Petition for Writ of Certiorari — Lozier v. Scott

we f= > 4 Suorems Court, U.S.

@ 166 FILED

Noy 13 1991

NUMBER Oriel OF THE CucwK

IN THE ;

UNITED STATES SUPREME COURT

OCTOBER TERM, 1991

NICK & BARBARA LOZIER

Petitioners

VS.

F. BRANTLEY SCOTT, JR., M.D.

Respondent

PETITION FOR WRIT OF CERTIORARI

FOR THE UNITED STATES COURT

OF APPEALS FOR THE

FIFTH CIRCUIT

PETITION FOR WRIT OF CERTIORARI

Arnold Anderson Vickery

COUNSEL FOR PETITIONER

VICKERY, KILBRIDE, GILMORE

& VICKERY

2929 Allen Parkway,

Suite 2770

Houston, Texas 77019

(713) 526-0700

NUMBER

IN THE

UNITED STATES SUPREME COURT

OCTOBER TERM, 1991

NICK & BARBARA LOZIER

Petitioners

VS.

F. BRANTLEY SCOTT, JR., M.D.

Respondent

PETITION FOR WRIT OF CERTIORARI

FOR THE UNITED STATES COURT

OF APPEALS FOR THE

FIFTH CIRCUIT

PETITION FOR WRIT OF CERTIORARI

Arnold Anderson Vickery

COUNSEL FOR PETITIONER

VICKERY, KILBRIDE, GILMORE

& VICKERY

2929 Allen Parkway,

Suite 2770

Houston, Texas 77019

(713) 526-0700

U

tN

4A.

ONS PRESEN OR

Whether, as a matter of law, the District

Court erred in holding that the standard for

consent to a routine medical procedure or

device, as developed in state common law,

was the same as the standard for consent to

Participation in research involving

"investigational devices," as set forth in 21

U.S.C. §360j(z) and 21 C.F.R. $§50.20-

50.27.

Whether, as a matter of law, a human

subject’s consent to participation in research

involving "investigational devices," as set

forth in 21 U.S.C. $360j(g) and 21 C.F.R.

§§50.20-50.27, must be in writing.

In the alternative, whether, as a matter of

law, the provisions of federal law which

mandate that a human subject consent in

writing to participation in research involving

"investigational devices," as set forth in 21

U.S.C. §$360j(g) and 21 C.F.R. §$§50.20-

50.27, preempt state law permitting oral

consent to surgery.

In the alternative, whether the District

Court erred in refusing to admit into

evidence the provisions of federal law

mandating that a human subject consent in

writing to participation in research involving

"investigational devices," as set forth in 21

U.S.C. §360j(g) and 21 C.F.R. §§50.20-

4B.

50.27, where consent to such participation is

a material issue in the lawsuit.

Also in the alternative, whether the District

Court erred in refusing to instruct the jury

on the provisions of federal law mandating

that a human subject consent in writing to

Participation in research involving

“Investigational devices," as set forth in 21

U.S.C. $360j(g) and 21 C.F.R. §§50.20-

50.27, where consent to such participation is

a material issue in the lawsuit.

Certificate of Interested Persons

The undersigned counsel of record certifies that the

following listed parties have an interest in the outcome of

this case. These representations are made in order that

the Justices of this Court may evaluate possible

disqualification or recusal.

(1) Nick and Barbara Loziez, Plaintiffs/Petitioners;

(2) Arnold A. Vickery, of the firm of VICKERY,

KILBRIDE, GILMORE & VICKERY, 2929 Allen

Parkway, Suite 2770, Houston, Texas 77019 and Macon

Cowles, Esq. of the firm, WILLIAMS, TRINE,

GREENSTEIN & GRIFFITH, 1435 Arapahoe Avenue,

Boulder, Colorado 80302, their attorneys.

(3) F. Brantley Scott, Jr., M.D.,

Defendant/Respondent;

(4) Robert Swift and Dan Brown of the firm of

FULBRIGHT & JAWORSKI, 1301 McKinney Street,

Houston, Texas 77010, counsel for Defendant.

iil

Table of Contents

QUESTIONS PRESENTED FOR REVIEW

CERTIFICATE OF INTERESTED PERSONS

TABLE OF CONTENTS

TABLE OF AUTHORITIES

CASES

STATUTES

OTHER REPORTS OF OPINIONS

GROUNDS FOR JURISDICTION OF

THE UNITED STATES SUPREME COURT

CONSTITUTION, STATUTES AND

REGULATIONS

STATEMENT OF THE CASE

A. Introduction

B. Factual Background

ARGUMENT AND AUTHORITIES

A. Framing the Issue

B. The Statutory Framework

iv

13

17

C. A Subject Cannot Consent

to the Use of an

Investigation Device

Governed by 21 U.S.C.

