use of the drug, and, thus, the Defendants withdrew the drug from the market on August 8,

2001. As a result of Defendants? negligence, thousands of patients have developed the above injuries,

and hundreds of thousands are at risk. Thousands of patients are seeking legal redress, and the vast

majority of these lawsuits are in this venue.

        Many patients who have not sued need immediate medical monitoring consisting of

monitoring of CoQ10 levels, CK levels, and a chest x-ray. As explained below, depleted CoQ10 levels is

associated with myalgia, myopathy, rhabdomyolysis and congestive heart failure. The potential for

congestive heart failure necessitates a chest x-ray. These victims also need medical advice as to the

availability of appropriate alternative medications to control their cholesterol levels since they can no

longer use Baycol. Defendants failed to warn Baycol users of the critical importance of the same. As

Defendants failed to conduct appropriate clinical studies of this potentially lethal drug, plaintiffs seek


                                                    2
benefits for epidemilogical studies to understand the effects of Baycol. Finally, these consumers did

not get what they paid for, a safe drug. Thus, refund is appropriate. Without such medical

surveillance , the health of Baycol users quite obviously remains in jeopardy, and this Court will

witness and additional avalanche of litigation that can be prevented.

           Baycol users deserve, and should receive, notice of the fact that such immediate medical

surveillance is required. Given the facts here, and given the fact that there are millions of Baycol

users dispersed nationwide, a class action is the most efficient and effective mechanism in which to

provide this relief.

           Accordingly, Plaintiffs move for certification of the following proposed medical surveillance

classes:

                  CLASS I -- All persons in the Commonwealth of Pennsylvania, or their
                  estates, administrators or other legal representatives, heirs or
                  beneficiaries, who were prescribed and ingested the drug, Baycol, also
                  known as cerivastatin. This class seeks, among other relief, medical
                  monitoring benefits for inter alia, testing for CoQ10 depletion, elevated
                  CK levels and a chest x-ray to determine to what extent they may
                  suffer from latent injury or may develop injury in the future in order
                  to provide timely appropriate medical care. Incidental to the Court-
                  supervised monitoring program, plaintiffs seek to obtain
                  epidemiological research benefits for scientists to further understand
                  the effects of Baycol and other equitable relief including restitution for
                  the cost of the drug. Excluded from this class are all persons and
                  entities with claims for personal injury. Also excluded from this class
                  are the defendants, any entities in which the defendants have a
                  controlling interest, and all of their legal representatives, heirs, and
                  successors.



                                                      3
       CLASS II -- All persons in the United States, its possessions and
       territories, or their estates, administrators or other legal
       representatives, heirs or beneficiaries, who were prescribed and
       ingested the drug, Baycol, also known as cerivastatin. This class seeks,
       among other relief, medical monitoring benefits for inter alia, testing
       for CoQ10 depletion, elevated CK levels and a chest x-ray to determine
       to what extent they may suffer from latent injury or may develop
       injury in the future in order to provide timely appropriate medical
       care. Incidental to the Court-supervised monitoring program,
       plaintiffs seek to obtain epidemiological research benefits for scientists
       to further understand the effects of Baycol and other equitable relief
       including restitution for the cost of the drug. Excluded from this class
       are all persons and entities with claims for personal injury. Also
       excluded from this class are the defendants, any entities in which the
       defendants have a controlling interest, and all of their legal
       representatives, heirs, and successors.

Plaintiffs also move for the following personal injury classes. These classes
        represent victims who have manifested personal injuries as a result of
        ingesting Baycol. These classes include:
        CLASS III -- All persons in the United States, its possessions and
        territories, or their estates, administrators or other legal
        representatives, heirs or beneficiaries, who were prescribed and
        ingested the drug, Baycol, also known as cerivastatin who now suffer
        from personal injury. This class represents all individuals who have
        suffered pain, swelling, debilitation, and other medical injuries.
        Included in this class are spouses and others entitled to loss of
        consortium, as well as dependents and others entitled to recover under
        the Wrongful Death or Survival statutes. This class seeks damages for
        personal injury, wrongful death, loss of consortium, etc.

       CLASS IV ? All persons in the Commonwealth of Pennsylvania, its
       possessions and territories, or their estates, administrators or other
       legal representatives, heirs or beneficiaries, who were prescribed and
       ingested the drug, Baycol, also known as cerivastatin who now suffer
       from personal injury. This class represents all individuals who have


                                           4
                suffered pain, swelling, debilitation, and other medical injuries.
                Included in this case are spouses and others entitled to loss of
                consortium, as well as dependents and others entitled to recover under
                the Wrongful Death or Survival statutes. This class seeks damages for
                personal injury, wrongful death, loss of consortium, etc.

        The proposed classes satisfy all of the elements of Pa. R.C.P. 1702. The classes, which include

hundreds of thousands of Baycol users, are so numerous as to make joinder of all class members

impracticable. There exist common issues of fact and law as to all of the class claims. Moreover, the

class representatives? claims are typical of those of the members of the classes they seek to represent.

Likewise, the representative plaintiffs will fairly and adequately protect the interests of the classes they

seek to represent. Finally, these classes will provide a fair and efficient method for adjudication of

the controversy.

        Common issues predominate over individual questions in this case. Having the benefit of

comparing the purported classes to those certified in other cases such as In re: Diet drugs Products

Liability Litigation, 2000 WL 1222042 (E.D. Pa. 2000), it is clear that the size of the classes and the

lack of difficulties likely to be encountered in managing the class action favor class treatment.

Considering the national scope of this litigation, individual actions may result in inconsistent results

that create incompatible standards of conduct for the defendants or obstacles to plaintiffs' abilities to

proceed individually. The extent and nature of litigation already commenced in Philadelphia County

favor class treatment in this forum.          As Glaxosmithkline?s principle place of business is in

Philadelphia and Bayer conducts substantial business here, this forum is an appropriate venue for all


                                                     5
class members' claims. Finally, the Defendants have acted or refused to act on grounds generally

applicable to the classes, thereby making final equitable or declaratory relief appropriate with respect

to the classes.

II.     FACTUAL BACKGROUND

        Members have personal injuries as a result of their exposure to Baycol.
                                     [Classes III and IV]

        Baycol, a cholesterol-lowering drug made by Bayer, was withdrawn from the market on August

8, 2001, due to the unacceptable risk of a severe disorder called rhabdomyolysis, kidney dysfunction

and death associated with the drug?s use. Third Consolidated Substitute Class Action Complaint

(?Complaint?) ? 49-51; Approximately 700,000 consumers have used Baycol and 10.6 million new

and refilled prescriptions have been dispensed for Baycol in the year 2000. See Complaint ? 52.

Since Baycol was introduced in the United States in February it has generated hundreds of millions of

dollars in sales, including sales in excess of $550 million in the year 2000 alone. See Complaint ? 52.

        Rhabdomyolysis is an acute, sometimes fatal disease, marked by the destruction of muscles.

See Complaint ? 31-33. Statin drugs1 generally, and Baycol specifically, cause the membranes of

skeletal muscle tissue to leak or release myoglobin, and myoglobin is then absorbed into the blood

See id. The function of myoglobin in the muscle tissue is to receive oxygen from the blood and to


        1
            Statin drugs are cholesterol lowering drugs that operate by blocking a specific liver enzyme
that is involved in the synthesis of cholesterol; thus, these drugs are referred to as HMG-CoA reductase
inhibitors. See Complaint ? ? 11,12


                                                   6
circulate oxygen throughout the muscles. id. Once muscle tissue releases myoglobin into the blood

stream, however, muscle cannot hold onto oxygen, and weakness and pain in the muscle results. One

of the complications of the release of the myoglobin into the blood is kidney or renal failure. id.

Blood circulates through the kidneys which filter the blood, including the myoglobin, and then

circulate clean blood throughout the body. id. Increased levels of myoglobin in the kidneys are

responsible for blocking the kidneys and causing renal failure. id. Sufficient quantities of myoglobin

will block the tubules of the kidneys, which will interfere with the supply of blood and oxygen to the

kidneys and will cause a condition known as tubular necrosis, which will then lead to kidney failure.

id. Indeed, in a letter to Janet Woodcock, M.D., Director of the Center for Drug Evaluation and

Research at the FDA, the consumer advocacy group Public Citizen requested that the FDA require a

black box warning on all statins and reported that 772 cases of rhabdomyolysis and 52 cases of

rhabdomyolysis death in association with statins were reported to the FDA between October 1997

and December 2000. Baycol was reported in association with 387 of these injury reports and with 31

of the 52 deaths. Defendants confirmed that they have received reports of at least 1,000 cases of

muscle weakness and/or damages associated with the use of Baycol. Complaint ? 36.

