* Pursuant to Local Rule 47.5, the court has determined

that this opinion should not be published and is not precedent

except under the limited circumstances set forth in Local Rule

47.5.4. UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

_____________________

No. 95-31080

_____________________

EDWARD A. LEWIS, et al.,

Plaintiffs-Appellants,

versus

INTERMEDICS INTRAOCULAR, INC.,

Defendant-Appellee.

_________________________________________________________________

Appeal from the United States District Court

for the Eastern District of Louisiana

(Nos. 93-CV-7, 93-CV-403, 93-CV-404, 93-CV-405, 93-CV-407)

_________________________________________________________________ April 9, 1997

Before BARKSDALE, EMILIO M. GARZA, and BENAVIDES, Circuit Judges.

PER CURIAM: *

At issue, in the light of the Supreme Court’s recent decision

concerning preemption under the Medical Device Amendments of 1976,

Medtronic, Inc. v. Lohr

,

___ U.S.

___, 116 S. Ct. 2240 (1996), is

a pre- Medtronic summary judgment granted Intermedics Intraocular,

Inc., on the basis of such preemption. We REVERSE in PART and

VACATE and REMAND in PART

.- 2 - I.

Under the Medical Device Amendments of 1976 (MDA) to the Food,

Drug and Cosmetic Act, Pub. L. No. 94-295, 90 Stat. 539 (codified

in scattered sections of 21 U.S.C.), all medical devices intended

for human use are subject to regulation by the Food and Drug

Administratio n (FDA). I d. at 539 (Preamble to MDA). The MDA

classifies devices into three categories based on the amount of

regulatory control needed to ensure their safety and effectiveness.

21 U.S.C. § 360c; H.R. Conf. Rep. No. 1090, 94th Cong., 2d Sess.

51, reprinted in 1976 U.S.C.C.A.N. 1070, 1103.

Class I devices are subject only to general controls, such as

good manufacturing practices regulations, labeling requirements,

and prohibitions on misbranding. 21 U.S.C. § 360c(a)(1)(A); 21

C.F.R. §§ 801.1-.150, 820.1-.198.

Class II devices are more compl ex and potentially more

hazardous; they are subject to more special con trols, such as

postmarket surveillance and the promulgation of specific

performance standards. 21 U.S.C. § 360c(a)(1)(B); 21 C.F.R. §§

861.1-.38.

Class III devices are those used in sustaining human life or

that present a potential unreasonable risk of injury; they require

premarket approval by the FDA before commercial distribution. 21

U.S.C. §§ 360c(a)(1)(C), 360e; 21 C.F.R. §§ 814.1-.84. In this

process, a manufacturer must submit a detailed application to the- 3 -

FDA, incl uding such information as known or published about the

device, samples of the device, proposed labeling, and description

of manufacturing methods. 21 U.S.C. § 360e(c); 21 C.F.R. § 814.20.

The FDA then typically refers the application to a panel of experts

to study the safety and effectiveness of the device. 21 U.S.C. §

360e(c)(2); 21 C.F.R. § 814.4 0. Action must be taken on the

application within six months. 21 U.S.C. § 360e(d)(1)(A); 21

C.F.R. § 814.40.

Th ere are, however, two major exceptions to the rule of

premarket approval. First, Class III devices that are

“substantially equivalent” to devices already on the market before

the effective date of the MDA (28 May 197 6) may be commercially

distributed without premarket approval. 21 U.S.C. § 360e(b)(1).

In a process known as “premarket notification”, the maker of the

device applies to the FDA for a “substantial equivalence”

determination. I d. § 360(k). This procedure is known colloquially

as the “§ 510(k) process” for the origi nal section number in the

Food, Drug and Cosme tic Act. S ee MDA § 4(a)(9), 90 Stat. at 580

(amending Food, Drug and Cosmetic Act, ch. 675, § 510, as added by

Drug Amendments of 1962, Pub. L. No. 87-781, § 302, 76 Stat. 790,

794 (1962)); see also Medtronic, 116 S. Ct. at 2247.

