Amicus Curiae Brief — Medtronic, Inc. v. Lohr

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% \M Supreme Court, U.S

\ C7 FILED

Nos. 95-754, 95-886 MAR 18 1996

“RK

In The on

Supreme Court of the United States

October Term, 1995

>

MEDTRONIC, INC.,

Petitioner/Cross-Respondent

Vv.

LORA LOHR and MICHAEL LOHR,

Respondents/Cross-Petitioners,

“aaa.

On Writ Of Certiorari

To The United States Court Of Appeals

For The Eleventh Circuit

SJ

BRIEF AMICUS CURIAE OF THE STATE OF

CALIFORNIA IN SUPPORT OF RESPONDENTS/

CROSS-PETITIONERS LORA LOHR

AND MICHAEL LOHR

°

Dante. E. LUNGREN

Attorney General

Roperick E. WALSTON

Chief Assistant Attorney General

THEODORA BERGER

Assistant Attorney General

Susan S. Frerinc*

ty Attorney General

(*Counsel of Record)

2101 Webster Street, 12th Floor

Oakland, California 94612-3049

(510) 286-3892

Counsel for Amicus Curiae

COCKER CALL COLLECT (402) 9829891

n5 fe

QUESTION PRESENTED

Under the Medical Device Amendments to the Federal

Food, Drug and Cosmetics Act, must requirements be

device-specific in order to preempt state law?

TABLE OF CONTENTS

Page

INTEREST OF AMICUS CURIAE ...............++: 1

SUMMARY OF ARGUMENT................+.005:: 4

rely 6 5 ie.) .) . Se rs 5

ps ct ewes Serer errr rrr iT TTT TreT TT Tri TT ce 10

I. THE EXPRESS PREEMPTION PROVISION OF

THE MDA SHOULD BE CONSTRUED NAR-

ROWLY TO PRESERVE THE ABILITY OF THE

STATES TO PROTECT THEIR CITIZENS

FUE MEIN s candice cdndeverrstevos cdesees es 10

II. ONLY DEVICE SPECIFIC REQUIREMENTS

UNDER THE MDA PREEMPT STATE LAW .. 11

A. The FDA Interpretation is Consistent with

the Language of the Statute............. 11

B. The FDA Interpretation is the Only Inter-

pretation Consistent with the Structure

and Intent of the MDA.................. 14

CRISIS 8 os vec ces onintccsvevescicdccceedecs 17

TABLE OF AUTHORITIES

Page

Cases

Anguiano v. Du Pont, 44 F.3d 806 (CA 9 1995)....... 14

pollone v. Liggett Group, Inc., 505 U.S. 504 (1992)