§360j(g) Except in Writing

D. Using a Federal Statue to

Supply the Duty or the

Defense for a State Tort

Remedy is Entirely Consistent

with Both Texas and Federal

Law

CONCLUSION

CERTIFICATE OF SERVICE

34

35

CASES PAGE

Gravis v. Physicians &

Surgeons Hospital, 427 S.W.2d

310 (Tex. 1968) 28

ills ou Vv.

Automated Medical Laboratories,

471 US., 105 S.Ct. at 26

Hines v. Davidowitz, 471 U.S.

52, 61 S.Ct. 399, 85 L.Ed.@d

581 (1941) 26

International Paper Co.

v. , 107 S.Ct.

805 (1987) 25

Johrson v. Whithurst,

652 S.W.2d 441 (Tex.App. --

Houston [1st Dist.] 1983,

writ ref'd n.r.e.) 28

732 S.W.2d 306 (Tex. 1987) 33

Merrell Dow Pharmaceutical,

Inc. v. Thompson, 478 U.S.

804, 106 S.Ct. 3229 (1986) 32

Moore v. Chesapeake & Ohio R.

Co., 291 U.S. 214 32

vl

Nixon v. q Mgt. Co.,

690 S.W.2d 546 (Tex. 1985)

Ouellette, 107 S.Ct. 810

Peek v. Oshman’s Sporting Goods,

Inc., 768 S.W.2d 841 (Tex.App. --

San Antonio, 1989, writ denied)

av v. At ic Richfield

Co., 435 US. 151, 98 S.Ct.

988, 55 L.Ed.2d 179 (1978)

Rice v. Santa Fe Elevator

Corp., 331 U.S. 218 (1947)

Vil

33

STATUTES

21 C.F.R. §50.1 - §50.27

Federal Food, Drug and

Cosmetic Act, 21 U.S.C. §360j(g)

Federal Food, Drug and

Cosmetic Act,21 U.S.C. §360k

28 U.S.C. §1254(1)

28 U.S.C. §1332

33 U.S.C. $1251

P.L. 94-295, 90 Stat. 574

(May 28, 1976)(codified

at 21 U.S.C. §§301-92)

Tex.Rev.Civ.Stat.Ann. art. 4590i,

§6.06 (Vernon Supp. 1991)

United States Constitutuion,

Article VI, Clause 2

Vill

PAGE

i, ii, 1, 3, 4,

13, 16, 19, 20,

22, 23, 24, 26,

27, 28, 29, 30,

34

a ey ae

4, 13, 15, 16, 17,

18, 19, 20, 23,

24, 26, 28, 29,

30, 33, 34

ix, 21

x

]

31

17

x, 23, 30

OTHER REPORTS OF OPINIONS

The only opinion that has been written in this

lawsuit so tar is that of the United States Court of

Appeals for the Fifth Circuit. This opinion was

unpublished, and Petitioners have provided a copy of the

opinion in the Appendix.

GROUNDS FOR JURISDICTION

OF THE UNITED STATES SUPREME COURT

The United States Court of Appeals for the Fifth

Circuit delivered its opinion on July 19, 1991. The Fifth

Circuit denied Petitioner’s Motion for Rehearing on

August 15, 1991.

This Court has jurisdiction of this Petition for Writ

of Certiorari pursuant to 28 U.S.C. §1254(1).

CONSTITUTION, STATUTES AND REGULATIONS

The following Constitutional provision, statutes and

regulations are involved in this case. Pursuant to Rule

14.1(f) of the Rules of the Supreme Court of the United

States, Petitioners give only their citations, and set forth

their text in the Appendix.

U.S. Const. art. VI, cl. 2.

Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

§360)(g) (1984).

Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

§360k (1984).

28 U.S.C. §1254(1)

21 C.E.R. §§ 50.1-50.27 (1980).

Medical Liability and Insurance Improvement Act

of Texas, Tex.Rev.Civ.Stat.Ann. art. 4590i, §6.06.

STATEMENT OF THE CASE

A. Introduction

Nick and Barbara Lozier filed this lawsuit against

Dr. F. Brantley Scott to recover personal injury damages

for Dr. Scott’s unauthorized insertion of an inflatable

prosthesis into Nick Lozier’s penis, which ultimately

resulted in Mr. Lozier’s total impotence. There was

federal jurisdiction of their claims based on diversity of

citizenship, 28 U.S.C. §1332.

The Loziers asserted three legal theories, two of

which are at issue in this Petition for a Writ of Certiorari:

(1) negligence based upon Dr. Scott’s failure to obtain a

written consent to implant the penile prosthesis from Nick

Lozier, as mandated by 21 U.S.C §360j(g) and the

regulations promulgated thereunder, 21 C.F.R. §§50.20-

$0.27; and (2) battery. The District Court ruled against

the Loziers on the negligence/informed consent theory,

first by denying their Motion for Partial Summary

Judgment, and later in the context of Dr. Scott’s Motion

for Directed Verdict. Moreover, the District Court even

refused to admit the federal regulations into evidence,

except as limited impeachment of Dr. Scott, and gave the

jury a limiting instruction.

