Reprinted with permission from Product Safety &
Liability Reporter, Vol. 24, No. 3, pp. 57-67 (Jan. 19, 1996).
Copyright 1996 by
The Bureau of National Affairs, Inc. (800-372-1033) www.bna.com
IS THERE A 'NONCOMPLIANCE' EXCEPTION
By Kenneth S. Geller * and Alan E. Untereiner
May a defendant assert a preemption defense based on
federal requirements it has not met? That question is being raised with
increasing frequency in tort actions against the makers of medical devices and
other products subject to preemptive federal regulation. Plaintiffs maintain
that it disserves the overarching goal of enhancing safety to permit a defendant
manufacturer who has not complied with federal safety standards to invoke the
shield of preemption.
In Talbott v. C.R. Bard, Inc., 63 F.3d
25 (1995), the First Circuit recently refused to recognize a noncompliance
exception to preemption under the Medical Device Amendments of 1976 (MDA) to the
Food, Drug, and Cosmetic Act. In fact, the court of appeals rejected three
variations of the "noncompliance" argument, including one advanced by the United
States government in an amicus brief.
In this article, we examine the argument for a
noncompliance exception to federal preemption. Endorsing the result in
Talbott, we explain why the exception is not available under the MDA. We
analyze the First Circuit's reasoning and identify additional reasons not
mentioned by the court of appeals why a noncompliance exception is both
inconsistent with the language of the MDA and unworkable in practice. Along the
way, we offer suggestions to defendants seeking to defeat arguments for a
noncompliance exception under other federal statutes.
Under the doctrine of federal preemption, Congress
may nullify state laws, including common law tort duties, in order to ensure
national regulatory uniformity or to achieve other federal
The doctrine is founded on the Supremacy Clause of
the U.S. Constitution, which states that the laws of the United States "shall be
the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any
state to the Contrary notwithstanding." Preemption defenses are routinely
asserted in a wide array of tort lawsuits brought under state
Preemption can be either implied or express. Under
the doctrine of implied preemption, state law may be preempted even without an
explicit statement by Congress, as where state law conflicts with federal law.
Preemption defenses, however, often rely on preemption clauses in federal
Among the many statutes in the United States Code
with express preemption provisions are the National Traffic and Motor Vehicle
Safety Act, 49 U.S.C. §30103(b) (formerly 15 U.S.C. §1392(d)); the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. §136v; the Federal
Boat Safety Act, 46 U.S.C. §4306; and the Medical Device Amendments of 1976
(MDA) to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a). In
Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1995), the First Circuit
recently upheld the dismissal on preemption grounds of numerous state-law tort
claims for damages brought against the manufacturer of a medical device and
several of its corporate officers.
The case is important because it illustrates the
kinds of arguments that increasingly are being made — not only in MDA preemption
cases but in other contexts as well — in support of exceptions to preemption
based on a defendant's alleged failure to comply with otherwise-preemptive
The fact that the United States government filed an
amicus brief urging adoption of one variation of the noncompliance
argument, moreover, is significant because it may reflect either a high-level
decision to press this theory in other preemption contexts or the government's
dissatisfaction with the broad preemptive reading given by most courts to the
In any event, device manufacturers and other
defendants who regularly invoke preemption as a defense can expect to encounter
arguments based on the noncompliance theory in the future.
Talbott arose out of a woman's death during
angioplasty, a procedure in which a medical device known as a heart catheter is
threaded up through an artery in the patient's leg to a coronary artery, where a
balloon is temporarily inflated to reduce arterial blockage.
The woman died when a catheter manufactured by C.R.
Bard failed to deflate. Her heirs' lawsuit included claims for negligence in the
design, manufacturing and marketing of the device, willful and wanton conduct
(punitive damages), breach of express and implied warranties, negligent
infliction of emotional distress, fraudulent misrepresentation and concealment,
battery, civil conspiracy, and unfair and deceptive trade
The district court dismissed all of plaintiffs'
claims as preempted under the MDA. 865 F. Supp. 37 (D. Mass. 1994). In
affirming, the First Circuit relied principally on the language of the MDA's
express preemption clause, which states:
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.
