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.
*
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that this opinion should not be published and is not precedent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.
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
Administration (FDA). Id. 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 complex and potentially more
hazardous; they are subject to more special controls, 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
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FDA, including 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. § 814.40. Action must be taken on the
application within six months. 21 U.S.C. § 360e(d)(1)(A); 21
C.F.R. § 814.40.
There 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 1976) 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. Id. § 360(k). This procedure is known colloquially
as the “§ 510(k) process” for the original section number in the
Food, Drug and Cosmetic Act. See 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 receive an investigational
device exemption (IDE) may be tested on humans without premarket
approval. 21 U.S.C. §§ 360e(a), 360j(g); 21 C.F.R. §§ 813.1-.170.
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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, which must
approve or reject it within 30 days. 21 C.F.R. §§ 813.20, 813.30.
The sponsor must also submit an investigatory plan, describing
aspects of the proposed study such as expected results, expected
duration, and patient population, which an institutional review
committee must approve. Id. §§ 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
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investigators (ophthalmologists) to Intermedics; data from the
adjunct group was not.
In the 1980s, Edward A. Lewis and the four other plaintiffs-
appellants were each implanted by the same doctor with at least one
Intermedics’ 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. They
presented state law claims for failure to obtain informed consent;
strict liability; 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; they 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.
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Intermedics Intraocular, Inc., 56 F.3d 703, 706-08 (5th Cir. 1995)
(Louisiana does not recognize claim against manufacturer for
failure 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 this 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.
(Pursuant to § 360k, the term “State” will include any of its
political subdivisions.) Medtronic, the Court’s only decision
addressing preemption 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
of substantial equivalence. Medtronic, 116 S. Ct. at 2248. The
recipient of the device presented claims for strict liability;
negligent design, manufacture, assembly, and sale; failure to warn;
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and violation of FDA regulations. Id. Medtronic urged preemption
under § 360k because: (1) the § 510(k) process and the regulations
governing good manufacturing practices and labeling constituted
federal “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. Id. at 2254-58. The separate opinions
reflect the continuing division 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 infra, 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 with 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
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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. Id. at 2245-46
(internal quotation marks and brackets omitted). The MDA was
enacted “[i]n response to the mounting consumer 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.” Id. 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 States [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 ...
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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.” Id.
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 “requirement” preempted by the
plain language of § 360k. Id. at 2251. He concluded that Congress
intended § 360k primarily to preempt “device-specific” positive law
enacted by state governmental and administrative bodies, not
general common-law duties. Id. at 2252-53. He found no evidence
in the legislative history that Congress intended to completely
immunize device manufacturers from state common-law liability. Id.
This is especially so because passage of the MDA indicated
congressional concern that the industry needed “more stringent
regulation”, id. at 2251 (citing Preamble to MDA, 90 Stat. at 539),
yet the MDA does not provide 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
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most, let alone all, general common-law duties enforced by damages
actions”, with the result “that at least some common-law claims
against medical device manufacturers may be maintained after the
enactment of the MDA.” Id. at 2253.
Because Justice 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 regulations interpreting the scope of §
360k’s pre-emptive effect”. Id. 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 “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); and, state requirements of
“general applicability” are not preempted unless they have “the
effect of establishing 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. Medtronic, 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
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rarely preempt state requirements, especially common-law duties.
See Medtronic, 116 S. Ct. at 2251-53, 2257-58. “[G]iven the
critical importance of device-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, Justice Stevens concluded that the
defective design claims were not preempted. Id. at 2254-55. The
§ 510(k) determination that the device (pacemaker lead) was
“substantially equivalent” to pre-MDA devices did not equal FDA
approval of the device on safety and effectiveness grounds. Id. 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 2256-58. Regulations governing good
manufacturing practices and labeling were not specific enough
because they applied to all medical devices, not just the pacemaker
lead. Id. 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 requirements were “not the kinds of requirements
that Congress and the FDA feared would impede the ability of
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federal regulators to implement and enforce specific federal
requirements.” Id.
Finally, the claims based on violations of federal regulations
were not preempted. Id. 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 requirements.” Id. at 2255 (emphasis added).
Such a remedy is simply not an “additional” or “different”
requirement, id., and the FDA regulation interpreting § 360k
supported this conclusion. Id. at 2256; see 21 C.F.R. §
808.1(d)(2) (state requirements “equal to, or substantially
identical to” federal 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 literal 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
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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 preemption provision of a different statute,
addressed by the Court in Cipollone v. Liggett Group, Inc., 505
U.S. 504 (1992), “‘easily’ encompassed tort actions because
‘[state] regulation can be as effectively exerted through an award
of damages as through some form of preventive relief.’” Medtronic,
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 of care or behavior imposed by a
state-law tort action. It is possible that
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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. Id. 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 requirements, 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 other
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. Id. 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
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if numerous, are not ‘specific’ in any relevant sense”, he found
none of the claims preempted. Id. 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. Id. On the 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’”. Id.
at 2262 (Breyer, J., concurring).