120 L.Ed.2d 407, 112 S.Ct. EE odd bcddsdub cdcave 10

Committee of Dental Amalgam Alloy Manufacturers

and Distributors and Lentsply, Inc. v. Stratton and

Lungren, 871 F.Supp. 1278 (S.D. Cal. 1994) ....... 2,3

Duvall v. Bristol-iMyers-Squibb, 65 F.3d 392 (CA 4

stink sihanededeatecnceccesstccdasttide ce cls 14

English v. Mentor, 67 F.3d 477 (CA 3 1995).......... 14

Feldt v. Mentor Corp., 61 F.3d 431 (CA 5 1995)....... 14

Hillsborough County v. Automated Medical Laborato-

SED. ls re ee FE ec cc cecéctbccéccescéas 10

Jacobs v. DuPont, 67 F.3d 1219 (CA 6 1995).......... 14

Kennedy v. Collagen Corp., 67 F.3d 1453 (CA 9 1995).... 14

Lamontagne v. E.1. Du Pont, 41 F.3d 846 (CA 2 1994).... 14

Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273

EE ee ae en 14

Lohr v. Medtronic, 56 F.3d 1335 (CA 11 1995) ..4, 5, 14, 15

Mendes v. Medtronic, 18 F.3d 13 (CA 1 1995)......... 14

Moore v. Kimberly-Clark Corp., 867 F.2d 243 (CA 5

Sewell ag bddeddeddccddésededubeddeesdcessacceces 14

National Bank of Commerce v. Kimberly-Clark Corp.,

EE ED OD BODE ccccccccensevectsccceces: 14

iv

TABLE OF AUTHORITIES - Continued

Page

New Jersey Guild of _—— Aid Dispensers v. Long,

384 A.2d 795 (N.J. 1978). ....- 000 e ccc e eee n ee weeee 14

Reeves v. Acromed, 44 F.3d 300 (CA 5), cert.denied,

132 L.Ed.2d 258, 115 S.Ct. 2251 (1995) ..........-. 14

Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947) .... 10

Smith v. Pingree, 651 F.2d 1021 (CA 5 1981) ......... 14

FepeRAL STATUTES

United States Code

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BO OG: OWN diss inde cssacdonss abcteoomeie 5

28 UDR. 0 SERINE... oiicinds sscuscrediccs vests 7

50 CU 0 I, og 5 on cukiccccdeusecnsaenins 7

21 U.S.C. § 360c(a)(1)(B),(C)......... 2222 e cece 4, 7, 16

Ss Cie a niecstikescokavabecdassdanaen 9

SO WBE. © TIED oc a.cccsccececcacnnsssdtiae 9

38 WAL. 6 DIDO shea is co ccnsmacsindsctetnctl 5

28 UGC. © SUBADMTIMAD. ....<0.cccccccccoccncecccesés 9

v

TABLE OF AUTHORITIES - Continued

Page

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is i dup ecn vecdosetnbscccecdteten un 5

cs nbc isd ddcdecunsdeusens suck cues 9

ee oc cocaks ccevetedaoccadecclecwes 11, 16

FepeRAL REGULATIONS

Code of Federal Regulations

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vi

TABLE OF AUTHORITIES - Continued

Page

BB Coe Oe GE cc cnccbeccccaccuctocccnscsacenuense 6

EK Sf RP 2

Federal Register

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BE Ges TR ee eo ccnccivecodsccsecsscnsrcces 2

State STATUTES AND REGULATIONS

California Health & Safety Code

Health & Saf. Code §§ 25249.5 et seq.............005. 1

Saeati G Gab. CaGe © TBGINS. .cccccovccccaccccvdvsye 1

California Code of Regulation

22 Cal. Code of Reg. § 12601(b).................0005. 1

OrHerR AUTHORITIES

Robert S. Adler and Richard A. Mann Preemption

and Medical Devices The Courts Run Amok 59 Mo.

ee FES SE enc nsncsceccvcsuksbinasds cade 9, 15

H.R. Rep. No. 808 101st Cong., 2d Sess. 14

reprinted in 1990 U.S.C.C.A.N. 6307 .............55. 9

H.R. Rep. No. 853, 94th Cong. 2d Sess. 8-10 (1976) .... 15

INTEREST OF AMICUS CURIAE

Pursuant to Supreme Court Rule 37.5, Amicus Curiae,

the State of California, submits this brief in support of

respondents/cross-petitioners Lora and Michael Lohr.

The State of California has a strong and specific interest

in preserving its traditional police power authority to

enforce state statutes and regulations that protect public

health and welfare. The Eleventh Circuit’s decision

erodes that traditional area of state regulation in a man-

ner that leaves the citizens of the various states open to

potentially devastating harm from medical devices.

One aspect of the preemption issue before this Court

is of particular interest to the State. In 1986 the People of

the State of California enacted the Safe Drinking Water

and Toxic Enforcement Act (“Proposition 65”), California

Health & Safety Code sections 25249.5 et seq. (“Cal.