The District Court allowed the Loziers to submit

their battery theory to the jury, but instructed the jury that

“[t]he law, however, does not require that consent to

surgery be in writing.” Without the benefit of the federal

statute and regulations, the jury did not find that Dr. Scott

had implanted the penile prosthesis without Nick Lozier’s

consent, and the District Court entered a take-nothing

judgment against the Loziers based on the jury’s verdict.

The Court of Appeals for the Fifth Circuit affirmed the

District Court in an unpublished opinion.

The Loziers now seek a Petition for Writ of

Certiorari from this Court, pursuant to Rule 10.1(c) of the

Rules of the Supreme Court of the United States. What

is at stake is not only the fate of Nick and Barbara

Lozier’s lawsuit but also the viability of 21 U.S.C. §360j(g)

and 21 C.F.R. §§50.20-50.27 as protection for those who

participate in experiments involving "investigational

devices," inventions for which the FDA has granted an

exemption from its usual regulatory requirements so that

the inventors can explore the viability of their inventions

for commercial licensing and use. If this Court adopts Dr.

Scott’s view -- that an experimental subject’s consent to

the use of such a device can be oral rather than wnitten,

as the statute and regulations provide -- it will thwart

Congress’ intent, and could seriously undermine the public

health and safety that Congress sought to protect by

prescribing extensive disclosures, to be put in writing and

signed by the subject.

The Loziers maintain that the written consent

requirement of the federal statute and regulations must

apply in the area of experimental medical devices, both as

the duty component of the Loziers’ negligence/informed

consent theory and as the affirmative defense to their

battery theory. Believing that the Courts below have

misconstrued and misapplied 21 U.S.C §360j(g), and 21

C.F.R. §50.1, et seg., and that this Petition presents an

important question of federal law, the Loziers now request

this Court to effect the intent of Congress and hold that

this statute and these regulations do indeed mean what

they say.

B. Factual Background

The facts germane to this Petition for Writ of

Certiorari are undisputed. See Admissions of Fact

contained in the Joint Pretrial Order, included in the

Appendix. As a result of an automobile accident in 1953,

Nick- Lozier had problems with scar tissue blocking his

urethra. In 1986, he consulted Dr. Ralph Hopkins in

Lander, Wyoming, about his blockage problems.

Unfortunately, Dr. Hopkins removed so much of the scar

tissue that Nick Lozier was rendered incontinent. Tr. at

Vol. 16, p. 21. After he became incontinent, Lozier also

had periodic problems with functional impotence -- not

surprising for a man who constantly dripped urine, even

during intercourse. Tr. at Vol. 16, p. 30. Ultimately, Dr.

Hopkins referred Lozier to Dr. F. Brantley Scott in

Houston, Texas for treatment of his incontinence.

Dr. Scott was a world famous urologist who

achieved fame not only as a physician but also as an

inventor. Dr. Scott invented two devices (and subsequent

improvements on those devices) which have been used

extensively in the treatment of two major urological

problems: (i) an artificial urethral sphincter used to treat

incontinence, and (ii) an inflatable penile prosthesis used

to treat impotence, Tr. at Vol. 10, p. 43. Dr. Scott’s name

appears on various patents pertaining to these devices.

Along with several other principals, Dr. Scott founded

American Medical Systems ["AMS"] to manufacture and

market some of these devices. Tr. at Vol. 10, p. 103.

Both Lozier and Dr. Scott agreed that Lozier came

to Houston to obtain an implant of the urethral sphincter,

in order to control the flow of his urine. Tr. at Vol. 16, p.

51 (Lozier), and Vol. 10, p. 108 (Dr. Scott). Lozier

wanted the sphincter implant, and signed a written

informed consent for the sphincter surgery. Dr. Scott

successfully implanted the sphincter into Mr. Lozier’s

abdomen; Mr. Lozier has had no significant problems

resulting from the sphincter; and the sphincter is not at

issue in this litigation.

Unfortunately, as Nick Lozier -- under general

anesthesia -- was being wheeled into the operating room

to receive the sphincter, the charge nurse pointed out to

Dr. Scott that he had scheduled Mr. Lozier not only for

the implantation of the sphincter, for which Mr. Lozier

had signed a written consent torm, but also for the

implantation of a penile prosthesis, for which he had

signed no such form.’ Tr. at Vol. 10, p. 10 (Dr. Scott).

Nonetheless, Dr. Scott made a unilateral, conscious

decision to proceed with both surgeries, even though there

was no written consent form for the penile implant. Tr.

at Vol. 10, p. 10, 15 (Dr. Scott). There is no question that

Dr. Scott was fully aware that Mr. Lozier had not signed

' Mr. Lozier had discussed the possibility of a penile prosthesis

with Dr. Scott, but had decided against it.

a written, informed consent for the implantation of the

penile prosthesis prior to and during the surgery.

Furthermore, Dr. Scott proceeded with the penile

implant with full knowledge that federal statutes and

regulations required a written consent form signed by the

patient for this type of device. The penile prosthesis at

issue is called a Hydroflex. Before Nick Lozier’s

operation, Dr. Scott’s company, AMS, had secured an

Investigative Device Exemption from the Federal Food

and Drug Administration ["FDA"] pursuant to 21 U.S.C.

