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					                            NO. 09-0737
________________________________________________________________________

              IN THE SUPREME COURT OF TEXAS

  TEXAS DEPARTMENT OF STATE HEALTH SERVICES, AND DAVID L.
               LAKEY, M.D., COMMISSIONER,

                                  Petitioners
                                       v.

                      NANCY HOLMES, CLHRP, CME

                               Respondent
________________________________________________________________________

    On Petition for Review from the Third Court of Appeals at Austin, Texas
                               (03-08-00497-CV)

              HOLMES’ RESPONSE BRIEF ON THE MERITS



                                          Jennifer S. Riggs
                                          State Bar No. 16922300
                                          Bill Aleshire
                                          State Bar No. 24031810
                                          Riggs Aleshire & Ray, P.C
                                          700 Lavaca St., Suite 920
                                          Austin, Texas 78701
                                          512 457-9806
                                          512 457-9066 Facsimile


                                          ATTORNEYS FOR RESPONDENT
                                             TABLE OF CONTENTS
                                                                                                                       PAGE

TABLE OF CONTENTS .................................................................................................... ii

INDEX OF AUTHORITIES .............................................................................................. iv

RESPONSE TO STATEMENT OF THE CASE................................................................ x

RESPONSE TO STATEMENT OF JURISDICTION....................................................... xi

RESTATEMENT OF AND REPLY TO ISSUES PRESENTED .................................... xii

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

SUMMARY OF THE ARGUMENT.................................................................................. 5

ARGUMENT....................................................................................................................... 7

I. No conflicts jurisdiction .................................................................................................. 7

II. (Issue 1) The Department’s seizure of private property without notice and a hearing
was subject to the trial court’s review. .............................................................................. 10

                   A.     Regardless of whether the Department is ultimately correct on the
                   law and/or facts, which it is not, it must nonetheless establish that it is
                   correct on the facts and law in some kind of fair hearing…………………10

                   B.    The Department did not establish a prima facie case that its seizure
                   was authorized or warranted under the facts or the law…………………..18

III. (Issue 2) This Court’s decision in City of El Paso v. Heinrich, 284 S.W.3d 366 (Tex.
2009), did not hold that a state agency is immune from lawsuits alleging a constitutional
claim……………………………………………………………………………………...27

IV. (Issue 3) The evidence in this case creates a fact question regarding the jurisdictional
issue, preventing the trial court from granting the Department’s plea to the jurisdiction.30

V. (Issue 4) The trial court did not abuse its discretion in granting a temporary
injunction………………………………………………………………………………...33



Holmes’ Response Brief on the Merits
ii
                    A.         Standard of Review ……………………………………………….33

                    B.        Cause of action…………………………………………………….34

                    C.    Holmes’ use of the laser was not “prima facie” illegal; she showed a
                    probable right to recover…………………………………………………..35

                    D.        Holmes showed irreparable injury…………………………………39

PRAYER ........................................................................................................................... 41

CERTIFICATE OF SERVICE.......................................................................................... 42




Holmes’ Response Brief on the Merits
iii
                              INDEX OF AUTHORITIES

CASES                                                                               PAGE

Baker v Smith & Nephew Richards, Inc., 1999 WL 1999 811334
      (Tex. Dist. Ct., Harris Co. 152nd Judicial Dist., June 7, 1999)…...………...……23

Bell v. Texas Workers Compensation Commission, 102 S.W.3d 299
        (Tex. App.-Austin, 2003)………………………………………………..……13, 14

Bland Indep. Sch. Dist. v. Blue, 34 S.W.3d 547 (Tex.2000)…………………………….33

Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012,
     148 L.Ed.2d 854 (2001)……………………………………………………..……24

Butnaru v. Ford Motor Company, 84 S.W.3d 198 (Tex. 2002)…………………………34

Canteen Corp. v. Republic of Tex. Props., Inc., 773 S.W.2d 398
      (Tex. App.-Dallas 1989, no writ)…………………………………………………34

Christy v. Williams, 156 Tex. 555, 298 S.W.2d 565 (1957)……………………………8, 9

Church of Scientology of Cal. v. Richardson, 437 F.2d 214 (9th Cir. 1971)………..……36

City of Austin v. Savetownlake.Org, 2008 WL 3877683
       (Tex.App.-Austin, Aug 22, 2008, no pet.)…………………………………..……32

City of El Paso v. Heinrich, 284 S.W.3d 366 (Tex. 2009)…...vi, vii, 5, 6, 8, 10, 27, 28, 29

City of Fort Worth v. Shilling, 266 S.W.3d 97 (Tex. App. – Fort Worth, pet. denied)….32

Cleveland Bd. of Educ. v. Loudermill, 470 U.S. 532, 105 S. Ct. 1487,
      84 L. Ed. 2d 494, 23 Ed. Law Rep. 473 (1985)……………………………..……15

Coastal Corp. v. Garza, 979 S.W.2d 318 (Tex.1998)…………………….………………8

County of Sacramento v. Lewis, 523 U.S. 833, 118 S.Ct. 1708,
      140 L.Ed.2d 1043 (1998)…………………………………………………………41

Crossman v. City of Galveston, 112 Tex. 303, 247 S.W. 810 (1923)……………………13

Daniels v. Williams, 474 U.S. 327, 106 S. Ct. 662, 88 L. Ed. 2d 662 (1986)……...……14


Holmes’ Response Brief on the Merits
iv
Electronic Data Sys. Corp. v. Powell, 508 S.W.2d 137
       (Tex.Civ.App.-Dallas 1974, no writ)…………………………………..…………33

Francisco v. Board of Dental Examiners, 149 S.W.2d 619
      (Tex. Civ. App.—Austin 1941, writ ref’d.)…………………………..…………..40

Fuentes v. Shevin, 407 U.S. 67, 92 S.Ct. 1983, 32 L.Ed.2d 556 (1972)…………………41

Gonzalez v. Avalos, 907 S.W.2d 443 (Tex. 1995)…………………………………..…vi, 8

Gonzalez v. Hidalgo County, 489 F.2d 1043 (5th Cir. 1973)……………………………15

Hajek v. Bill Mowbray Motors, Inc., 647 S.W.2d 253 (Tex.1983)……………………vi, 8

House of Tobacco, Inc. v. Calvert, 394 S.W.2d 654 (Tex. 1965)………………………..36

Hudson v. Palmer, 468 U.S. 517, 104 S. Ct. 3194, 82 L. Ed. 2d 393 (1984)……………15

Industrial Accident Board v. O'Dowd, 157 Tex. 432, 303 S.W.2d 763 (1957)………….13

In re J.F.C., 96 S.W.3d 256 (Tex. 2002)…………………………………………...……41

Kellogg v Mattox, 763 F. Supp. 1369 (N.D. Tex. 1991)…………………………..…18, 40

Logan v. Zimmerman Brush Co., 455 U.S. 422, 102 S. Ct. 1148,
      71 L. Ed. 2d 265 (1982)……………………………………………………..……15

Madden v. Texas Board of Chiropractic Examiners, 663 S.W.2d 622
     (Tex. Civ. App. – Austin 1983, writ ref’d n.r.e.)…………………………………26

Mathews v. Eldridge, 424 U.S. 319, 334, 96 S.Ct. 893, 47 L.Ed.2d 18 (1976)…….……14

Mauldin v. Texas State Bd. of Plumbing Examiners, 94 S.W.3d 867
      (Tex. App. – Austin 2002)…………………………………………………..……35

McAllen Medical Center, Inc. v. Cortez, 66 S.W.3d 227 (Tex. 2001)…………...……vi, 8

McClane v. State, 343 S.W.2d 447 (Tex. Crim. App. 1960)………………………….…36

Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)…...19, 24

Pacific T. & T. Co. v. Kuykendall, 265 U.S. 196, 44 S.Ct. 553, 68 L.Ed. 975…………..40


Holmes’ Response Brief on the Merits
v
Parratt v. Taylor, 451 U.S. 527, 101 S. Ct. 1908, 68 L. Ed. 2d 420 (1981)………....14, 29

Porter v. Investors' Syndicate, 286 U.S. 461, 52 S.Ct. 617, 76 L.Ed. 1226……………..40

Prairie View A & M University v. Brooks, 180 S.W.3d 694
       (Tex. App. – Houston [14th Dist.] 2005, no pet.)…………………………………33

Rayford v. State, 16 S.W.3d 203 (Tex. App.—Dallas 2000, pet denied)……36, 37, 38, 39

Schware v. Board of Bar Examiners, 353 U.S. 232 (1957)………………………...……36

Stockwell v State, 110 Tex. 550, 221 S. W. 932 (1920)………...……………………12, 13

Sun Oil Co. v. Whitaker, 424 S.W.2d 216 (Tex.1968)…………………………………..34

Swanson v. Houston Independent School Dist., 800 S.W.2d 630
     (Tex. App.- Hous. [14 Dist.], 1990, writ denied)………………………..….……13

Tesoro v. Alvarez, 281 S.W.3d 654 (Tex. App.- Corpus Christi, 2009, no pet.)….……..24

Texas Department of Parks and Wildlife v. Miranda,
      133 S.W.3d 217 (Tex. 2002)………………...………vi, vii, 5, 6, 7, 8, 9, 30, 31, 32

Texas Department of Protective and Regulatory Services v. Mega Child Care, Inc.,
      145 S.W. 3d 170 (Tex. 2004)……………………………..………………………28

Texas Dept. of State Health Services v. Holmes, 294 S.W.3d 328
      (Tex.App.-Austin, 2009, pet. filed)……………………………………………9, 32

Texas Educ. Agency v. Leeper, 893 S.W.2d 432 (Tex. 1994)……….....vii, 6, 9, 27, 28, 29

Texas Workers' Comp. Comm'n v. Patient Advocates of Tex.,
      136 S.W.3d 643 (Tex. 2004)……………………………………………...………41

Universal Health Servs. v. Thompson, 24 S.W.3d 570
      (Tex.App.-Austin 2000, no pet.)………………………………………………….34

University of Tex. Med. Sch. v. Than, 901 S.W.2d 926 (Tex.1995)………………..……14

Walling v. Metcalfe, 863 S.W.2d 56 (Tex.1993)……………………….………....…33, 34

West Disinfecting Co. v. Trustees of Crosby Indep. Sch. Dist., 135 Tex. 492,
      143 S.W.2d 749 (1940)…………………………………………………………….8

Holmes’ Response Brief on the Merits
vi
Wichita Falls State Hosp. v. Taylor, 106 S.W.3d 692 (Tex. 2003)……………….....27, 28