H&SC”) Proposition 65 is a general “Right to Know”

statute which applies to a list of several hundred chemi-

cals that are known carcinogens and/or reproductive

toxins. The statute requires that anyone, in the course of

doing business, who exposes any individual to certain

levels of the listed carcinogens or reproductive toxins,

must first give a clear and reasonable warning to the

exposed individual. Cal. H&SC § 25249.6. The warning

requirement applies whether the exposure occurs from

smokestack emissions, through ingestion of food, through

the use of a consumer product,' or in any other

' For consumer products containing reproductive toxins,

the “safe harbor” warning language is: “WARNING: This

product contains a chemical known to the State of California to

cause birth defects or other reproductive harm.” 22 California

Code of Regulations § 12601(b).

environment or circumstance, including through the use

of a medical device.

In 1994, the federal district court for the Southern

District of California ruled that Proposition 65, as it

applies to dental mercury, a Class I device,? was pre-

empted by the Medical Device Amendments to the Fed-

eral Food, Drug and Cosmetics Act (“MDA”). Committee

of Dental Amalgam Alloy Manufacturers and Distributors and

Dentsply, Inc. v. Stratton and Lungren, 871 FSupp. 1278

(S.D. Cal. 1994). The court concluded that the general

labeling requirements contained in 21 U.S.C. section

352(f) and 21 C.F.R. section 801.109, that apply to all

medical devices or all prescription devices, were “specific

requirements” that preempted Proposition 65 and pre-

vented enforcement of that statute’s warning require-

ment. Dental Amalgam, 871 F.Supp. at 1284. The State

appealed and the case is pending before the Court of

Appeals of the Ninth Circuit. (Nos. 94-56508 and

94-56512) While the decision in the Dental Amalgam

appeal involves a Class I medical device, it is also possi-

ble that exposures to Proposition 65 chemicals may result

2 When placed in teeth dental mercury exposes the dental

patient to quantities of mercury, a listed reproductive toxin

under Proposition 65, thereby making it potentially subject to

the warning requirements of Proposition 65.

Dental mercury was originally proposed to be classified as

a Class II medical device. While recognizing that elemental

mercury is a poison that posed a threat to patients with allergic

reactions and to dental professionals, the FDA stated that a

performance standard would not alleviate these risks and

therefore classified the device as Class I. 21 C.F.R. § 872.3700; 52

Fed. Reg. 30089 (1987).

from the use of Class II and Class III medical devices. The

Court’s ruling therefore may equally affect the ability of

the State to enforce Proposition 65 as it applies to these

more dangerous devices.

One of the central questions at issue in the case

before this Court —- whether federal requirements under

the MDA must be device specific in order to preempt

state requirements — is the same as the question that is

currently pending in the Dental Amalgam appeal.? Thus,

the Court’s ruling here may not only determine the ongo-

ing validity of state common law tort claims as they

apply to medical devices, it may equally determine the

ability of the states to enforce public health and safety

statutes.

Because the Dental Amalgam decision raises the ques-

tion of preemption of statutory enactments, rather than

common law claims, the State of California is filing this

separate amicus brief to address that portion of the Elev-

enth Circuit decision that applies to statutory enactments

as well as common law claims.

The State of California urges this Court to rule that

only device-specific requirements under the MDA may

preempt state requirements, and that the general require-

ments applicable to al! devices or to broad categories of

devices under the MDA do not preempt state law.

°

3 The State has also asserted that Proposition 65 is a

requirement of general applicability not directed at medical

devices and therefore is not preempted pursuant to 21 C.F.R.

§ 808.1(d).

SUMMARY OF ARGUMENT

This Court is faced with the intersection of federal

law intended to protect consumers from harm caused by

medical devices and the traditional police power of the

States to regulate in the area of health and safety. While

the case before the Court involves common law claims, its

ruling may affect statutory enactments as well, making it

more difficult or impossible for the States to perform

their traditional role in safeguarding the public welfare.

In enacting the MDA, Congress established three cat-

egories of medical devices ranging from the least regu-

lated (Class I) to the most regulated (Class III). Congress

also established a two part structure of regulation. On the

one hand there are the broad general controls applicable

to all devices. These do not reflect any knowledge by the

FDA of the particular hazards of a device or how to

ensure the safety of that device. In marked contrast to the

general controls are the special controls directed at speci-

fic devices and reflecting the FDA’s study of the particu-

lar device and determination of how to ensure that the

device is safe.