§360j(g) to implant the Hydroflex in 100 patients on an

experimental basis. One of the purposes of the clinical

trials was to determine the degree to which the Hydroflex

could maintain rigidity in a man with a large penis. Px 53.

Dr. Scott found the perfect subject for this aspect of the

clinical trials in Nick Lozier, whom Dr. Scott has described

as in a "class by himself." Tr. at Vol. 10, p. 58.

As the inventor of the Hydroflex device, a founder

and officer of AMS, and the chief physician involved in

the clinical experiments, Dr. Scott participated actively in

AMS’ request for FDA approval and even signed a

written document promising the tederal regulators that he

would make sure that his patients gave their consent in

the form and manner required by federal law. Px 2.

Furthermore, the surgical protocol for the

Hydroflex device at St. Luke’s Hospital, where Dr. Scott

practiced, and elsewhere, required a detailed, written

form. Tr. at Vol. 10, p. 29, 39-42 (Dr. Scott). Indeed, Dr.

Scott wrote (or revised) the Informed Consent document

to be used in the clinical trials. Px 7 is his letter with a

copy of his revisions to the Informed Consent. Thus, Dr.

Scott established a standard of disclosure for the

"Hydroflex" clinical trials requiring written disclosure, but

then failed to adhere to his own standard.

Despite the fact that Dr. Scott had invented the

Hydroflex; despite the fact that he knew that it was an

experimental device which he could use only because the

FDA had granted an exception to its usual regulatory

requirements, and which could not be licensed for

commercial use until its clinical probation had ended;

despite the fact that he was tamiliar with the written

consent requirement of the federal statute and regulations

concerning the implantation of this device in human

subjects; despite the tact that he had helped write the

Informed Consent form that was to be signed by the

subjects in the clinical experiment phase; despite the fact

that he had expressly promised the federal regulators that

he would insure that he obtained written, informed

consent as required by law before implanting the

Hydroflex into any participant in the experiments; despite

the fact that he had found in Nick Lozier a one-of-a-kind

10

subject, and that he had a direct tinancial incentive to pass

quickly through the clinical trials so that he could reap the

benefits of commercial licensing of the Hydroflex’, both

of which called his objectivity directly into question; and

despite the fact that he knew that Nick Lozier had NOT

signed the required Informed Consent form to participate

in the experiment, Dr. Scott proceeded with his

irreversible experiment, and implanted the Hydroflex in

Nick Lozier’s penis on January 24, 1984.

The penile implant was a disaster. It was extremely

painful for Lozier. Tr. at Vol. i6, p. 54. It never worked

properly. Tr. at Vol. 17, p. 67. Ultimately, Mr. Lozier

> Although the District Court instructed the jury that "[t}he law,

however, does not require that consent to surgery be in writing,”

essentially reducing the consent issue to a swearing match between a

world-famous physician and a “country-boy type" with a ninth-grade

education, the Court did not allow the jury to consider Dr. Scott’s

direct financial incentive to implant as many Hydroflexes as possible

in assessing his credibility. After the Hydroflex clinical trials were

completed, Dr. Scott sold his stock in AMS for over $5,000,000.00.

Tr. at Vol 10, p. 177.

1]

had to have it removed. Tr. at Vol. 16, p. 58. In all

likelihood, the implantation of the Hydroflex device by Dr.

Scott caused irrevocable, irreversible tissue damage, so

that Lozier is now permanently, organically, impotent.

See Tr. at Vol. 17, p. 91 (Mr. Lozier), Vol. 20, p. 35 (Mrs.

Lozier).’

In his own detense, Dr. Scott testified that he had

spoken to Mr. Lozier before the operation, and that Mr.

Lozier had informed Dr. Scott that he wanted both the

urethral sphincter and the penile implant. Tr. at Vol. 10,

p. 12. Lozier maintained steadtastly that he did not

> There was considerable dispute in the record concerning the

degree to which Nick Lozier was impotent prior to the surgery by Dr.

Scott. Both Loziers maintained that, although Nick did not maintain

as full an erection as he had previously enjoyed, he was still able to

consummate sexual intercourse to the mutual satisfaction of himself

and his wife. Tr. at Vol. 17, p. 83; Vol. 20, p. 27. According to the

definition of impotency used by all of the experts in this case, this

meant that Lozier was not impotent, and, therefore, not even a

candidate for the Hydroflex prosthesis. Tr. at Vol. 19, p. 75, 124 (Dr.

Hopkins); Vol. 12, p. 455 (Dr. Scott); Vol. 7, p. 3 (Dr. Paulsen).