Second, Class III devices that receiv e an investigational

device exemption (IDE) may be tested on humans wi thout premarket

approval. 21 U.S.C. §§ 360e(a), 360j(g); 21 C.F.R. §§ 813.1-.170.- 4 -

With an IDE, information about the device and its effect on humans

is collected through clinical study groups. This information can

then be used in an application for premarket approval. To obtain

an IDE, the sponsor of an investigatory study (often the device

manufacturer) must submit an application to the FDA, wh ich must

approve or reject it within 30 days. 21 C.F.R. §§ 813.20, 813.30.

The sponsor must also submit an inv estigatory plan, describing

aspects of the proposed study such as expected results, expected

duration, and patient population, whic h an institutional review

committee must approve. I d

. §§ 813.20(b)(6)-(7), 813.25, 813.42.

At issue is an intraocular lens, a Class III medical device

used to replace the natural lens of the eye. Intermedics

Intraocular, Inc. designs and manufactures these lenses; in 1982,

it received an IDE from the FDA to study a particular lens. In its

investigational plan, Intermedics divided its clinical studies into

three groups: a trial investigation group, an expanded core

investigation, and an adjunct investigation. The trial group and

core group (an expansion of the trial group) contained a relatively

small number of patients (100-500), who were monitored several

times a year for approximately two years. On the other hand, the

adjunct group contained an unlimited number of patients, who were

given only two postoperative visits. Each patient was to sign a

consent form, a copy of which was included with the application.

Data collected from the trial and core groups was submitted by- 5 -

investigators (ophthalmologists) to Intermedics; data from the

adjunct group was not.

In the 1980s, Edward A. Lewis and the four other plaintiffsappellants were each implanted by the same doctor with at least one

I ntermedics’ Model 44B intraocular lens in conjunction with

cataract extraction surgery. Plaintiffs were part of Intermedics’

adjunct study group.

Each Plaintiff brought suit in Louisiana state court in 1993,

alleging that complications developed, such as extreme pain,

removal of the lens, injuries to the eye, and blindness. T hey

presented state law claims for failure to obtain informed consent;

strict liabil ity; design and manufacturing defects; failure to

warn; breach of express and implied warranty; fraud,

misrepresentation, and concealment of information; and failure to

follow FDA regulations.

Intermedics removed the actions to federal court; th ey were

consolidated for purposes of discovery. Intermedics moved for

summary judgment on the ground that each claim was preempted.

The district court granted summary judgment on that basis on

all but the failure to obtain informed consent claim. (Each

Plaintiff denies being aware of the 44B’s experimental nature or of

his participation in any clinical study group, let alone an adjunct

group.) And, as for the informed consent claim, on interlocutory

appeal, our court rendered judgment for Intermedics. Lewis v.- 6 -

Intermedics Intraocular, Inc.

, 56 F.3d 703, 706-08 (5th Cir. 1995)

(Louisiana does not recognize cla im against manufacturer for

failu re to obtain informed consent). The district court then

entered final judgment on the other claims.

II.

We are tasked with applying the MDA’s preemption provision to

the claims at hand. As stated at 21 U.S.C. § 360k(a):

[N]o State or political subdivision of a 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 thi s chapter 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 chapter.

(Pur suant to § 360k, the term “State” will include any of its

political subdivi sions.) M edtronic, the Court’s only decision

addressing preempt ion under the MDA, charts a narrow course.

Because the majority shifts on several key sub-issues, that opinion

must be analyzed meticulously.

A.

Medtronic concerned a defective implanted heart pacemaker lead

manufactured by Medtronic pursuant to an FDA § 510(k) determination

o f substantial equivalence. Medtronic

, 116 S. Ct. at 2248. The

recipient of the d evice presented claims for strict liability;

negligent design, manufacture, assembly, and sale; failure to warn;- 7 -

and violation of FDA regulations. I d. Medtronic urged preemption

under § 360k because: (1) the § 510(k) process and the regulations

governing good manufacturing practices and labeling constituted

feder al “requirements” applicable to the lead; (2) States cannot

maintain additional or different “requirements” relating to safety

or effectiveness; and (3) the common-law tort claims constituted

such additional or different requirements. Id. at 2248-49.

A divided Supreme Court (three opinions) held that none of the

claims were preempted. I d. at 2254-58. The separate opinions

reflect the continuing d ivision in the Court over statutory

construction: whether to look to a statute’s plain words, as

opposed to looking to legislative history or some other source, for

a statute’s meaning. As discussed i nfra

, there are three different

majorities for sub-issues on the deference to be given the FDA

regulation on the scope of § 360k; the necessary specificity of the

federal “requirements” for § 360k; and the frequency w ith which

state common-law duties will equal state “requirements” for §

360k’s purposes.