STATUTES AND RULES

TEX. CIV. PRAC. & REM. CODE §37.006(b)…………………………………………27

TEX. GOV’T CODE § 22.001(a)(1)……………………………………………………...8

TEX. GOV’T CODE § 22.001(a)(2)……………………………………………………...8

TEX. GOV’T CODE § 22.001(a)(3)……………………………………………………...8

TEX. GOV’T CODE § 22.225(b)………………………………………………...……vi, 8

TEX. HEALTH & SAFETY CODE §431.084………………………………………….18

TEX. HEALTH & SAFETY CODE §431.114………………………………………….18

TEX. HEALTH & SAFETY CODE §431.115………………………………………….18

TEX. HEALTH & SAFETY CODE § 431.048……………………………….6, 17, 18, 34

TEX. HEALTH & SAFETY CODE § 431.059…………………………………….……40

TEX. HEALTH & SAFETY CODE § 431.112(f)(l)……………………………………37

TEX. HEALTH & SAFETY CODE § 431.112(f)(r)……………………………………37

TEXAS ADMINISTRATIVE CODE

25 TAC §289.301………………………………………………………...………..…1, 19

25 TAC §301(a)(1)………………………………………………………………………25

25 TAC §289.301(a)(2)…………………………………………………………….....1, 25

25 TAC §289.301(b)(1)……………………………………………………………….…25

25 TAC §289.301(d)(30)………………………………………………………...……1, 25

25 TAC §289.301(p)……………………………………………………………………..25


Holmes’ Response Brief on the Merits
vii
25 TAC §289.301(q)……………………………………………………………………..26

UNITED STATES CODE

21 USC § 331(a)…………………………………………………………………………20

21 USC § 332…………………………………………………………………………….20

21 USC § 333(f)………………………………………………………………………….20

21 USC § 351(f)…………………………………………………………………………20

21 USC § 352(o)…………………………………………………………………………20

21 USC § 360c(a)(1)(A)…………………………………………………………………19

21 USC § 360c(a)(1)(B)…………………………………………………………………19

21 USC § 360c(a)(1)(C)………………………………………………………...……19, 20

21 USC § 360j(e)…………………………...……………………………………………21

21 USC § 360j(e)(1)(A)…………………………………………………………………21

21 USC § 360j(e)(1)(B)………………….………………………………………………21

21 USC § 360k……………………………………………………………………..……24

CODE OF FEDERAL REGULATION

21 CFR §801.109…………………………………………………………………..……23

OTHER

Alice’s Adventures in Wonderland………………………………………………………10

Pete Schenkkan, “Texas Administrative Law: Trials, Triumphs, and New Challenges,”
       7 Tex. Tech. Admin. L.J. 288 (Summer 2006)……………………………...……30

Ron Beal, “A Miry Bog Part II: UDJA and APA Declaratory Judgment Actions and
     Agency Statements Made Outside a Contested Case Hearing Regarding the
     Meaning of the Law,” 59 Baylor L.Rev. 267 (Spring 2007)………………..……30


Holmes’ Response Brief on the Merits
viii
O’Reilly, James T., 2 Food and Drug Admin., §25.19 (2009)…………………………..23




Holmes’ Response Brief on the Merits
ix
                    RESPONSE TO STATEMENT OF THE CASE

Nature of the case. This case is about the Department’s statutory authority to seize

private property without procedural due process and just compensation and about

whether the trial court abused its discretion in enjoining that seizure.

Disposition by the trial court.     The trial court did not deny, “preliminarily” or

otherwise, the Department’s plea to the jurisdiction. The trial courted granted in part

exactly what the Department requested, ordering the Department to provide a SOAH

hearing and abating the case pending exhaustion of that SOAH remedy, and simply

deferred ruling on the other aspects of the plea to the jurisdiction. (CR 189)

The parties in the court of appeals.       The Appellant in the court of appeals was not

“the State,” the Appellants are one state agency, the Department of State Health Services,

and its Commissioner, David M. Lakey, M.D.




Holmes’ Response Brief on the Merits
x
                 RESPONSE TO STATEMENT OF JURISDICTION

       The Department asserts that the court of appeals decision holds differently from

prior decisions of this Court: Texas Department of Parks and Wildlife v. Miranda, 133

S.W.3d 217 (Tex. 2002) and City of El Paso v. Heinrich, 284 S.W.3d 366 (Tex. 2009). In

the body of its brief the Department also relies on the fact that this case involves the

interpretation of statutes and the health and safety of the public. (Petitioners’ Brief, p. 1)

That is no basis for jurisdiction here.

       Jurisdiction over interlocutory appeals is generally final in the courts of appeals.

McAllen Medical Center, Inc. v. Cortez, 66 S.W.3d 227, 236-237 (Tex. 2001) (citing

TEX. GOV'T CODE § 22.225(b)). In interlocutory appeals, a party may invoke this

Court’s jurisdiction only under subsection (a)(1) (dissent) or subsection (a)(2) (conflicts),

but not under subsection (a)(3) (statutory construction). Gonzalez v. Avalos, 907 S.W.2d

443, 444 (Tex. 1995) (citing Hajek v. Bill Mowbray Motors, Inc., 647 S.W.2d 253 (Tex.

1983)). As a result, only the conflicts jurisdiction arguments of the Department should be

considered. No conflict exists here since the court of appeals simply applied the Miranda

and Heinrich cases and since material factual differences legitimately distinguish the

holdings in the court of appeals case.




Holmes’ Response Brief on the Merits
xi
           RESTATEMENT OF AND REPLY TO ISSUES PRESENTED

1.    Whether the Department’s seizure of private property without notice and a
hearing is subject to the trial court’s review.

The Department’s position would do away with due process simply because the
government asserted it was acting under the police power and would resurrect the old
demurrer practice. The Department’s position also would deprive the courts of their long-
standing jurisdiction to review the constitutionality of statutes and government actions
under statutes.

2.     Whether City of El Paso v. Heinrich, 284 S.W.3d 366 (Tex. 2009), held that a
state agency is immune from lawsuits alleging a constitutional claim.

Under Texas Educ. Agency v. Leeper, 893 S.W.2d 432 (Tex. 1994), and its progeny,
which was affirmed in City of El Paso v. Heinrich, 284 S.W.3d 366 (Tex. 2009), a party
may challenge the constitutionality of a statute and must name the governmental body. To
accept the Department’s position would be to overrule Leeper and its progeny.

3.     Whether the evidence in this case creates a fact question regarding the
jurisdictional issue, preventing the trial court from granting the Department’s plea
to the jurisdiction.

       The Department’s issue 3 relies on the Department’s “pleadings and jurisdictional
evidence” and asserts that this evidence negated subject-matter jurisdiction “as a matter
of law,” thereby taking it outside of Texas Parks and Wildlife v. Miranda, 133 S.W.3d
217 (Tex. 2002). Under Miranda, however, if the evidence creates a fact question
regarding the jurisdictional issue, the trial court cannot grant the plea to the jurisdiction.

4.    Whether the trial court abused its discretion in granting a temporary
injunction.

The Department suggests that the trial court abused its discretion because Holmes used
her laser in violation of state and federal law. The Department, however, simply failed to
establish a legal and factual basis for its summary seizure of private property without
prior notice and hearing.




Holmes’ Response Brief on the Merits
xii
                               STATEMENT OF FACTS

       The Department of State Health Services has rules regarding the use of lasers. 25

TAC §289.301. Those rules specify requirements for “the registration of persons who

receive, possess, acquire, transfer, or use” lasers. §289.301 (a)(2)(emphasis added). The

rules set forth the training requirements for those who use lasers. §289.301 (a)(1), (p).

The rules require that a laser safety office (LSO) be specified for each laser registered

with the DSHS. See §289.301 (a)(2). The rules define a LSO as

       (30) Laser safety officer (LSO)--An individual who has a knowledge of and the
       authority and responsibility to apply appropriate laser radiation protection rules,
       standards, and practices, and who must be specifically authorized on a certificate
       of laser registration.

25 TAC §289.301(d)(30). No Department rule purports to repeal this rule or substitute a

medical doctor or a medical doctor’s prescription for the LSO or to require a prescription

for each use of the laser.

       Holmes has provided hair removal services with electrolysis since 1981 and hair

removal with lasers since 2001. (RR 32) Her lasers “entered commerce,” i.e. she bought

them, with orders from a medical doctor, as required by federal law. (RR 45) The lasers

she uses are registered with the Department and have been since 2002. (RR 43-44, 70 and

Plaintiff’s Exhibit 3) She is certified in laser safety. (RR 41) It is undisputed that Holmes

is the designated LSO for her lasers, as required under the Department’s Rule

289.301(a)(2), (d)(30). (RR 40-41, 44)

       Despite these undisputed facts, in an abrupt departure from its published rules, the

Department summarily seized Holmes’ personal property – her laser. The basis for the


Holmes’ Response Brief on the Merits
Page 1
seizure was an assertion that is not in any state or federal statute, much less published in

any Department rule. The basis for the seizure is the ad hoc, new position of the

Department that before Holmes may use her property on a customer, she must have an

individual written order from a medical doctor for each session, or at least for each

customer. In other words, no one may have laser hair removal without a prescription.

       At issue is Holmes’ laser – unique, financed personal property worth $100,000.00.

(RR 35, 37) The laser at issue was the tool of Holmes’ trade for seven years prior to the

seizure. (RR 32-33) The seizure effectively prevented Holmes from acting as a LSO and

from engaging in the major part of her chosen occupation just as clearly as would the

deprivation of a professional license. The Department knew what Holmes and dozens of

other businesses like hers have been doing for at least 7 years prior to the summary

seizure. (RR 43, 66, 70 and Plaintiff’s Exhibit 3) The Department presented no evidence

of any exigent circumstances or emergency to warrant the seizure, particularly a

summary seizure. The Department presented no evidence of any unusual circumstances

that prevented it from acting sometime earlier during the 7 years or that it could not have

provided a hearing.

       Holmes established a relationship with a medical doctor when she obtained her

first laser and continued to use the laser under his supervision. (RR 54, 56-57) After

initially reviewing every file (RR 56-57), he did not deem a review or consult, much less

a written order prior to every laser hair session to be medically necessary; only when

particular conditions existed would a medical consult be necessary. (See RR 56-57) The

Department’s notice incorrectly stated that such supervision was non-existent. The

Holmes’ Response Brief on the Merits
Page 2
Department also contended that a prescription was required. With no medical evidence to

support it, the Department erroneously equates not having a medical doctor’s prescription

for each cosmetic procedure with “no” physician supervision. The lack of written orders

and supervision was the basis for the Department’s extrapolation that Holmes’ lasers

were “misbranded.”