The First Circuit reasoned that all of plaintiffs'
claims would impose "requirement[s]" that are "different from, or in addition
to" those imposed by federal law on the Bard heart catheter.
As a so-called "Class III" medical device, the
catheter was subject to extensive federal regulation and oversight, including
premarketing approval (PMA) by the Food and Drug Administration (FDA) of the
device's design, manufacture, and labeling. It was also subject to various
post-approval reporting requirements.
The result reached by the First Circuit in
Talbott is consistent with many other federal and state decisions that
uphold preemption of claims relating to Class III devices under the broad reach
of the MDA's preemption clause. See, e.g., Martello v. Ciba Vision
Corp., 42 F.3d 1167, 1169 (8th Cir. 1994), cert. denied, 115 S. Ct. 2614
(1995); Gile v. Optical Radiation Corp., 22 F.3d 540, 542, 544,
546 (3d Cir.) cert. denied, 115 S. Ct. 429 (1994); Stamps v. Collagen
Corp., 984 F.2d 1416, 1419-25 (5th Cir.), cert. denied, 114 S. Ct. 86
(1993). See also Martin v. Telectronics Pacing Systems, Inc., 70
F.3d 39 (6th Cir. 1995) (upholding broad preemption of claims relating to
investigational medical devices).
Noncompliance Exception to
The issue of compliance with federal safety standards
frequently arises in product liability and other tort
As a general matter, evidentiary rules in federal and
in state courts permit the introduction of evidence of a defendant's violation
of (or compliance with) federal safety requirements to prove (or disprove)
non-preempted claims under state law.
Thus, a plaintiff might introduce evidence of a
defendant's failure to comply with federal regulations mandating that a certain
warning accompany a particular product in seeking to prove that the defendant
negligently failed to provide an adequate warning. See Restatement (Second)
of Torts §§288B(2), 288C (1965).
Similarly, the tort law of many states treats the
violation of (state or federal) safety requirements as negligence "per se."
Id. §288B(1). In these jurisdictions, a plaintiff may be able to
establish negligence by proving that a defendant failed to comply with a federal
Analytically, however, these contexts are quite
different from that of preemption. Preemption turns on Congress's intent and the
relationship between federal and state law, not on the relevance of evidence to
non-preempted causes of action or the manner in which a State chooses to define
non-preempted duties under state law. As the American Law Institute recently
When a court concludes that a defendant is not liable
by reason of having complied with safety design or warnings statutes or
regulations, it is deciding that the product in question is not defective as a
matter of the law of that state. The safety statute or regulation may be a
federal provision but the decision to give it determinative effect is a state
law determination. In contrast, in federal preemption, the court decides as a
matter of federal law that the relevant federal statute or regulation reflects,
expressly or impliedly, the intent of Congress to displace state law, including
state tort law, with the federal statute or regulation. The question of
preemption is thus a question of federal law and a determination that there is
preemption nullifies otherwise operational state law.
Restatement (Third) of Torts: Products Liability,
§7 cmt. e (Tentative Draft No. 2, Mar. 13, 1995).
The Talbott case is an instructive example of
noncompliance arguments in this unconventional context.
In its amicus brief in support of the
plaintiffs, the United States urged the First Circuit to create an exception to
MDA preemption where the FDA has made a determination that a defendant failed to
comply with otherwise-preemptive federal requirements.