Justice Stevens announced the judgment of the Court and wrote

an opinion joined in full by three other justices (Kennedy, Souter,

Ginsburg) and in part by one (Breyer). He began by contrasting the

roles played by the States and the Federal Government in the field

of health and safety: the States have an historical and prominent

role in “protecting the health and safety of their citizens”, these- 8 -

being “primarily, and historically, ... matters of local concern”

for which “the States traditionally have had great latitude under

their police powers to legislate”; but, “in recent decades the

Federal Government has played an increasingly significant role” in

this arena such as the approval of new drugs. I d. at 2245-46

(internal quotatio n marks and brackets omitted). The MDA was

enacted “[i]n response to the mounting cons umer and regulatory

concern” over the injuries resulting from the failure of newly

introduced medical devices. Id. at 2246.

Concerning the scope of § 360k preemption, Justice Stevens

stated that, “[a]lthough our analysis of [its] scope

... must begin

with its text ... [our] interpretation is informed by two

presumptions about the nature of pre-emption.” I d. at 2250

(citation omitted). “First, because the States are independent

sovereigns in our federal system, we have long presumed that

Congress does not cavalierly pre-empt state-law causes of action”;

in other words, “we start with the assumption that the historic

police powers of the Stat es [are] not to be superseded by the

Federal Act unless that was the clear and manifest purpose of

Congress”; and this “approach is consistent with both federalism

concerns and the historic primacy of state regulation of matters of

health and safety.” Id. (citations and internal quotation marks

omitted). And, “[s]econd, our analysis of the scope of the

statute’s pre-emption is guided by our oft-repeated comment ...- 9 -

that ‘the purpose of Congress is the ultimate touchstone’ in every

preemption case”; this purpose, or intent , is found primarily in

the language of the preemption section and its surrounding

“statutory framework”, but “[a]lso relevant ... is the structure

and purpose of the [Act] as a whole,

.. . as revealed not only in

the text, but through the reviewing court’s reasoned understanding

of the way in which Congress intended the [Act] and its surrounding

regulatory scheme to affect business, consumers, and the law.” I d.

at 2250-51 (internal quotation marks and brackets omitted).

Justice Stevens then rejected Medtronic’s contention that any

state common-law claim is a state “requirem ent” preempted by the

plain language of § 360k. I d. at 2251. He concluded that Congress

intended § 360k primarily to preempt “device-specific” positive law

enacted by state governmental and administrative bodi es, not

general common-law duties. Id. at 2252-53. He found no evidence

in the legislative history that Congress intende d to completely

immunize device manufacturers from state common-law liability. I d.

This is especially so because passage of the MDA indicated

congressional concern that the indust ry needed “more stringent

regulation”, id. at 2251 (citing Preamble to MDA, 90 Stat. at 539),

yet the MDA does not provid e expressly for a private action and

there is “no suggestion that the Act created an implied private

right of action.” Id. This “legislative history also confirm[ed

his] understanding that § 360k simply was not intended to pre-empt- 10 -

most, let alone all, general common-law duties enforced by damages

actions”, with the result “that at least some common -law claims

against medical dev ice manufacturers may be maintained after the

enactment of the MDA.” Id. at 2253.

Because J ustice Stevens found “the language of [§ 360k] not

entirely clear”, and because “Congress has given the FDA a unique

role in determining the scope of § 360k’s pre-emptive effect”, his

“interpretation of the pre-emption statute [was] substantially

informed by” the “FDA regulatio ns interpreting the scope of §

360k’s pre-emptive effect”. I d. at 2255; 21 C.F.R. § 808.1. Under

the FDA regulation, preemption occurs only when “specific [federal]

requirements applicable to a particular device” make “div ergent

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); and, state requirements of

“general applicability” are not preempte d unless they have “the

effect of establishi ng a substantive requirement for a specific

device”. Id. § 808.1(d)(1),(6)(ii); see Medtronic , 116 S. Ct. at

2256-57 & n. 18. Justice Stevens noted also that, as stated in §

360k, state requirements must also relate to either the safety or

effectiveness of the device or to any other matter included in a

requirement applicable to the device under the Act. M edtronic

, 116

S. Ct. at 2257; see 21 U.S.C. § 360k(a)(2). Consequently, in

Justice Stevens’ view, § 360k is a very narrow provision that will- 11 -

rarely preempt state requirements, especially common-law duties.

