January 15, 1993 UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
No. 92-1278
JANE KING,
Plaintiff, Appellant,
v.
COLLAGEN CORPORATION,
Defendant, Appellee.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. A. David Mazzone, U.S. District Judge]
Before
Torruella, Circuit Judge,
Aldrich and Campbell, Senior Circuit Judges.
Clinard J. Hanby, with whom Susan A. Allinger, John O'Quinn,
O'Quinn, Kerensky & McAninch, Michael M. Essmyer, Michael M.
Essmyer & Associates, Frank Lynch and LeComte, Emanuelson, Tick &
Doyle, were on brief for appellant.
Bob Gibbins and Jeffrey R. White, were on brief for the
Association of Trial Lawyers of America, amicus curiae.
Joseph J. Leghorn, with whom Peter T. Wechsler, Warner &
Stackpole, Joe W. Redden, Jr., W. Curtis Webb, and Beck, Redden &
Secrest, were on brief for appellee.
Bruce N. Kuhlik, Lars Noah, Covington & Burling, Edwin H.
Allen, and Retta M. Riordan, were on brief for Health Industry
Manufacturers Association, amicus curiae.
TORRUELLA, Circuit Judge. Jane King appeals from a
grant of summary judgment entered in favor of Collagen
Corporation ("Collagen") by the United States District Court for
the District of Massachusetts. The district court determined
that plaintiff's claims were preempted by the Medical Device
Amendments of 1976 ("MDA"), 21 U.S.C. 360c et seq. Because the
district court correctly construed the preemption provision of
the MDA, we affirm.
FACTS
Defendant Collagen manufactures and distributes Zyderm,
a cosmetic medical device used to correct wrinkles and other skin
deformities. Zyderm treatment consists of injecting processed
cow tissue directly under the skin. Zyderm then supports the
skin from underneath, smoothing out deformities on the surface of
the skin. The course of treatment may run for several weeks and
requires up to six applications. Researchers at Stanford
University developed Zyderm in the early 1970's and Collagen
placed it on the market in the early 1980's.
As a medical device, Zyderm falls within the scope of
the MDA and thus must be approved and regulated by the Food and
Drug Administration ("FDA"). As a Class III medical device under
the MDA scheme, it is subject to the most extensive pre-marketing
approval requirements imposed by the MDA and to similarly
extensive regulation post-approval. The premarket approval
process is designed to provide a "reasonable assurance of . . .
safety and effectiveness" for medical devices which are too
dangerous or unknown to permit less regulation. 21 U.S.C.
360c(1)(C). Post-approval regulation is designed to keep the FDA
apprised of ongoing safety findings or any other information
about the device as it becomes available. Id. 360e(e) &
360i(a).
Pursuant to the pre-marketing approval process, the FDA
requires applicants to submit proposed labeling, extensive safety
testing data and descriptions of manufacturing methods and
materials. Id. 360e(c)(1). Upon reviewing the materials in a
comprehensive manner, the FDA may approve the device for sale or
return the application to the applicant for further information
or testing. Id. 360e(d)(1). When the FDA returns an
application to the applicant, the FDA must apprise the applicant
of how to correct all deficiencies. Id. 360e(d)(2). Once the
device is approved, the FDA retains the power to withdraw
approval of the product permanently or suspend its approval
temporarily if it determines that the device has become unsafe or
its labeling inadequate. Id. 360e(e)(1)(3). To assist the FDA
in making these determinations, manufacturers must maintain
records and make reports to the FDA on information pertinent to
the device. Id. 360i(a). Zyderm passed through the Class III
approval process prior to marketing, and underwent revisions to
the original approval afterwards.
Appellant Jane King sought Zyderm treatment in 1987.
Following the normal procedure, Ms. King's physician administered
a test dose of Zyderm before proceeding with the full treatment.
Shortly after receiving this test dose, Ms. King suffered muscle
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and joint pains, as well as other symptoms. Her doctor
subsequently diagnosed her as having dermatomyositis/polymyositis
("DM/PM"), an autoimmune disease in which the immune system
attacks skin and muscle tissue as if it were a foreign substance.