       The risk of rhabdomyolysis is greater in patients taking a statin drug concurrently with

gemfibrozil (Lopid), an antihyperlipidemic drug, which decreases or reduces the fat in the blood and

lowers cholesterol as well. Complaint ? 33. While the risk of developing rhabdomyolysis from use of

most statin drugs that are prescribed as monotherapy is lower than, the risk of developing

                                                  7
rhabdomyolysis from use of a statin drug concomitantly with gemfibrozil increases substantially.

Complaint ? 30. Bayer failed to inform either doctors or consumers that the incidence of

rhabdomyolysis from Baycol was much higher than the reported incidence of rhabdomyolysis with any

other statins. See Complaint ? ? 42, 47, 50.    In fact, a review of the warning history of the drug

from 1998 through 2001 indicates that Bayer provided, as part of its package insert, information

which could arguably be understood to mean that the risk of rhabdomyolysis was even greater with

the other statins than with Baycol.

       Cerivastatin was originally approved by the FDA and cleared for marketing on June 26, 1997.

See Complaint ? 15. The drug was originally approved in dosages of 0.2 mg and 0.3 mg. See

Complaint ? 15. In July 1997, Bayer and SmithKline Beecham entered into a co-promotion

agreement for cerivastatin which obligated SmithKline Beecham to provide marketing, sales support

and other services in conjunction with cerivastatin.2 Complaint ? 22. Both companies made

cerivastatin available under the marketed name Baycol as of February 18, 1998. Bayer increased

Baycol?s dosage to 0.4 mg and received approval from the FDA for the increased dosage on May 24,

1999. The low doses turned out not to be effective and sales were low, so Bayer increased its dosage

to 0.8 mg, which was approved by the FDA on July 23, 2000. But before Bayer even sought approval

from the FDA for marketing an increased dosage of 0.8 mg tablets, reports of cases of rhabdomyolysis


       2
               Smithkline Beecham later merged with Glaxo Wellcome to form GlaxoSmithKline.
CSCAC ? 6.


                                                 8
had already been received by Bayer. Moreover, the promotional material used by Bayer in the

promotion, marketing and sale of Baycol, even the lower dosages of 0.2 mg and 0.3 mg, was cited by

the FDA in an October 25, 1999, letter it sent to Bayer to be ?...false, lacking in fair balance, or

otherwise misleading? because Bayer was implying that Baycol was superior to other statin drugs

because of its synthetic properties. Complaint ? 28

       Bayer?s voluntary removal of Baycol from the market occurred on August 8, 2001, and the

voluntary removal was communicated by Bayer in the medium of a ?Dear Healthcare Professional?

letter dated August 8, 2001. Complaint ? ? 49-51 Concurrent with the withdrawal of the drug from

the market, the United States Food and Drug Administration issued one of its ?Talk Papers? that

indicated that it had received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with

the use of Baycol, only 12 of which involved concomitant gemfibrozil use. Moreover, thousands of

individuals have suffered permanent injuries. Classes III and IV of Plaintiff?s Third Consolidated

Amended Class Action Complaint include individuals with manifested injuries.

All victims who have not manifested a diagnosable injury require medical monitoring. [Classes I
                                           and II]

       Not only does Baycol have an unreasonable risk of causing severe disorders including

rhabdomyolysis, kidney dysfunction and death associated with the drug use, Baycol is a statin drug

which lowers the liver?s ability to produce the coenzyme Q10 (CoQ10). See Generally Exhibit 1 of

Affidavit of Emile G. Bliznakov, M.D. CoQ10 is essential in the human body for cells to produce



                                                 9
energy. Id. Unfortunately, Baycol is a statin drug which reduces the level of CoQ10. The risk of

CoQ10 depletion include congestive heart failure, high blood pressure, angina, mitrovalve prolapse,

stroke, cardiac arrhythmias, cardiomyopathy, lack of energy, gingivitis and generalized weakening of

the immune system. Id.

        The attempt to reduce cardiovascular morbidity and mortality with statins is negated by lowering the

Co-Q10 level which is essential for cellular function. Bliznakov Affidavit at ? 6 attached as Exhibit 1, See

also Emil G. Bliznakov, M.D., Advances in Therapy, Biochemical and Clinical Consequences of

Inhibiting Co-Enzyme Q10 Biosynthesis by Lipid-Lowering HMG-CoA Reducate Inhibitors (Statins):

A Critical Overview (Volume XV, No. 4, July/August, 1998, at p. 219), attached as Exhibit ?2". 3 This

leads to mitochondrial injury. It is imperative that during extended therapy with statins, testing be done to

identify, among other things, depleted Co-Q10 levels, and supplements should be administered to support

cellular bioenergetic demand as well as minimize potential lipid peroxidative insult. Id. at 218 and Bliznakov

Affidavit at ? 9. Former Baycol users can be suffering from, or at risk of suffering from Rhabdomyolysis

and/or congestive heartfailure caused by depleted Co-Q10 levels and not be aware of it. Bliznakov Affidavit

at ? 10. Defendants knew that Baycol depleted Co-Q10 levels, yet never warned of this effect which can

lead to rhabdomylosis, myalgia, myopathy and/or congestive heart failure. See Bliznakov Affidavit at ? 6.

                                             CO -ENZYME Q 10



        3
        Ubiquinone is a lipid-soluble electron-transferring co-enzyme (Co-Enzyme Q10) in the
mitochondrial respiratory change.




                                                     10
        Co-Enzyme Q10 has characteristics similar to vitamins and, is essential to the healthy functioning of

an organism. Co-Q10 preserves cellular integrity and function. Bliznakov, Biomedical Land Clinical

Consequences of Inhibiting CoEnzyme Q10, at 218. Additionally, it prevents injury to DNA, lipids,

proteins and other molecules. Id. This slows down or prevents the development of many cardiovascular,

neoplastic and neurodegenertive diseases. Id. at 220 and Bliznakov Affidavit at ? 5.

        The clinical manifestations of Co-Q10 deficiency are diverse and determined by the cells and organs

involved. Id. at 221. Because of its high constant intra-cellular energy requirements, the human

cardiovascular system is very sensitive to a Co-Q10 deficiency. Id.

        Studies shows that reasons for diminished levels of Co-Q10, include: (1) change in the diet for health

reasons ? avoidance of fatty meat and fish, rich in Co-Q10, and adherence to a diet rich in fruits, vegetables,

and fiber, but with a very low Co-Q10 content; (2) use of non-absorbent fat substitutes as slimming

(?nutrients?); (3) increased use of food supplements high in dietary fiber, which entrap many nutrients,

preventing their absorbstion; and (4) increased use of drugs that alter the cholesterol biosynthetic pathway,

and therefore inhibit the biosynthesis of other vital products of this pathway, including Co-Q10. Id. at 221.

Baycol is in the class of drugs known as statins, which deplete Co-Q10. Blizankov Affidavit at ? 7.

        Detecting and treating Co-Enzyme Q10 depletion early can reduce the risk of death from a cardiac

event, as well as myalgia and myopathy.4 In most instances, Co-Enzyme Q10 depletion can be detected


        4
         ?A deficiency of coenzyme Q10 is associated with impairment of myocardial function, with liver
dysfunction and with myopathies (including cardiomyopathy and congestive heart failure.? Blizankov,
Coenzyme Q10 Lipid-Lowering Drugs (Statins) and Cholesterol: A Present Day Pandora?s Box,
The Journal of the American Nutraceutical Association, Vol. 5, No. 3, Summer 2002, citing The Tan
Sheet, CoQ10 Adjunctive Use with TX Statins Encouraged in Citizen Petition, F-D-C Reports, Inc.
June 3, 2002:10:22:4. Exhibit 3.

                                                      11
relatively inexpensively and with no health risk through existing and accepted technology, specifically, a

blood screen. Those individuals who suffer from Co-Enzyme Q10 depletion are also at risk of an enlarged

heart and congestive heart failure. Routinely, physicians require a radiograph of the chest to identify and

diagnose an enlarged heart or congestive heart failure. Even those individuals with but a modest decrease in

Co-Enzyme Q10 and who do not need supplementation will, nonetheless, benefit from the detection because

they can be cautioned against the use of drugs that deplete Co-Enzyme Q10, particularly statins, as well as

being advised of cautionary lifestyle changes.