       The Department offered no evidence at the temporary injunction hearing of any

injury or harm to any of Holmes’ clients because there has been none. (RR 32-33) The

Department presented no evidence of any imminent danger. The Department presented

no evidence of any fraud on consumers. There was only the Department’s lay testimony,

over objection, that lasers can be dangerous because the federal regulations state that

lasers can be dangerous if misused and the lay testimony equating such alleged misuse

with “misbranded.” (RR 166-167) Holmes agrees that lasers can be dangerous. That is

why she has taken extensive training in the proper use of lasers for laser hair removal.

(RR 40-42) That is why she has complied with the Department’s published LSO rules

since she first obtained her laser.

       The bulk of the testimony was that Holmes’ laser hair business is safe and that a

written order by a medical doctor for each hair removal session or even each client is not

part of adequate medical supervision. (RR 57-58, 94, 99) That testimony included the

testimony of one of Holmes’ experts, Dr. Steven Finder, a medical doctor who also

possesses experience and skill with lasers and with laser hair removal. (RR 92-93) In fact,

the testimony was that it would amount to “overutilization” to require a written order or

prescription for each customer session. (RR 119) The training of laser technicians,

Holmes’ Response Brief on the Merits
Page 3
following the label instructions for the lasers, and having medical guidelines in place to

identify those clients with particular conditions that should have a medical consult prior

to treatment could and should be effected without a consultation with a medical doctor in

every case. (RR 117-118)

       Based on the evidence, the trial court entered a temporary injunction and granted

in part and denied in part the Department’s plea to the jurisdiction. The trial court granted

that part of the Department’s plea that contended that Holmes had not exhausted her

administrative remedies. The trial court enjoined the summary seizure of Holmes’

property by the Department, thereby releasing the laser; required that the Department

provide an administrative hearing on the basis for the seizure; and abated the case until

that hearing was completed.

       The Department’s Statement of Facts does not fully or accurately describe the

administrative proceedings that were ordered by the trial court. (CR 189) Only after it

had been directed to do so did the Department schedule a hearing at the State Office of

Administrative Hearings (SOAH) on its complaints against Holmes. That hearing was in

no way limited, as asserted by the Department, to whether the detention should be

continued, modified, or ended. Holmes raised the merits of the seizure in that proceeding

and proceeded to defend against the Department’s allegations. The Department, however,

did not wish to proceed with a hearing on the merits and attempted to dismiss its

complaint against Holmes without prejudice. Holmes objected that she would still be

subject to an action for misbranding. It was only after that concern was raised and the



Holmes’ Response Brief on the Merits
Page 4
Department had the opportunity to raise its claims on the merits against Holmes that the

Department’s case was dismissed with prejudice.

       Contrary to the Department’s assertion, the SOAH proceeding was not moot on

the basis that the laser had been released by the temporary injunction, that release is

clearly only temporary. The Department, with the exercise of due diligence, could have

and should have litigated its claim that the laser was misbranded in the SOAH proceeding

but declined to do so. It is now too late to do so.

                           SUMMARY OF THE ARGUMENT

       The Department asserts that this Court should review this case because it involves

the interpretation of state and federal statutes and the health and safety of the public.

(Petitioners’ Brief, p. 1) In interlocutory appeals, however, a party may invoke this

Court’s jurisdiction only in limited circumstances that do not include Government Code

section 22.001(a)(3)(interpretation of a state statute). Only the conflicts jurisdiction

arguments of the Department should be considered. No conflicts exist between the court

of appeals decision and this Court’s decisions in Heinrich or Miranda. Applying the

principles announced in Heinrich and Miranda to the facts of this case would not operate

to overrule the court of appeals decision.

       Under Miranda, if evidence is necessary to decide a jurisdictional issue, if the

evidentiary issues on the merits and on jurisdiction are related, and if the evidence creates

a fact question regarding the jurisdictional issue, the trial court cannot grant the plea to

the jurisdiction. That is precisely what happened in this case. The significant factual

issues are (1) the circumstances that allegedly made the situation exigent such that the

Holmes’ Response Brief on the Merits
Page 5
Department could skip notice and a hearing and (2) whether the level of medical

supervision in place for Holmes’ laser was medically adequate. The Department’s whole

house of cards on the merits rests on this second issue of disputed fact. The court of

appeals did not err in concluding that the trial court did not abuse its discretion because

there is no conflict with the Miranda decision.

       The court of appeals decision did not conflict with Heinrich for purposes of

conflicts jurisdiction. Under the UDJA, as interpreted and applied in Texas Educ. Agency

v. Leeper, 893 S.W.2d 432 (Tex. 1994), which was affirmed in Heinrich, a party may

seek an interpretation of a statute and must name the governmental body. While the

Department may have authority to seize a business’ property under certain circumstances

described by statute, that Department cannot avoid a claim of ultra vires act by seizing

property under other circumstances not described in the law. Petitioners argue that

seizing Holmes’ laser was authorized, not ultra vires, by ignoring the trial court’s

findings—affirmed by the court of appeals—that the State did not have such seizure

authority under these circumstances.

       The Department’s protestations that it “conclusively established” its case and that

“the jurisdictional evidence, as a matter of law” deprived the trial court of jurisdiction

(Petitioners’ Brief, p. xiii) simply highlight the factual nature of the underlying case. This

case is about the Department’s statutory authority to seize private property without

procedural due process and just compensation and about whether the trial court abused its

discretion in enjoining that seizure. The trial court did not abuse its discretion because the

Department simply failed to show the trial court any factual basis for its summary seizure

Holmes’ Response Brief on the Merits
Page 6
of Holmes’ private property, even if its arguments about the requirements of state and

federal law were correct. Those arguments are not, however, correct since no provision of

state or federal law and no rule of the Department requires a prescription for each use of a

laser.

         Finally, the Department is simply wrong on the law. The United States Congress

cannot authorize a state agency to do anything without parallel state legislation. As will

be shown, State law, in the form of the Dangerous Drug Act, simply does not apply since

the federal Medical Devices Act separates drugs and devices, regulates them separately,

provides that prescription devices are not drugs, and preempts the states from adopting

contrary law. Moreover, the Department’s own published regulations, which are based on

federal law and which are the best reflection of the Department’s interpretation of federal

law, expressly authorize laser safety officers (LSOs) such as Holmes to use lasers without

any requirement of a written order from a medical doctor for each use of the laser. Only if

the manner of use of a laser constitutes the practice of medicine will such an order be

necessary. The use of lasers for non-ablative hair removal is not the practice of medicine.

                                      ARGUMENT

I.       No conflicts jurisdiction

         The Department’s Statement of Jurisdiction does not specify the basis for its

assertion of conflicts jurisdiction, i.e. the Texas Supreme Court or court of appeals cases

with which the court of appeals decision purportedly conflicts. In the body of its brief,

however, the Department asserts that the court of appeals decision holds differently from

prior decisions of this Court: Texas Department of Parks and Wildlife v. Miranda, 133

Holmes’ Response Brief on the Merits
Page 7
S.W.3d 217 (Tex. 2002) and City of El Paso v. Heinrich, 284 S.W.3d 366 (Tex. 2009). In

the body of its brief the Department also relies on the fact that this case involves the

interpretation of statutes and the health and safety of the public.

       Jurisdiction over interlocutory appeals is generally final in the courts of appeals.

McAllen Medical Center, Inc. v. Cortez, 66 S.W.3d 227, 236-237 (Tex. 2001) (citing

TEX. GOV'T CODE § 22.225(b)). In interlocutory appeals, a party may invoke this

Court’s jurisdiction only under Government Code section 22.001(a)(1) (dissent) or

section 22.001(a)(2) (conflicts), but not under section 22.001 (a)(3) (statutory

construction). Gonzalez v. Avalos, 907 S.W.2d 443, 444 (Tex. 1995) (citing Hajek v. Bill

Mowbray Motors, Inc., 647 S.W.2d 253 (Tex.1983)). As a result, only the conflicts

jurisdiction arguments of the Department should be considered.

       Based on a long line of cases from this Court, there is no conflict, as described by

this Court, between the court of appeals decision and Heinrich or Miranda. “[T]he

conflict must be on the very question of law actually involved and determined, in respect

of an issue in both cases, the test being whether one would operate to overrule the other

in case they were both rendered by the same court.” McAllen, 66 S.W.3d at 237 (quoting

Coastal Corp. v. Garza, 979 S.W.2d 318, 319-20 (Tex.1998) (quoting Christy v.

Williams, 156 Tex. 555, 298 S.W.2d 565, 568-69 (1957) (quoting West Disinfecting Co.

v. Trustees of Crosby Indep. Sch. Dist., 135 Tex. 492, 143 S.W.2d 749, 750 (1940)). The

Court must decide whether the rulings in the allegedly conflicting cases are “‘so far upon

the same state of facts that the decision of one case is necessarily conclusive of the

decision in the other.’ ” McAllen, 66 S.W.3d at 237 (quoting Gonzalez v. Avalos, 907

Holmes’ Response Brief on the Merits
Page 8
S.W.2d 443, 444 (Tex.1995)) (quoting Christy, 298 S.W.2d at 567). No conflict between

the cases exists if material factual differences legitimately distinguish the holdings.

McAllen, 66 S.W.3d at 237.

         Under Miranda, if evidence is necessary to decide the jurisdictional issue, if the

evidentiary issues on the merits and on jurisdiction are related, and if the evidence creates

a fact question regarding the jurisdictional issue, the trial court cannot grant the plea to

the jurisdiction. That is precisely what happened in this case. As a result, there is no

conflict with the Miranda decision. The factual issues that prevent a “conflict” with

Miranda are (1) the circumstances that allegedly made the situation exigent such that the

Department could skip notice and a hearing and (2) whether the level of medical

supervision in place was medically adequate. Under Miranda, if the evidence creates a

fact question regarding the jurisdictional issue, the trial court cannot grant the plea to the

jurisdiction until the fact question is resolved. Texas Dept. of State Health Services v.

Holmes, 294 S.W.3d 328, 335 (Tex.App.-Austin, 2009, pet. filed) (quoting Texas

Department of Parks and Wildlife v. Miranda, 133 S.W.3d 217, 227-228 (Tex. 2002)).