In enacting this statutory scheme, Congress speci-

fically found that the general controls applicable to all

devices were insufficient to ensure the safety and effec-

tiveness of the Class II and III devices. 21 U.S.C.

§§ 360c(a)(1)(B)(C).

The Eleventh Circuit in Lohr v. Medtronic, 56 F.3d

1335, 1351 (CA 11 1995) held that the general controls

applicable to all devices preempt state law and prevent

the States from regulating particular medical devices.

Furthermore, even though thousands of the most dan-

gerous devices are now marketed pursuant only to the

general controls and these general controls were deemed

by Congress to be inadequate, under Lohr the states are

still prohibited from exercising their traditional police

powers to provide needed protection to their citizens.

Contrary to the Lohr decision, Congress did not

intend to eradicate state law protection until the FDA

exercises its own regulatory control of specific devices. It

is only device-specific regulation that will assure con-

sumers of the safety of particular medical devices and

only device-specific regulation that relieves the states of

their traditional duties to protect public health and wel-

fare. Thus, contrary to the decision by the Lohr court, the

skeletal outlines of regulation contained in the general

controls do not preempt state law.

S

STATUTORY OVERVIEW

The State of California will not repeat the detailed

description of the MDA provided to the Court by the

Lohrs. A brief description, however, of the structure of

regulation in the MDA is necessary to set the stage for the

argument below.

The MDA’s general controls, defined by 21 U.S.C.

section 360c(h) as those controls authorized by sections

351, 352, 360, 360f, 360h, 360i and 360j, are applicable to

all medical devices and are the skeletal outline of the

regulatory scheme. The statutory general controls contain

broad requirements not directed at particular devices. For

example, the general controls prohibit adulterated

devices that contain filthy, putrid or decomposed sub-

stances or that do not conform to current good manufac-

turing practice; or prohibit misbranded devices if the

labeling is false or misleading or does not contain “ade-

quate directions for use” and warnings against use in

pathological conditions. 21 U.S.C. §§ 351(a)(1), 352(a),(f).

The FDA has enacted regulatory counterparts to the

statutory general controls. While these regulations are

sometimes more detailed in subject matter than the statu-

tory provisions, they are not device specific and retain

the open-ended quality of the statute. For example, 21

C.F.R. section 801.109(c), one of the “Exemptions from

Adequate Directions for Use,” states that prescription

medical devices need not comply with the “adequate

directions for use” requirement of 21 U.S.C. section 352(f)

if the label contains use information, and warnings, i.e.

“hazards, contraindications, side effects, and precautions

.... ” Similarly 21 C.F.R. sections 820.1 et seq. simply

instruct manufacturers to prepare quality assurance pro-

grams, to have sufficient personnel with appropriate

training, to use buildings of suitable design and space, to

use appropriately designed equipment, and the like. 21

C.F.R. §§ 820.5, 820.25, 820.40, 820.60.

In each instance, the general controls were promul-

gated with no knowledge of a specific device or its dan-

gers and do not inform the manufacturer of exactly what

must be done with a particular device to protect the

public. Thus, the general controls initially leave to the

manufacturer the decision on how to ensure the safety of

a particular device. The manufacturer remains free to

argue to the FDA and, if necessary, to the courts, that the

general controls did not impose a particular requirement

on him or his device or that whatever actions he took

were sufficient to comply with the statutory require-

ments.

Congress specifically found that the general controls

applicable to all devices were insufficient to assure the

safety and effectiveness of the more dangerous Class II

and III devices* and therefore authorized that these

devices would be subject to device specific special con-

trols (Class II) or the premarket approval process (Class

III). 21 U.S.C. § 360c(a)(1)(B),(C).