                                     CO -ENZYME Q10 AND STATINS

        The effects of statins on Co-Q10 levels have been widely studied. A 1990 report indicated that

lovastatin treatment results in a measurable decrease in cardiac function, associated with a decrease of Co-

Q10 blood level. Folkers et al., Lovastatin decreases conenzyme Q levels in humans, Proc. Natl. Acad.

Sci. USA, , Vol. 87, pp. 8931-8934, November, 1990. Exhibit 4. Supplementation with Co-Q10

compensated for this decreased level and cardiac function improvement followed. Id. Watts, et al.

reported that hyperlipidemic patients given simvastatin had significantly lower plasma Co-Q10 levels and Co-

Q10 cholesterol ratios then untreated individuals. Emil G. Bliznakov, M.D., Advances in Therapy,

Biochemical and Clinical Consequences of Inhibiting Co-Enzyme Q10 Biosynthesis by Lipid-Lowering

HMG-CoA Reducate Inhibitors (Statins) at 224. The investigators warned that the possible adverse

effects of simvastatin on Co-Q10 metabolism may be clinically important. Ghirlanda, et al. disclosed that

treatment of healthy volunteers and hypercholesterolemia patients with prevastatin or simvastatin reduced

their cholesterol, but also their Co-Q10 level by 40%. See G. Ghirlanda, MD, Evidence of Plasma CoQ10

- Lowering Effect by HMG-CoA Reductase Inhibitors: A Double-Blind, Placebo-Controlled Study, J.

                                                    12
Clin. Pharmacol., 1993:33:226-229. Exhibit 5. The authors also concluded that the reduced Co-Q10

bioavailability may cause cellular membrane alterations, with consequent cellular injury. Id. Lastly,

Bargossi, et al. presented evidence that patients given simvastatin had a significantly reduced level of

cholesterol and of Co-Q10 in plasma and platelets. Oral administration of Co-Q10 prevented these

decreased without effecting the cholesterol lowering effect. Emil G. Bliznakov, M.D., Advances in

Therapy, Biochemical and Clinical Consequences of Inhibiting Co-Enzyme Q10 Biosynthesis by Lipid-

Lowering HMG-CoA Reducate Inhibitors (Statins) at 224.

        Investigators surmise that Co-Q10 supplementation may reverse any muscle injury related to

mitochondrial dysfunction after treatment with the statins. Id. at 225. Package inserts and publicity material

for various marketed statins usually do not mention the Co-Q10 statin relationship. Id. at 225. This is true

with respect to the package inserts for cerivastatin.

          BAYER?S AND GSK?S KNOWLEDGE OF THE EFFECT OF BAYCOL ON CO -Q10 LEVELS

        As early as 1994, Bayer was aware of the effect of Baycol on the concentration of ubiquinone in

dogs. This is reflected in the product report of Bayer, dated November 24, 1994 entitled ?Influence on the

Concentration of Ubiquinone 50 and Tocopherol in Various Canine Tissues During a Chronic Study?

Exhibit 6. This study showed that inhibition HMG-CoA Reducates by Baycol led not only to a lowering of

plasma cholesterol, but also to a reduction of the plasma and tissue levels of other substances, such as

Ubiquinone. Bayer?s own dog studies show that the influence on Ubiquinone syntheses was apparent in all

tissues investigated, except the brain. See Exhibit ?6? at p. 3. Bayer?s own animal studies clearly showed

the influence of cerivastatin on the Ubiquinone concentrations in heart muscle tissue in dogs. Inhibition was

shown in both males and females. After 54 weeks, treatment tissue samples showed convincingly that

                                                        13
changes occurred after 28 weeks. Id. at p. 11. Decreasing levels of Ubiquinone were also apparent in

male and female muscle tissue. Id. at 14. The most certain Ubiquinone decreases were noted in the tissues

with the highest Ubiquinone concentrations, including the heart, muscles and liver. Id. This effect was

assured to be stronger in females. Id.

        Bayer also proposed performing a ubiquinone supplementation study in the United States.

However, GSK objected ?due to a perceived jeopardy to the .8 mg submission under review.? Exhibit 7.

This is despite the fact that Bayer knew ?A co-medication of ubiquinone is a way to very likely avoid most

of the side effects seen with cerivastatin.? Exhibit 8. Amazingly, Bayer concluded ?But performing and

publishing such a study could again lead to the perception that high dose monotherapy with cerivastatin is

not safe.? Id. Defendants lack of concern to perform adequate testing and health studies, have left

Plaintiffs? Classes I and II in need of medical testing and Court approved studies to determine the adverse

effects of Baycol. The class is also entitled to reimbursement for the costs of the prescription.

III.    MEDICAL MONITORING IS A VIABLE ACTION IN PENNSYLVANIA

        Under Pennsylvania law, plaintiff may bring a medical monitoring claim. Redland Soccer Club,

Inc. v. Department of Army and Department of Defense of the United States, 696 A.2d 137, 145, 146 (Pa.

1997). In order to prove a common law claim for medical monitoring, the plaintiff must

demonstrate the following elements:

                ??       exposure greater than normal background levels;
                ??       to a proven hazardous substance;
                ??       caused by defendant?s negligence;
                ??       as a proximate result of the exposure, plaintiff has significantly
                         increased risks of contracting a serious latent disease;


                                                     14
                ??      a monitoring procedure exists that makes the early detection
                        of the disease possible;
                ??      the prescribed monitoring regime is different from that
                        normally recommended in the absence of the exposure; and
                ??      the prescribed monitoring regime is reasonably necessary according to the
                        contemporary scientific principles.

Redland Soccer Club, 696 A.2d at 145,146.

        In fact, under Pennsylvania law, there is a preference for plaintiffs to recover these costs

through a supervised administrative trust fund instead of through a lump sum damage award. In re:

Pennsylvania Diet Drugs Litigation, 41 Pa. D.N.C. 478, 89 (Pa. Com. PL. 1999). The injury from which

a medical monitoring claimant seeks is the ?quantifiable costs of periodic medical examinations

necessary to detect the onset of physical harm?. Id. The medical monitoring costs actually incurred,

limit defendant?s liability to plaintiff?s incurred expenses. A medical monitoring program is

encouraged because it serves a public interest in monitoring victims toward pharmaceutical drug and

toxic tort exposure. Id. Most importantly, medical monitoring attempts to detect and prevent

injuries. John Faust v. Southeastern Pennsylvania Transportation Authority, 756 A.2d 112, 117, 118. (Pa.

Commwlth. Ct. 2000). As will be demonstrated below, plaintiff?s claim for medical monitoring,

satisfies the criteria necessary for certification under Pennsylvania law.

        CoQ10 depletion is a direct result of ingesting Baycol, and the direct result of defendants

failing to warn and/or require patients who are ingesting Baycol to also take CoQ10 supplements.

Plaintiffs are now exposed to a significant risk of future injuries including congestive heart failure,



                                                  15
high blood pressure, angina, mitrovalve prolapse, stroke, cardiac arrhythmias, cardiomyopathy, lack of

energy, gingivitis and generalized weakening of the immune system. See Exhibit 1. There are tests

available to determine whether an individual suffers from CoQ10 depletion and injuries as a result of

that depletion and this is not normally recommended in the absence of exposure to a CoQ10 reducing

drug such as Baycol. Id. These diagnostic tests discussed above are necessary for patients who have

ingested Baycol to ensure that they do not develop injuries in the future as a result of CoQ10

depletion. Thus, this medical monitoring program is necessary.

IV.    THESE CLASSES ARE CERTIFIABLE

       Plaintiffs are moving for certification of four classes. These classes include individuals who

have been injured as a result of ingesting Baycol and individuals who require medical monitoring as a

result of ingesting Baycol.5 As Plaintiff?s will demonstrate below, all four Classes should be certified

pursuant to the Pennsylvania Rules of Civil Procedure.




       5
         Classes I and II of Plaintiff?s Third Consolidated Amended Complaint include individuals who
are seeking medical monitoring and reimbursement of the costs of prescription as a result of ingesting
Baycol. Classes III and IV represent individuals who have actual physical injuries as a result of
ingesting Baycol.