         The court of appeals decision did not conflict with Heinrich for purposes of

conflicts jurisdiction.1 Under the UDJA, as interpreted and applied in Texas Educ.

Agency v. Leeper, 893 S.W.2d 432 (Tex. 1994), which was affirmed in Heinrich, a party

may seek an interpretation of a statute and must name the governmental body. As a result,



         1
           The court of appeals decision conflicted with Heinrich but not for the reasons stated by the Department
and not for reasons that would support this Court’s jurisdiciton to consider the case. The court of appeals ignored
footnote 6 of the Heinrich decision when it reversed the trial court’s decision “to the extent it denies the plea to the
jurisdiction as to Holmes's statutory ultra vires claims against the Department.”

Holmes’ Response Brief on the Merits
Page 9
there is no conflict with Heinrich in not dismissing the remaining claims. While the

Department may have authority to seize a business’ property under certain circumstances

described by statute, that Department cannot avoid a claim of ultra vires act by seizing

property under other circumstances not described in the law. Petitioners argue that

seizing Holmes’ laser was authorized, not ultra vires, by ignoring the trial court’s

findings—affirmed by the court of appeals—that the State did not have such seizure

authority under these circumstances.

II.   (Issue 1) The Department’s seizure of private property without notice and a
hearing was subject to the trial court’s review.

      A.     Regardless of whether the Department is ultimately correct on the law
      and/or facts, which it is not, it must nonetheless establish that it is correct on
      the facts and law in some kind of fair hearing.

      The Department’s issue 1 takes over 40 words to articulate an issue that is

essentially that Holmes was guilty and, therefore, did not deserve due process in the form

of a pre-detention hearing and that the courts have no power to review such executive

decisions. In other words,

      “Let the jury consider their verdict,” the King said, for about the twentieth time
      that day.

      “No, no!” said the Queen. “Sentence first--verdict afterwards.”

      “Stuff and nonsense!” said Alice loudly. “The idea of having the sentence first!”

      “Hold your tongue!” said the Queen, turning purple.

      “I won't!” said Alice.

      “Off with her head!” the Queen shouted at the top of her voice.



Holmes’ Response Brief on the Merits
Page 10
Lewis Carroll, Alice’s Adventures in Wonderland, Chapter 12. Literary analogies aside,

on the merits, the Department continues to miss the point of due process – unless exigent

circumstances exist, due process must come before a deprivation of property. And even

with exigent circumstances, meaningful notice and hearing must promptly follow the

deprivation. Neither was afforded here.

      Throughout its discussion of Issue 1, the Department omits reference to Holmes’

complaints about the summary nature of the seizure. It is the summary nature of the

seizure and the lack of a hearing, much less the lack of any finding of exigent

circumstances under section 431.048(a), that formed the primary basis for Holmes’

request for interim injunctive relief. (CR 11, 69) It is undisputed that there was no pre-

deprivation notice and hearing. That evidence supports jurisdiction and the trial court’s

temporary injunction.

      The Department never established an imminent threat to the public health safety

and welfare. The Department simply repeated, as it does here, that federal law says lasers

can be dangerous, therefore, anything the Department wants to do to those who own and

use lasers is justified. The Department urges that its interpretation of the law is correct

and that Holmes’ only remedy was to agree – that immunity bars her claims. The

Department left out an important consideration – that it might be wrong on the law. And

even if it is right on the law, it must nonetheless establish the facts to justify summary

action that affects private property rights and establish those facts in some kind of

hearing.



Holmes’ Response Brief on the Merits
Page 11
      The “police power” does not supersede the Texas Constitution and does not

deprive the courts of the power to review the executive department’s exercise of the

police power. The Department would like to change the fundamental balance of power

between the courts and the executive department. Texas courts, however, have

historically limited the situations in which administrative agencies may take summary

action. For example, in Stockwell v State, 110 Tex. 550, 221 S. W. 932 (1920), the Court

considered summary action under a statute related to the destruction of diseased fruit

trees by the Commissioner of Agriculture. The Court declined to sustain the validity of

this statute because its effect was to deny a hearing on the question as to whether or not

the particular trees involved constituted a nuisance which ought to be summarily

destroyed.

      In Stockwell, the Court held:

              The trial court denied the defendant a hearing evidently upon the theory
      that it was competent for the Legislature to invest the commissioner with such
      unlimited authority, and this view was affirmed by the Court of Civil Appeals. In
      our opinion the commissioner could not be clothed with any such arbitrary power.

             The state, in the exercise of its public power, may denominate certain
      things to be public nuisances, and because of their having that character provide
      for their summary abatement. This power is limited to declaring only those things
      to be such nuisances which are so in fact, since even the state may not denounce
      that as a nuisance which is not in fact. Tiedeman's Limitation of Police Power, s
      122a. The police power is subordinate to the Constitution, as is every other
      power of the government.

             The state may also remit to such agencies as health boards, or other proper
      administrative officers, the authority of determining whether other things
      constitute public nuisances, with the power to abate them. But where this is done,
      the determination of such boards or officers is not conclusive and cannot be
      made so, unless it be with respect to something having the nature of a public
      emergency, threatening public calamity, and presenting an imminent and

Holmes’ Response Brief on the Merits
Page 12
      controlling exigency before which, of necessity, all private rights must
      immediately give way. If this were not true, all property would be at the
      uncontrolled will of temporary administrative authorities, exercising, not
      judicial powers, but purely executive powers. The result would be to subject the
      citizen's property solely to executive authority, putting it beyond the protection of
      the courts, and depriving the courts of their essential power of determining what,
      under the written law, is lawful and what is not - declaring the law of the land -
      and adjudging property rights accordingly. (Emphasis added.)

Stockwell v State, 110 Tex. 550, 554-555, 221 S. W. 932, 934-935. See also Crossman v.

City of Galveston, 112 Tex. 303, 247 S.W. 810 (1923).

      Since the Stockwell case was decided, Texas courts of appeals have addressed

numerous challenges to summary government action. Many of those cases denied relief,

but only because they determined that the government action at issue did not occur until

after notice and hearing had been provided. See, e.g., Swanson v. Houston Independent

School Dist., 800 S.W.2d 630, 633 (Tex. App.- Hous. [14 Dist.], 1990, writ denied); see

also Bell v. Texas Workers Compensation Commission, 102 S.W.3d 299, 305 (Tex. App.-

Austin, 2003) (Commission rules provided for notice and opportunity to contest validity

of grounds from removal from approved doctor list before removal); Industrial Accident

Board v. O'Dowd, 157 Tex. 432, 303 S.W.2d 763, 767 (1957)(IAB provided the two

attorneys with notice and a full administrative hearing before finding them guilty of

unethical and fraudulent conduct and barring them from practice before the IAB)

      In contrast, here, it is undisputed that neither Chapter 431 nor the Department’s

rules provide for prior notice or hearing, nor did the DSHS actually provide Holmes with

notice or hearing before seizing her property. Providing notice of the reason for the

summary seizure while the property is being seized is not prior notice. Although the


Holmes’ Response Brief on the Merits
Page 13
DSHS does have an informal, written policy – not published as a rule -- of providing for a

post-deprivation “review” and ultimately some kind of “administrative hearing,” in the

“review,” the DSHS shifts the burden of proof to the person challenging the embargo.

The review process does not involve an evidentiary hearing at which the DSHS has to

shoulder its burden of proof and persuasion supporting an emergency seizure. There is

nothing prompt about the process. There is no standard established in Chapter 431 to

limit the DSHS’s discretion. Finally, the “review’ is by the same officials who decided to

put the summary seizure in place.

       This limited review process followed by an administrative hearing of some type at

some point the in future is insufficient to pass constitutional muster. As a general rule,

exactly how much process is due in a given situation is measured by a flexible standard

that depends on the practical requirements of the circumstances. Bell, 102 S.W.3d at 304

(citing Mathews v. Eldridge, 424 U.S. 319, 334, 96 S.Ct. 893, 47 L.Ed.2d 18 (1976); and

University of Tex. Med. Sch. v. Than, 901 S.W.2d 926, 930 (Tex.1995)). The flexible

standard balances three factors: (1) the private interest affected by the state action; (2) the

risk of erroneous deprivation of a constitutionally protected interest under the procedures

used and the likely benefit of any additional procedures; and (3) the government's

interest, including the fiscal and administrative burdens that additional procedural

requirements would entail. Id. Those standards, however, apply to pre-deprivation due

process.

       A post-deprivation hearing is less likely to satisfy due process. In matters of due

process, Texas Courts traditionally follow federal due process applications. University of

Holmes’ Response Brief on the Merits
Page 14
Tex. Med. Sch. v. Than, 901 S.W.2d 926, 929 (Tex.1995); Bell, 102 S.W.3d at 304. In

Parratt v. Taylor, 451 U.S. 527, 101 S. Ct. 1908, 68 L. Ed. 2d 420 (1981) (overruled on

other grounds, Daniels v. Williams, 474 U.S. 327, 106 S. Ct. 662, 88 L. Ed. 2d 662

(1986)), the United States Supreme Court outlined the factors to apply in determining the

validity of summary government actions:

      (1) if the deprivation of the property interest is authorized by established state
      procedures, a pre-deprivation hearing is essential to ensure conformity with those
      procedures;
      (2) the requirement of a pre-deprivation hearing is directly related to the impact of
      the deprivation on the party's livelihood;
      (3) the imperative of quick state action is a weighty consideration; and
      (4) the imperative of a pre-deprivation hearing wanes when impractical, as in a tort
      situation, particularly when the state provides an adequate post-deprivation
      remedy.

451 U.S. at 539-43; see Gonzalez v. Hidalgo County, 489 F.2d 1043 (5th Cir. 1973).

      In Hudson v. Palmer, 468 U.S. 517, 104 S. Ct. 3194, 82 L. Ed. 2d 393 (1984), the

state provided an adequate post-deprivation remedy to a prisoner for alleged destruction

of his property by a state employee during a shakedown search, when there were several

common-law remedies available to the prisoner that would provide adequate

compensation for his property loss, and when state employees did not enjoy sovereign

immunity for their intentional torts. Absent the necessity of quick action by the state or

the impracticality of providing any pre-deprivation process, however, even a post-

deprivation hearing can be constitutionally inadequate. Logan v. Zimmerman Brush Co.,

455 U.S. 422, 102 S. Ct. 1148, 71 L. Ed. 2d 265 (1982). In Cleveland Bd. of Educ. v.

Loudermill, 470 U.S. 532, 105 S. Ct. 1487, 84 L. Ed. 2d 494, 23 Ed. Law Rep. 473

(1985), the Court held that a public employee who can be discharged only for cause and

Holmes’ Response Brief on the Merits
Page 15
who is entitled to a post-termination administrative hearing under state law must also be

given a pre-termination opportunity to respond to the charges as a matter of due process;

a governmental interest in immediate termination does not outweigh the private interest

in retaining employment and the risk of erroneous termination.