See Medtronic

, 116 S. Ct. at 2251-53, 2257-58. “[G]iven the

critical importance of devi ce-specificity in our (and the FDA’s)

construction of § 360k, it is apparent that few, if any, common-law

duties have been pre-empted by this statute.” Id. at 2259.

Under these principles, J ustice Stevens concluded that the

defective design claims were not preempted. Id. at 2254-55. The

§ 510(k) determination that the device (pacemake r lead) was

“substantially equivalent” to pre-MDA devices did not equal FDA

approval of the device on safety and effectiveness grounds. I d. at

2254. The § 510(k) process focused more on equivalence, not

safety, and it did not “require” the lead to “take any particular

form for any particular reason”. Id.

Likewise, the manufacturing and labeling claims were not

preempted. Id. at 22 56-58. Regulations governing good

manufacturing practi c es and labeling were not specific enough

because they applied to all medical devices, not just the pacemaker

lead. I d. at 2258. They reflected “generic concerns about device

regulation generally” and did not impose a “specific mandate” on

manufacturers. Id. In addition, the state requirements (in that

instance, common-law duties) were not developed specifically “with

respect to” medical devices and hence were too general to be

preempted; such requirement s were “not the kinds of requirements

that Congress and the FDA feared would impede the ability of- 12 -

federal regulators to implement and enf orce specific federal

requirements.” Id.

Finally, the claims based on violations of federal regulations

were not preempted. I d

. at 2255-56. Having earlier stated, as

noted, that the MDA does not create a private action against

manufacturers, id. at 2251, Justice Stevens explained: “Nothing in

§ 360k denies [a State] the right to provide a traditional damages

remedy for violations of common-law duties when those duties

parallel federal requireme nts.” I d. at 2255 (emphasis added).

S uch a remedy is simply not an “additional” or “different”

r equirement, id.

, and the FDA regulation interpreting § 360k

supported this conclusion. I d. at 2256; see 21 C.F.R. §

808.1(d)(2) (state requirements “equal to, or substantially

identical to” fed eral requirements are not preempted). In fact,

such state requirements would not be preempted even if they

required showing violation of the federal regulations plus another

factor, such as negligence because

such additional elements of the state-law

cause of action would make the state

requirements narrower, not broader, than the

federal requirements. While such a narrower

requirement might be ‘different from’ the

federal rules in a l iteral sense, such a

difference would surely provide a strange

reason for finding pre-emption of a state rule

insofar as it duplicates the federal rule.

The presence of a damages remedy does not

amount to the additional or different

‘requirement’ that is necessary under the

statute; rather, it merely provides another- 13 - reason for manufacturers to comply with

identical existing ‘requirements’ under

federal law.

Medtronic , 116 S. Ct. at 2255.

Justice Breyer concurred in the judgment, agreeing that none

of the claims were preempted; but, he joined only part of Justice

Stevens’ opinion, because he found § 360k to be broader in scope

than the plurality suggested, in large part because he was in

general agreement with the position taken by Justice O’Connor on

this point in her separate opinion

-- he read the term

“requirements” in § 360k to encompass state tort actions. Id . at

2259 -62 (Breyer, J., concurring). As he explained, similar

language in a preemptio n provision of a different statute,

addressed by the Court in Cipollone v. Liggett Group, Inc.

, 505

U.S. 504 (1992), “‘easily’ encompas sed tort actions because

‘[state] regulation can be as effectively exerted through an award

of damages as through some form of preventive relief.’” M edtronic

,

116 S. Ct. at 2259 (Breyer, J., concurring) (quoting Cipollone

, 505

U.S. at 521). In Justice Breyer’s view, a “requirement” includes

“legal requirements that grow out of the application, in particular

circumstances, of a State’s tort law.” Id . Therefore, he

believe[s] that ordinarily, insofar as the MDA

pre-empts a state requirement embodied in a

state statute, rule, regulation, or other

administrative action, it would also pre-empt

a similar requirement that takes the form of a

standard o f care or behavior imposed by a

state-law tort action. It is possible that- 14 - the plurality also agrees on this point,

although it does not say so explicitly.