                                                  16
       A.     Class Certification of the Four Proposed Classes are Appropriate Under Pa.
       R.C.P. 1702

       In Pennsylvania, class actions are favored as ?a procedural device designed to promote

efficiency and fairness in the handling of large numbers of similar claims? Lilian v. Commonwealth, 467

Pa. 15, 21, 354 A.2d 250, 253 (1976)). Indeed, ??decisions in favor of maintaining a class action

should be liberally made.?? Janicik v. Prudential Insurance Co. of America, 305 Pa. Super. 120, 128, 451

A.2d 451, 454 (1982) (quoting Bell v. Beneficial Consumer Discount Co., 241 Pa. Super. Ct. 192, 205,

360 A.2d 681, 688 (1976)).




       Pennsylvania courts and as well as courts nationwide have become increasingly receptive to the

use of class actions to handle claims rising out of a mass tort. See, e.g., Foust v. Southeastern Pa.

Transportation Authority, 756 A.2d 112 (Pa. Commw. Ct. 2000); In re Pennsylvania Diet Drugs, No. 9709-

3162 (CCP Phila. Cty, Mar. 12, 1999) (certifying medical monitoring class of all persons in

Pennsylvania who had used the diet drugs fenfluramine and dexfenfluramine); Floyd v. Philadelphia

(No.2), 8 Pa. D. & C. 3d 380 (CCP Phila.Cty. 1978) (certifying class for personal injuries arising from

leak of chlorine gas from water treatment plant); Cipriani v. Sun Pipeline Co., 46 Bucks Cty. Law Rptr

249 (1985) (certifying class for damages arising from ruptured pipeline). See generally Rauch v. United

Instruments, Inc., 368 Pa. Super. 294, 299, 533 A.2d 1382, 1384 (1982) (class actions evolved as a

practical way of providing some recovery to large groups of individuals, united in interest, from



                                                  17
culpable defendants who might otherwise escape liability as a result of the difficulty of presenting

proof on an individual basis). Nationwide class actions seeking medical monitoring have been

accepted. See, Jeffers v. American Home Products Corp., C.A. No. 98-CV-20626 (E.D. Pa.) (In re:

Diet Drug Products Liability Litigation, MDL 1203) (nationwide medical monitoring class);6 State

Classes have also been certified in Burch, et al. v. American Home Products Corp., C.A. No. 97-C-

204(1-11) (West Virginia statewide personal injury and medical monitoring class); Rhyne v. AHP, 98 CH

409 (Illinois statewide refund and monitoring reimbursement class); Vadino, et al. v. AHP, Docket No.

MID-L-425-98 (New Jersey statewide unfair and deceptive acts and practices in medical monitoring

class); New York Diet Drug Litigation, Index No. 700000/98 (New York statewide medical monitoring

class); Pennsylvania Diet Drug Litigation, Master Docket No. 9709-3162 (CCP, Phila.) (Pennsylvania

statewide medical monitoring class); Earthman v. AHP, No. 97-10-03970 CV, (Dist. Ct. Mont. Co.

Tex.) (Texas statewide medical monitoring class); St. John v. AHP, 97-2-06368-4 (Washington statewide

medical monitoring class).

        For the reasons set forth below, each of the criteria of Rule 1702 have been met. Moreover,

certifying the proposed classes and enabling this litigation to proceed as a class action will minimize

the burdens on this Court, conserve the resources of the parties, and provide a forum for the efficient

and economical litigation of class members? claims, which might not otherwise be heard and resolved.

Indeed, in mass tort cases such as Classes I and II, particularly those in which personal injury claims


        6
        But See In Re: Propulsid Products Liability Litigation, 208 F.R.D. 133 (E.D.La. 2002); In
Re: Rezulin Products Liability Litigation, MDL No. 1348 Master File 00 Civ. 2843. (September 12,


                                                  18
are excluded, class treatment of the claims has routinely been found to yield significant benefits. 7 See,

e.g., Pennsylvania Diet Drugs, supra. See also In re School Asbestos Litig., 789 F.2d 996, 1008-11 (3rd Cir.

1986); In re ?Agent Orange? Product Liability Litig., 100 F.R.D. 718, 724 (E.D.N.Y. 1983). Thus where,

as here, Defendants have injured many through their manufacture, fraudulent marketing, sale and

distribution of a defective product, a class action will enable common proof of the defective nature of

the product and of the Defendants' wrongful conduct and common adjudication of Plaintiffs? and

class members? claims.

        Accordingly, Plaintiffs? class certification motion should be granted.

        B.      The Requirements of Pa. R.C.P. 1702 Have Been Satisfied

                1.       The Classes are Sufficiently Numerous That Joinder Is Impracticable

        To satisfy the numerosity requirement of Pa. R.C.P. 1702(1), a class must be both numerous

and identifiable. Pennsylvania Diet Drugs, slip op. at 13. ?A class is sufficiently numerous when ?the

number of potential individual plaintiffs would pose a grave imposition on the resources of the court

and an unnecessary drain on the energies and resources of the litigants should [plaintiffs] sue




2002)
        7
        Federal case law is instructive for determining viability of class. Cambanis v. Nationwide Ins.
Co., 501 A.2d 635, 637 (Pa. Super. 1985).




                                                    19
individually.?? Pennsylvania Diet Drugs, slip op. at 13 (quoting Temple University v. PA Dep?t of Public

Welfare, 30 Pa. Commw. 595, 603, 374 A.2d 991, 996 (1977); ABC Sewer Cleaning Co. v. Bell

Telephone Co. of Pennsylvania, 293 Pa. Super. 219, 225, 438 A.2d 616, 619 (1981); Ablin, Inc. v. Bell

Telephone Co. of Pennsylvania, 291 Pa. Super. 40, 51, 435 A.2d 208, 214 (1981).

        Stated another way, Rule 1702(1) requires that the class be so large that joinder of all class

members would be ?impracticable.? See Pennsylvania Diet Drugs, slip op. at 13. This language tracks

Rule 23(a)(1) exactly, and as the Superior Court noted in Janicik, supra, where Pennsylvania's Rules

track the federal rules, "federal precedent is instructive in construing" the Pennsylvania Rules. 451

A.2d at 454 n.3. As interpreted by federal courts, ?impracticability does not mean 'impossibility,' but

only the difficulty or inconvenience of joining all members of the class." Harris v. Palm Springs Alpine

Estates, Inc, 329 F.2d 909, 913-914 (9th Cir. 1964). Although there is no "magic number" which

satisfies the numerosity requirement, Snider v. Upjohn Co., 115 F.R.D. 536, 539 (E.D. Pa. 1987), "[t]he

difficulty inherent in joining as few as 40 class members should raise a presumption that joinder is

impractical, and the plaintiff whose class is that large or larger should meet the test of [numerosity] on

that fact alone." See 1 Newberg on Class Actions, ? 3.05, at 142 (2d ed. 1985). See also Andre H. ex rel.

Lula H. v. Ambach , 104 F.R.D. 606, 611 (S.D.N.Y. 1985) (numerosity may be satisfied by 40 children

seeking individualized educational programs at a juvenile facility).

        In this case, the proposed class containing thousands of personal injury victims (Classes III and

IV) and hundreds of thousands of victims requiring drug reimbursement and medical monitoring

                                                   20
(Classes I and II) may threaten "a grave imposition on the resources of the court and an unnecessary

drain on the energies and resources of the litigants." See Cook v. Highland Water and Sewer Authority,

108 Pa. Commw. 222, 229, 530 A.2d 499, 503 (1987). Thus, sufficient "numerosity" is present. See,

e.g., Janicik, 305 Pa. Super. at 132, 451 A.2d at 456. See also Temple University v. Pa. Dept of Public

Welfare, 30 Pa. Commw. 595, 603, 374 A.2d 991, 996 (1977) (numerosity requirement satisfied where

there were 123 class members).

        Besides being sufficiently numerous, the classes proposed herein are ?identifiable.? A class is

?identifiable? for purposes of Rule 1702(1), where it ?is narrowly and precisely drawn, but there are

still so many potential members that joinder is impractical or impossible. . . .? Pennsylvania Diet Drugs,

slip op. at 14 (quoting Weismer v. Beech-Nut Corp, 419 Pa. Super. 403, 408, 615 A.2d 428, 430 (1992)).

As was the case in Pennsylvania Diet Drugs, the classes here are sufficiently identifiable because medical

and prescription records will reveal who received and ingested the drug.

        Accordingly, the classes are sufficiently numerous and identifiable and thus satisfy the

numerosity requirement.

                2.      Common Questions of Law and Fact Are Shared Among the Classes

        In order to satisfy Rule 1702(2), Plaintiffs need only show that common questions of law or

fact exist. Here, that requirement easily is satisfied.