‘aici

consent to implantation of the penile prosthesis, because

he was not convinced that he needed it or wanted it. Tr.

at Vol. 16, p. 48. Although the jury -- without the benefit

ot the federal regulations, tendered as Px 63, and the

evidence ot Dr. Scott's direct financial bias in implanting

as many Hydroflexes as quickly as possible, but with the

District Judge’s instruction that consent could be oral --

did not find that Dr. Scott implanted the Hydrotlex

without Lozier’s consent, the Loziers assert that the jury

should have never even considered this issue. As a matter

of law, 21 U.S.C §360j(g), and the regulations

promulgated thereunder, Protection of Human Subjects,

21 C.F.R. $50.1, et seq., superseded the issue of consent

to the use of experimental devices on human subjects.

The Fifth Circuit erred in holding to the contrary.

ARGUMENT AND AUTHORITIES

A. Framing the Issue

Much as an antitrust litigant must first determine

the relevant product and market, the first task in the case

at bar is to determine the scope of the Loziers’ assertions.

Dr. Scott has successfully advanced the idea in the Courts

below that:

the issue in this case is whether Congress

intended, by passage of the Federal Food,

Drug and Cosmetic Act (FDCA), to compel

the states to provide tor civil tort recovery

for any failure to document consent in

writing.

Brief of Appellant F. Brantley Scott, Jr.. M.D. in the

United States Court ot Appeals tor the Fifth Circuit at 12.

The Fifth Circuit adopted Dr. Scott’s approach. Opinion

at 5.

The Loziers have not made such a sweeping

assertion in this case. First and foremost, the holding in

this case does not apply to all medical negligence cases

involving the issue of informed consent. The Hydrotlex

was a "device for investigational use’ -- an experimental

14

device on probation until it had proven its worth and

reliability in controlled, clinical tests. 21 U.S.C. §360)(g).

Certainly, the analysis of how a subject must consent to

the use of an experimental device on probation Is vastly

different than the analysis of how a patient may consent

to the use of a proven device or a routine procedure in

commercial use.

Second, the Loziers do not contend that the FDCA

compels (or, for that matter, could compel) the State of

Texas to enact a comprehensive scheme for civil tort

recovery. Dr. Scott attempts to argue that, if a federal

statute preempts state law, it must do so on a grand scale.

This is not true. lf a federal statute preempts state law,

it need not preempt every facet of the preempted subject.

As any first-year law student could attest, a tort

consists of a duty, breach of that duty, causation and

damages. The Loziers do not argue that 21 U.S.C.

15

§$360)(g) and 21 C.F.R. §50.1 et seg. establish the tort of

negligence based on failure to obtain intormed consent

under Texas law, or detine its elements. What 21 U.S.C.

§360)(g) and 21 C.F.R. §§50.20-50.27 do in this regard is

define the duty -- how one must obtain informed consent -

- in the limited area of ‘Investigational Devices."

Likewise, concerning the Lozier’s theory that Dr. Scott

committed battery by implanting a Hydroftlex in Nick

Lozier’s penis, the federal statute and regulations do not

create the tort of battery in Texas, or alter the elements

of or defenses to that tort. The federal statute and

regulations do, however, detine how one must consent to

what would otherwise constitute a battery, where the

tortfeasor commits the battery by implanting an

‘Investigational Device."

The Loziers and Dr. Scott have drawn the battle

lines clearly. The Loziers assert that, when dealing with

16

"Investigational Devices,” informed consent must be in

writing, period. Dr. Scott asserts that the subject may give

his informed consent orally.

B. The Statutory Framework

Congress amended the Food, Drug and Cosmetic

Act ["FDCA"] in 1976 to confer authority on the FDA to

regulate both drugs and medical devices. P.L. 94-295, 90

Stat. 574 (May 28, 1976)(coditied at 21 U.S.C. §§301-92).

Section 360j of the FDCA sets torth "[g]eneral provisions

respecting control of devices intended for human use,” and

prescribes regulations applicable to such devices.

The statutory section at issue in this lawsuit, 21

U.S.C. §360j(g), provides an “[e]xemption for devices for

investigational use," and exempts "investigational devices”

from the usual regulatory requirements of the FDCA. In

their stead, section 360j(g) prescribes its own regulatory

requirements tor ‘investigational devices’ that are separate

17

trom and more stringent than the requirements applicable

to other devices tegulated by the FDCA, based on the

unproven nature of such devices.

It is the purpose of [21 U.S.C. $360)(g)] to

encourage, to the extent consistent with the

protection of the public health and satety

and with ethical standards, the discovery

and development of useful devices intended

for human use and to that end to maintain

optimum freedom for scientific investigators

in their pursuit of that purpose.

21 U.S.C. §360j(g)(1). Accordingly, Congress enacted

section 360j(g) to encourage invention and innovation, but

only to the extent consistent with public health and safety

and with ethical standards.

The most important provision of 21 U.S.C. §360)(g)

with regard to public health and safety and to ethical

standards addresses the issue of informed consent. If

citizens are tO participate in experiments, the scientist

must fully inform them as to the risks, and must obtain

18

their knowing consent. Congress mandated that the

person applying for an investigative device exemption

(D) assure that informed consent will be

obtained from each human subject (or his

representative) of proposed clinical testing

involving such device, except [in life-

threatening situations]...