When Ms. King received Zyderm, Zyderm's FDA-approved
labeling contraindicated use by those with a personal history of
autoimmune disease. Since that time, however, the FDA has
gradually allowed Collagen to change the labeling as it related
to autoimmune disease. By 1991, Zyderm was no longer
contraindicated for persons with a history of autoimmune disease.
The FDA required a warning in 1991, however, that some recipients
have suffered from unwanted autoimmune reactions, but that no
causal connection between Zyderm and these reactions has been
shown.
Ms. King subsequently filed a first amended complaint
detailing seven claims against Collagen.1 First, she claimed
that Collagen was strictly liable for her injuries because Zyderm
1 Ms. King filed suit against Collagen in 1990 alleging that the
test dose of Zyderm caused her to develop DM/PM. Count one of
her suit alleged that Collagen negligently tested, manufactured
and sold Zyderm. Count two alleged that Collagen breached
implied warranties of merchantability. Count three alleged fraud
and deceit in the sale of Zyderm.
Ms. King subsequently filed the amended complaint. Appellee
contends that Ms. King informed appellee that she would withdraw
this amended complaint. As such, appellee never opposed its
entry. The district court entered the amended complaint, noting
that no opposition was filed. The district court, however,
proceeded to grant summary judgment on the basis of Ms. King's
original complaint. Because the amended complaint contains
essentially similar claims as the original complaint, with few
additions, we will address the claims in the amended complaint.
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was unsafe for its intended purpose and unreasonably dangerous to
users. Second, she alleged that Zyderm was not safe and fit for
the purpose intended and therefore was sold in breach of the
warranty of merchantability. Third, Ms. King alleged that
negligence in the design, manufacture, marketing and sale of
Zyderm, including negligence in not revealing dangerous
propensities of the product, led to her injury. Fourth, she
maintained that Collagen misbranded and/or mislabeled Zyderm.
Fifth, she asserted that Collagen made misrepresentations of
material fact to Ms. King in selling Zyderm to her. Sixth, she
alleged that Collagen failed to warn her of any defective
condition. Finally, Ms. King alleged that Collagen fraudulently
obtained FDA approval.
Collagen moved for summary judgment shortly after
Ms. King filed her amended complaint, arguing that FDA regulation
of Zyderm under the MDA preempted all of the causes of action
alleged in the complaint. The district court granted this
motion, relying on a similar case from the Southern District of
Texas. This case, Stamps v. Collagen Corp., No. H-90-2242, 1991
U.S. Dist. LEXIS 20666 (S.D. Tex. 1991), held that plaintiff's
various products liability claims arising out of Zyderm treatment
were preempted by FDA regulation under the MDA.
LEGAL ANALYSIS
I.
Article VI of the Constitution dictates that federal
law "shall be the supreme Law of the Land; and the judges in
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every State shall be bound thereby, any Thing in the Constitution
or Laws of any State notwithstanding." U.S. Const. art. VI, cl.
2. State laws that conflict with federal laws and regulations,
therefore, are preempted. E.g., Malone v. White Motor Corp., 435
U.S. 497 (1978). In determining whether such a conflict exists,
it is well settled that the intent of Congress governs. That is,
preemption does not occur unless Congress so intended. Rice v.
Santa Fe Elevator Corp., 435 U.S. 497, 504 (1978).
Congress may express its intent to preempt state law
explicitly in the language of the statute. Jones v. Rath Packing
Co., 430 U.S. 519, 525 (1977). Congress may express its intent
implicitly by passing an extensive statutory scheme that
extensively covers the field of regulation. Fidelity Federal
Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982).
Implied preemption also occurs when a conflict between state and
federal law makes compliance with both impossible, or when state
law would frustrate the purpose and objectives of the federal
law. Id. (citing Florida Lime & Avocado Growers, Inc. v. Paul,
373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67
(1941)).