        "Common questions of law or fact will generally exist if the class members' legal grievances

arise out of the same practice or course of conduct on the part of the class opponent." McCarthy v.

                                                   21
Mize, 84 Pa. Commw. 511, 516, 479 A.2d 693, 696 (1984). Cases involving a common disaster,

environmental contamination from a known source, and exposure to toxins present the necessary

core of common issues. See generally Pennsylvania Diet Drugs, supra; see also In re: Agent Orange

Litigation, supra. That is certainly the case here with regard to each claim sought to be advanced by

the putative class members.

        As described more fully below, the claims of all class members will be resolved primarily on the

basis of the following common questions:

                (a)     whether Baycol was and is unsafe for human ingestion;

                (b)     whether the defendants conducted adequate study, testing, and analysis to

determine whether and to what extent Baycol was unsafe for human consumption;

                (c)     whether defendants? post-marketing safety and surveillance system was

designed and implemented in a reasonable manner;

                (d)     whether defendants failed to warn adequately of the adverse effects of Baycol;

                (e)     whether defendants falsely and fraudulently misrepresented the safety,

potential side effects, convenience and efficacy of Baycol in their advertisements, promotional

materials and other materials;

                (f)     whether defendants designed and manufactured a drug that was dangerously

defective because its use leads to or poses a substantial increased risk of the existence of potentially




                                                  22
dangerous side effects, including, but not limited to, myopathy and a potentially fatal muscle-

weakening condition called rhabdomyolysis (hereinafter ?side effects?);

                (g)      whether defendants knew or should have known that the ingestion of Baycol

leads to or poses a substantial increased risk of side effects;

                (h)      whether defendants continued to manufacture, label, license, market,

distribute, promote and/or sell the drug, Baycol, notwithstanding their knowledge of the drug?s

dangerous nature and side effects;

                (i)      whether the warnings and information defendants provided with Baycol were

adequate in warning of the potential hazards resulting from its use;

                (j)      whether defendants knowingly, recklessly or intentionally concealed,

suppressed or omitted material facts and information about the unsafe and defective nature of Baycol

from government regulators, the medical community and/or the consuming public;

                (k)      whether defendants negligently tested, manufactured, labeled, licensed,

marketed, distributed, promoted, and/or sold the drug Baycol;

                (l)      whether defendants engaged in unconscionable and/or deceptive business

practices and conduct;

                (m)      whether the Classes have been injured by virtue of defendants? negligence,

recklessness, and/or unconscionable and/or deceptive business practices and conduct;

                (n)      whether ingestion of Baycol causes an increased risk of side effects;


                                                    23
                (o)     whether plaintiffs and class members are entitled to notice alerting them to

the need for timely medical evaluation; and

                (p)     whether plaintiffs need a medical program to ensure they do not have injuries

as a result of Baycol, and if they are injured they can seek adequate treatment.

        This partial list of common questions of law and fact unquestionably satisfies the commonality

requirement of Rule 1702(2). Underlying these basic common questions is a common nucleus of

operative facts, supported by Plaintiffs? factual allegations. For example, Plaintiffs and class members

have ingested and thus been exposed to Baycol, which has been linked with rhabdomyolysis and

kidney disease. Common evidence and common scientific testimony will show that exposure to

Baycol places class members at increased risk of disease. In addition, Defendants? uniform pattern of

dangerous misconduct is common to all class members. Plaintiffs? fundamental allegation is that

Defendants have engaged in a common, uniform fraudulent scheme by manufacturing, warranting,

advertising, selling, and distributing Baycol that they knew to be hazardous, while concealing the

dangers of the drug. In addition, since the withdrawal of Baycol from the market, Defendants have

failed to alert Plaintiffs and class members of their need for immediate medical attention. Indeed, it

is anticipated that Defendants will oppose Plaintiffs by presenting common scientific and medical

testimony to the effect that class members are not at risk of disease. There is no justification in trying

these issues on a case-by-case basis when they can be heard once in a class action trial. Accordingly, the

commonality requirement has been satisfied.


                                                   24
                 3.      The Claims of the Representative Plaintiff Are
                         Typical of the Other Class Member Claims

        The typicality requirement of Rule 1702(3) requires that "?the class representative's overall

position on the common issues is sufficiently aligned with that of the absent class members to ensure

that her pursuit of her own interests will advance those of the proposed class members.?" Pennsylvania

Diet Drugs, slip op. at 25 (quoting D?Amelio v. Blue Cross of Lehigh Valley, 347 Pa. Super. 441, 458, 500

A.2d 1137, 1146 (1985); Janicik, 305 Pa. Super. at 134, 451 A.2 at 457; Ablin, 291 Pa. Super. at 47,

435 A.2d at 212). See also 1 Newberg on Class Actions ? 3.13 at 3-77. The typicality requirement of

Rule 1702(3) provides "an assurance that the Plaintiffs? [class representative's] interests are more or

less co-extensive with those of the class." Klusman v. Bucks County Court of Common Pleas, 128 Pa.

Commw. 616, 625, 564 A.2d 526, 531 (1989), aff?d., 524 Pa. 593, 574 A.2d 604 (1990).

        Courts uniformly have found the requisite typicality to be present when "the class

representative?s claims arise ?out of the same general course of conduct by the defendants and are

'based on the same or similar legal theories as those of the class.?? Hedges Enterprises, Inc. v.

Continental Group, Inc., 81 F.R.D. 461, 465 (E.D. Pa. 1979). This is true ?irrespective of varying fact

patterns which underlie individual claims.? Smith v. Univ. of Washington Law School, 2 F. Supp. 2d

1324, 1342 (W.D. Wash. 1998) (internal quotations, citations omitted); 1 Newberg on Class Actions ?

3.13 at 3-77.8



        8
                 ?A Plaintiffs? claim is typical if it arises from the same event or practice or course of

                                                      25
        Here, the claims of the Plaintiffs, like those of the other class members, arise from

Defendants? design, manufacture, sale, and distribution of a drug that causes rhabdomyolysis and

kidney disease and Defendants? failure to warn about the association between Baycol use and such

diseases and their failure to warn about the need for immediate medial attention. Plaintiffs and class

members also share an interest in receiving notice about the immediate need for medical attention,

so as to prevent serious physical injury or death.

        Because of these aspects common to Plaintiffs? claims and those of class members and because

Plaintiffs and class members have a shared interest in being warned immediately of the immediate

need for medical attention, there is no reason to believe that the Plaintiffs will pursue their own

interests to the detriment of the proposed class members. See D'Amelio v. Blue Cross of Lehigh Valley,

347 Pa. Super. 441, 457, 500 A.2d 1137, 1146 (1985). The typicality requirement is thus satisfied.

                4.      The Representative Plaintiffs Will Fairly
                        and Adequately Protect the Interests of the Class




conduct that gives rise to the claims of the other class members, and if his or her claims are based on the
same legal theory. When it is alleged that the same unlawful conduct was directed at or affected both
the named plaintiff and the class sought to be represented, the typicality requirement is usually met
irrespective of varying fact patterns which underlie individual claims.? 1 Newberg on Class Actions ?
3.13 at 3-77.




                                                     26
        In determining whether the class representatives will fairly and adequately assert and protect

the interests of class members, a court should consider the following:

                (1)     whether the attorney for the representative parties will
                        adequately represent the interests of the class,

                (2)     whether the representative parties have a conflict of interest
                        in the maintenance of the class action, and

                (3)     whether the representative parties have or can acquire
                        adequate financial resources to assure that the interests of the
                        class will not be harmed.

Pa. R.C.P. 1709. Applied here, these factors favor certification.

        To begin, it is clear that Plaintiffs? proposed class counsel will adequately represent the

interests of the class. Indeed, ??until the contrary is demonstrated, courts will assume that members of

the bar are skilled in their profession.?? Pennsylvania Diet Drugs, slip op. at 30 (quoting Janicik, 305 Pa.

Super. at 136, 451 A.2d at 458). Plaintiffs? proposed class counsel have extensive experience litigating

complex class actions and mass tort actions, and they possess the resources to actively and vigorously

prosecute this case.9

        Second, the representative Plaintiffs have no interests which conflict with the unnamed class

members. To begin, ??[c]ourts have generally presumed that no conflict of interest exists unless


        9
                Firm Resumes, illustrating Plaintiff Class Counsels? experience, can be supplied at the
Court?s request.