The determination required by

subparagraph (D) shall be concurred in by

a licensed physician who is not involved in

the testing of the human subject with

respect to which such determination is

made unless immediate use of the device is

required to save the lite of the human

subject of such testing and there is not

sufficient time to obtain such concurrence.

21 U.S.C. §360)(g)(3).

The Regulations promulgated under 21 U.S.C.

§360)(g) are set forth at 21 C.F.R. $50.1, et seq., under the

general heading "PROTECTION OF HUMAN

SUBJECTS." Subpart B -- Informed Consent of Human

Subjects addresses the issue of informed consent, and

specifically mandates that

19

[e]xcept as provided in §56.109(c), informed

consent shall be documented by the use of

a written consent form approved by the

IRB and signed by the subject or the

subject’s legally authorized representative.

21 C.F.R. §50.27(a)[emphasis added].

There is no dispute that the Hydroflex penile

prosthesis that Dr. Scott implanted in Nick Lozier on

January 24, 1984 was an "Investigative Device" subject to

the requirements of 21 US.C. §360j(g) and the

Regulations promulgated thereunder. Likewise, there is

no dispute that Nick Lozier never signed a written

Informed Consent for the implantation of the Hydroflex.

Finally, the Loziers cite portions of the FDCA and

the Regulations that provide some guidance on whether

Congress intended to preempt state law regarding

informed consent concerning investigative devices.

(a) General rule. Except as provided in

subsection (b), no State or political

subdivision of a State may establish or

20

continue in effect with respect to a device

intended for human use any requirement --

(1) which is different from, or in

addition to, any requirement

applicable under this Act to the

device, and

(2) which relates to the safety or

effectiveness of the device or to any

other matter included in a

requirement applicable to the device

under this Act.

(b) Exempt requirements. Upon

application of a State or a_ political

subdivision thereof, the Secretary may, by

regulation promulgated after notice and

opportunity for an oral hearing, exempt

trom subsection (a), under such conditions

as may be prescribed in such regulation, a

requirement of such State or political

subdivision applicable to a device intended

for human use it --

(1) the requirement is more stringent

than a requirement under this Act

which would be applicable to the

device if an exemption were not in

etfect under this subsection; .. .

21 U.S.C. §360k[{underlining added; boldface in original].

The regulations provide that:

21

(c) The informed consent requirements in

these regulations are not intended to

preempt any applicable Federal, State, or

local laws which require additional

information to be disclosed for intormed

consent to be legally effective.

21 C.F.R. §50.25[emphasis added].

The clear message trom these provisions is that

Congress intended the federal statute and regulations to

establish the minimum standard tor informed consent

concerning "investigational devices.” If a State wishes to

impose additional, more stringent requirements for

informed consent to be legally binding, it can do so.

However, a State cannot allow a human subject involved

in research to consent to the use of an investigative device

in any manner that does not meet the tederally-imposed

minimum standard. The Loziers assert that, under the

Statute and Regulations, Nick Lozier could not legally

DBs

ae

consent to the implantation of the Hydroflex except in

Writing. °

te A Subject Cannot Consent to the Use of an

Investigative Device Governed by 21 U.S.C.

3360} cept in Writi

The Loziers assert that 21 U.S.C. §360j(g) and 21

C.F R. §§50.20-50.27 set the minimum standard tnat any

purported consent to the use of an "investigational device’

must meet. To the extent that this minimum standard

4

Interestingly, Texas law also indicates that consent should be

given in writing:

Manner of Disclosure

Section 6.06. Consent to medical care that

appears On the panel's list requiring disclosure shall

be considered effective under this subchapter if it is

given in writing, signed by the patient or a person

authorized to give the consent and by a competent

witness, and if the written consent specifically states

the risks and hazards that are involved in the

medical care or surgical procedure in the form and

to the degree required by the panel under Section

6.04 of this subchapter.

Tex.Rev.Civ.Stat.Ann. art. 45901 (Vernon Supp. 1991). Thus, the

District Judge’s instruction that "[t]he law, however, does not require

that consent to surgery be in writing” appears all the more curous.

conflicts with state law, the tederal statute and regulations

would preempt any form of consent that falls below this

standard (i.e. that is not in writing). In the case at bar,

however, there is not necessarily a conflict. The District

Judge simply assumed that consent under Texas common

law, developed to analyze intormed consent in the context

of routine devices and procedures, was the same as

consent tO participation- in research involving

"investigational devices’ as understood by 21 U.S.C.

§$360)(g) and 21 C.F.R. §$50.20-50.27. In so doing, the

District Judge equated apples and oranges -- or, more

appropriately, apples and kumquats. This was entirely

inappropriate. While oral consent may be pertectly

acceptable in routine devices and procedures, it is

certainly not acceptable when dealing with devices to

which 21 U.S.C. §360j(g) and 21 C.F.R. §§50,20-50.27

apply. The Loziers assert that, as a matter of law, the

federal statutes apply to consent to participate in research

involving investigational devices, and state law applies to

consent to routine matters. Accordingly, the District

Court erred in refusing to apply the federal statute and

regulations to the case at bar.