We are aided in our determination of preemption in this
case by the Supreme Court's recent treatment of the subject in
Cipollone v. Liggett Group, Inc., 112 S. Ct. 2608 (1992). In
Cipollone, a victim of lung cancer sued several cigarette
manufacturers for breach of warranties contained in cigarette
advertisements, for failure to warn of health hazards related to
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smoking, for fraudulently misrepresenting those hazards to the
public, and for conspiracy to deprive the public of important
health information. Id. at 2613. The cigarette manufacturers
contended that petitioner's claims were preempted by the federal
law requiring a health warning to appear on all cigarette
advertisements and containers.2 Id. at 2614.
In analyzing preemption, the Court relied only on the
specific language of the provision regarding preemption. The
Court reasoned that "Congress' enactment of a provision defining
the preemptive reach of a statute implies that matters beyond
that reach are not preempted." Id. at 2618. The opinion thus
analyzed each of petitioner's claims in light of the express
language of the preemption provision in the cigarette warning
statute.
The plurality held that the provision preempted failure
to warn claims as to advertising practices, but not as to testing
or research practices. Id. at 2621-22. The plurality reasoned
that the Act only preempted state law claims arising out of
cigarette advertising and promotion, and that appellant's claims
arising out of testing and research did not relate to advertising
and promotion. The provision preempted petitioner's fraudulent
misrepresentation claim that cigarette advertising neutralized
2 That law stated that "[n]o requirement or prohibition based on
smoking or health shall be imposed under State law with respect
to the advertising or promotion of any cigarettes the packages of
which are labeled in conformity with the provisions of this Act."
Federal Cigarette Labeling and Advertising Act of 1965, 5, as
amended by Public Health Cigarette Smoking Act of 1969, 2, 15
U.S.C. 1334.
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the effect of the warning in a similar fashion. Id. at 2623-24.
The provision, however, did not preempt fraud claims arising out
of communication other than advertising, such as information
required to be disclosed to an administrative agency, or out of
fraudulent statements made in the advertising but unrelated to
the health warning. Id.
The plurality further held that the provision did not
preempt express warranty claims, because those claims arose due
to the conduct of the manufacturers who made the warranties
rather than from state law. Id. at 2622. Finally, the plurality
held that the provision did not preempt the conspiracy to deprive
the public of material facts claims, because they did not arise
out of state law pertaining to smoking and health, but rather
arose out of a "duty not to conspire to commit fraud." Id. at
2624.
The analysis of the plurality in Cipollone guides our
analysis in this case. We begin by noting that the express
preemption provision in the MDA, 21 U.S.C. 360k, forecloses
inquiry into implied preemption, because the fact that Congress
included it in the MDA implies that matters beyond its reach are
not preempted. Further, we note that the Cipollone plurality
carefully construed the preemption provision to extend no further
than its language warranted. In doing so, the plurality sought
to pay proper respect to federal-state relations. This concern
arises out of "the assumption that the historic police powers of
the states [are] not to be superseded by . . . Federal Act unless
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that [is] the clear and manifest purpose of Congress."
Cipollone, 112 S. Ct. at 2617 (citing Rice, 331 U.S. at 230). We
too will carefully construe the preemption provision of the MDA
to give due regard to questions of federal-state relations.
II.
Bearing these principles in mind, we turn to the
language of the statute in question. The MDA states that
(a) Except as provided in subsection (b)
of this section, no 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.
21 U.S.C. 360k. Under subsection (b) of 360k, a state may
petition the FDA in certain circumstances to allow state
requirements to continue in force. Because no such petition
affects this case, we are concerned only with the preemptive
effect of subsection (a). Under subsection (a), we must
determine whether appellant's products liability claims give rise
to state law requirements in addition to or different from those
mandated by the FDA.
We turn first to the FDA's own understanding of
subsection (a) for guidance. See Chevron U.S.A., Inc. v. Natural
Resources Defense Council, Inc., 467 U.S. 837 (1984) (agency's
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interpretation of its own statute is controlling so long as not
contrary to Congress' intent). FDA regulations provide that
preemption does not apply when the FDA has issued no regulations
or other requirements specific to the particular device. 21
C.F.R. 808.1(d). In this case, it is clear that the FDA has
imposed requirements on Zyderm related to labeling, design,
manufacturing and other aspects of the device pursuant to the MDA
scheme.