                                                    27
otherwise demonstrated, . . . .?? Pennsylvania Diet Drugs, slip op. at 30 (quoting Janicik, 305 Pa. Super.

at 136, 451 A.2d at 459). In addition, the named class Plaintiffs have expressed their willingness to

serve as class representatives and to vigorously prosecute this case on behalf of the entire class. Also,

as discussed above, the class representatives? claims are coextensive with, and not antagonistic to, the

claims asserted on behalf of the class. Each potentially faces the same problem: they purchased

Baycol and require notice of the need for prompt medical attention and testing.

        Finally, it is clear that the representative parties have adequate financial resources to assure

that the interests of the class will be protected. As is common procedure and consistent with ethical

rules, Plaintiffs? counsel will advance the costs of class action litigation. See, e.g., Pennsylvania Diet

Drugs, slip op. at 31; Janicik, 305 Pa. Super. at 136-37, 451 A.2d at 459-60. Thus, the class

representative will face no financial impediments to prosecuting this case on behalf of the class.

                5.      A Class Action Is an Efficient and Fair Way
                        To Adjudicate the Class Members' Claims

        To determine whether a class should be certified, Rule 1708(a) requires consideration of the

following: (1) whether common issues predominate over individual questions; (2) the size of the class

and difficulties likely to be encountered in managing the class action; (3) whether individual actions

may engender inconsistent results that may create incompatible standards of conduct for the

defendants or obstacles to plaintiffs' abilities to proceed individually; (4) the extent and nature of

litigation already commenced; (5) whether this forum is an appropriate venue for all class members'



                                                   28
claims; (6) whether expected expenses and complexities may not support individual actions; (7)

whether class members' recoveries will be so small as to not justify a class action; and (8) whether the

party opposing the class has acted or refused to act on grounds generally applicable to the class,

thereby making final equitable or declaratory relief appropriate with respect to the class. Pa. R.C.P.

1708.




                        a.      Common Questions Predominate

        In analyzing whether common questions predominate, the Court must evaluate whether

proving the elements of the class claims can be done through common questions or whether the

proof will be overwhelmed with individual issues. See Foust v. Southeastern Pa. Transportation Authority,

756 A.2d 112, 120-121 (Pa. Commw. Ct. 2000). See also Hanlon v. Chrysler Corp., 150 F.3d 1011,

1022 (9th Cir. 1998). The predominance inquiry ?focuses on the relationship between the common

and individual issues. When common issues present a significant aspect of the case and they can be

resolved for all members of the class in a single adjudication, there is clear justification for handling

the dispute on a representative rather than on an individual basis.? Id. (citations and quotations

omitted). See also In re Prudential Insurance Co. of America Sales Practices Litigation, 148 F.3d 283, 314-

15 (3rd Cir. 1998) (certifying nationwide consumer fraud class).

        Importantly, the mere existence of individual issues will not defeat predominance. Indeed, as

one court recently noted:

                                                    29
                 common issues must be shown to predominate, [but that] does not
                 mean that individual issue[s] need be nonexistent. All class members
                 need not be identically situated upon all issues, so long as their claims
                 are not in conflict with each other.

Cannon v. Cherry Hill Toyota, Inc., 184 F.R.D. 540, 545 (D.N.J. 1999). See also Rodriguez v. Carlson,

166 F.R.D. 465, 479 (E.D. Wash. 1996) (holding that any individual issues regarding damages were

overshadowed by the ?predominant common questions of liability?); In re Badger Mtn. Irrigation Dist.

Secs. Litig., 143 F.R.D. 693, 697 (W.D. Wash. 1992) (?[w]here plaintiffs allege a common course of

wrongdoing based on the same misrepresentations, individual issues of reliance do not preclude

certification of the class?); Janicik, 305 Pa. Super. at 141, 451 A.2d at 461 (?Individual questions, even

those essential to recovery, are not necessarily fatal to the class action.?).

          This case involves a single product and a request for a unitary determination of Defendants?

liability to provide notice to class members. The predominance of common facts and issues is strong.

Central to the claim of every class member in this action is common proof that a single product,

manufactured, marketed, sold and distributed by Defendants, poses a significant health hazard when

ingested and that immediate medical attention is required to preserve and protect Baycol users?

health. Such proof is common to all class members, will not vary from plaintiff to plaintiff and does

not depend on the knowledge or conduct of any plaintiff. The predominance requirement therefore

is met.

                         b.      The Size of the Class Favors Class Certification,
                                 Yet There Will Be Few, if Any, Difficulties


                                                    30
                                Encountered in Managing the Class Action

        As mentioned above, the proposed classes number in the thousands, which highly favors

adjudication of class members? claims in a class action setting. On the other hand, the size of the

classes will not present difficulties in managing the litigation. Indeed, there is no evidence before this

Court that a class action would prove unmanageable for the Court, counsel, or the class members. In

particular, as noted above in the discussion of commonality, typicality and predominance, given that

the issues of Defendants? conduct, the nature of Baycol and the legal claims sustainable against

Defendants are common to Plaintiffs and the Classes, it is clear that liability easily can be established

on a class-wide basis. Moreover, the remedy in this case also will be manageable. The notice sought

by Plaintiffs as preliminary injunctive relief presents no individual issues, and the notice itself is a

routine class certification procedure.

        In addition, there are no state law variances that make this case unmanageable. Under

Pennsylvania?s choice of law rules, Pennsylvania?s substantive law applies. First, there is no conflict

between the law of Pennsylvania and the laws of the states where class members live and the policies

underlying those laws. Here, class members? legal claims tend to merge in the failure to warn context

due to a uniform focus on what Defendants knew or should have known about their product?s risks

and about the need for immediate medical attention.

        Thus, this Court may properly apply the law of one state ? Pennsylvania ? where the

Defendants? have their principal places of business and where they carried out the tortious conduct


                                                   31
which is the subject of this litigation, to the claims of all class members because the relevant laws of

this state and other interested states do not materially or directly conflict. See Phillips Petroleum Co. v.

Shutts, 472 U.S. 797, 817-822 (1985).

        In fact, a choice of law analysis requires this Court to apply Pennsylvania law to all of the

classes. Under Pennsylvania?s choice of law analysis, the Supreme Court of Pennsylvania abandoned

the lex loci delicti rule and adopted a significant relationship theory. Griffith v. United Airlines, Inc., 203

A.2d 796 (Pa. 1964). Thus, the Court should not automatically apply the law and place in which the

incident occurred, but instead, analyze the policies and interests underlying the particular issue before

the Court. Miller v. Gay, 470 A.2d 1353, 1355 (Pa. Super. 1984). The weight of contacts should be

measured qualitatively rather that quantitatively. Cipolla v Shaposka, 267 A.2d 854, 856 (Pa. 1970).

The following contacts are to be applied qualitatively rather than quantitatively:

        ??       the place where the injury occurred,

        ??       the place where the conduct causing the injury occurred,

        ??       the domicile, residence, nationality, place of incorporation and place of business of the

                 parties, and

        ??       the place where the relationship in between the parties is centered.

Laconis v. Burlington County Bridge Commission, 583 A.2d 1218, 1223 (Pa. Super. 1990).

        In evaluating these factors to the relative importance of the issue in this case, the decision

making activity of the Baycol defendants, occurred in the Commonwealth of Pennsylvania justifying

                                                     32
employing the state law rather than the laws of other states. In other words, all the tortious conduct

took place at Bayer defendants and Smithkline defendants principle place of business and place of

incorporation. Both of these defendants principle place of business and state of incorporation is

located in the Commonwealth of Pennsylvania. Since plaintiffs? allegations are that defendants?

decisions making activities of marketing and manufacturing Baycol out of Pennsylvania and

manufacturing of Baycol out of Pennsylvania, justifies applying the Commonwealth of Pennsylvania?s

law. Thus, the choice of law for all four classes should be Pennsylvania. See Allstate Insurance

Company v. Hague 101 S. Ct. 633, 640 (1981). (It is constitutionally permissible to apply a state?s law

when significant conduct or significant aggregation of contacts create a state interest such that choice

of law is neither arbitrary nor fundamentally unfair.) As discussed earlier, the Commonwealth of

Pennsylvania is the sight where all tortious conduct by defendants occurred. Defendants? marketing

strategy, advertisements and manufacture of Baycol were all originated and done in Pennsylvania.