      The Department cannot justify a post-deprivation hearing. Under the United States

Supreme Court’s four-part test, (1) the Department does have an established procedure

for the seizure of property and, therefore, should also be able to provide for a pre-

deprivation hearing; (2) the deprivation had a direct impact on Holmes’ livelihood; (3)

the Department produced no evidence that immediate action was imperative, particularly

in light of the fact that the allegedly offending conduct had been going on with the

Department’s knowledge for over 7 years; and (4) there is no adequate post-deprivation

remedy (i.e. for damages) because of the doctrine of sovereign immunity.

       The Department simply failed to demonstrate an emergency or imminent threat to

the public health and safety. Holmes has engaged safely in the hair removal business,

initially with electrolysis, for 27 years. She has safely engaged in laser hair removal for

over 7 years. During that 7 years, there was nothing secretive about her business. She has

registered her lasers with the Department and is a LSO under Department rules. How the

Defendants “suddenly” became aware of her has more to do with the fact that she gave a

deposition in the TMB Rule case than with any public health emergency. Without some

emergency or imminent threat to the public, there can be no valid summary seizure.

       The governing state law appears to require a finding of exigent circumstances.

Section 431.048 of the Texas Health & Safety Code provides:

Holmes’ Response Brief on the Merits
Page 16
       (a) The commissioner or an authorized agent shall affix to an article that is a food,
       drug, device, cosmetic, or consumer commodity a tag or other appropriate marking
       that gives notice that the article is, or is suspected of being adulterated or
       misbranded and that the article has been detained or embargoed if the
       commissioner or the authorized agent finds or has probable cause to believe that
       the article:

       (1) is adulterated;
       (2) is misbranded so that the article is dangerous or fraudulent under this chapter;
       or
       (3) violates Section 431.084, 431.114, or 431.115. 2 (Emphasis added)

TEX. HEALTH & SAFETY CODE §431.048 (Vernon Supp. 2007).

       The Department presented no evidence that Holmes’ laser is dangerous or

fraudulent, only the allegation that it was “misbranded” since each use was not

accompanied with a written order from a medical doctor. Standing alone, that allegation

is not enough for summary seizure under a due process analysis or under a pure statutory

construction analysis. Holmes challenged section 431.048 “facially” because it fails to

provide for a pre-detention hearing and “as applied” because the Department did not

provide a hearing and did not present evidence of any danger or fraud as required under

section 431.048, much less evidence that a prescription was required by state or federal

law for each use of the device. To date, the Department has presented no state or federal

law or rule that imposes such a requirement and there is no evidence in the record that

such a requirement may be extrapolated from the fact that a “practitioner’s” supervision

is required.



2
   Sections 431.084, 431.114, or 431.115 do not apply in this case. Section 431.084 covers
emergency permits for food contaminated with microorganisms, section 431.114 covers new
drugs, and section 431.115 covers new animal drugs.
Holmes’ Response Brief on the Merits
Page 17
       For these reasons, the trial court did not err or abuse its discretion in enjoining the

detention of Holmes’ property and in ordering an administrative hearing. Holmes’

procedural due process claims, standing alone, justified the issuance of the temporary

injunction. As a result, this Court need go no further than to decide that state agencies are

not above the law.

       B.    The Department did not establish a prima facie case that its seizure was
       authorized or warranted under the facts or the law

       1.     Federal law does not require a written order for each use of a laser for
       hair removal

       The Department sets up a house of cards to urge that its seizure of Holmes’ laser

was legal under state and federal law, and, therefore beyond the trial court’s jurisdiction

to review. As indicated, that puts the cart before the horse since the courts have express

authority under the Texas Health and Safety Code to review whether the Department’s

seizure is valid. TEX. HEALTH & SAFETY CODE §431.048(b), (c); see, e.g., Kellogg v

Mattox, 763 F. Supp. 1369, 1377 (N.D. Tex. 1991)(although plaintiff failed to sustain

burden, the court noted that an injunction would issue to enjoin an improper embargo).

Moreover, the Department’s analysis of state and federal requirements is just plain

wrong. Nothing in state or federal law requires that a person who obtained a laser with an

order from a medical doctor must have a written order prior to each use of the laser.

       The Department begins with a discussion of federal law. The United States

Congress, however, cannot authorize a state agency to do anything without parallel state

legislation. As will be shown, State law, in the form of the Dangerous Drug Act simply

does not apply since the federal Medical Devices Act separates drugs and devices,

Holmes’ Response Brief on the Merits
Page 18
regulates them separately, and provides that prescription devices are not drugs and since

federal law preempts the states from adopting contrary law. See Medtronic, Inc. v. Lohr,

518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Moreover, the Department’s own

published regulations, which are based on federal law and which reflect the Department’s

interpretation of federal law, expressly authorize LSOs to use lasers. 25 TAC §289.301.

       Congress classifies medical devices in three categories based on the risk of their

use. See 21 U.S.C. §§ 301-395 (1994). Devices that do not “present an unreasonable risk

of illness or injury” and are not “purported or represented to be for a use in supporting or

sustaining human life” are designated Class I and are subject to minimal regulation by

“general controls.” 21 U.S.C. § 360c(a)(1)(A); see Medtronic, Inc. v. Lohr, 518 U.S. 470,

476-77, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). “Devices that are potentially more

harmful are designated Class II; although they may be marketed without advance

approval, manufacturers of such devices must comply with federal performance

regulations known as ‘special controls.’ ” Medtronic, Inc., 518 U.S. at 477, 116 S.Ct.

2240 (quoting 21 U.S.C. § 360c(a)(1)(B)). Devices that either “present a potential

unreasonable risk of illness or injury,” or which are “purported or represented to be for a

use in supporting or sustaining human life or for a use which is of substantial importance

in preventing impairment of human health,” are designated Class III.” Id. (quoting 21

U.S.C. § 360c(a)(1)(C)). As a general rule, Class III devices may not be shipped in

interstate commerce for use in human subjects without meeting specific performance

standards or pre-market approval of the device.



Holmes’ Response Brief on the Merits
Page 19
       A Class III device is subject to the statutory requirement of pre-market approval.

21 U.S.C. § 360c(a)(1)(C). A Class III device that is introduced, or delivered for

introduction, into interstate commerce without such approval violates the statute because

it is “adulterated” under 21 U.S.C. § 351(f) as it lacks required approval, and also is

“misbranded” under 21 U.S.C. § 352(o) because it has neither approval nor pre-market

clearance. 21 U.S.C. § 331(a). Commission of a prohibited act can lead to an injunction,

criminal prosecution, and a civil penalty. 21 U.S.C. § 332, 21 U.S.C. § 333(a), and 21

U.S.C. § 333(f), respectively.

       Hence, once pre-market clearance is obtained and the device itself is accompanied

with appropriate labels, the federal requirements have been satisfied. In this case, the

Department admits that Holmes’ laser had pre-market clearance. (Petitioners’ Brief, p.

13, note 47) After that point, however, the Department’s argument gets muddled because

the Department equates “prescriptive device” with a requirement that each use of the

laser, as opposed to the entry of the laser into commerce, requires a written order from a

medical doctor. That requirement does not appear in any provision of federal or state law.

       In fact, the law upon which the Department apparently relies, but does not quote,

provides as follows:

       (e) Restricted devices

       (1) The Secretary may by regulation require that a device be restricted to sale,
       distribution, or use--

              (A) only upon the written or oral authorization of a practitioner licensed by
              law to administer or use such device, or



Holmes’ Response Brief on the Merits
Page 20
              (B) upon such other conditions as the Secretary may prescribe in such
              regulation,

              if, because of its potentiality for harmful effect or the collateral measures
              necessary to its use, the Secretary determines that there cannot otherwise be
              reasonable assurance of its safety and effectiveness. No condition
              prescribed under subparagraph (B) may restrict the use of a device to
              persons with specific training or experience in its use or to persons for use
              in certain facilities unless the Secretary determines that such a restriction is
              required for the safe and effective use of the device. No such condition may
              exclude a person from using a device solely because the person does not
              have the training or experience to make him eligible for certification by a
              certifying board recognized by the American Board of Medical Specialties
              or has not been certified by such a Board. A device subject to a regulation
              under this subsection is a restricted device.

       (2) The label of a restricted device shall bear such appropriate statements of the
       restrictions required by a regulation under paragraph (1) as the Secretary may in
       such regulation prescribe.

21 U.S.C. §360j(e) (emphasis added).

       In other words, the Secretary could require that the use of a prescriptive device

such as a laser be only pursuant to the written or oral order of a “practitioner.” 21 U.S.C.

§360j(e)(1)(A). Instead, however, the Secretary chose the second option, of imposing

“such other conditions” on the use of the device. 21 U.S.C. §360j(e)(1)(B). Those

conditions do not require a written order for each use; they require supervision by a

practitioner and labeling on the device with appropriate warnings for use.

       The federal regulations promulgated pursuant to section 360j provide in full as

follows:

       A device which, because of any potentiality for harmful effect, or the method of its
       use, or the collateral measures necessary to its use is not safe except under the
       supervision of a practitioner licensed by law to direct the use of such device, and
       hence for which “adequate directions for use” cannot be prepared, shall be exempt
       from section 502(f)(1) of the act if all the following conditions are met:

Holmes’ Response Brief on the Merits
Page 21
      (a) The device is:

             (1)(i) In the possession of a person, or his agents or employees, regularly
             and lawfully engaged in the manufacture, transportation, storage, or
             wholesale or retail distribution of such device; or

             (ii) In the possession of a practitioner, such as physicians, dentists, and
             veterinarians, licensed by law to use or order the use of such device; and

             (2) Is to be sold only to or on the prescription or other order of such
             practitioner for use in the course of his professional practice.

      (b) The label of the device, other than surgical instruments, bears:

             (1) The statement “Caution: Federal law restricts this device to sale by or
             on the order of a __________”, the blank to be filled with the word
             “physician”, “dentist”, “veterinarian”, or with the descriptive designation of
             any other practitioner licensed by the law of the State in which he practices
             to use or order the use of the device; and

             (2) The method of its application or use.