Unlike the general controls, the device specific

requirements reflect careful scrutiny by the FDA of a

particular device and a studied determination of how to

make the device safe and effective. The contrast between

the general controls, whether statutory or regulatory, and

the device specific requirements is illuminated by the

requirements contained in 21 C.F.R. sections 801.403 et

seq., a regulatory Subpart entitled “Special Requirements

for Specific Devices.” (emphasis added). This Subpart

* Class II devices are those for which the general controls

are insufficient to provide reasonable assurance of the safety

and effectiveness of the device and for which the FDA can

establish special controls. 21 U.S.C. § 360c(a)(1)(B).

Class III devices are those which present an unreasonable

risk of illness or injury or which are used in sustaining human

life or preventing impairment of human health and whose

safety and effectiveness cannot be assured by the general or

special controls. 21 U.S.C. § 360c(a)(1)(C).

contains, for example, device specific warning require-

ments,5 testing requirements,® and labeling require-

ments.”

The Congressional determination that the general

controls are not adequate to ensure the safety and effec-

tiveness of the Class II and Class III devices is partic-

ularly significant because, at the time the MDA was

enacted, thousands of devices were already on the mar-

ket. The FDA lacked the resources to classify and regulate

all of the preexisting devices® and to process the

5 Denture reliners: “Warning - For temporary use only.

Long term use of this product may lead to faster bone loss,

continuing irritation, sores and tumors. For Use Only Until A

Dentist Can be Seen.” (21 C.F.R. § 801.403.)

Intrauterine Devices: “Contraindications - I[UDs should not

be inserted when the following conditions exist: 1. Pregnancy or

suspicion of pregnancy. 2. Abnormalities of the uterus resulting

in distortion of the uterine cavity. ...” 21 C.F.R. § 801.427.

6 Impact resistant sun glasses: “In the impact test, a °/s-inch

steel ball weighing approximately 0.56 ounce is dropped from a

height of 50 inches upon the horizontal upper surface of the

lens. The ball shall strike within a °/e-inch diameter... .” 21

C.F.R. § 801.410(d)(2).

indicating operating controls, user adjustments, and battery

compartment. (ii) Information on the function of all controls

intended for user adjustment. (iii) A description of any

accessory that may accompany the hearing aid... . ” 21 C.FR.

§ 801.420(c)(1).

8 As the FDA noted in 1987, it lacked the resources to

establish performance standards for all devices already

classified or being classified as Class II devices. Therefore,

“{u]nder the amendments, FDA is using the regulatory controls

premarket approval requirements for all of the preexist-

ing Class III devices. The preexisting devices, therefore,

including the most dangerous Class III devices, were

“grandfathered” into the statute and were permitted to

remain on the market subject only to the general controls.

See 21 U.S.C. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1). Fur-

thermore, any new devices that were substantially equiv-

alent to the grandfathered devices were similarly allowed

to enter the market through the “510(k) premarket noti-

fication process” and were subject only to the general

controls applicable to all devices. See 21 U.S.C. § 360(k),

360c(f)(1), 360c(i)(1)(A); H.R. Rep. No. 808, 101st Cong.,

2d Sess. 14, reprinted in 1990 U.S.C.C.A.N. 6307; Robert S.

Adler & Richard A. Mann, Preemption and Medical Devices:

The Courts Run Amok, 59 Mo. L. Rev. 895, 914 (1994).

Despite the substantial passage of time since the

enactment of the MDA, a large portion of all devices,

including the most dangerous Class III devices, have

entered the market through the premarket notification

process and simply remain subject to the general controls

applicable to all devices until such time as the FDA acts

to classify and regulate them. H.R. Rep. No. 808, 101st

Cong., 2d Sess. 14, reprinted in 1990 U.S.C.C.A.N. 6307.

See also Adler and Mann, Preemption and Medical Devices,

59 Mo. L. Rev. at 914 and n. 98. These preexisting and

substantially equivalent Class II and Class III medical

devices therefore remain in regulatory limbo — subject to

of class I to regulate a device classified into class II until a

performance standard is established under sections 514 of the

act (21 U.S.C. 360d) for a class II device.” 52 Fed. Reg. 10082

(1987).

