Stamps v. Collagen Corp. ( 1993 )

IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
_______________
No. 92-2084
_______________
JENNIFER STAMPS,
Plaintiff-Appellant,
VERSUS
COLLAGEN CORPORATION,
Defendant-Appellee.
_________________________
Appeals from the United States District Court
for the Southern District of Texas
_________________________
(February 19, 1993)
Before GOLDBERG, SMITH, and EMILIO M. GARZA, Circuit Judges.
JERRY E. SMITH, Circuit Judge:
Contending that she contracted a rare autoimmune disease
from being injected with defendant Collagen Corporation's ("Colla-
gen") products, Jennifer Stamps filed suit to recover damages in
state court, alleging causes of action based upon defective design,
inadequate warnings, and negligent failure to warn. Collagen
timely removed and thereafter moved for summary judgment. The
district court found all of Stamps's state law claims to be
preempted by federal law and granted summary judgment. We affirm.
I.
A.
Zyderm and Zyplast are so-called Class III medical devices
regulated under the Medical Device Amendments of 1976 ("MDA"), 21
U.S.C. §§ 360c-360l, pursuant to which the Food and Drug Adminis-
tration ("FDA") classifies all medical devices in one of three
categories. See 21 U.S.C. § 360c. Class I devices generally pose
little or no threat to public health and safety; tongue depressors
are an example. Accordingly, Class I devices are subject only to
general controls on manufacturing processes.
Class II items are more complex than Class I and include such
devices as oxygen masks used in anesthesiology and tampons. These
may be subject to recommendations, guidelines, post-marketing
surveillance, the development of patient registries, and even the
promulgation of specific performance standards, should the FDA deem
them a sufficient health hazard as to require strict product
specifications or warnings. See 21 U.S.C. § 360c(a)(B).
Class III devices, such as Zyderm, require premarket approval
("PMA"), which process permits the FDA to determine whether a
proposed product provides "reasonable assurance of its safety and
effectiveness." 21 U.S.C. § 360c(a)(C). Such devices are subject
to the more stringent PMA process because they "present[] a
potential unreasonable risk of illness or injury." 21 U.S.C.
§ 360c(a)(1)(C)(ii)(II).
The PMA process requires a manufacturer to submit a detailed
application to the FDA, including information pertaining to product
2
specifications, intended use, manufacturing methods, and proposed
labeling. See 21 U.S.C. § 360e(c). The FDA refers each applica-
tion to a panel of qualified experts that prepares a report and
recommendation. Within six months, the FDA must either accept or
reject the application. 21 U.S.C. § 360e(d).
B.
In March and April 1988, Stamps was injected with Zyderm and
Zyplast, which contain processed bovine collagen that Collagen
markets as an anti-wrinkle treatment for middle-aged women. A
typical treatment consists of a series of injections directly under
the skin, the collagen then remaining to smooth out any wrinkles or
deformities on the skin's surface.
Shortly after receiving her injections, Stamps began complain-
ing of muscle and joint pains that subsequently were diagnosed as
dermatomyositis/polymyositis ("DM/PM"). DM/PM is a relatively rare
autoimmune disease in which an individual's immune system identi-
fies one's own skin and muscle tissue as foreign and attacks them.
Stamps claims that Collagen's products attached to her tissues and
provoked an immune response that destroyed her body tissue.
II.
In granting summary judgment, the district court likened the
instant case to Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th
Cir. 1989), in which we found a plaintiff's state-law-based
failure-to-warn and labeling claims regarding a Class II medical
3
device (tampons) to be preempted, although her defective construc-
tion and design claims survived. Reasoning that collagen implants
are regulated under Class III, which requires FDA pre-market
approval of not just labeling and packaging, but manufacturing
methods as well, see, e.g., 21 C.F.R. §§ 814.20, 814.80, the court
concluded that Stamps's claims are completely preempted.
Appellant Stamps disputes the district court's interpretation
of the MDA and its application of Moore, contending that the MDA
neither expressly nor impliedly preempts general state tort law and
that Moore must be limited to the Class II regulatory context it
describes. As a final matter, Stamps argues that even if we find
Moore compelling precedent in the Class III context as well, the
most it can be said to require is the preemption of her defective
labeling and negligent failure-to-warn claims; her products
liability, fraud, and negligence per se causes of action, as in
Moore, should be reinstated.
III.
The question is whether the MDA preempts Stamps's state law
claims. The Supremacy Clause of the Constitution invalidates state
laws that "interfere with, or are contrary to" federal law. U.S.