      (c) Labeling on or within the package from which the device is to be dispensed
      bears information for use, including indications, effects, routes, methods, and
      frequency and duration of administration, and any relevant hazards,
      contraindications, side effects, and precautions under which practitioners licensed
      by law to administer the device can use the device safely and for the purpose for
      which it is intended, including all purposes for which it is advertised or
      represented: Provided, however, That such information may be omitted from the
      dispensing package if, but only if, the article is a device for which directions,
      hazards, warnings, and other information are commonly known to practitioners
      licensed by law to use the device. Upon written request, stating reasonable
      grounds therefor, the Commissioner will offer an opinion on a proposal to omit
      such information from the dispensing package under this proviso.

      (d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or
      within a package from which the device is to be dispensed, distributed by or on
      behalf of the manufacturer, packer, or distributor of the device, that furnishes or
      purports to furnish information for use of the device contains adequate information
      for such use, including indications, effects, routes, methods, and frequency and
      duration of administration and any relevant hazards, contraindications, side
      effects, and precautions, under which practitioners licensed by law to employ the

Holmes’ Response Brief on the Merits
Page 22
       device can use the device safely and for the purposes for which it is intended,
       including all purposes for which it is advertised or represented. This information
       will not be required on so-called reminder--piece labeling which calls attention to
       the name of the device but does not include indications or other use information.

       (e) All labeling, except labels and cartons, bearing information for use of the
       device also bears the date of the issuance or the date of the latest revision of such
       labeling.

21 CFR §801.109(emphasis added). In other words, supervision by a “practitioner” and

proper labeling or guidelines for use is required -- a written or oral order from a

“practitioner” is not.

       The Department has another major obstacle to overcome with respect to its

argument that a written order from a medical doctor is required for each use of Holmes’

laser. Federal law and regulations do not dictate which “practitioners” may supervise the

use of prescriptive devices. Section 801.109 provides that the labeling include “the

descriptive designation of any other practitioner licensed by the law of the State in which

he practices to use or order the use of the device.” Nor does federal law dictate how such

practitioners are to use the devices in their practices. See Baker v Smith & Nephew

Richards, Inc., 1999 WL 1999 811334, at 12 FN33 (Tex. Dist. Ct., Harris Co. 152nd

Judicial Dist., June 7, 1999); O’Reilly, James T., 2 Food and Drug Admin., §25.19

(2009). All that the federal law and regulations require is that prescriptive devices bear

labels that state that use is limited to practitioners authorized by state law and bear

appropriate warnings. The federal regulations promulgated by the FDA leave to the states

the authority to define various practitioners’ scope of practice.




Holmes’ Response Brief on the Merits
Page 23
       2.     State law does not require a written order for each use of a laser for
       hair removal

       That leaves the Department with a dilemma. State law does not expressly state or

implicitly require that the only “practitioner” qualified to supervise a laser is a medical

doctor. Nor does the use of lasers for hair removal otherwise constitute the practice of

medicine. See Tesoro v. Alvarez, 281 S.W.3d 654 (Tex. App.- Corpus Christi, 2009, no

pet.) The Department attempts to rely instead on the Texas Dangerous Drug Act.

       The Department’s reliance on the Dangerous Drug Act is misplaced, however,

since, in 1976, when Congress enacted the Medical Devices Act (MDA), it separated the

regulation of drugs and devices. Medical devices are not subject to the federal regulations

applicable to drugs; they are subject to the federal regulations applicable to devices.

Texas cannot impose the additional requirements set forth in provisions applicable to

drugs to medical devices since such regulation is expressly preempted. 21 USC §360k;

see Medtronic, Inc. v. Lohr, 518 U.S. 470; see also Buckman Co. v. Plaintiffs' Legal

Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Such a requirement

would also be inconsistent with the Department’s published regulations.

       The Department’s own published regulations, which are presumably based on the

Department’s effort to be compliant with federal law and which presumably reflect the

Department’s official interpretation and application of federal law, do not limit the use of

lasers to a medical doctor or upon a medical doctor’s written order:

       Except as otherwise specifically provided, this section applies to all persons who
       receive, possess, acquire, transfer, or use lasers that emit or may emit laser
       radiation. Individuals shall not use lasers or IPL devices on humans unless under
       the supervision of a licensed practitioner of the healing arts and unless the use of

Holmes’ Response Brief on the Merits
Page 24
       lasers or IPL devices is within the scope of practice of their professional license.
       Nothing in this section shall be interpreted as limiting the intentional exposure of
       patients to laser or IPL device radiation for the purpose of diagnosis, therapy, or
       treatment by a licensed practitioner of the healing arts within the scope of practice
       of their professional license. This section does not apply to the manufacture of
       lasers or IPL devices.

25 TAC §289.301(b)(1).

       In addition, nothing in the other portions of the rules requires a written order from

a “practitioner” prior to each use of the laser. The rules set forth the training requirements

for those who use lasers. §289.301 (a)(1), (p). The rules require that a laser safety office

(LSO) be specified for each laser registered with the DSHS. See §289.301 (a)(2). The

rules define a LSO as

       (30) Laser safety officer (LSO)--An individual who has a knowledge of and the
       authority and responsibility to apply appropriate laser radiation protection rules,
       standards, and practices, and who must be specifically authorized on a certificate
       of laser registration.

25 TAC §289.301(d)(30).

       The Department’s rules also expressly authorize persons such as Holmes to

perform certain tasks:

       (q) LSO duties. Specific duties of the LSO shall include, but not be limited to the
       following:

       (1) ensuring that users of lasers are trained in laser safety, as applicable for the
       class and type of lasers the individual uses;

       (2) assuming control and having the authority to institute corrective actions
       including shutdown of operations when necessary in emergency situations or
       unsafe conditions; and

       (3) specifying whether any changes in control measures are required following:



Holmes’ Response Brief on the Merits
Page 25
              (A) any service and maintenance of lasers that may affect the output power
              or operating characteristics; or

              (B) whenever deliberate modifications are made that could change the laser
              class and affect the output power or operating characteristics.

       (4) ensuring maintenance and other practices required for safe operation of the
       laser(s) are per-formed;

       (5) ensuring the proper use of protective eyewear and other safety measures; and

       (6) ensuring compliance with the requirements in this section and with any
       engineering or operational controls specified by the registrant.

25 TAC §289.301(q)(emphasis added).

       No Department rule purports to repeal this rule or substitute a medical doctor or a

medical doctor’s prescription for the LSO or to require a prescription for each use of the

laser. The unpublished standard the Department attempted to apply to Holmes is flatly

inconsistent with the Department’s own published rules. 3 Holmes’ laser was registered

with the Department and has been since 2002. (RR 43, 70 and Plaintiff’s Exhibit 3)

Holmes is certified in laser safety. (RR 41) And it is undisputed that Holmes is the

designated LSO for her lasers, as required under the Department’s Rule 289.301(a)(2),

(d)(30). (RR 41, 44)

       As a result, the Department’s contention that it “legally detained” Holmes’ laser

borders on the frivolous.




       3
        It is also a denial of due process to apply such a standard. See Madden v. Texas Board of
Chiropractic Examiners, 663 S.W.2d 622 (Tex. Civ. App. – Austin 1983, writ ref’d n.r.e.).
Holmes’ Response Brief on the Merits
Page 26
III. (Issue 2) This Court’s decision in City of El Paso v. Heinrich, 284 S.W.3d 366
(Tex. 2009), did not hold that a state agency is immune from lawsuits alleging a
constitutional claim.

       Under Texas Educ. Agency v. Leeper, 893 S.W.2d 432 (Tex. 1994), which was

affirmed in Heinrich, a party may challenge the constitutionality of a statute and must

name the governmental body. The Department’s Issue 2 is based on the faulty premise

that City of El Paso v. Heinrich, 284 S.W.3d 366 (Tex. 2009), held that plaintiffs do not

have a general right to bring declaratory judgment suits against governmental entities.

That is not an accurate statement of the Heinrich court’s holding. Heinrich reaffirmed the

Court’s 1994 decision in Tex. Educ. Agency v. Leeper, 893 S.W.2d 432 (Tex. 1994), in

which the court held that the UDJA is a waiver of immunity for just such lawsuits.

Heinrich, 284 S.W.3d at 373, note 6.

       In that footnote, the Heinrich court reaffirmed that the UDJA is a waiver of

immunity that allows challenges to the validity of statutes.

               For claims challenging the validity of ordinances or statutes, however, the
       Declaratory Judgment Act requires that the relevant governmental entities be
       made parties, and thereby waives immunity. TEX. CIV. PRAC. & REM. CODE §
       37.006(b) (“In any proceeding that involves the validity of a municipal ordinance
       or franchise, the municipality must be made a party and is entitled to be heard, and
       if the statute, ordinance, or franchise is alleged to be unconstitutional, the attorney
       general of the state must also be served with a copy of the proceeding and is
       entitled to be heard.”); see Wichita Falls State Hosp. v. Taylor, 106 S.W.3d 692,
       697-698 (Tex. 2003) (“[I]f the Legislature requires that the State be joined in a
       lawsuit for which immunity would otherwise attach, the Legislature has
       intentionally waived the State’s sovereign immunity.”); Tex. Educ. Agency v.
       Leeper, 893 S.W.2d 432, 446 (Tex. 1994) (“The DJA expressly provides that
       persons may challenge ordinances or statutes, and that governmental entities must
       be joined or notified. Governmental entities joined as parties may be bound by a
       court’s declaration on their ordinances or statutes. The Act thus contemplates that
       governmental entities may be—indeed, must be—joined in suits to construe their
       legislative pronouncements.”). Here, Heinrich is not challenging the validity of the

Holmes’ Response Brief on the Merits
Page 27
       bylaws or the governing statute, but rather petitioners’ actions under them.
       (Emphasis added.)

Heinrich, 284 S.W.3d at 373, note 6.

       In Heinrich, the Texas Supreme Court addressed the claims of Mrs. Heinrich, the

widow of a member of the El Paso Police Department, an officer who died from wounds

received in the line of duty. Heinrich sought a declaratory judgment to invalidate the

pension fund’s reduction, by approximately one-third, of the amount of her husband’s

pension benefits that she was receiving when her son reached a certain age. The fund

contended that her claim was not truly a claim for declaratory relief and that she, instead,

sought to use the UDJA to obtain damages for which there had been no waiver of

immunity. As indicated, the court “granted the petition for review to clarify the relief that

may be sought without legislative consent.” Heinrich, slip op. at 2 (emphasis added).