The plaintiffs advanced several variations of this
argument. They contended that MDA preemption does not apply to a device whose
approval by the FDA was fraudulently obtained. Plaintiffs also argued that the
MDA does not preempt state-law tort duties that impose requirements that are
identical to those imposed under the MDA. Although this last theory resembles a
traditional preemption argument in that it turns on the relationship between
state and federal law (rather than on the defendant's compliance with the
latter), plaintiffs, in order to prevail on the merits of such a claim, would
have to prove that the defendant failed to comply with standards embodied in
In making their arguments about noncompliance with
federal standards, the plaintiffs and the United States both relied on the fact
that Bard and six of its employees had been criminally prosecuted by the United
States Attorney for Massachusetts.
Bard itself pleaded guilty to a 391-count information
including counts of conspiracy, mail fraud, submission of false statements to
the FDA, shipment of adulterated medical devices, and failure to submit required
reports to the FDA. See United States v. C.R. Bard, Inc., 848 F.
Supp. 287 (D. Mass. 1994).
According to the government's charging document in
the criminal case, between 1987 and 1990 six Bard employees (including the two
individuals named as defendants in the Talbott case) engaged in a course
of illegal conduct in response to revelations that Bard heart catheters were
The illegal conduct included failing to notify the
FDA of reports of problems, distributing significantly redesigned catheters
without first obtaining the requisite FDA approval and without disclosing the
fact of redesign to physicians, and making false statements to the FDA
concerning the location where catheters were being manufactured (in violation of
the FDA's good manufacturing practices rules).
In pleading guilty, Bard agreed to implement various
remedial measures and to pay a penalty of more than $61,000,000, consisting of
$30,500,000 as part of a civil settlement, $30,500,000 in criminal fines, and
$78,200 in special assessments. 848 F. Supp. at 289, 291-92.
Notwithstanding this unusual and extremely negative
backdrop to plaintiffs' noncompliance arguments, the First Circuit declined to
recognize any of the proposed exceptions to preemption under the
As we explain below, this result was correct—for
reasons both stated by the First Circuit and unmentioned in the court's
decision. The proposed exceptions for noncompliance are inconsistent with the
language of the MDA and utterly unworkable in practice.
The Talbott case, moreover, illustrates well
the kind of arguments that can be advanced by defense counsel to defeat claimed
exceptions to preemption for noncompliance in other preemption
A Fraud-On-The-FDA Exception to MDA
Relying on the fact of Bard's guilty plea, the
plaintiffs in Talbott argued that the company was not entitled to the
shield of preemption because it had defrauded the FDA in obtaining approval of
the Bard catheter for marketing.
According to the plaintiffs, Bard had failed to
disclose to the FDA all of the information required to be disclosed by federal
Allowing preemption in this circumstance, plaintiffs
argued, "would conflict . . . with the MDA's basic purpose of protecting
individuals from unreasonably dangerous and defective medical devices."
Talbott, 63 F.3d at 28. Accord Evraets v. Intermedics
Intraocular, Inc., 29 Cal. App. 4th 779, 790-91, 34 Cal. Rptr. 2d 852, 858
(2d Dist. 1994) ("It is fair to say that for a medical device manufacturer to
claim the shield of preemption, the manufacturer must 'play by the rules.' If
the manufacturer subverts the rules and obtains approval to market its product
by misrepresenting [to the FDA] the risks involved, knowing that this
disinformation will ultimately harm patients, the injured party should be
entitled to sue.").
In rejecting this version of the noncompliance
exception, the First Circuit relied primarily on the language of Section
360k(a), the MDA's preemption clause. Section 360k(a), the court explained,
"preempts broadly any state tort law 'requirement' that is
'different from, or in addition to' the comprehensive and detailed requirements
set forth by federal law." Talbott, 63 F.3d at 28-29 (emphases added).
The statutory language, moreover,
make[s] no distinction based upon whether or not a
manufacturer has in fact complied with the federal standard. We find nothing to
indicate that preemption is conditional upon satisfactory compliance with the
federal standard. Section 360k(a) does not mention compliance at all. As
§360k(a) reads, the relevant inquiry is simply whether, in the abstract, the
state tort law requirement is "different from, or in addition to" the federal
requirement. If a device manufacturer fails to meet the federal requirements, it
will be subject to federal penalties as set forth in the MDA. Nothing in
§360k(a) suggests that the state requirements are somehow revived by this
failure to comply with the federal standard.