CONST. art. VI, cl. 2. When "the field which Congress is said to
have pre-empted has been traditionally occupied by the States . . .
``we start with the assumption that the historic police powers of
the States [are] not to be superseded by the Federal Act unless
that [is] the clear and manifest purpose of Congress.'" Jones v.
4
Rath Packing Co., 430 U.S. 519, 525 (1977) (quoting Rice v. Santa
Fe Elevator Corp., 331 U.S. 218, 230 (1947)) (citations omitted);
see also Hillsborough County v. Automated Medical Lab., 471 U.S.
707, 715 (1985) (recognizing a "presumption that state or local
regulation of matters related to health and safety is not invali-
dated under the Supremacy Clause"). Accordingly, "``[t]he purpose
of Congress is the ultimate touchstone'" of preemption analysis.
Malone v. White Motor Corp., 435 U.S. 497, 504 (1978) (quoting
Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)).
Congress's intention to preempt may be either express or
implied from the statutory text. Absent an express declaration,
Congressional intent to preempt state law may be inferred only if
state law actually conflicts with federal law, see Pacific Gas &
Elec. Co. v. Energy Resources Conservation & Dev. Comm'n, 461 U.S.
190, 204 (1983), or where the scheme of federal legislation is so
comprehensive "``as to make reasonable the inference that Congress
left no room for the States to supplement it.'" Fidelity Fed. Sav.
& Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982) (quoting
Rice, 331 U.S. at 230).
IV.
A.
The Supreme Court's most recent and authoritative treatment of
preemption doctrine is Cipollone v. Liggett Group, Inc., 112 S. Ct.
2608 (1992). In Cipollone, a plurality held that a lung cancer
victim's suit against cigarette manufacturers alleging breach of
5
warranty, failure to warn, fraudulent misrepresentation, and
conspiracy to deprive the public of medical information regarding
smoking was not preempted by the 1965 Federal Cigarette Labeling
and Advertising Act; certain of her failure to warn and fraudulent
misrepresentation claims were, however, preempted by the language
added by Congress to the Public Health Cigarette Smoking Act of
1969. Id. at 2625.
In Cipollone, the Court relied exclusively upon the express
language of the statutory provision regarding preemption.
Reasoning that "Congress' enactment of a provision defining the
pre-emptive reach of a statute implies that matters beyond that
reach are not pre-empted," the Court concluded,
When Congress has considered the issue of pre-emption and
has included in the enacted legislation a provision
explicitly addressing that issue, and when that provision
provides a "reliable indicium of congressional intent
with respect to state authority," "there is no need to
infer congressional intent to pre-empt state laws from
the substantive provisions" of the legislation . . . .
Therefore, we need only identify the domain expressly
pre-empted by [the statute].
112 S. Ct. at 2618 (citations omitted). See also id. at 2625
(Blackmun, J., concurring) (same).
The MDA was enacted in 1976 as an amendment to the Federal
Food, Drug and Cosmetic Act of 1938. Like the Public Health
Cigarette Smoking Act addressed in Cipollone, it contains a
provision expressly addressing its intended preemptive scope:
[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
6
chapter to the device, and
(2) which relates to the safety or effec-
tiveness 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) (Supp. 1992).
B.
Applying Cipollone, we reject, at the outset, Collagen's
contention that we may resort to the doctrine of implied preemption
to uphold the district court. The existence in the MDA of an
express preemption provision precludes any such reliance.
C.
We likewise must reject Stamps's argument that Congress did
not intend to preempt state tort law remedies when it enacted the
MDA. Section 360k(a) speaks broadly: Any state requirement
"different from, or in addition to," federal law is preempted.
Moreover, Stamps's contention that the MDA does not preempt
common law tort actions is necessarily foreclosed by Moore.
Implicit in our holding that certain of Moore's state law claims
were preempted by the applicable FDA Class II regulations is the
conclusion that Congress intended the preemption of state tort
liability where such liability effectively creates a requirement
"different from, or in addition to" specific federal requirements.
Congress, of course, has the power so to displace state tort law
remedies. See, e.g., Chicago & N.W. Transp. Co. v. Kalo Brick &
Tile Co., 450 U.S. 311, 331 (1981) (state common law may be
7
preempted by federal law).