       The DSHS confuses this case with a case in which immunity has not been waived.

The Heinrich case changed the way in which an ultra vires case, in which there is no

waiver of immunity, should be pled. The court’s focus, however, was on the extent of the

remedy available for claims for which there is no waiver of sovereign immunity. The

court did not hold that the UDJA is not a waiver of immunity and may not be used to

interpret statutes or that plaintiffs do not have a general right to bring declaratory

judgment suits against governmental entities as alleged by the Department.

       If this theory were expanded, as urged by the Department, it would require that

this Court ignore Wichita Falls State Hosp. v. Taylor, 106 S.W.3d 692, 697-698 (Tex.

2003), Tex. Educ. Agency v. Leeper, 893 S.W.2d 432, 446 (Tex. 1994), and even Texas


Holmes’ Response Brief on the Merits
Page 28
Department of Protective and Regulatory Services v. Mega Child Care, Inc., 145 S.W. 3d

170 (Tex. 2004). After all, the basis for Leeper is the need to name government entities in

a lawsuit:

       The DJA expressly provides that persons may challenge ordinances or statutes,
       and that governmental entities must be joined or notified. Governmental entities
       joined as parties may be bound by a court's declaration on their ordinances or
       statutes. The Act thus contemplates that governmental entities may be-indeed, must
       be joined in suits to construe their legislative pronouncements. These provisions
       provide the context for the Act's authorization, in § 37.009, of attorney fee awards.
       We conclude that by authorizing declaratory judgment actions to construe the
       legislative enactments of governmental entities and authorizing awards of attorney
       fees, the DJA necessarily waives governmental immunity for such awards.
       (Emphasis added.)

893 S.W.2d at 445-46. To accept the Department’s argument, this Court would have to

conclude that the Heinrich court intended to overturn, rather than reaffirm, Leeper and

Taylor, and, by virtue of the same rationale, Mega Child Care.

       One may quibble over the fact that Heinrich did not use the more expansive

“construe legislative enactments” language of Leeper. Instead, the Heinrich court referred

in footnote 6 to “claims challenging the validity of ordinances or statutes.” As a result,

the court of appeals technically erred in reversing that portion of the trial court’s order

that denied the Department’s plea as to Holmes’ “statutory” claims, but since Holmes’

claims all had a basis in due process, it makes little difference to the ultimate resolution

of the case. There remains a jurisprudential controversy about whether the UDJA waives

immunity to resolve statutory interpretation questions absent a claim regarding the




Holmes’ Response Brief on the Merits
Page 29
validity of the statute. 4 After all, if one could sue over an “ultra vires” deprivation of

constitutional rights already, i.e. without a waiver of immunity, what purpose was the

UDJA intended to serve? The Department is just plain wrong, however, to assert that

Heinrich means that the courts do not have jurisdiction to consider UDJA challenges

against state agencies regarding the validity of statutes.

       As indicated, however, it is not necessary to resolve the breadth of the waiver of

immunity in the UDJA (validity versus construction) at this time. Although Holmes did

challenge the actions of the DSHS and its Commissioner on what could be characterized

as traditional “ultra vires” grounds, Holmes also brought constitutional takings claims

and a challenge to the validity of the statutes and the regulatory framework, facial and as

applied. Because of the nature of her claims, under the express language of Heinrich,

Holmes properly named the Department as a defendant with respect to her challenge to

the validity of the statute, facially and as applied, under the UDJA and with respect to her

takings claim. Mrs. Heinrich did not allege a “takings” claim, Ms. Holmes does.

IV. (Issue 3) The evidence in this case creates a fact question regarding the
jurisdictional issue, preventing the trial court from granting the Department’s plea
to the jurisdiction.

       Under Texas Parks and Wildlife v. Miranda, 133 S.W.3d 217 (Tex. 2002), if

jurisdiction depends on evidence of the merits and that evidence creates a disputed fact



4
  The better approach is that the UDJA is not limited to claims that a public official has engaged
in “ultra vires” conduct. See Pete Schenkkan, “Texas Administrative Law: Trials, Triumphs, and
New Challenges,” 7 Tex. Tech. Admin. L.J. 288, at 313-314; (Summer 2006); see also Beal, “A
Miry Bog Part II: UDJA and APA Declaratory Judgment Actions and Agency Statements Made


Holmes’ Response Brief on the Merits
Page 30
question, the trial court cannot grant the plea to the jurisdiction until the fact question is

resolved. The Miranda decision thoroughly details the procedure that courts and litigants

should follow in examining questions of subject matter jurisdiction. See 133 S.W.3d at

226-28. The Miranda decision recognized that reviewing jurisdictional determinations

may require that the courts examine the evidence supporting a claim. 133 S.W.3d at 228.

When the trial court has examined the evidence and made a ruling on subject matter

jurisdiction, Miranda requires that appellate courts apply a standard of review like that

applicable to summary judgment motions, holding that a reviewing court must "take as

true all evidence favorable to the non-movant," and "indulge every reasonable inference

and resolve any doubts in the non-movant's favor." 133 S.W.3d at 228. As with a motion

for summary judgment, however, a disputed question of fact will prevent resolution in a

summary fashion.

       The court of appeals applied and followed Miranda:

       [W]hen a plea to the jurisdiction challenges the existence of jurisdictional facts,
       “we consider relevant evidence submitted by the parties when necessary to resolve
       the jurisdictional issues raised, as the trial court is required to do.” Miranda, 133
       S.W.3d at 227. “[I]n a case in which the jurisdictional challenge implicates the
       merits of the plaintiffs' cause of action and the plea to the jurisdiction includes
       evidence, the trial court reviews the relevant evidence to determine if a fact issue
       exists.” Id. at 227. “If the evidence creates a fact question regarding the
       jurisdictional issue, then the trial court cannot grant the plea to the jurisdiction,
       and the fact issue will be resolved by the fact finder.” Id. at 227-28.




Outside a Contested Case Hearing Regarding the Meaning of the Law,” 59 Baylor L.Rev. 267, at
280 (Spring 2007)
Holmes’ Response Brief on the Merits
Page 31
Texas Dept. of State Health Services v. Holmes, 294 S.W.3d 328, 335 (Tex.App.-Austin,

2009, pet. filed) (quoting Texas Department of Parks and Wildlife v. Miranda, 133

S.W.3d 217, 227-228 (Tex. 2002)).

      The Department’s argument regarding Miranda is based on the faulty premise that

“[t]here are no genuine issues of material jurisdictional fact that require further

development of the case.” (Petitioners’ Brief, p. 28) Based on the record, there most

definitely were disputed questions of fact on the merits. For example, just what was the

Department’s probable cause to believe that Holmes’ laser was “misbranded so that the

article is dangerous or fraudulent” under Chapter 431 of the Health and Safety Code as

required for a seizure under section 431.048? Assuming for the sake of argument that

“practitioner” means medical doctor, where is the evidence that Holmes did not obtain

her laser with an order from a medical doctor? Most important, where is the

Department’s evidence that the level of supervision provided by her Medical Director

was insufficient? These facts are essential in evaluating the Department’s claim that it

legally detained Holmes’ laser.

      Deferring a decision on a plea to the jurisdiction that delves into the merits is not

an isolated interpretation or application of Miranda. See City of Austin v.

Savetownlake.Org, 2008 WL 3877683 (Tex.App.-Austin, Aug 22, 2008, no pet.) (not

published in S.W.3d)(trial court properly deferred decision on plea contending that

Savetownlake.Org’s pleadings were false allegations); City of Fort Worth v. Shilling, 266

S.W.3d 97 (Tex. App. – Fort Worth, pet. denied)(trial court properly deferred decision on

plea based on contention that alleged whistleblower had not “initiated” complaint when

Holmes’ Response Brief on the Merits
Page 32
fact question existed about whether he had done so); see also Prairie View A & M

University v. Brooks, 180 S.W.3d 694 (Tex. App. – Houston [14th Dist.] 2005, no pet.). In

fact, in Brooks, the trial court deferred the jurisdictional issue until after a jury trial.

Although the case was tried before the Miranda decision was issued, the court of appeals

considered Miranda significant and found that the trial court had not abused its discretion

under a Miranda-like standard. 180 S.W.3d at 704.

       In this case, the Department’s plea is based on the merits. It urges that it was

justified in summarily seizing Holmes’ laser because she was violating state and federal

law by not having a prescription for every laser hair session. That is an argument on the

merits. A plea to the jurisdiction "should be decided without delving into the merits of the

case." Bland Indep. Sch. Dist. v. Blue, 34 S.W.3d 547, 554 (Tex.2000). The Department

is simply attempting to resurrect a procedure akin to the old demurrer practice. That is

not proper procedure in Texas.

V.    (Issue 4) The trial court did not abuse its discretion in granting a temporary
injunction.

       A.     Standard of Review

       The purpose for equitable injunctive relief is to preserve the status quo of the

litigation's subject matter pending a trial on the merits. Butnaru v. Ford Motor Company,

84 S.W.3d 198, 204 (Tex. 2002); Walling v. Metcalfe, 863 S.W.2d 56, 57 (Tex.1993);

Electronic Data Sys. Corp. v. Powell, 508 S.W.2d 137, 139 (Tex.Civ.App.-Dallas 1974,

no writ). To obtain a temporary injunction, the applicant must demonstrate three

elements: (1) a cause of action against the defendant; (2) a probable right to the relief


Holmes’ Response Brief on the Merits
Page 33
sought; and (3) a probable, imminent, and irreparable injury in the interim. Butnaru, 84

S.W.3d at 204; Walling, 863 S.W.2d at 57; Sun Oil Co. v. Whitaker, 424 S.W.2d 216, 218

(Tex.1968). With respect to the second element, the applicant need not prove that he or

she will prevail at trial; rather the burden is to show a probable right to recovery of relief

following a trial on the merits. Walling, 863 at 58; Universal Health Servs. v. Thompson,

24 S.W.3d 570, 576 (Tex.App.-Austin 2000, no pet.). With respect to the third element,

an injury is irreparable if the injured party cannot be adequately compensated in damages

or if the damages cannot be measured by any certain pecuniary standard. Butnaru, 84

S.W.3d at 204; Canteen Corp. v. Republic of Tex. Props., Inc., 773 S.W.2d 398, 401

(Tex. App.-Dallas 1989, no writ). Holmes met all three of these elements.