If the FDA has issued requirements for a device,
subsection (a) prohibits states from imposing any requirements
which differ from or add to the FDA requirements, or which relate
to the safety or effectiveness of the device. A "State . . .
requirement" in subsection (a) may emanate from any requirement
established by a state including statutes, regulations, court
decisions or ordinances. 21 C.F.R. 808.1(b); see also San
Diego Building Trades Council v. Garmon, 359 U.S. 236, 247 (1959)
("[State] regulation can be as effectively exerted through an
award of damages as through some form of preventive relief. The
obligation to pay compensation can be, indeed is designed to be,
a potent method of governing conduct and controlling policy.").
The language of subsection (a) and the definition of
state requirement promulgated under it demonstrate a field of
preemption which is broad, but limited. Any state requirement
which, in effect, establishes a new substantive requirement for
the device in a regulated area such as labeling, is preempted.
21 C.F.R. 808.1(d)(6)(ii). As the Seventh Circuit noted,
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however, subsection (a) of the MDA does not preempt such claims
as negligent implantation or removal of devices, or claims
arising out of contaminated devices. Slater v. Optical Radiation
Corp., 961 F.2d 1330, 1334 (7th Cir. 1992), cert. denied, 1992
U.S. LEXIS 6436 (Oct. 13, 1992).
Armed with this understanding of subsection (a), we
will analyze petitioner's claims individually to determine the
effect of the MDA preemption provision on each.
A. Strict Liability
Appellant contends that Zyderm is unsafe for its
intended purpose and unreasonably dangerous to users, and that
Collagen therefore is liable for any injuries Zyderm may cause.
Indeed, class III devices such as Zyderm are those that present a
"potential unreasonable risk of illness or injury" such that
extensive regulation is required to ensure reasonably safe use.
21 U.S.C. 360c(a)(1)(C). The FDA must evaluate these devices
with regard to those for whose use the device is intended. Id.
360c(a)(2)(A). The entire MDA scheme for such Class III
devices as Zyderm, therefore, is aimed at determining and
regulating the intended purpose of the device, and at ensuring a
reasonable level of safety for its users.
It is clear that appellant's strict liability claim
would impose requirements related to the safety and effectiveness
of Zyderm. If successful, the claim would require Collagen to
redesign Zyderm, remove it from the market, or be subject to
strict liability. The MDA does not permit this. Appellant's
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claim would force us to determine that Zyderm is unsafe and
dangerous, in opposition to the contrary determination made by
the FDA under the MDA. Subsection (a) protects manufacturers of
medical devices approved by the FDA under the MDA from such state
law intrusion.
B. Breach of Warranty
Appellant claims that Collagen breached express and
implied warranties of merchantability and fitness for a
particular purpose. Appellant's express warranty claims arise
out of the labeling and packaging of Zyderm, all of which are
regulated by the FDA. In labeling and packaging, Collagen could
not say any less than what the FDA required, and appellee could
only add extra warnings or safety information, but not
warranties, without FDA approval. Appellant's express warranty
claims therefore are preempted because any such warranties only
could arise out of the FDA-approved labeling and packaging.
Allowing appellant's express warranty claims effectively would
impose additional or different requirements on Zyderm's labeling
and packaging.
We note that the Court's holding in Cipollone would
seem to require the opposite result in this case. However, the
warnings at issue in Cipollone were different than those here.
In Cipollone, the statute required cigarette manufacturers to
include a brief health warning in their advertisements; this
warning did not affect cigarette advertisements in any other way.
The manufacturers were free to make any claims they wished,
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including express warranties. Here, however, the MDA has imposed
much more extensive regulation upon class III device
manufacturers. The FDA retains rigid control over the entirety
of the labeling and packaging of class III products, largely
displacing the ability of manufacturers to make additional
claims. This high level of control contrasts with the low level
of control in Cipollone, and ensures that manufacturers will not
be held liable for packaging and labeling imposed by the FDA.