10

the general controls of the MDA but not yet subject to

any device-specific requirements and not yet fully evalu-

ated by the FDA for safety and effectiveness.

¢

ARGUMENT

I. THE EXPRESS PREEMPTION PROVISION OF THE

MDA SHOULD BE CONSTRUED NARROWLY TO

PRESERVE THE ABILITY OF THE STATES TO

PROTECT THEIR CITIZENS FROM HARM

Preemption analysis begins with the basic assump-

tion that “the historic police powers of the States [are] not

to be superseded by . . . Federal Act unless that [is] the

clear and manifest purpose of Congress.” Cipollone v.

Liggett Group, Inc., 505 U.S. 504; 112 S.Ct. 2608, 2617; 120

L.Ed.2d 407, 422 (1992) (quoting Rice v. Santa Fe Elevator

Corp., 331 U.S. 218, 230 (1947). In determining whether an

express preemption provision preempts state law, this

Court in Cipollone held that courts must construe the

express language of the statute “in light of the presump-

tion against the pre-emption of state police power regula-

tions.” 112 S.Ct. at 2618; 120 L.Ed.2d at 424.

The presumption against preemption is particularly

strong when applied to state health & safety regulations.

“(T]he regulation of health and safety matters is primar-

ily, and historically, a matter of local concern.” Hills-

borough County v. Automated Medical Laboratories, Inc. 471

U.S. 707, 719 (1985).

As noted above, while this Court is faced with the

preemption of common law claims, its rulings may

11

equally affect state statutory enactments like Proposition

65, intended to warn citizens about exposures to toxic

chemicals. If Congress intends to preempt statutes like

Proposition 65 and to restrain the states from regulating

in the traditional area of health and safety, it must do so

expressly. Any expression of Congressional intent that is

less than clear and manifest, and any ambiguity in the

statute, must be construed against preemption.

Il. ONLY DEVICE SPECIFIC REQUIREMENTS

UNDER THE MDA PREEMPT STATE LAW

A. The FDA Interpretation is Consistent with the

Language of the Statute

Preemption analysis begins with the express lan-

guage of the statute. The preemption provision of the

MDA states that:

no State .. . may establish or 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 chap-

ter to the device, and

(2) which relates to the safety or effective-

ness of the device or to any other matter

included in a requirement applicable to the

device under this chapter. 21 U.S.C. § 360k(a).

While the statute does not expressly define a

“requirement applicable under this chapter to the device”

that is intended to be preemptive, the language at least

suggests that Congress was focused on particular devices

12

and the requirements applicable to those particular

devices.

Consistent with this language, as well as with the

strong presumption against preemption of state health

and safety statutes, it has been the longstanding inter-

pretation of the FDA that preemption only applies when

the FDA has enacted a device specific requirement.

State or local requirements are preempted only

when the Food and Drug Administration has

established specific counterpart regulations or

there are other specific requirements applicable

to a particular device under the act, thereby

making any existing divergent State or local

requirements applicable to the device different

from, or in addition to, the specific Food and

Drug Administration requirements. 21 C.F.R.

§ 808.1(d) (Emphasis added).

Throughout the years, prompted in part by a concern

with avoiding a “regulatory hiatus,”* the FDA has reiter-

ated its view that preemption only results from device

specific requirements. Thus, the Commissioner of the

FDA noted that he believed that:

* “Consistent with his understanding of the intent of

Congress, the Commissioner has narrowly construed the

preemption provisions so that section 521(a) of the act preempts

State and local requirements only when a particular Federal

requirement becomes applicable to a particular device by

operation of the act. This avoids disruption of vital State and

local programs relating to the regulation of medical devices and

reduces the possibility of a regulatory hiatus that could result if

State or local requirements were considered preempted prior to

the time FDA implemented Federal requirements.” 42 Fed. Reg.