In the alternative, if the federal statute and

regulations do conflict with state !aw regarding consent,

the tederal statute and regulations preempt state law with

regard to investigational devices. To determine whether

there is federal preemption of any particular subject, one

must ascertain whether Congress intended to preempt

state law on that subject.

There are three principal indications of

preemption. First, Congress can expressly state that it

intends to preempt state law. This method is sufficient,

though not necessary, to demonstrate federal preemption.

International Paper Co. v. Ouellette, 1U7 S.Ct. 805, 811

(1987). Second, courts may infer preemption "when the

federal legislation is ‘sufficiently comprehensive to make

reasonable the inference that Congress "left no room" tor

supplementary state regulation.” Ibid.(ultimately quoting

Rice _v. Santa Fe Elevator Corp., 331 U.S. 218, 230

(1947)). Finally,

{iJn addition to express or implied pre-

emption, a state law also is invalid to the

extent that it “actually conflicts witha...

federal statute." Ray v. Atlantic Richfield

Co., 435 U.S. 151, 158, 98 S.Ct. 988, 994, 55

L.Ed.2d 179 (1978). Such a conflict will be

found when the state law "’stands as an

obstacle to the accomplishment and

execution of the full purposes and objectives

of Congress.” Hillsborough County _v.

’

Automated Medical Laboratories, supra

471 US., at 713, 105 S.Ct. at __—s (quoting

Hines v. Davidowitz, 312 U.S. 52, 67, 61

S.Ct. 399, 404, 85 L.Ed.2d 581 (1941).

Ouellette, 107 S.Ct., at 811. Under either the second or

third types of preemption, 21 U.S.C. §360j(g) and 21

C.F.R. §$§50.20-50.27 supersede Texas state law to the

extent that Texas law would permit a human subject to

26

ee

consent orally to the use of an "investigational device’

such as the Hydroflex.

Preemption is most obvious under the third,

"conflict with state law" analysis. If Dr. Scott (and the

District Court) is correct in his assertion that Nick Lozier

could consent orally to the implantation of the Hydroflex -

- at least as a defense to battery -- there is a blatant

conflict with 21 C.F.R. §50.27(a), which mandates that

consent be documented on an approved, written consent

form.

Texas law allows a medical negligence plaintiff in

Nick Lozier’s. position to recover under a theory of

battery. The lead case in Texas unambiguously states the

rule of law as follows:

[A] surgeon is subject to liability for assault

and battery where he operates without the

consent of the patient or the person legally

authorized to give such consent.

Gravis _v. Physicians & Surgeons Hospital, 427 S.W.2d

310, 311 (Tex. 1968). Accord Johnson v. Whitehurst, 652

S.W.2d 441, 444 (Tex. App. -- Houston [1st Dist.] 1983,

writ refd n.r.e.)("a doctor must secure the authority or

consent of his patient in order to legally perform medical

procedures."). Consent is an affirmative defense to

battery. Likewise, it is clear that the purpose of 21 U.S.C.

§360)(g) and 21 C.F.R. §§50.20 - 50.27 is to protect human

subjects from participation in experiments involving

"investigational devices" until the scientist explains all the

risks involved and allows the subject to see them in

writing, reflect on them and physically consent to them by

his/her signature. Did Congress intend Dr. Scott’s

proterred result: that oral consent to the implantation of

an experimental device is adequate as a defense to

battery, thereby depriving a plaintiff such as Nick Lozier

of exactly the protection that Congress has afforded him?

Certainly not. Such a result would "stand[] as an obstacle

to the accomplishment and execution of the full purposes

and objectives of Congress." Quellette, 107 S.Ct., at 811.

This analysis is a fortiori true of the Loziers’

negligence/lack of informed consent theory. Again, if oral

consent could suffice, Dr. Scott would negate Congress’

protection for human subjects like Nick Lozier in its

entirety, rendering the express words of 21 U.S.C. §360j(g)

and 21 C.F.R. $50.27(a) utterly meaningless.

In summary, the method that Congress chose to

reach its goal of protecting public health and safety and

upholding ethical standards in the area of "investigational

devices" was to require a written consent form

documenting informed consent. To allow oral consent

where an "investigational device" is involved would

frustrate Congress’ intent. "A state law [] is preempted if

it interferes with the methods by which the federal statute

was designed to reach [Congress’] goal." Ouellette, 107

S.Ct., at 813.

The Court could reach the same result using the

"implied preemption" analysis. At first blush, it appears

that 21 U.S.C. §360j(g) and 21 C.F.R. $§50.20 - 50.27 are

not "sufficiently comprehensive to make reasonable the

inference that Congress ‘left no room’ for supplementary

state regulation.” Quellette, 107 S.Ct., at 811. This seems

particularly true in light of the following language:

The informed consent requirements in these

regulations are not intended to preempt any

applicable Federal, State, or local laws

which require additional information to be

disclosed for informed consent to be legally

effective.