Appellant also alleges that Collagen breached an
implied warranty of merchantability, and that this breach caused
her injuries. As an implied warranty is a requirement upon a
product that arises exclusively from the operation of state
contract law, this claim is preempted expressly by the MDA.
Otherwise, it would impose a requirement additional to those
imposed under the MDA.
C. Negligence
Appellant's third claim alleges negligence in the
design, manufacture, marketing and sale of Zyderm. This claim
also is preempted by the MDA. If the MDA does nothing else, it
regulates the design, manufacture, sale and marketing of class
III medical devices in an extensive way. The MDA does this
through the packaging and labeling requirements which directly
affect the marketing and sale of the product. The same
requirements also affect the design and manufacture of the
product in that these processes must be approved by the FDA and
described in the product's packaging and labeling.
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As the design, manufacture, marketing and sale of
Zyderm is the subject of FDA regulation, the negligence claim is
preempted. Otherwise, a finding of negligence would force
Collagen to alter these aspects of Zyderm in response to the
finding of liability, or be subject to liability. Either result
impermissibly would impose an additional or different state
requirement upon the design, manufacture, marketing and sale of
Zyderm.
D. Product Misbranding, Misrepresentation & Failure to
Warn
Appellant contends that Zyderm was misbranded or
mislabeled. Misbranding generally occurs when labeling is "false
or misleading" in any particular. 31 U.S.C. 352(a). Under the
MDA, the FDA must reject proposed labeling when the labeling is
"false or misleading in any particular." Id. 360e(d)(2)(D).
As there is no indication in the record that the Zyderm
administered to Ms. King was anything but what the FDA-approved
labeling said it would be, notwithstanding appellant's bald
statements, we find this claim preempted.
Appellant's fifth and sixth claims of misrepresentation
and failure to warn are preempted for similar reasons. A finding
that Collagen misrepresented Zyderm to appellant would impose a
requirement on Collagen to change its packaging or labeling in
order to correct the misrepresentation. The failure to warn
claims similarly challenge the adequacy of Zyderm's FDA-regulated
packaging and labeling. The MDA forecloses these claims because
Collagen cannot be forced to change Zyderm's packaging and
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labeling by virtue of these state law damage claims.
E. Fraud
Appellant's final cause of action alleges that Collagen
fraudulently obtained FDA approval at the premarketing stage of
the MDA process, and asks for treble damages due to the fraud.
This cause of action is more unclear than her other causes of
action. Collagen insists that the claim originally was based
upon Mass. Gen. L. ch. 231, 85J, an antifraud statute, while
appellant urges that it was based on a more general duty not to
deceive.
Section 85J provides that "[w]hoever, by deceit or
fraud, sells personal property shall be liable in tort to a
purchaser in treble the amount of damages sustained by him." The
language of this statute corresponds to Ms. King's fraud claim in
providing for treble damages. Because Ms. King has not specified
any applicable statute, or other reason why she is entitled to
treble damages under a general duty not to deceive, we must
conclude that the fraud claim originally arose under 85J. The
district court made the same finding in its memorandum and order
in this case.
To state a claim for fraud under 85J, the plaintiff
must be in privity with the seller. Kourouvacilis v. General
Motors Corp., 410 Mass. 706, 575 N.E.2d 734, 735 (1991). In this
case, no privity existed between appellant and Collagen, as
Collagen only sold its product directly to appellant's physician.
Thus, as a matter of Massachusetts law, appellant's fraud claim
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must fail.
We further note that the fraud claim is, at bottom, a
failure to warn claim. It seeks to show that Collagen had a duty
to provide different information in Zyderm's packaging and
labeling than that which was approved by the FDA. As such, the
claim is preempted expressly by the MDA.
CONCLUSION
Because we have determined that the MDA expressly
preempts Ms. King's state law tort claims, the judgment of the
district court is affirmed.