30383 (1977) (emphasis added).

13

Congress intended section 521(a) [360k(a)] of

the act to preempt only those different or addi-

tional State and local requirements that relate to

matters already governed by specific, estab-

lished Federal requirements applicable to a

specific device. 42 Fed. Reg. 9186 (1977)

(emphasis added).

The FDA went on to note that:

a preempting FDA requirement will become

applicable to a device within the meaning of

section 521(a) [360k(a)] only after FDA takes a

regulatory or administrative action involving

the application of a particular requirement of

the act to a particular device. 42 Fed. Reg. 30384

(1977) (emphasis added).

In the same discussion, the FDA provided a concrete

example of the manner in which it envisioned preemption

applying:

For example, as noted in the recent regulation

relating to professional and patient labeling and

conditions for sale of hearing aids, State or local

requirements that relate to such labeling

requirements or conditions for sale will be pre-

empted by section 521(a) on the effective date of

the hearing aid regulation. . . . Id. (emphasis

added).

In other words, it is not the broad, general labeling

requirements contained in 21 U.S.C. section 352(f) or 21

C.F.R. section 801.1 et seq. that preempt state law; it is the

14

device specific requirements, such as that contained in 21

C.F.R. section 801.420, that are preemptive.”

B. The FDA Interpretation is the Only Interpreta-

tion Consistent with the Structure and Intent of

the MDA

Ultimately, the goal of preemption analysis is to

determine the intent of Congress. Congress enacted the

© Until relatively recently, most case law was consistent

with the FDA interpretation and the courts based their

preemption analysis only on device specific requirements. See,

e.g., Kennedy v. Collagen Corp., 67 F.3d 1453, 1458-59 (CA 9 1995);

Jacobs v. DuPont, 67 F.3d 1219, 1234-1236 (CA 6 1995); Anguiano

v. Du Pont, 44 F.3d 806, 810 (CA 9 1995); National Bank of

Commerce v. Kimberly-Clark Corp., 38 F.3d 988, 990 (CA 8 1994);

Lamontagne v. E.1. Du Pont, 41 F.3d 846, 853, 855 (CA 2 1994);

Moore v. Kimberly-Clark Corp., 867 F.2d 243, 246 (CA 5 1989);

Smith v. Pingree, 651 F.2d 1021, 1024 (CA 5 1981); Larsen v.

Pacesetter Systems, Inc. 837 P.2d 1273, 1282 (Hawaii, 1992); New

Jersey Guild of Hearing Aid Dispensers v. Long, 384 A.2d 795,

812-13 (N.J., 1978).

The Eleventh Circuit in Lohr, is part of a series of decisions

which have failed to recognize the authority of the states to

protect the health and safety of their citizens and the strong

presumption against preemption of that authority. See, e.g.,

English v. Mentor, 67 F.3d 477, 482 (CA 3 1995); Duvall v. Bristol-

Myers-Squibb, 65 F.3d 392, 399 (CA 4 1995); Feldt v. Mentor Corp.,

61 F.3d 431, 435 (CA 5 1995); Reeves v. Acromed, 44 F.3d 300, 305

(CA 5), cert.denied, 132 L.Ed. 2d 258, 115 S.Ct. 2251 (1995);

Mendes v. Medtronic, 18 F.3d 13, 17-18 (CA 1 1994). To the extent

that these recent decisions find preemption based on the general

controls applicable to all devices or to broad categories of

devices, they are inconsistent with the earlier caselaw, with the

recent decisions of the Second, Sixth, Eight and Ninth Circuits

and with the interpretation of the FDA.