Id . at 2260 (Breyer, J., concurring).

But, for deciding whether the claims in issue were preempted,

Justice Breyer, like Justice Stevens, relied on the FDA regulation

interpreting § 360k. I d. at 2260-61 (Breyer, J., concurring). He

did so because he found § 360k “highly ambiguous”; concluded,

therefore, that Congress “must have intended that courts look

elsewhere for help as to just which federal requirements pre-empt

just which state req uirements, as well as just how they might do

so”; stated that the “Court [had] previously suggested that, in the

absence of a clear congressional command as to pre-emption, courts

may infer that the relevant administrative agency possesses a

degree of leeway to determine which rules, regulations, or o ther

administrative actions will have pre-emptive effect”; and,

moreover, found quite relevant that “the FDA has promulgated a

specific regulation designed to help”

-- 21 C.F.R. § 808.1(d).

Medtronic, 116 S. Ct. at 2260 (Breyer, J., concurring).

Looking to that regulation, he concluded that only specific

federal requirements , applicable to a particular device, could

preempt state requirements. I d. at 2260-61 ( Breyer, J.,

concurring) (“regulation’s word ‘specific’ does narrow the universe

of federal requirements that the [FDA] intends to displace at least

some state law”). Because he agreed with Justice Stevens that the

federal regulations applicable to Medtronic’s pacemaker lead “even- 15 -

if numerous, are not ‘specific’ in any relevant sense”, he found

none of the claims preempted. I d. at 2261 (Breyer, J.,

concurring).

In addition, Justice Breyer invoked principles of “conflict”

and “field” preemption to support his conclusion, explaining that

federal requirements preempt state requirements only if there is an

actual conflict between the two or if federal regulation in a field

is so pervasive as to leave no room for States to participate; he

found neither. I d. O n th e other hand, as noted, one of the two

reasons given for not joining Justice Stevens’ opinion in full was

because Justice Breyer was “not convinced that future incidents of

MDA pre-emption of common-law claims will be ‘few’ or ‘rare’”. I d.

at 2262 (Breyer, J., concurring).

Justice O’C onnor, joined by the Chief Justice and Justices

Scalia and Thomas, concurred in par t and dissented in part. She

agreed with J ustice Breyer that state common-law claims were one

type of state “requirements” and therefore could be preempted by §

360k. I d. at 2262-63 (O’Connor, J., concurring in part and

dissenting in part). She disagreed, however, that the FDA

preemption regulation was entitled to any deference, especially in

the light of § 360k’s plain and explicit meaning. I d. at 2263

(O’Connor, J., concurring in part and dissenting in part).

Accordingly, Justice O’Connor would not uti l ize the more

narrow construction of § 360k found in the FDA regulation and,- 16 -

therefore, would not amend § 360k’s “clear” meaning by adding, as

found in the regulation, “a requirement of specificity” to the “any

requirement” language in § 3 60k. I d. As a result, Justice

O’Connor doubtless would find preemption more often than either the

plurality or Justice Breyer. Id.

Turning to the claims, Justice O’Connor concluded that those

for design defect and violation of FDA regulations were not

preempted: as for the former, the § 510(k) substantial equivalence

process only ensures “equivalenc[e], and places no ‘requirements’

on a device”; as for the latter, a state claim “s eek[ing] to

enforce

... [a] requirement [under the Act] does not impose a

requirement that is ‘differen t from, or in addition to’” federal

requirements. I d

. at 2263-64 (O’Connor, J., concurring in part and

dissenting in part). In explaining why a state law claim seeking

damages for violations of federal requirements was not preempted,

she stated:

To be s ure, the threat of a damages remedy

will give manufacturers an additional cause to

comply, but the requirements imposed on them

unde r state and federal law do not differ.

Section 360k does not preclude States from

imposing different or additional remedies

, but

only different or additional requirements

.

Id . at 2264.

On the other hand, Justice O’Connor concl uded that the

manufacturing and labeling and the failure to warn claims were

preempted, beca use there were extensive federal regulations on- 17 -

these points applicable to the device and the common-law claims at

issue would compel compliance with requirements different from, or

in addition to, those required by the Act. Id.