The First Circuit also relied on practical
considerations in rejecting the fraud-on-the-FDA exception. "If state tort
claims were allowed to go forward" on such a basis, the court
a state court would initially have to determine
whether the manufacturer had complied with the MDA. If, as in this case, the
plaintiff claimed that the manufacturer had defrauded the FDA, the state court
would need to determine whether the FDA had in fact been defrauded and whether
the FDA would have approved the device absent the fraud. Under this scheme, a
device manufacturer could potentially be subject to numerous inconsistent
interpretations and applications of the MDA across different states, thus
undermining the MDA's goal of uniformity. Moreover, if state courts erred in
their application of the MDA, they would effectively be imposing requirements
"different from, or in addition to" those imposed by federal
"To avoid the possibility of disuniform treatment,"
the court explained, "Congress placed enforcement authority in the FDA."
Ibid. If a manufacturer defrauds the FDA or otherwise violates federal
requirements, the FDA may employ the "broad power[s]" granted to it by Congress
— including ordering a recall of the device or rescinding its approval for
marketing — to redress the violation. Ibid.
Resolution Of Conflicting
The court of appeals' holding in Talbott
resolves conflicting signals in prior First Circuit cases concerning the
validity of the fraud-on-the-FDA exception to MDA preemption.
In King v. Collagen Corp., 983 F.2d
1130 (1st Cir.), cert. denied, 114 S. Ct. 84 (1993), two members of the panel,
in a separate opinion oddly labeled a concurrence, concluded that a plaintiff's
claim of "fraud on the FDA" (id. at 1140 n.8) was preempted because it
would require a jury to decide, on the issue of causation, whether the FDA would
have required a different labeling or approved a different use for the device if
the manufacturer had provided the FDA with the information that it fraudulently
withheld. Id. at 1140.
In a later MDA preemption case, however, a different
panel of the First Circuit, without citing the King concurrence,
purported to reserve the issue of "whether products liability claims are
preempted only if the manufacturer complied with applicable FDA regulations."
Mendes v. Medtronic, Inc., 18 F.3d 13, 19-20 (1st Cir.
Accord With Other Federal Appeals Courts
The First Circuit's rejection of the fraud-on-the-FDA
theory is consistent with the decisions of at least three other federal courts
of appeals. See Mitchell v. Collagen Corp., 67 F. 3d 1268, 1283
(7th Cir. 1995); Michael v. Shiley, 46 F.3d 1316, 1328-29 (3d
Cir.), cert. denied, 116 S. Ct. 67 (1995); Reeves v. AcroMed, 44
F.3d 300, 306 (5th Cir.), cert. denied, 115 S. Ct. 2251 (1995). See also
Mears v. Marshall, 905 P.2d 1154, 1166-67 (Ore. Ct. App. 1995)
(rejecting fraud-on-the-FDA theory) rehearing denied, 1996 Ore. App. LEXIS 5
(Jan. 3, 1996); Papas v. Upjohn, 985 F.2d 516, 518-19 (11th Cir.)
(per curiam) (rejecting argument that pesticide manufacturer is not entitled to
shield of preemption under FIFRA where it allegedly failed to disclose certain
information to Environmental Protection Agency) ("[I]t is for the EPA
Administrator, not a jury, to determine whether labelling and packaging
information is incomplete and inaccurate, and if so what label changes, if any,
should be made."), cert. denied, 114 S. Ct. 300 (1993). But see Reiter v.