This result is fortified not merely by Moore's compatibility
with the analysis pursued in Cipollone but also by the Court's
determination that the language of the statute at issue there,
preempting any state "requirement or prohibition," "sweeps broadly
and suggests no distinction between positive enactments and common
law . . . ." Cipollone, 112 S. Ct. at 2620. It would be anomalous
to interpret the MDA differently from the Public Health Cigarette
Smoking Act solely on the basis that while they both employ
"requirement," the MDA omits "prohibition."1 Thus, Moore correctly
decided this issue; section 360k(a) also "sweeps broadly" and
encompasses common law tort actions within its preemptive scope.
See also Morales v. Trans World Airlines, Inc., 112 S. Ct. 2031,
2037 (1992) (finding state common law actions "relating to" airline
advertising preempted by Airline Deregulation Act of 1978).
D.
Returning to Cipollone's admonition that our inquiry be guided
solely by the express language of the statute's preemption
provision, we glean from section 360k(a) the following analysis:
A state tort cause of action will be preempted if, in the context
of the particular case, it (1) constitutes a requirement different
from, or in addition to, any requirement the MDA makes applicable
to the device at issue and (2) relates either to (a) the safety or
1
Indeed, the FDA regulation that parallels § 360k(a), 21 C.F.R.
§ 808.1(b), extends the "any requirement" language of that section to any
medical device standard "having the force and effect of law (whether estab-
lished by statute, ordinance, regulation, or court decision) . . . ." (Empha-
sis added.)
8
effectiveness of the device or (b) any other matter included in a
requirement made applicable to the device by the MDA.2 See also
King v. Collagen Corp., 1993 U.S. App. LEXIS 432, at *12-*13 (1st
Cir. Jan. 15, 1993) (applying similar test to identical product).
By this test, we find that our decision in Moore logically
extends to the FDA Class III regulatory context and that Stamps's
claims may be preempted under the MDA. Simply put, Texas tort
liability, following Cipollone, would constitute a requirement
either different from, or in addition to, a requirement )) the
Class III PMA process )) that the MDA has made applicable to Zyderm
and Zyplast. The second part of the analysis, involving as it does
the "relates to" language of section 360k(a)(2) recently given a
sweeping interpretation by the Supreme Court in Morales, 112 S. Ct.
at 2037-38, is even simpler than the first. In the context of this
case, Stamps's state law claims undoubtedly "relate to" either the
safety or effectiveness of Zyderm and Zyplast, or to some other
matter included in the PMA requirements applicable to the
2
The FDA's gloss on § 360k(a) poses essentially the same test:
(d) State or local requirements are preempted only when the
[FDA] 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 [FDA] requirements. There are other
State or local requirements that affect devices that are not
preempted by section [360k(a)] of the act because they are not
"requirements applicable to a device" within the meaning of
section [360k(a)] of the act.
21 C.F.R. § 808.1(d). As with administrative agencies generally, the FDA's
construction of the statute is entitled to "controlling weight unless it is
plainly erroneous or inconsistent with the regulation." Bowles v. Seminole
Rock & Sand Co., 325 U.S. 410, 414 (1945). Neither party contests the
validity of the FDA's regulations pursuant to the MDA.
9
products.3
V.
Because the MDA, like the statute at issue in Cipollone, fails
to "indicate that any familiar subdivision of common law claims is
or is not pre-empted," Cipollone, 112 S. Ct. at 2621, we must
pursue the "straightforward" inquiry commended to us by the Supreme
Court: "[W]e ask whether the legal duty that is the predicate of
the common law damages action constitutes" a requirement relating
to the safety or effectiveness of Zyderm and Zyplast or to any
other matter included in a requirement made applicable to it by the
MDA. Id.
A.
We need not conduct a categorical inquiry into each cause of
action pursued by the plaintiff, as did the Court in Cipollone, as
Moore tells us that Stamps's inadequate labeling (paragraph IV of
the original petition) and failure to warn (paragraph V) allega-
tions are preempted by the MDA. The Class III regulatory struc-
ture, no less than that of Class II, involves the FDA in consider-
able oversight regarding proposed package labeling of a device.4
3
Applying the language of § 808.1(d), see supra note 2, yields the
same result: The PMA process constitutes a "specific requirement[] 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 [FDA] requirements."
4
See 21 U.S.C. § 360e(c)(1)(F) (requiring PMA application to contain
samples of device's proposed labeling); 21 C.F.R. § 814.20(b)(10), (e) (same);
(continued...)
10
Nor can Stamps's third cause of action (paragraph VI), based upon
the defective design and manufacture of Collagen's products,
survive preemption, as the Class III PMA process includes FDA
scrutiny and approval of these particular aspects of a device.5
B.