Medtronic

, therefore, produced a narrow majority on the

standard for determining whether a state law claim is preempted

under § 360k. Five justices agreed that deference to the FDA

regulation on the scope of § 360k was appropriate. I d. at 2257-58

(plurality opinion); id. at 2260-61 (Breyer, J., concurring).

Medtronic produced a different majority, however, for how

often such preemption probably would occur. As noted, only Justice

Stevens and the three justices who joined his opinion in full

concluded that preemption of a state law claim would be rare, on

the basis that state common-law duties are usually too general to

satisfy § 360k an d its corresponding regulation, 21 C.F.R. §

808.1(d). M

edtronic

, 116 S. Ct. at 2258-59 (plurality opinion).

The balan ce of the Court (Justice Breyer, together with Justice

O’Connor and the three justices who joined her opinion) would find

preemption more often, on the basis that state common-law duties

are “requirements” under § 360k. I d. at 2258-59 (Breyer, J.,

concurring); id. at 2262-63 (O’Connor, J., concurring in part and

dissenting in part).

But, these fiv e justices did not agree on the necessary

specificity of the federal requirements for § 360k preemption; as

discussed , Justice Breyer would require a greater level of- 18 -

specificity than the other four justices. Therefore, as dictated

by Medtronic

, a § 360k preemption question will be resolved, in

most cases, by focusing primarily on an y applicable federal

regulations.

In sum, a state law claim is preempted pursuant to § 360k only

under the following conditions: (1) there is a speci fic federal

requirement, u s ually a regulation, applicable to a particular

device; (2) there is a state requirem ent (statute, regulation,

ordinance, or common-law duty, see 21 C.F.R. § 808.1(b)) maintained

with respect to the device that is related to safety and

effectiveness or to any other matter included in a requirement

applicable to the device under the A ct, i d .; and (3) the state

requirement is different from, or in addition to, the federal

req uirement. Accordingly, as Justice Stevens noted, courts will

have to undertake a most “careful comparison” of the federal and

state requirements to determine state law claim preemption vel non

.

Medtronic

, 116 S. Ct

. at 2257-58.

Based on our reading of Medt ronic , we conclude that this

preemption analysis applies regardless of the class of the device

and of whether it is made available through premarket approval or

through the two exceptions to it: § 510(k) (as in M edtronic ) or an

IDE (as here). Mindful of the delicate balance in Medtronic , we

turn to the claims at issue.- 19 - B.

Plaintiffs’ major contention i s that, because they were

participants in an adjunct study, preemption does not apply to any

of their claims. They point to the MDA and the regulations on

intraocular lens IDEs and assert that only well-control led core

study gro ups are contemplated. Citing an internal product

bulletin, they maintain that Intermedics simply used the adjunct

group as a guise to commercially distribute thousands of untested,

unapproved lenses to ophthalmologists. Because IDEs are intended

to enable manufacturers to develo p information on safety and

effectiveness, see 21 U.S.C. § 360j(g)(2)(A); 21 C.F.R. § 813.1(a),

Plaintiffs ma intain that Intermedics’ actions were outside the

scope, and at odds with the purpose, of the regulations, meaning

Intermedics should not be en titled to whatever preemptive

protection those regulations afford.

As support, Plaintiffs cite the conclusion in Medtronic that

the § 510(k) process did not preempt the state tort claims in issue

there because the process focused primarily on equivalence, not on

safety or effectiveness. Like the § 510(k) process, they maintain,

an adjunct study is not concerned with safety or effectiveness but

is simply a way to enable manufacturers to avoi d premarket

approval. They also point to statements by the FDA expressing

concern that manufacturers would use IDEs as “subterfuge for

commercial distribution of

... lenses” an d contemplating that- 20 -

consumers could look to tort law for protection, because “[it is]

not the duty of the FDA to protect sponsors or investigators from

lawsuits by subjects”. 42 Fed. Reg. 58874-75, 58881 (1977).

In response, Intermedics maintains that adjunct studies are a

by-product of a congressional mandate to make intraocular lenses

reasonably available to physicians. It points to a provision in

the MDA that the FDA shall make IDE regulations governing certain

devices “applicable in such a manner that the device[s] shall be

made reasonably available to physic ians”. 21 U.S.C. §

360j(l)(3)(D)(iii). The MDA legislative history makes clear that

this provision applies only to intraocular lenses. H.R. Conf. Rep.