"Concurrence follows"
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ALDRICH, Senior Circuit Judge, with whom CAMPBELL,
Senior Circuit Judge, joins, concurring. While we agree with
our brother Torruella's result, and a good deal that he says,
we approach this case somewhat differently. First, a matter
of housekeeping. On December 13, 1991, a year past the
scheduled date for completion of the pleadings, plaintiff
filed a motion to allow an amended complaint, accompanied by
the complaint. On December 17 she wrote defendant that she
would withdraw her motion. Defendant, accordingly, did not
oppose. On December 27 defendant moved for summary judgment.
In opposing defendant's motion for judgment plaintiff made no
mention of the proposed new complaint, but, in fact, she did
not withdraw her motion, and the court later allowed it.
However, the court's ultimate order granting summary judgment
did not mention the amendment.
At first blush we might agree with defendant's
objection that there were substantive additions in the
amended complaint, particularly with relation to fraud.
Apart from fraud, the rest of the amended complaint contains
six claims as against, originally, two -- negligence and
breach of implied warranty. There was definitely a purported
enlargement -- a state tort of strict liability, and a claim
of express warranty. While the negligence alleged is limited
to designing and producing a dangerous product, and not that
the sample sold plaintiff was in some way a departure and
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individually defective, plaintiff adds mislabeling and
misrepresentation, and, finally, failure to warn.
Taking defendant's now alleged seven sins, we group
them as follows. Strict liability (negligent design),
implied warranty, negligence, mislabeling, and failure to
warn are really all of a piece -- failure to warn. On the
record it is clear that had there been a warning that the
product might cause the disease that plaintiff allegedly
suffered she would have no claim under any of these headings.
On this basis there is thus no real enlargement by the
amended complaint. Express warranty might be enlargement,
but there is no basis for claiming it.3 Finally, fraud and
misrepresentation are not as newly put as they look.
Defendant would have it that the original allegation related
only to representations made to the plaintiff. Plaintiff
states that she intended her language to include
misrepresentations to the agency. Two of her exhibits
seeking to raise an issue on the motion for summary judgment
bear this out. The amendment should stand, as mere
clarification. However, we read fraud more broadly than does
our brother, and shall return to it later.
All agree that there is one basic issue: federal
preemption. Preemption may apply against state judicial as
3. Express warranty might have created a problem for the
defense of preemption, cf. Cipollone v. Liggett Group, Inc.,
112 S. Ct. 2608, 2622-23 (1992).
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well as legislative action,4 Cipollone v. Liggett Group,
Inc., 112 S. Ct. 2608 (1992), and may take two forms, express
and implied, with a heavy burden upon the party asserting it.
Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977). This is
especially so when the subject is the state interest in
health and safety. Hillsborough County v. Automated Medical
Labs, Inc., 471 U.S. 707, 715, 718-19 (1985). The question
is Congressional intent. Wood v. General Motors Corp., 865
F.2d 395, 401 (1st Cir. 1988), cert. denied, 494 U.S. 1065
(1990). Here, concededly, the statute's purpose is health
protection, but the parties disagree as to its scope.
Plaintiff says it is directed to the individual user by
keeping harmful products off the market and assuring proper
warnings. Defendant says it is also to benefit the public at
large by shielding regulated manufacturers against
inconsistent state regulation, including lawsuits. If their
legal risks may be too great, worthwhile medical devices may
be left in the laboratory, to the public's loss.
Public health is a valid federal purpose, and
Congress can reasonably weigh possible loss to the
idiosyncratic few against benefits to the public generally.
See, e.g., Mary Beth Neraas, The National Childhood Vaccine
Injury Act of 1986: A Solution to the Vaccine Liability
4. A matter that may have troubled the court in Wood v.
General Motors, post. See, also, 21 C.F.R. 808.1(b).