Zimmer, 830 F. Supp. 199, 204 (S.D.N.Y. 1993) (in case involving Class
III device, holding that claim for negligent manufacture is not preempted where
plaintiff alleges that manufacturer failed to comply with "the FDA's
The analysis set forth in Talbott and the
King concurrence is correct. If a plaintiff is permitted to sue for
design defect or negligent design on the ground that the FDA would not have
granted premarket approval of the device's design if the manufacturer had made
full disclosure of the information required to be disclosed by federal law, some
entity other than the expert agency that enforces the MDA and its implementing
regulations — a state or federal court, or perhaps a jury — will have to answer
the hypothetical question of what the FDA would have done had it received the
Would the FDA have deemed the withheld information a
violation of its disclosure requirements? Would it have approved the device
The same questions would arise with respect to
failure-to-warn claims, where a manufacturer allegedly withholds information
concerning the risks associated with a device in obtaining approval of the
device's labeling. To allow state court judges or lay juries to decide how the
FDA would have acted under counterfactual circumstances would necessarily
threaten the very uniformity Congress intended to safeguard.
Incursion On Agency Authority
Indeed, the interference with federal prerogatives
goes beyond the threat of disuniform results. It includes the incursion upon the
expert federal agency's exclusive authority to enforce the commands of federal
Congress has vested in the federal government certain
enforcement powers, including the authority to approve or disapprove Class III
devices, to ban unsafe devices, and to order a device to be withdrawn from the
market where subsequent information raises concerns over the device's safety and
efficacy. See 21 U.S.C. §§360e(d), 360e(e)(1), 360f; 21 C.F.R. §814.46 (1995).
The federal government is also empowered to issue orders requiring, for example,
notification, repair, replacement, or refund. 21 U.S.C. §360h.
In Michael, the Third Circuit relied primarily
on the potential for interference with the FDA's exclusive enforcement authority
in rejecting a fraud-on-the-FDA exception to MDA preemption. The court of
[The plaintiff] seeks to use this general prohibition
on deception [under Pennsylvania law] to encourage the district court to review
the PMA application Shiley submitted to the FDA. This inquiry could ultimately
require that a court determine whether the information Shiley submitted was
truthful, whether it was complete, whether FDA procedures sufficed to avoid a
material misrepresentation, and whether the FDA should have or would have
approved the device despite the misrepresentations. In sum, this claim requires
a court, applying state law, to perform the same functions initially entrusted
to the FDA. Section 360k does not permit such a searching state inquiry into the
inner workings of FDA procedures.
No Private Right Of Action
It is significant in this regard that Congress did
not create a private right of action under the MDA. See Talbott, 63 F.3d
at 30-31. As the district court in Talbott explained, Congress's failure
to include any private right of action reflects a determination to vest in "the
FDA and other agencies of the United States government" the exclusive authority
to assert a claim "that the FDA has been defrauded" or federal regulations
violated. 865 F. Supp. at 47.
It would severely frustrate Congress's goal of
uniformity if the meaning of federal requirements under the MDA were routinely
explicated in actions between private parties to which the FDA was not a party
(such as the Talbott lawsuit).
The fraud-on-the-FDA theory is also flawed for
another reason the First Circuit did not mention: if accepted, it would
effectively deprive manufacturers in MDA cases of the right to obtain dismissal
of preempted claims on the pleadings.
This would dilute much of the benefit to device
manufacturers offered by the preemption defense. As the district court correctly
explained, "[i]f a fraud on the FDA exception exists, it is foreseeable that it
would often be alleged to apply in MDA cases. Initially, those allegations would
have to be accepted as true. At a minimum, such cases would require extensive
and expensive discovery." Talbott, 865 F. Supp. at 47. Elimination of
manufacturers' rights to obtain dismissal of preempted claims at the threshold
of a lawsuit would do much to nullify Congress's purpose of protecting
manufacturers from undue litigation costs and thereby stimulating investment and
Affirmative Evidence Of
Finally, it is worth noting that the MDA's preemption
provision contains affirmative evidence that Congress did not
intend to permit a fraud-on-the-FDA exception to preemption (or for that matter
any exception based on noncompliance).