No. 1090, 62- 63 (“This new provision applies solely to the

intraocular lens ....”).

In addition, Intermedics cites an FDA Commissioner’s

statements at a c ongressional hearing that the FDA established a

dual (core-adjunct) study system to investigate intraocular lenses

in response to the above quoted language in the MDA. S ee Cataract

Surgery: Fraud, Waste, a nd Abuse: Hearing Before the Subcomm. on

Health and Long-Term Care of the Select Comm. on Aging

, 99th Cong.,

1st Sess. 206-10 (1985) (statement of Dr. Frank E. Young,

Commissioner, FDA). It further asserts that, because the MDA

allows adjunct studies , state law cannot make them illegal or

prohibit them through state law claims.- 21 -

On this issue, the facts of this case are unique, and we find

little guidance in case law, the MDA, or the federal regulations.

Pre- Medtronic

, other federal courts addressed preemption in the IDE

and intraocular lens context, but none seems to have faced this

core-adjunct questio n. S ee, e.g.

, Becker v. Optical Radiation

Corp.

, 66 F.3d 18 (2d Cir. 1995); Gile v. Optical Radiation Corp.

,

22 F.3d 540 (3d Cir.), cert. denied

, 115 S. Ct. 429 (1994); Slater

v. Optical Radiation Corp.

, 961 F.2d 1330 (7th Cir.), cert. denied

,

506 U.S. 917 (1992)

. P ost- Medtronic

, several courts have addressed

MDA preemption but, again, not in the core-adjunct context. See,

e.g.

, Papike v. Tambrands Inc. , 1997 WL 74338 (9th Cir. Feb. 20.,

1997); Martin v. Telectronics Pacing Sys., Inc.

, 105 F.3d 1090 (6th

Cir. 1997); Reeves v. Acromed Corp

., 103 F.3d 442 (5th Cir. 1997);

Duvall v. Bristol-Myers-Squibb Co. , 103 F.3d 324 (4th Cir. 1996);

Sanders v. Optical Radiation Corp.

, 92 F.3d 1181 (4th Cir. 1996)

(table); Committee of Den tal Amalgam Mfrs. and Distribs. v.

Stratton

, 92 F.3d 807 (9th Cir. 1996), cert. denied

, 65 U.S.L.W.

3369 (U.S. Jan. 13, 1997) (No. 96-705); Berish v. Richards Medical

Co.

, 937 F. Supp. 181 (N.D.N.Y. 1996); Armstrong v. Optical

Radiation Corp.

, 50 Cal. App. 4th 580 (Cal. Ct. App. 1996);

Connelly v. Iolab Corp. , 927 S.W.2d 848 (Mo. 1996) (en banc).

In addition, the MDA, the general IDE regulations , and the

lens IDE regulations do not mention adjunct studies. Intermedics- 22 -

cites regulations it says support a dual (core-adjunct) clinical

study system, but none of the cited regulations supports its

assertion. S ee 21 C.F .R. §§ 813.25(a)(7),(8); 813.30(c)(4),(6).

In fact, the only specific references we find to adjunct studies

are the FDA commissioner’s statements and i n Intermedics’

investigatory plan. In any event, Plaintiffs ask us to hold as a

matter of law that adjunct studies are not concerned with safety

and effectiveness; and are therefore outside the scope of an IDE;

and are therefore not shielded by § 360k from common-law liability.

We can not agree with Plaintiffs’ interpretation. First, we

are not convinced that adjunct studies are outside the scope of the

MDA or the regulations. It is impossible to overlook the fact that

Intermedics’ investigatory plan includes an adjunct study group

that will be monitored less than the core study group and that this

plan was approved by the FDA. Also, we refuse to engraft onto the

MDA or applicable regulations a judicially-created distinction

between core and adjunct studies, especially when there is no clear

congressional intent on the question. The statements cited by

Plaintiffs do evidence a concern about adjunct studies; but, that

is all they evidence. Second, M edtronic provides the test for all

claims of MDA preemption, re gardless of whether the device in

question has been made available to t he public pursuant to

premarket approval, a fi nding of substantial equivalence, or an

IDE. Whether Plaintiffs’ claims are preempted turns on the device-- 23 -

specifici ty of the federal and state requirements at issue, not

whether the claim arose out of an adjunct or a core study.