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Crisis? 63 Wash. L. Rev. 149 (1988). The legislative
history shows that this was precisely the Congressional
intent. Concededly, the U.S. Code Congressional and
Administrative News, 94th Congress, Second Session, Vol. 3,
pp. 1070 et seq., Medical Device Amendments of 1976, shows
the principal emphasis to be on the protection of the
individual user. But it also shows the intent to "encourage
. . . research and development" and "permit new and improved
devices to be marketed without delay." Infra. Perfection is
impossible and a few individuals may be denied full
protection at the cost of benefitting the rest.
Contained within the Senate Report (94-33)5 are
the following.
As medicine progresses, as research
makes new breakthroughs, an increasing
number of sophisticated, critically
important medical devices are being
developed and used in the United States.
These devices hold the promise of
improving the health and longevity of the
American people. The Committee wants to
encourage their research and development.
[1071]
S. 2368 recognizes the benefits that
medical research and experimentation to
develop devices offers to mankind. It
recognizes, too, the need for regulation
to assure that the public is protected
and that health professionals can have
more confidence in the performance of
devices. [1075]
5. The Senate bill was passed in lieu of the House bill.
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The Committee recognizes the rapidly
changing nature of the devices field and
therefore feels that provisions must be
made to amend standards on the basis of
improved technology or new scientific
evidence. Such amendments should be made
in an expedited fashion so that
appropriate changes can be rapidly
implemented. The purpose of this
authority is to permit new or improved
devices to be marketed without delay so
that the public may have such beneficial
devices available to them as soon as
possible. [1083]
Translating this into a simple concept, and taking
the difference of opinion between the parties to be whether
the FDA requirements are merely minimum, or are the total
maximum protection afforded the individual user, we believe
this a clear demonstration of Congressional choice of the
latter. We further find that the comprehensive statutory
language conforms thereto.
21 U.S.C. 360e(c)(1) provides,
(1) Any person may file with the
Secretary an application for premarket
approval for a class III device. Such an
application for a device shall contain --
(A) full reports of all
information, published or known to
or which should reasonably be known
to the applicant, concerning
investigations which have been made
to show whether or not such device
is safe and effective;
(B) a full statement of the
components, ingredients, and
properties and of the principle or
principles of operation, of such
device;
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(C) a full description of the
methods used in, and the facilities
and controls used for, the
manufacture, processing, and, when
relevant, packing and installation
of, such device;
(D) an identifying reference
to any performance standard under
section 360d of this title which
would be applicable to any aspect of
such device if it were a class II
device, and either adequate
information to show that such aspect
of such device fully meets such
performance standard or adequate
information to justify any deviation
from such standard;
(E) such samples of such
device and of components thereof as
the Secretary may reasonably
require, except that where the
submission of such samples is
impracticable or unduly burdensome,
the requirement of this subparagraph
may be met by the submission of
complete information concerning the
location of one or more such devices
readily available for examination
and testing;
(F) specimens of the labeling
proposed to be used for such device;
and
(G) such other information
relevant to the subject matter of
the application as the Secretary,
with the concurrence of the
appropriate panel under section 360c
of this title, may require.
Following these detailed requirements, and we note
especially subsection (F), comes Section 360k(a).
[N]o State or political subdivision of a
State may establish or continue in effect
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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.
Particularly in the light of the legislative history we read
this as maximum protection and express preemption, leaving no
need to seek implications. As all but one of plaintiff's
sustainable claims are premised on a failure to warn,
preemption here is unavoidable, given the subsection (F)
requirement that labels be reviewed by the FDA.
It follows that most of plaintiff's arguments are
beside the mark. A few, however, may deserve mention.
Plaintiff claims that because of the regulation reported in
21 C.F.R. 814.39(d)(1), to the effect that a manufacturer
"may," without prior approval, make certain changes that
enhance safety, defendant had a duty to make such here. It
is sufficient to say that to interpret "may" as "should"
would unravel the entire garment. Second, citing Silkwood v.
Kerr-McGee Corp., 464 U.S. 238, 251 (1984), plaintiff says
that, if defendant is correct, she has no cause of action.