Justice O’Connor, joined by the Chief Justice and Justices
Scalia and Thomas, concurred in part and dissented in part. She
agreed with Justice Breyer that state common-law claims were one
type of state “requirements” and therefore could be preempted by §
360k. Id. 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. Id. at 2263
(O’Connor, J., concurring in part and dissenting in part).
Accordingly, Justice O’Connor would not utilize the more
narrow construction of § 360k found in the FDA regulation and,
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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 § 360k. Id. 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 “seek[ing] to
enforce ... [a] requirement [under the Act] does not impose a
requirement that is ‘different from, or in addition to’” federal
requirements. Id. 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 sure, the threat of a damages remedy
will give manufacturers an additional cause to
comply, but the requirements imposed on them
under 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 concluded that the
manufacturing and labeling and the failure to warn claims were
preempted, because there were extensive federal regulations on
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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. Id. 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 and its corresponding regulation, 21 C.F.R. §
808.1(d). Medtronic, 116 S. Ct. at 2258-59 (plurality opinion).
The balance 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. Id. at 2258-59 (Breyer, J.,
concurring); id. at 2262-63 (O’Connor, J., concurring in part and
dissenting in part).
But, these five 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
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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 any applicable federal
regulations.
In sum, a state law claim is preempted pursuant to § 360k only
under the following conditions: (1) there is a specific federal
requirement, usually a regulation, applicable to a particular
device; (2) there is a state requirement (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 Act, id.; and (3) the state
requirement is different from, or in addition to, the federal
requirement. 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 Medtronic, 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 Medtronic) or an
IDE (as here). Mindful of the delicate balance in Medtronic, we
turn to the claims at issue.
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B.
Plaintiffs’ major contention is 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-controlled core
study groups 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 develop information on safety and
effectiveness, see 21 U.S.C. § 360j(g)(2)(A); 21 C.F.R. § 813.1(a),
Plaintiffs maintain that Intermedics’ actions were outside the
scope, and at odds with the purpose, of the regulations, meaning
Intermedics should not be entitled 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 avoid premarket
approval. They also point to statements by the FDA expressing
concern that manufacturers would use IDEs as “subterfuge for
commercial distribution of ... lenses” and contemplating that
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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 physicians”. 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 congressional 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. See Cataract
Surgery: Fraud, Waste, and 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.
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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 question. See, 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). Post-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 Dental 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
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cites regulations it says support a dual (core-adjunct) clinical
study system, but none of the cited regulations supports its
assertion. See 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 in 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 cannot 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, Medtronic provides the test for all
claims of MDA preemption, regardless of whether the device in
question has been made available to the public pursuant to
premarket approval, a finding of substantial equivalence, or an
IDE. Whether Plaintiffs’ claims are preempted turns on the device-
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specificity 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 its investigatory plan, thereby
permitting an adjunct study group, provides blanket preemption of
Plaintiffs’ claims. Medtronic 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 intraocular 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 painstaking) analysis must be
made of each claim. Except for the violations of FDA regulations
claim, discussed infra, 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. See
Sanders, 1996 WL 423124, at *1-2 (concerning § 360k preemption vel
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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 allegations that Intermedics failed to follow the
regulations 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 Medtronic,
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
are preempted because, as discussed, the Food, Drug and Cosmetic
Act does not provide a private right of action to enforce such
violations, 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.
These claims are not preempted. The Medtronic Court was
unanimous (and explicit) in holding that state law claims providing
a remedy for violations of FDA regulations were not preempted under
§ 360k. See Medtronic, 116 S. Ct. at 2255-56 (plurality opinion);
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id. at 2260-61 (Breyer, J., concurring); id. at 2264 (O’Connor, J.,
concurring in part and dissenting in part); 21 C.F.R. §
808.1(d)(2). As discussed supra, 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 addition 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 812-17. 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 Merrell Dow prevents a federal court
from hearing a state law claim (assuming, of course, it otherwise
has jurisdiction) that premises liability on violation of an FDA
regulation. Plaintiffs’ state law claims premising Intermedics’
liability on violations of FDA regulations are not preempted.
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III.
Accordingly, we REVERSE the summary judgment as to the
violation of FDA regulations claim; VACATE the summary judgment as
to the remaining claims; and REMAND for further proceedings
consistent with this opinion.
REVERSED IN PART, VACATED IN PART, AND REMANDED
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