15

MDA in 1976 against a particular backdrop - the deaths

and injuries that had occurred to many American women

of child bearing age from the Dalkon Shield Intrauterine

Device, a medical device largely unregulated by the Food

and Drug Administration. See H.R. Rep. No. 853, 94th

Cong. 2d Sess. 8-10 (1976) (“House Report”); Adler &

Mann, Preemption and Medical Devices, 59 Mo. L. Rev. at

911-12. As a result of that and similar tragedies with

other unregulated devices, Congress passed the MDA,

with the expressed intent to increase consumer protection

and safeguard the public health by assuring the safety

and effectiveness of medical devices. House Report at 12.

The Eleventh Circuit in Lohr v. Medtronic, 56 F.3d

1335, 1351 (CA 11 1995) held that the general controls

under the MDA preempt state requirements. Under the

Lohr analysis, the FDA need do nothing more than issue

broad, general controls applicable to all devices in order

to prevent the states from exercising their traditional

police powers to protect their citizens. In fact, the broader

and more general the control, the greater the preemption.

Even if the state has studied and examined a particular

device, is aware of its dangers and knows what is needed

to remedy those dangers, the state remains powerless. It

can impose no device specific warning requirement and

no device specific manufacturing requirement, simply

because the FDA has issued a broad instruction applica-

ble to all devices to provide necessary warnings and to

use good manufacturing processes.

The anomaly set up by Lohr is made even more

apparent when the Court considers that there are thou-

sands of Class II and Class III devices being marketed

16

subject only to the general controls, controls that Con-

gress specifically determined were not sufficient to

ensure the safety and effectiveness of those devices: 21

U.S.C. 360c(a)(1)(B),(C).

It is difficult to imagine that Congress established a

system of general controls that it deemed to be inade-

quate for certain classes of devices, permitted the large

majority of those devices to be marketed subject only to

the general controls and then simultaneously preempted

state safety and health statutes that offer consumers some

additional measure of protection. If general controls are

deemed to be preemptive, medical devices subject only to

the general controls, including those recognized by the

FDA as presenting a potential unreasonable risk of dan-

ger, would suddenly be freed from state regulation in

vital areas such as warning and manufacturing processes

and subject only to the same federal requirements used to

regulate crutches, tongue depressors and bandages,

requirements which Congress itself has recognized to be

insufficient to assure the safety and effectiveness of these

devices.

Given the real-world backdrop to the MDA - the

deaths, miscarriages and sterility that resulted from an

unregulated medical device - it is improbable that Con-

gress intended that the general controls applicable to all

devices would preempt state law and that dangerous

devices would be freed from state regulation only to be

ruled by the broadest and vaguest of federal require-

ments. Rather, the FDA interpretation of section 360k(a),

that only device specific requirements can preempt state

law, is a reasonable construction of the statute that com-

ports with Congressional intent to increase consumer

17

protection. In order for there to be preemption of tradi-

tional state police powers to enforce health and safety

statutes, the FDA must exercise its regulatory authority to

study and examine a particular device and determine

exactly what device-specific requirements are necessary

to protect the safety of citizens relying on the device.

Then, and only then, can the states relax their vigilance,

knowing that the FDA has asserted full regulatory control

over the device and will protect state citizens from unnec-

essary harm.

°

CONCLUSION

Thousands of dangerous medical devices remain in

what might best be termed regulatory limbo, subject only

to the general controls applicable to all devices, controls

that Congress has determined are not adequate to assure

the safety and effectiveness of these devices. Until such

time as the FDA can bring to bear on these devices its full

regulatory oversight and impose device-specific controls

and standards, the states must be left free to fill in the

interstices of the regulatory scheme and continue to pro-

tect the health and safety of their citizens. Amicus Curiae,

the State of California, therefore requests that this Court

rule that only device-specific requirements preempt state

law and the general controls applicable to all devices or

18

to broad categories of devices do not preempt the police

powers of the states.

Respectfully submitted,

Dante. E. LUNGREN

Attorney General

Roperick E. WALSTON

Chief Assistant Attorney General

THEODORA BERGER

Assistant Attorney General

Susan S. Frerinc*

Deputy Attorney General

(*Counsel of Record)

Counsel for Amicus Curiae

State of California

Dated: March 12, 1996

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