Stamps's claim that even if preemption applies to the Class
4
(...continued)
see also 21 U.S.C. § 360e(d)(2)(A)-(B),(D) (requiring denial of PMA applica-
tion for insufficient showing that the device is safe and effective "under the
conditions of use prescribed, recommended, or suggested in the proposed
labeling thereof," or if the proposed labeling is false or misleading in any
particular).
5
See 21 U.S.C. § 360e(c)(1)(B)-(C) (requiring, in PMA application,
statements and descriptions of the ingredients, components, methods, controls,
and facilities used in the manufacture and processing of the device); id.
§ 360e(d)(2)(C) (requiring denial of application where "the methods used in,
or the facilities or controls used for, the manufacture, processing, packing,
or installation of such device do not conform to the requirements of section
360j(f) of this title . . ."). See also 21 C.F.R. § 814.80 ("A device may not
be manufactured, packaged, stored, labeled, distributed, or advertised in a
manner that is inconsistent with any conditions to approval specified in the
PMA approval order for the device.").
Moreover, § 360j(f)'s "[g]ood manufacturing practice requirements"
impose further requirements upon the manufacture of Class III devices, leaving
us with little doubt as to whether the MDA tolerates different or additional
state requirements, respecting design or manufacture, in the form of common
law products liability duties.
Lastly, we note that we have not analyzed Stamps's fraud-based cause of
action in accordance with Cipollone because we are convinced that her original
petition contains no adequate averment of fraud. Although the petition does
state in paragraph V that "Defendant engaged in an active campaign to suppress
the facts, blame the adverse reactions on some other cause, and prevent
discovery of the risks associated with its products," this sentence comes
sandwiched between allegations of negligence in a paragraph that concludes
only that "Defendant's conduct was negligent and was the proximate cause of
Plaintiff's damages." Such an allegation of fraud would not suffice under
Fed. R. Civ. P. 9(b); and while Stamps is technically correct that the burden
lies with the defendant to request a more definite statement under Fed. R.
Civ. P. 12(e) when a pleading or allegation is too vague or ambiguous to admit
of a response, we do not believe such was the case here. Paragraph V is not
vague or ambiguous; it reads quite plainly as an allegation of negligence.
Albeit liberal with respect to the formalities, notice pleading is yet to be
distinguished from reading tea leaves. To require Collagen to move for a more
definite statement in order to determine whether, when Stamps pled negligence,
she in fact meant fraud, would go far towards erasing that distinction.
11
III context, the MDA preempts state law only to the extent that the
state mandates a similar PMA process, presents a close question.
In Larsen v. Pacesetter Sys., 837 P.2d 1273, 1282 (Haw. 1992), for
example, the court has found that an implant patient's claims
arising from the recall of a "substantially equivalent" Class III
pacemaker were not preempted by the MDA, noting that "the statutes
and regulations governing premarket approval set forth general
procedural requirements and, therefore, do not trigger a preemption
analysis under [21 C.F.R.] § 808.1(b)."6 On this subject, the FDA
has stated,
Like all other medical device requirements, differ-
ent or additional State and local [PMA] requirements are
preempted when FDA establishes specific counterpart
regulations or there are other specific requirements
applicable to the device under the act.
43 Fed. Reg. 13,664 (1978) (emphasis added).
This passage might be construed exclusively )) to the effect
that only different or additional state PMA processes are preempted
6
Larsen is distinguishable from the instant case in that it involved a
device that passed through a less stringent Class III review process by virtue
of its being "substantially equivalent" to devices already allowed to be
marketed. As the court stated, "Although a determination of substantial
equivalence involves a review by FDA of what is known of the safety and
effectiveness of the devices, and may even include some additional clinical
testing, it is not equivalent to an approval by the FDA of the device's safety
and effectiveness." Larsen, 837 P.2d at 1282 (citing H.R. Rep. No. 8081,
101st Cong., 2d Sess. 14, reprinted in 1990 U.S.C.C.A.N. 6305, 6307; 21 C.F.R.
§ 807.97 (FDA's acceptance of claim of substantial equivalence does not denote
official approval of the device)).
The instant devices are not "substantially equivalent" to marketable
devices; rather, they have been subjected to the full rigor of the PMA
process. While we do not rely upon this ground, one could argue that 21
C.F.R. § 807.97's explicit statement that the FDA does not officially approve
"substantially equivalent" devices creates at least the presumption )) by way
of the doctrine expressio unius est exclusio alterius )) that the FDA does
officially approve those products it scrutinizes through the regular Class III
PMA process. Such official approval, of course, strongly would imply that
federal preemption is present.