Thus, Pennsylvania law should apply. Moreover, plaintiffs have brought state class action claims in

the alternative to their nation class action complaints. See Plaintiffs? Complaint at ? 53 Class I and

Class IV.10


        10
           Since Pennsylvania has the most significant relationships with the class members,
Pennsylvania is the only forum which is appropriate to bring a nationwide class. Parsky v. First Union
Corporation, 2001 WL 987764 *3-4 (Pa. Com PL 2001)(Nationwide class may be certified in
Pennsylvania when Pennsylvania has the most significant relationships to the class). Pennsylvania has the
most significant contacts with the lawsuit, thus Pennsylvania is the most appropriate venue to bring a
nationwide class. Moreover, Pennsylvania is the only venue which a nationwide class can be brought.
See, In re: Bridgestone Firestone, 288 F.3d 1012, 1015 (7th Cir. 2002). Federal Courts will not

                                                   33
        Clearly, manageability will not present a barrier to class treatment of this litigation.

                         ?       Individual Actions Would Engender Inconsistent Results, Thereby
                                 Creating Incompatible Standards of Conduct
                                 for the Defendants or Obstacles to Plaintiffs' Abilities
                                 To Proceed Individually

        In the present litigation, proceeding on an individual basis would create a significant risk of

inconsistent adjudications, which could create obstacles to Plaintiffs? abilities to proceed individually

and/or create incompatible standards of conduct for the Defendants. First and foremost, Plaintiffs

seek notice which will alert and notify them and class members of the need for immediate medical

attention. If Plaintiffs and class members were forced to proceed individually, it is possible that

certain courts would grant the request for notice, while others would not. This would create the

anomalous and dangerous situation in which certain users of Baycol are alerted to the need for

medical attention, while others would remain ignorant of this need for medical attention and thus at

enhanced risk of suffering grave and serious injury.

        Likewise, Defendants will be harmed by incompatible standards of conduct established in

individual litigation. See, e.g., Pennsylvania Diet Drugs, slip op. at 36. For example, if Plaintiffs and


certify a class due to the varying conflicts of law principles of the fifty states. Pennsylvania is the only
venue with the significant interest to certify a nationwide class and thus apply one unitary body of law.
Parsky, 2001 WL *3-4. This is the utility in seeking a nationwide class in the defendants? home state.
cf In Re: Propulsid, supra, and In Re: Rezulin, supra.




                                                     34
class members were forced to proceed individually and succeeded in such individual litigation,

Defendants likely would be confronted with a situation in which one Court orders one type of notice

regarding the need for medical attention, while another Court orders a far more reaching and

expansive notice plan.

        Finally, the judicial system is harmed by piecemeal adjudication of this controversy. Individual

actions in which plaintiffs seek notice similar to that sought here, would force this Court and/or

other courts to oversee separate notice plans. By contrast, if this action is certified, the notice plan

that Plaintiffs seek would be overseen by one court ? this Court, after it had reviewed one uniform set

of evidence regarding Defendants? conduct, the nature of Baycol and the need for immediate medical

attention for Baycol users. See Pennsylvania Diet Drugs, slip op. at 36.

                         ?      The Extent and Nature of Litigation Already Commenced

        At this point, litigation efforts against Defendants relating to Baycol are just underway. There

are a number of personal injury actions filed in this Court and throughout the country for those

Baycol users who already have suffered physical injury. Given that the need for medical attention is

immediate, this forum is uniquely appropriate for hearing class members? claims.

                         ?      This Forum Is an Appropriate Venue for
                                All Class Members' Claims

        Venue is appropriate in the county in which the transaction or some part thereof occurred out

of which the cause of action arose. See Pa. R.C.P. 1006(a). Plainly, the transaction giving rise to



                                                  35
Plaintiffs? causes of action, i.e., Defendants? conduct in manufacturing, marketing, selling and

distributing Baycol, occurred in whole or in part in Philadelphia County, where Bayer Corporation

and Glaxosmithkline have their principal places of business.

                        ?       The Amounts in Question Dictate that a Class Be Certified
                                [Classes I and II]

        Given the relatively small value of the cost of medical monitoring, reimbursement of the costs

of the drug, the prohibitively expensive expert, and other litigation costs necessary to advance and

prevail upon any separate claim, piecemeal individual litigation is not economically viable. See, e.g.,

Hanlon, 150 F.3d 1011. The cost of notice to an individual is also small relative to the litigation costs

required to obtain that relief from Defendants in an individual action. Even if feasible, individual

adjudication would unnecessarily burden the courts and would eliminate the possibility of class-wide

injunctive/equitable relief. See id. It would also impose a substantial risk of inconsistent or

contradictory adjudications of the claims. Accordingly, class treatment of Classes I and II are

necessary.

        Indeed, absent a class action, the Court and the litigants will be faced with repetitive separate

trials brought on behalf of separate plaintiffs, each of whom has ingested Baycol and who is at

significant risk of suffering serious and life-threatening disease. The main issues at all the trials would

be the same, and the witnesses and evidence presented over and over again in these cases would be

the same. Moreover, preparing these cases for repetitive trials will involve huge expert witness fees



                                                    36
and thousands of additional depositions. While expert witnesses, court reporters and lawyers may

profit from such an exercise, the burden on the parties and the judicial system need not be tolerated

where, as here, the class action device will streamline the case. Rules 1708(6) and (7) of the

Pennsylvania Rules of Civil Procedure state that the amount in question should be considered by the

Court when determining whether to certify a class. Here, the damages suffered, while significant, are

modest compared to the expenses that would be associated in procuring individual expert evidence on

behalf of each plaintiff, and opposing the scores of experts Defendants will undoubtedly assemble.

        In short, the amount in dispute is neither large enough nor small enough to warrant this

Court finding that a class-based recovery would not be meaningful. Thus, Pa. R.C. P. 1708(6) & (7)

are satisfied.



                       ?       Defendants Have Acted or Refused To Act on
                               Grounds Generally Applicable to the Class,
                               Thereby Making Final Equitable or Declaratory
                               Relief Appropriate with Respect to the Class
                                            [Classes I and II]

        Under Rule 1708(b) certification is appropriate where ?the party opposing the class has acted

or refused to act on grounds generally applicable to the class, thereby making appropriate final

injunctive equitable or declaratory relief . . . .? Here Defendants have manufactured, marketed, sold

and distributed Baycol nationwide, to any and all users of the drug, without informing those users of

the dangerous nature of the drug and the need for immediate medical surveillance. As a result of this



                                                 37
conduct, which is generally applicable to the Class, what is required, among other things, is uniform

notice to the users of Baycol regarding the need to see their doctors immediately. Such notice clearly

and unquestionably is equitable relief, and the issue of whether that notice should be provided should

be resolved once, on a class-wide basis, in this litigation.

        For these reasons, the requirements of Rule 1708(b) are met.




        6.     PLAINTIFF?S PERSONAL INJURY CLASS MEET THE ELEMENTS FOR
        CERTIFICATION UNDER PENNSYLVANIA RULES OF CIVIL PROCEDURE
                                      [Classes III and IV]

        The Supreme Court of the United States found that when class members are exposed to

different products, in different ways, at different time periods over many years, a class is not

certifiable. See Amchem Products, Inc. v. Windsor, 117 S.Ct. 2231, 2250, 521 U.S. 591 (1997).

        Not all mass torts are the same, however. This proposed class does not suffer from the same

impediments, as were present in Amchem. In fact, recent cases interpreting Amchem have certified

more expansive tort classes. See, e.g., In re Diet Drugs v. American Home Products Corporation, 2000 WL

1222042 (E.D. Pa., Aug. 28, 2000).

        In re Diet Drug Litigation, 2000 WL 1222012 (E.D. Pa. 2000), involved a class of six million

individuals who ingested Fen/Phen which was manufactured by one defendant. The court found the

class certifiable because plaintiffs? claims stemmed from a common course of conduct. Id. at *8. The

court found that despite the size of the class, it was not sprawling. Id. The class did not involve

                                                    38
persons exposed to a product in differing ways. There was also only one scientific theory of causation.

Id.

        Not unlike In re Diet Drug Litigation, this case too does not present the Amchem problems.

This class involves injuries as result of the ingestion of Baycol. The class is not sprawling. The class is

defined as individuals who ingested Baycol. All of the classes? injuries are the result of the same

conduct by defendants. Class counsel have no side deals or inventory settlements. Thus, there are no

conflicts of interest. Certification of this class is appropriate.