By the same token, however, we do not agree with Intermedics

that the FDA’s approval of it s investigatory plan, thereby

permitting an adjunct study group, provides blanket preemption of

Plaintiffs’ claims. M edtronic makes clear that, for § 360k

preemption, specific federal requirements must conflict with

specific state requirements. Finding no statute or regulation that

even mentions adjunct groups, let alone mentions them in connection

with intraocula r lenses or other ophthalmological devices, we

refuse to conclude that Intermedics is “required” by federal law to

conduct its IDE studies using a core-adjunct system. In addition,

Plaintiffs’ claims are not premised solely on the fact that they

were adjunct patients.

The preemption question simply cannot be resolved on the basis

of the core-adjunct distinction. Instead, as mandated by

Medtronic

, a careful (indeed, most painsta king) analysis must be

made of each claim. Except for the violations of FDA regulations

claim, discussed i nfra

, and because of the claims presented, the

issues raised, and the changes effected by Medtronic, this analysis

must be performed first by the district court, after the parties

are permitted to supplement the summary judgment record and sharpen

and clarify the claims, bases and sub-issues for each. S ee

Sanders

, 1996 WL 423124, at *1-2 (concerning § 360k preemption vel- 24 -

non

, and in light of Medtronic, holding negligence per se claims

for violations of FDA regulations not preempted but remanding

remaining state law claims for reconsideration).

C.

Plaintiffs’ claim that Intermedics violated FDA regulations,

based on allegati ons that Intermedics failed to follow the

reg ulations governing lens IDEs, including failing to recall the

device, with the result that the safety of the lens was not

adequately tested or investigated. Plaintiffs point to M edtronic

,

in which state tort claims imposing duties parallel to the federal

requirements were held not preempted. Id. at 2255-56.

Notwithstanding the clear adverse holding in Medtronic,

Intermedics contends that these violation-of-FDA-regulations claims

a re preempted because, as discussed, the Food, Drug and Cosmetic

Act does not provide a private right of action to enforce such

viol ations, a matter solely within the discretion of the FDA.

Intermedics points to Merrell Dow Pharmaceuticals v. Thompson

, 478

U.S. 804, 810 (1986), in which the Supreme Court assumed, without

deciding, that there was no private right of action in the Food,

Drug and Cosmetic Act.

Th ese claims are not preempted. The M edtronic Court was

unanimous (and explicit) in holding that state law claims providing

a remedy for violations of FDA regulations were not preempted under

§ 360k. S ee Medtronic

, 116 S. Ct. at 2255-56 (plurality opinion);- 25 -

id. at 2260-61 (Breyer, J., concurring); id. at 2264 (O’Connor, J.,

concurring in part and dissenting in p art); 21 C.F.R. §

808.1(d)(2). As discussed s upra

, the Court reasoned that, if state

law paralleled federal requirements, the state claim would impose

requirements that were equal or substantially identical to, rather

than different from or in addit ion to, the federal requirements,

even if the State required a plaintiff to prove that the violations

were the result of negligence. Medtronic , 116 S. Ct. at 2255-56.

The MDA preemption regulation supports this interpretation. 21

C.F.R. § 808.1(d)(2).

Intermedics’ reliance on Merrell Dow is misplaced. It simply

held that a state law claim premising liability on violation of a

federal regulation ( i.e

., negligence per se ) did not present a

federal question, meaning that a district court would not have 28

U.S.C. § 1331 subject matter jurisdiction. Merrell Dow , 478 U.S.

at 81 2-17. In other words, federal courts could not “create” a

federal cause of action by treating a state tort claim, for which

an FDA regulation violation was a component, as one that arose

under federal law. Nothing in M errell Dow prevents a federal court

from hearing a state law claim (assuming, of course, it otherwise

has jurisdiction) that premises liability on violation of a n FDA

regulation. Plaintiffs’ state law claims premising Intermedics’

liability on violations of FDA regulations are not preempted.- 26 - III.

Accordingly, we REVERSE the summary judgment as to the

violation of FDA regulations claim; VACATE the summary judgment as

to the remaining claims; an d REMAND f or further proceedings

consistent with this opinion.

REVERSED IN PART, VACATED IN PART, AND REMANDED