Given an ambiguity, this objection is a factor in statutory
construction, but, of itself, it cannot create an ambiguity,
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or there could never be preemption. Finally, plaintiff says
that the FDA's preemption regulation, 21 CFR 808.1(d)
conflicts with our result. When a statute is clear the
agency interpretation must give way. Hillsborough County,
471 U.S. at 714-15.
A more troublesome issue is the claim labeled
fraud.
FRAUD
. . . Defendant Collagen Corporation
fraudulently obtained FDA approval of the
Zyderm PMA, product and labeling, which
was a producing or proximate cause of
damage and injury to Plaintiff.
Defendant . . . further acted to suppress
the facts, blame injuries or other causes
that its product (sic) and prevent
disclosure of the true risks.[6]
Plaintiff has a case in point. In Hurley v.
Lederle Laboratories Division of American Cyanamid Co., 863
F.2d 1173 (5th Cir. 1988), the court, though agreeing with
the district court that the FDA regulation with respect to
defendant's vaccine labeling was intended to be preemptive,
remanded. At issue was the same tension between protecting
idiosyncratic individuals and the public health. Balancing
these, the Court concluded,
6. As in the original complaint, plaintiff sought treble
damages. Though not mentioned, presumably this demand
invoked Mass. G.L. c. 231, 85J, that awards treble damages
in certain cases of "deceit or fraud." We do not read it,
however, as limiting the scope of plaintiff's claims.
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[T]his issue should be presented to the
jury in the form of special
interrogatories, questioning whether and
what information the manufacturer
withheld from the FDA, if any, and
whether possession of this information
would have materially altered the content
of the FDA's warning. This special
procedure is justified by the federal
interest in encouraging manufacturers to
produce vaccines, in that those
manufacturers need some assurance that if
they follow certain prescribed
procedures, such as including an FDA-
approved warning, they are complying with
the law.
Id. at 1180. With respect, one may wonder how "encouraging"
manufacturers would view the ruling.7 Rather, we side with
the later case of Papas v. Upjohn Co., 926 F.2d 1019 (11th
Cir. 1991), where the court said, at 1026 n.8,
To the extent that Hurley purports to
recognize an exception to federal
preemption of common law tort labeling
claims when the federal statute involved
explicitly prohibits state regulation of
labeling and the federal agency has
received incomplete information from the
manufacturer, we reject its holding at
least as applied to FIFRA-regulated
pesticides. Given the FIFRA regulatory
scheme, it would be up to the EPA -- and
not a jury -- to determine first (1)
whether the information provided was
incomplete or inaccurate; (2) whether the
omitted information is significant enough
to mandate a change in the label; and (3)
how, if at all, the label should be
corrected.
7. Indeed, we are reminded of the observation that the
British hanged a negligent admiral "pour encourager les
autres." Voltaire, Candide, Ch. 23.
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To prove fraud, plaintiff must show causality. Surely, where
the FDA was authorized to render the expert decision on
Collagen's use and labeling, it, and not some jury or judge,
is best suited to determine the factual issues and what their
effect would have been on its original conclusions. Further,
if the court erred, and incorrectly posited the effect on the
FDA's use and labeling decision, this would impose a state
requirement "which is different from, or in addition to, any
requirement applicable . . . to the device." 21 U.S.C.
360k(a). In addition to running afoul of the general
principle against implying personal causes of action, Royal
Bus Group, Inc. v. Realist, Inc., 933 F.2d 1056 (1st Cir.
1991), plaintiff would be breaching the federal dyke in the
absence of its keeper.
Papas has been vacated and remanded for further
consideration in the light of Cipollone, 112 S. Ct. 2608, but
we do not believe this to be a reversal on that point. Our
position is consistent with Cipollone, that did not preempt
fraud found to be outside the communication targeted by the
regulation.8 112 S. Ct. at 2623-24.
8. Plaintiff similarly presents a claim for
misrepresentation, both to the public and to plaintiff's
physician. As the record shows no statements to the public
or physicians that go beyond those approved by the FDA, this
claim collapses into that of fraud on the FDA.
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