12
when the FDA has classified a device under Class III. We believe,
instead, that the emphasized language above )) added to the fact
that the passage was written in response to public comments seeking
clarification from the FDA as to "whether or when State and local
[PMA] requirements are preempted," id. )) demonstrates that the
better reading is that PMA processes are preempted in addition to
any other state requirements relating to safety or effectiveness or
any other MDA requirement established for the device.7
We believe the literal language of the statute compels this
result: State requirements pertaining to the safety or effective-
ness of a device, or to any other matter included in a requirement
made applicable to the device by the MDA, are preempted whenever
they are different from, or in addition to, any requirement imposed
upon the device under the MDA. Zyderm and Zyplast, it is undis-
puted, are required by the MDA to undergo the FDA's stringent PMA
7
See Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333 (7th
Cir.), cert. denied, 113 S. Ct. 327 (1992) (finding that MDA Class III devices
developed under the FDA "Investigational Device Exemption" ("IDE") regulations
are preempted from state tort law liability; although IDE regulations "do not
specify the safe and effective design [,] they specify the procedures for
determining whether the experimental design is safe and effective" and thus
"are requirements relating to safety and effectiveness and they can therefore
have preemptive effect"). To our knowledge, Slater and King are the only
decisions by federal courts of appeals to have reached the preemptive scope of
the MDA's Class III regulations, and both have reached conclusions consistent
with our analysis herein. Inasmuch as we have previously determined in Moore
that preemption applies in the MDA Class II sphere, extension of that holding
to Class III regulations comports with logic and our understanding of the MDA
regulatory scheme. Moreover, although we do not need to consult legislative
history to decide this issue, we note that Senator Kennedy stated, when he
introduced the MDA, that "[t]he most hazardous devices . . . would require
full premarket testing and clearance before they are allowed on the market.
Premarket clearance represents the highest degree of regulatory control . . .
." 121 CONG. REC. 10,688 (1975) (emphasis added); see also King, 1993 U.S.
App. LEXIS 432, at *22-*28 (Aldrich and Campbell, JJ., concurring) (finding
intent of Congress in enacting MDA was to provide maximum of protection
available to medical device users).
13
process. State tort causes of action )) to the extent they relate
to safety, effectiveness, or other MDA requirements )) constitute
requirements "different from, or in addition to" the Class III
process; they are, therefore, preempted.8
C.
Stamps also argues that Collagen's ability to strengthen the
contraindications in its packaging and labeling proves that it
could comply with both state tort law and the federal statute. In
essence, Stamps argues that the MDA forms only the floor of
regulation; the states are free to construct a regulatory ceiling.
We agree with Stamps that, under the Class III regulatory
framework, Collagen could have strengthened its warning labels
without first obtaining prior FDA approval. The "Conditions of
Approval" issued with respect to Zyderm, for example, provide,
Changes in labeling, manufacturing, sterilization,
packaging, or performance of design specification which
enhance safety of the device or safety in the use of the
device may be placed into effect by the sponsor prior to
the receipt of a written FDA approval of the supplemental
PMA . . . .
Specific examples of changes permitted are:
8
Nor does the seemingly more restrictive language of § 808.1(d) compel
a different result. That section provides that state and local requirements
are preempted "only when the [FDA] has established specific counterpart
regulations or there are other specific requirements applicable to a particu-
lar device under the act . . . " (emphasis added).
Stamps apparently reads out the latter half of this clause and points to
the fact that the FDA premarket approval process is not a "specific counter-
part regulation" to state tort law. We disagree with this interpretation and
need look no further than the second half of the quoted clause. It is plain
that § 808.1(d) poses the same test as the statute: When there exists a
specific requirement applicable to a particular device under the act )) such
as the MDA's PMA requirement for Zyderm and Zyplast )) additional or different
state laws are preempted.
14
(1) addition of warnings, contraindications,
or side effects . . . .
See also 21 C.F.R. § 814.39(d)(2)(i) (permitting without prior FDA
approval "[l]abeling changes that add or strengthen a contraindica-
tion, warning, precaution or information about an adverse reac-
tion.").
We cannot agree, however, with the conclusion Stamps draws
from this )) that the lack of direct conflict between the state and
federal regulations compels a finding of no preemption. While we
are aware that the court in Ferebee v. Chevron Chem. Co., 736 F.2d
1529, 1540-43 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984),
interpreting the Federal Insecticide, Fungicide, and Rodenticide
Act's ("FIFRA") similar express preemption provision, found no
preemption where there was no direct conflict between the state and
federal regulation, we do not believe the analysis therein applied
can be said to have survived Cipollone, and was directly refuted in
Morales. See Morales, 112 S. Ct. at 2038 (rejecting contention
that express preemption is inappropriate where state and federal
law are consistent).