       B.     Cause of action

       For all the reasons stated under the discussion of Issue 1, Holmes stated a cause of

action for constitutional violations. In addition, the Department has asserted that section

431.048 provides for judicial review. That section provides, in pertinent part, as follows:

       (b)    The tag or marking on a detained or embargoed article must warn all
       persons not to use the article, remove the article from the premises, or dispose of
       the article by sale or otherwise, until permission for use, removal, or disposal is
       given by the commissioner, the authorized agent, or a court.

       (c)    A person may not use a detained or embargoed article, remove a detained
       or embargoed article from the premises, or dispose of a detained or embargoed
       article by sale or otherwise without permission of the commissioner, the
       authorized agent, or a court. The commissioner or the authorized agent may
       permit perishable goods to be moved to a place suitable for proper storage.
       (Emphasis added.)

TEX. HEALTH & SAFETY CODE §431.048(c). As a result, there is also a statutory

waiver of immunity and cause of action.

Holmes’ Response Brief on the Merits
Page 34
       C.   Holmes’ use of the laser was not “prima facie” illegal; she showed a
       probable right to recover

       The Department asserts that the status quo pending trial cannot preserve a course

of conduct that is “prima facie illegal.” (Petitioners’ Brief, p. 32) The Department,

however, glosses over two things: (1) even if the Department is right on the law, a party

is entitled to notice and a hearing prior to the deprivation of his or her property absent

exigent circumstances for a summary deprivation and (2) the Department did not

demonstrate a prima facie case. For all the reasons stated under the discussion of Issue 1

above, the trial court did not abuse its discretion in enjoining the Department’s summary

seizure of Holmes’ private property.

       Holmes has two distinct property interests here: the right to possession of her

tangible personal property and the right to use the laser she registered with Defendants.

At issue here is not just a property interest, but property itself – her laser, worth in excess

of $100,000.00. (RR 35) In addition, the embargo notice restricts what she may do with

the laser on her real property. (RR 34-35, 59) Moreover, the laser is essential to her

ability to engage in her profession. (RR 58-59) Seizing the laser is akin to seizing a

lawyer’s computer or books or a cab driver’s taxicab. The DSHS peremptorily prevented

her from engaging in her chosen occupation just as clearly as would the deprivation of a

professional license.

       Although the pursuit of one’s chosen, lawful occupation may not be a fundamental

right, it is a liberty interest worthy of constitutional protection. Mauldin v. Texas State

Bd. of Plumbing Examiners, 94 S.W.3d 867, 872 (Tex. App. – Austin 2002)(citing


Holmes’ Response Brief on the Merits
Page 35
Schware v. Board of Bar Examiners, 353 U.S. 232 (1957)). The DSHS’ detention is also

akin to the deprivation of the registration of her laser, which, once conferred, cannot be

taken without due process. See House of Tobacco, Inc. v. Calvert, 394 S.W.2d 654, 657

(Tex. 1965). As discussed under Issue 1, Texas case law has historically and consistently

limited the situations in administrative agencies may take summary action.

       The Department’s statement that Holmes has no vested property right in her

personal property by equating Holmes’ laser with the possession of “illegal goods” or a

bomb is simply ludicrous. (Petitioners’ Brief, p. 33) The Department’s reliance on

Church of Scientology of Cal. v. Richardson, 437 F.2d 214 (9th Cir. 1971) and McClane

v. State, 343 S.W.2d 447 (Tex. Crim. App. 1960) is misplaced. Possession of a laser that

has received premarket clearance from the FDA, that has been obtained with an order

from a medical doctor, that is registered with the Department, and that is being used

under the supervision of a medical doctor and by an LSO pursuant to Department rules, is

not an illegal device. A bomb is.

       It is undisputed that Holmes obtained her laser with an order from a medical

doctor. (RR 44) That is the focus of the statutory authority of the Department, along with

inspection to determine whether all of the labels required to be on such lasers pursuant to

federal law and the Department’s rules are present. All required labels were in place with

respect to Holmes’ laser. (RR 173-174) No law requires a similar “label” prior to each

use of the device. Holmes does not sell or distribute lasers to the public: she uses the laser

in the practice of laser hair removal, an approved use. This is not a case in which an

unapproved use is at issue. See, e.g., Rayford v. State, 16 S.W.3d 203 (Tex. App.—Dallas

Holmes’ Response Brief on the Merits
Page 36
2000, pet denied).

       The Rayford case supports Holmes’ position, not the DSHS’ position. The Rayford

decision was based on the following uncontroverted facts:

       The undisputed facts controlling this case are:

              • The RT-50 is a medical device.

              • GE filed a premarket notification (510(k)) with the Food and Drug
              Administration (FDA) representing that the RT-50's intended diagnostic
              use was for fetal imaging and other abdominal/gynecological uses.

              • Rayford used the RT-50 ultrasound device for fetal videography, without
              diagnostic purpose.

              • The FDA had not approved the RT-50 for a nondiagnostic use.

              • Rayford's RT-50 did not display adequate directions for use by a
              layperson.

              • Erma Rayford is not a practitioner licensed to practice medicine in Texas.

              • Rayford possessed the RT-50 without an order from a licensed
              practitioner in Texas.

              • Rayford's use of the RT-50 was not supervised by a practitioner licensed
              in Texas.

16 W.S.3d at 206 (emphasis added).

       In Rayford, the court of appeals rejected the State’s arguments that the ultrasound

device was adulterated, rejected the State’s false advertising and DTPA claims, and

rejected all but one of the State’s claims regarding misbranding. The court of appeals

held

       A device may be misbranded by improper labeling or unapproved use. See TEX.
       HEALTH & SAFETY CODE ANN. § 431.112(f)(1), (r) (Vernon Supp.2000).
       Under section 431.112(f)(1) and (2) of the FDCA, a device is misbranded unless it

Holmes’ Response Brief on the Merits
Page 37
       has adequate directions for use and has been exempted from requirements for
       adequate warnings against specified improper use by appropriate regulations. See
       id. § 431.112(f)(1), (2). As discussed above, the federal regulatory scheme does
       not contemplate a user or possessor having labeling responsibilities[.] (Emphasis
       added.)

16 S.W.3d at 209. As indicated, it was undisputed that Rayford used the device for an

unapproved, non-diagnostic” purpose and used the device “without the supervision or

order of a licensed practitioner.” Id. (emphasis added).

       In contrast, in this case, the following significant distinctions exist:

        • The manufacturer of Holmes’ laser filed a premarket notification (510(k)) with
       the Food and Drug Administration (FDA) representing that the use of the laser
       included non-ablative cosmetic laser hair removal as an intended use. (RR
       Defendants’ Exhibit 4)

       • The FDA has approved the laser for laser hair removal. (RR 106-107,
       Defendants’ Exhibit 4)

       • Holmes’ laser did display adequate directions for use by a layperson. (RR 44-45,
       173-174)

       • Holmes possessed her laser with an order from a licensed practitioner in Texas.
       (RR 44)

       • Holmes’ use of her laser was and is supervised by a practitioner licensed in
       Texas. (RR 56-58)

       The DSHS may not like the level of supervision provided, but it cannot dispute

that Holmes obtained the device with a prescription and that Holmes has a medical

director who supervises her practice. Moreover, unlike the ultrasound scanner at issue in

Rayford, Holmes’ laser was approved and labeled for laser hair removal. If the device at

issue in Rayford had been approved for a non-diagnostic purpose, based on the Dallas




Holmes’ Response Brief on the Merits
Page 38
Court of Appeals reasoning, the outcome of the case most likely would not have been

adverse to Rayford.

       The Rayford case does not stand for the proposition for which the DSHS relied on

it in the court of appeals – i.e. that a written order (which is a prescription) is required for

each use of all prescriptive medical devices or that the DSHS can dictate the level of

supervision provided by a “practitioner.” As indicated, the Rayford case was based on

undisputed facts that included the following facts:

              • Rayford possessed the RT-50 without an order from a licensed
              practitioner in Texas.

              • Rayford's use of the RT-50 was not supervised by a practitioner licensed
              in Texas.

Rayford, 16 W.S.3d at 206. The order referenced is the order by which the device is

initially obtained – not an order for each use. The Rayford references to the “order of a

licensed practitioner” to mean the initial order required for purchase of the device. The

second finding was based on the undisputed premise that Rayford had no supervision at

all, not some unsupported alleged insufficient supervision. There is a difference – a

factual difference. As indicated the Department provided no evidence of the level of

medical supervision that would be appropriate. Holmes did.

       D.     Holmes showed irreparable injury.

       The Department contends that Holmes had an adequate remedy at law.

(Petitioners’ Brief, p. 34) The Department’s inclusion of this argument in this case is

fraught with more than a little irony. Holmes pursued legal recourse to remedy due

process violations – in particular to obtain a hearing. The Department filed a plea in

Holmes’ Response Brief on the Merits
Page 39
abatement to compel Holmes to go back and pursue her claims in a hearing. The

Department then dismissed its claims, with prejudice, before that hearing could be held.

If the Department had really wanted to afford Holmes a hearing it could have and should

have done so. To argue that she has to start over again is simply ludicrous, particularly

when the SOAH order entered provides that she has exhausted her administrative

remedies.

      Holmes’ injury was irreparable. Even under the more stringent federal standard for

a preliminary injunction, the court in Kellogg v. Mattox acknowledged that irreparable

harm would be presumed from the finding of a probable constitutional violation. 763 F.

Supp. at 1385. The probable constitutional violation in this case is the deprivation of due

process that occurred with the summary seizure. Under Texas case law a summary

suspension without due process has been described as irreparable injury:

      However, even where judicial review of an administrative agency's order is
      accorded, if no stay of the effect of such order is provided, and if, meanwhile,
      irreparable injury would result, subjecting the party affected by the order to
      criminal prosecution for its violation, due process is not satisfied. Pacific T. & T.
      Co. v. Kuykendall, 265 U.S. 196, 44 S.Ct. 553, 68 L.Ed. 975; Porter v. Investors'
      Syndicate, 286 U.S. 461, 52 S.Ct. 617, 76 L.Ed. 1226.

Francisco v. Board of Dental Examiners, 149 S.W.2d 619, 622 (Tex. Civ. App.—Austin

1941, writ ref’d.). A violation of Chapter 431 is criminal. TEX. HEALTH & SAFETY

CODE § 431.059.

       Moreover, this case involves unique personal property, a laser, the tool of Holmes’

trade for the past seven years, not “just” the right to make a living. The Department

would have this Court believe that due process does not apply to a deprivation of


Holmes’ Response Brief on the Merits
Page 40

				
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