First, the preemption provision does
recognize a different exception—and indicates by its plain language that
the exception is exclusive. See 21 U.S.C. §360k(a) (mandating preemption of
certain state law requirements "[e]xcept as provided in subsection (b) of this
section"); id. §360k(b) (permitting states to apply to the federal
government to exempt from preemption state requirements that are either (1)
"more stringent than a requirement under this chapter which would be applicable
to the device if an exemption were not in effect under this subsection"; or (2)
"required by compelling local conditions" and such that "compliance with the
requirement would not cause the device to be in violation of any applicable
requirement under this chapter.").
The exception allowed by Congress, moreover, is one
that ultimately remains under the control of the expert federal agency charged
with enforcing federal law.
Second, the drafters of the MDA's preemption
clause plainly contemplated the subject of the effect of violations of (and
compliance with) state and federal requirements on the scope of
Thus, as just noted, Section 360k(b) authorizes the
federal government to exempt state requirements that are "required by compelling
local conditions" where "compliance with the [state] requirement would
not cause the device to be in violation of any applicable requirement
under this chapter." 21 U.S.C. §360k(b)(2)(B) (emphasis added).
In addition, Section 360h, which authorizes the
federal government to issue orders requiring manufacturers (among other things)
to make repairs, replace defective devices, or reimburse purchasers for the cost
of a device, also states:
Compliance with an order issued under this section
shall not relieve any person from liability under Federal or State law. In
awarding damages for economic loss in an action brought for the enforcement of
any such liability, the value to the plaintiff in such action of any remedy
provided him under such order shall be taken into
21 U.S.C. §360h(d). In view of these explicit
references in the statute to the issue of compliance, the absence of any mention
of a noncompliance exception in the MDA's preemption clause is all the more
Effect Of FDA Determination Of
The United States' amicus brief in
Talbott urged the First Circuit to recognize an exception to MDA
preemption where the FDA has made a determination that a manufacturer failed to
comply with federal requirements.
According to the United States, the fact of the FDA's
determination eliminates any concern about nonuniformity in the enforcement of
federal requirements. Relatedly, the Talbott plaintiffs argued that there
was no preemption because their claims were founded on proven violations of
federal law, as demonstrated by Bard's guilty plea.
The First Circuit rejected this exception as well,
reasoning, again, that "neither the language of §360k(a) nor the legislative
history give[s] any hint of congressional intent to create such a unique
exception to the MDA's preemption clause." Talbott, 63 F.3d at
The court stressed the absence of a private right of
action under the MDA. In declining to recognize the exception urged by the
United States, however, the Talbott court stated that this exception "may
be a workable arrangement" and "may or may not be . . . a desirable rule, from a
policy standpoint." Ibid. These statements contrasted sharply with the
court of appeals' characterization as "unwieldy" (id. at 29) of the
claimed exception for state requirements that are identical to federal
requirements (discussed below).
The First Circuit was correct to reject the variation
of the noncompliance argument pressed by the government. The exception finds no
support in the language of the MDA's preemption clause.
As explained above, the fact that the statute
elsewhere mentions compliance shows that Congress thought about the issue but
did not intend to create an exception to MDA preemption for
Indeed, this argument is even stronger with respect
to the government's version of the noncompliance argument. The exception allowed
by Congress under Section 360k(b), after all, empowers the federal government to
grant exceptions to states under limited circumstances.
Thus, Congress obviously thought about and provided
for a method by which the FDA, through its actions, could exempt state standards
from MDA preemption. But Section 360k(b) does not authorize the FDA to
create an exemption simply by finding that a particular defendant violated
federal requirements applicable to the device.
Difficulties With Government
Although the First Circuit reached the correct
result, it appears to have seriously underestimated the practical difficulties
that the government's rule would entail.