21 C.F.R. §50.25(c). See also 21 U.S.C. §360k(b).

However, the analysis must return to the intent of

Congress: to establish the minimum standard for informed

consent to the use of "investigational devices." In fact,

Congress left no room for supplementary state regulation

30

of anything less than the federal standards for informed

consent. See Quellette, 107 S.Ct., at 810, 812 (Clean

Water Act, 33 U.S.C. §1251 et seg., provision that allowed

state in which a pollution source was located to adopt

more stringent discharge limitations than those of the

federal government was valid to preempt attempted

application of the laws of adjacent states).

As the Loziers pointed out above, Dr. Scott has

implied that a federal statute must set forth a

comprehensive civil tort recovery scheme in order to

preempt state law that overlaps the federal statute. This

is simply untrue. Federal law can preempt certain

provisions of state law, while leaving other provisions in

force. See Quellette, 107 S.Ct., at 814-15 (Vermont

residents allowed to maintain nuisance action in federal

court, sitting in Vermont, against company with pollution

point source discharge in New York, despite provisions of

31

Clean Water Act; BUT Clean Water Act mandated that

court apply substantive law of New York). Just as the

plaintiffs in Quellette were able to maintain their action in

Vermont, with federal law supplying only the choice of

law, the Loziers may maintain their action against Dr.

Scott under Texas law, with federal law supplying only the

standard for consent.

D. Using a Federal Statute to Supply the Duty or the

Def f State Tort R ty _is Entire!

Consistent with Both Texas and Federal Law

This Court has recognized that there can be

circumstances where "a breach of the duty imposed by the

federal statute”, gives rise to state tort claims. Merrell

Dow ica vy. , 478 U.S. 804, 106

S.Ct. 3229, 3236n.14 (1986)(quoting Moore v. Chesapeake

& Ohio R. Co., 291 U.S. at 214-15).’ That is precisely the

issue in this case.

This holding is entirely consistent with Texas law.

Texas courts have long recognized that the breach of a

Statute, ordinance, or regulation is negligence per se so

long as it is clear to the court that the plaintiff is a

member of the class of persons for whom the law in

question is designed to protect. El Chi v. Poole

732 S.W.2d 306, 312 (Tex. 1987)(establishing per se

liability for violation of alcoholic beverage code); Nixon v.

Mr. Property Mgt. Co., 690 S.W.2d 546, 549 (Tex. 1985).

The Texas Court of Appeals in San Antonio has made it

quite clear that the statute or regulation which establishes

the duty can be federal. Peek v. Oshman’s Sporting

Goods, inc,, 768 S.W.2d 841, 845 (Tex.App. -- San

> Ata minimum, Dr. Scott’s violation of 21 U.S.C. §360j(g)

should "constitute a ‘rebuttable presumption’ or a 'proximate cause’

under state law.” Merrell Dow, 478 U.S. at 812, 106 S.Ct. at 3234.

33

Antonio, 1989, writ denied)(affirming summary judgment

for defendant because no fact issue raised violation or

federal firearms statute and implementing regulations, but

specifically acknowledging that "we here recognize a

standard of care imposed by statute").

CONCLUSION

For the reasons set forth above, Petitioners urge

the Court to hold that, while oral consent to routine

medical devices and procedures under state law may be

acceptable, written consent pursuant to 21 U.S.C. §360j(g)

and 21 C.F.R. $§50.20-50.27 is required for a human

subject to participate in research involving "investigational

devices."

In the alternative, if the Court finds that there is a

conflict between 21 U.S.C. §360j(g) and 21 C.F.R.

§§50.20-50.27 on the one hand, and state law permitting

oral consent on the other, Petitioners urge the Court to

34

hold that the federal statute and regulations preempt state

law concerning the method of giving consent to one’s

participation in experiments involving “investigational

devices," as a matter of law.

In the alternative, Petitioners urge the Court to

hold that the District Court could and should have at least

admitted the regulations into evidence and given the jury

appropriate instructions concerning the mandatory nature

ot these laws, and to remand the case on that basis.

Respecifully submitted

VICKERY, KILBRIDE, GILMORE

& VICKERY

(LLL Ui La

Amold Anderson Vickery eS

S.D. Fed. I.D. No. 4470

Texas State Bar No. 20571800

2929 Allen Parkway, Suite 2770

Houston, Texas 77019

(713) 526-0700

PROOF OF SERVICE

CERTIFICATE OF SERVICE

Pursuant to Rule 29.3 of the Rules of the Supreme

Court of the United States, I certify that three copies of

the Petition for Writ of Certiorari has been served on

Robert J. Swift, FULBRIGHT & JAWORSKI, 1301

McKinney, Suite 5100, Houston, Texas 77010-3095 via

first class postage prepaid, on this 13th day of November,

as &. KoOD

36