In Ferebee, the court rejected Chevron's contention that
FIFRA's express preemption provision, 7 U.S.C. § 136v(b), which
said that states "shall not impose or continue in effect any
requirements for labeling . . . in addition to or different from
those required under this subchapter," required a holding of
preemption of state tort liability. Instead, the court noted that
Congress, although explicitly preempting state labeling "require-
ments," had not stated its intention to preempt state damages
15
actions. 736 F.2d at 1542. Yet in the statute at issue in
Cipollone, Congress had not expressly declared its intent to
preempt state damages actions, and the Court nevertheless found
them preempted, at least in part. Thus, no such "plain statement"
of congressional intent as Ferebee contemplated is required.
Moreover, we reiterate our belief that no sound distinction can be
drawn between the "no requirement or prohibition" language found
dispositive in Cipollone and the express preemption of "any
requirement" contained in the FIFRA and the MDA.9
D.
Finally, we acknowledge that our reading of the MDA effec-
tively denies Stamps access to state law damages actions as a
9
Lastly, to the extent Ferebee can be read to import a direct conflict
requirement into express preemption analysis, it runs afoul of Cipollone,
where the Court stated, 112 S. Ct. at 2618, that the language of the express
preemption provision alone must guide the preemption inquiry. Direct con-
flict, moreover, is more appropriately considered as an aspect of implied
preemption analysis, particularly of that version that applies where "compli-
ance with both federal and state regulations is a physical impossibility."
See Florida Lime & Avocado Growers v. Paul, 373 U.S. 132, 142-43 (1963);
Osburn v. Anchor Lab., 825 F.2d 908, 912-13 (5th Cir. 1987), cert. denied, 485
U.S. 1009 (1989) (finding no implied preemption in FDA label PMA process for
new animal drugs where FDA regulations permitted manufacturer to strengthen
label warnings without prior approval).
As Cipollone has clarified, resort to implied preemption analysis is
inappropriate where the statute specifies the scope of its intended preemptive
effect. Lastly, the MDA is different from FIFRA, although it incorporates a
similar express preemption provision. And as regards the preemptive scope of
the MDA, the FDA has stated,
Congress has expressly declared that the Federal Food, Drug &
Cosmetic Act preempts any State or local requirement with respect
to the safety or effectiveness of a medical device that is differ-
ent from or in addition to a requirement under the act applicable
to the device. The test of implied Federal preemption, therefore,
does not apply . . . . Under Section [360k(a)] of the act,
preemption is not restricted to State requirements that directly
conflict with Federal law . . . .
45 Fed. Reg. 67326, 67328 (1980).
16
remedy for her injuries. Stamps cites Silkwood v. Kerr-McGee
Corp., 464 U.S. 238, 251 (1984), for the proposition that there is
a strong presumption against preemption of state law remedies where
no federal remedy exists. Like Stamps's direct conflict argument,
however, this too is more appropriately addressed in the context of
implied preemption.10 That is to say, where Congress has expressly
preempted state common law damages actions, as in Cipollone and the
MDA, its failure to provide a federal remedy will not defeat its
intent to preempt state law.11
VI.
In conclusion, the district court did not err in finding
Stamps's state law claims completely preempted by section 360k(a).
The summary judgment is AFFIRMED.
10
See Silkwood, 464 U.S. at 256 (rejecting suggestion that "there could
never be an instance in which the federal law would pre-empt the recovery of
damages based on state law," but refusing to recognize any such preemption in
that case based upon implied "conflict" or "frustration" preemption); Abbott
by Abbott v. American Cyanamid Co., 844 F.2d 1108, 1112 (4th Cir.), cert.
denied, 488 U.S. 908 (1988) (applying unavailability of federal remedy
presumption in impled preemption context).
11
See Lee v. E.I. DuPont de Nemours & Co., 894 F.2d 755, 757 (5th Cir.
1990) (ERISA's express preemption provision preempts state tort law despite
unavailability of federal remedy); see also Slater, 961 F.2d at 1333 "(It
would be a mistake to conclude that preemption in these circumstances leaves
the consuming public remediless, at least if we have concern for economic
substance rather than legal formality and do not suppose that the only
``remedies'. . . are those that the law provides.").
17