V.      CONCLUSION

        This is an appropriate case for class treatment. The proposed classes are large, the class

representatives are adequate and their claims are typical. Moreover, common legal and factual issues

predominate, and injunctive relief applicable to the entirety of the classes is sought; therefore, a class

action is the manifestly fair and efficient method for adjudicating this controversy. Indeed, this

motion presents the Court with a unique opportunity to certify class claims in an action which will

prevent injuries and harm before they occur, a prospect which is far better than simply adjudicating

injury claims which could have been prevented in the first instance. Accordingly, the Court should

certify the classes consisting of all consumers who have purchased and/or ingested Baycol




                                                    39
manufactured, marketed, sold and distributed by Defendants, and who have not yet suffered injury.

(Classes I and II).

         The Court should also certify the proposed Classes III and IV for those individuals with

medical conditions that are manifested. These individuals will be give the right to opt out should

there desire to litigate their own classes. However, those that chose to participate will substantially

reduce the burden on this Court.

                                               Respectfully submitted,

                                               LEVIN, FISHBEIN, SEDRAN & BERMAN




                                               _______________________________________
                                               Arnold Levin, Esquire
                                               Daniel C. Levin, Esquire
                                               510 Walnut Street, Suite 500
Dated:                                         Philadelphia, PA 19106

                                               Richard S. Lewis, Esquire
                                               COHEN, MILSTEIN, HAUSFELD & TOLL, P.L.L.C.
                                               1100 New York Avenue, N.W.
                                               West Tower - Suite 500
                                               Washington, D.C. 20005

                                               Neil D. Overholtz, Esquire
                                               LEVIN, PAPANTONIO, THOMAS, MITCHELL,
                                               EICHSNER & PROCTOR, P.A.
                                               P.O. Box 12308
                                               316 South Baylen Street
                                               Pensacola, FL 32501



                                                  40
Lee B. Balefsky, Esquire
GREITZER & LOCKS
1500 Walnut Street, 20th Floor
Philadelphia, PA 19102

James J. McHugh, Esquire
BEASLEY, CASEY & ERBSTEIN
1125 Walnut Street
Philadelphia, PA 19107

Sol H. Weiss, Esquire
ANAPOL , SCHWARTZ, WEISS,
COHAN, FELDMAN & SMALLEY, P.C.
1900 Delancey Place
Philadelphia, PA 19103

Michael Coren, Esquire
LEVY, ANGSTREICH, FINNEY, BALDANTE,
RUBENSTEIN & COREN, PC
1616 Walnut Street, 18th Floor
Philadelphia, PA 19103

Stephen A. Sheller, Esquire
SHELLER, LUDWIG & BADEY
1528 Walnut Street
3rd Floor
Philadelphia, PA 19102

Russell D. Henkin, Esquire
Berger & Montague, P.C.
1622 Locust Street
Philadelphia, PA 19103

Bernard M. Gross, Esquire
1515 Locust Street, 2nd Floor
Philadelphia, PA 19103

Robert Gibson, Esquire
LAW OFFICES OF ROBERT GIBSON
319 West Front Street
Media, PA 19063

Robert Sink, Esquire
LAW OFFICES OF ROBERT SINK
1417 Crosby Drive
Fort Washington, PA 19034


  41
Michael Lombardi, Esquire
LOMBARDI AND LOMBARDI
1862 Oak Tree Road
P.O. Box 2065
Edison, NJ 08818

Kenneth Jacobson, Esquire
22 West Front Street
Media, PA 19063

Mark C. Rifkin, Esquire
FELDMAN & RIFKIN
Jenkintown Plaza, LLP 230
101 Greenwood Avenue
Jenkintown, PA 19046

Dianne M. Nast, Esquire
RODA & NAST, P.C.
801 Estelle Drive
Lancaster, PA 17601

Elizabeth J. Cabraser, Esquire
LIEFF, CABRASER, HEIMANN & BERNSTEIN
Embarcadero Center West
275 Battery Street, 30th Fl.
San Francisco, CA 94111

Steven Fineman, Esquire
LIEFF, CABRASER, HEIMANN & BERNSTEIN
780 Third Avenue, 48th Floor
New York, NY 10017-2024

Samuel L. Davis, Esquire
DAVIS, SAPERSTEIN & SOLOMON
375 Cedar Lane
Teaneck, NJ 07666

Counsel for Plaintiffs




  42
LEVIN, FISHBEIN, SEDRAN & BERMAN
BY:    ARNOLD LEVIN, ESQUIRE
ATTORNEY I.D. NO.:     02280
DANIEL C. LEVIN, ESQUIRE
ATTORNEY I.D. NO.:     80013
510 Walnut Street
Suite 500
Philadelphia, PA 19106
(215) 592-1500

               IN THE COURT OF COMMON PLEAS - CIVIL TRIAL DIVISION
                             PHILADELPHIA COUNTY

 JERRY EUGENE LEWIS, ARTHUR CONNORS,
 NAOMI CARROLL, DIANE JACOBS, MILTON
 ANGERT, LORRAINE FOWLER, OCTAVIO
 QUINCHIA , TERRI FLOWERS AND LENORE                       AUGUST TERM, 2001
 DEL BUONO for themselves and all others
 similarly situated,
                                                           NO. 002353
                                Plaintiffs,
         v.
                                                           CLASS ACTION
 BAYER AG, et al



                                Defendants.
                                              ORDER

       The Court now has before it the motion of Plaintiffs for class certification pursuant to Pa.

R.C.P. 1702.

       It is HEREBY ORDERED THAT the motion for class certification pursuant to the provisions

of Pa. R.C.P. 1702 is granted. The Court hereby orders certification of the following Classes:

                CLASS I -- All persons in the Commonwealth of Pennsylvania, or their
                estates, administrators or other legal representatives, heirs or
                beneficiaries, who were prescribed and ingested the drug, Baycol, also
known as cerivastatin. This class seeks, among other relief, medical
monitoring benefits for inter alia, testing for CoQ10 depletion, elevated
CK levels and a chest x-ray to determine to what extent they may
suffer from latent injury or may develop injury in the future in order
to provide timely appropriate medical care. Incidental to the Court-
supervised monitoring program, plaintiffs seek to obtain
epidemiological research benefits for scientists to further understand
the effects of Baycol and other equitable relief including restitution for
the cost of the drug. Excluded from this class are all persons and
entities with claims for personal injury. Also excluded from this class
are the defendants, any entities in which the defendants have a
controlling interest, and all of their legal representatives, heirs, and
successors.



CLASS II -- All persons in the United States, its possessions and
territories, or their estates, administrators or other legal
representatives, heirs or beneficiaries, who were prescribed and
ingested the drug, Baycol, also known as cerivastatin. This class seeks,
among other relief, medical monitoring benefits for inter alia, testing
for CoQ10 depletion, elevated CK levels and a chest x-ray to determine
to what extent they may suffer from latent injury or may develop
injury in the future in order to provide timely appropriate medical
care. Incidental to the Court-supervised monitoring program,
plaintiffs seek to obtain epidemiological research benefits for scientists
to further understand the effects of Baycol and other equitable relief
including restitution for the cost of the drug. Excluded from this class
are all persons and entities with claims for personal injury. Also
excluded from this class are the defendants, any entities in which the
defendants have a controlling interest, and all of their legal
representatives, heirs, and successors.

CLASS III -- All persons in the United States, its possessions and
territories, or their estates, administrators or other legal
representatives, heirs or beneficiaries, who were prescribed and
ingested the drug, Baycol, also known as cerivastatin, who now suffer
from personal injury. This class represents all individuals who have
suffered pain, swelling, debilitation, and other medical injuries.
                Included in this class are spouses and others entitled to loss of
                consortium, as well as dependents and others entitled to recover under
                the Wrongful Death or Survival statutes. This class seeks damages for
                personal injury, wrongful death, loss of consortium, etc.

                CLASS IV ? All persons in the Commonwealth of Pennsylvania, its
                possessions and territories, or their estates, administrators or other
                legal representatives, heirs or beneficiaries, who were prescribed and
                ingested the drug, Baycol, also known as cerivastatin, who now suffer
                from personal injury. This class represents all individuals who have
                suffered pain, swelling, debilitation, and other medical injuries.
                Included in this class are spouses and others entitled to loss of
                consortium, as well as dependents and others entitled to recover under
                the Wrongful Death or Survival statutes. This class seeks damages for
                personal injury, wrongful death, loss of consortium, etc.

         The parties shall submit a proposed form of notice to the class within twenty (20) days of this

Order.



                ENTERED this ________ day of ___________________, 2002.




                                                        _________________________________
                                                                                      J.

								
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