The government's suggestion that there need only be a
"judgment" or "finding" by the FDA would, of course, invite plaintiffs to seize
on any statement in FDA correspondence with manufacturers, inspection reports,
or other informal agency communications or documents that might suggest that the
manufacturer or the device has failed to comply with some federal requirement,
in order to preserve their claims from preemption.
It would also invite a deluge of inquiries to the
agency by plaintiffs concerning "judgments" the agency may have made but not
The government in its brief did not explain what is
meant by a "judgment" or what would happen if an FDA "judgment" leading to the
initiation of a civil or criminal proceeding were subsequently rejected by a
court or jury. Would the shield of preemption be applied
Although at first glance the plaintiffs' argument
based on Bard's plea agreement might appear to avoid these difficulties, in fact
it does not.
A considerable portion of the parties' briefs in the
First Circuit was devoted to discussing the significance of the Bard plea
agreement and what violations of federal law had, in fact, been
Thus, although plaintiffs noted that Bard illegally
redesigned its catheter and sold it to the public, the catheter used in the
particular angioplasty operation at issue in Talbott was not one of the
Defendants accordingly maintained that the violations
of federal law to which Bard pleaded guilty were not relevant to the
In addition, the parties disputed the precise meaning
and significance of Bard's plea agreement. Regardless of who was correct in
these disputes, this disagreement demonstrates the kind of thorny problems that
courts could face under plaintiffs' formulation of this
Finally, acceptance of the government's argument (or
for that matter the fraud-on-the-FDA variation) would require courts applying
the MDA preemption clause to engage in a time-consuming and complex inquiry into
the precise relationship between the federal requirements that were violated and
the defect or risk that forms the basis of the plaintiff's tort
This is so because even if a plaintiff is suing to
recover for an injury that was caused by a product that violated federal
requirements, it makes no sense to remove the shield of preemption unless the
federal violation somehow increased the risk that forms the basis of the
For example, if a manufacturer violates the federal
premarketing approval regulations by submitting an application for a Class III
device that fails to include in "separate sections" data on nonclinical
laboratory studies and on clinical studies (21 C.F.R. §814.20(b)(2)), the
manufacturer could not through this de minimis infraction lose the shield
of preemption for all claims of design defect, failure to warn, and so
Cf. Restatement (Third) of Torts: Products
Liability, §7 cmt. c (Tentative Draft No. 2, Mar. 13, 1995) (in describing
effect on liability of defendant's compliance or noncompliance with safety
standards, noting that "the safety statute or regulation must be such that
compliance reduces the risk that caused the harm in the actual
Such an inquiry into the relationship between risks
that form the basis for the plaintiff's claims and requirements imposed by
federal law would be cumbersome and difficult.
Where State And Federal Standards Are
In Talbott, the plaintiffs also argued that
the MDA does not preempt state-law claims that embody requirements that are
identical to federal requirements.
Plaintiffs maintained that a state-law tort claim
would not impose any requirement that is "different from, or in addition to"
federal requirements within the meaning of Section 360k(a)'s preemption clause
":so long as the state judge instructs the jury that a manufacturer's
obligations under state tort law were defined by the provisions of the MDA."
Talbott, 63 F.3d at 29.
Notably, this last version of the noncompliance
argument is somewhat different from the other two. It more closely resembles a
traditional preemption argument. The argument, after all, seeks to win
recognition not so much of an exception to preemption under Section 360k(a) as
of a limitation on the scope of Section 360k(a) itself.
Nonetheless, to prevail on a tort claim spared from
preemption under this theory, the plaintiff would be required to show that the
defendant failed to comply with a federal requirement. Otherwise, the
plaintiff's claims would fail — not for preemption, but for lack of
The First Circuit in Talbott rejected this
argument as well. In rejecting "[t]his theory of cooperative preemption," the
court of appeals relied on dictum on a previous First Circuit case: "’We find
nothing to support that Congress intended such a radical, unwieldy form of
preemption . . . particularly where Congress did not intend to create a private
right of action under the Federal Food, Drug, and Cosmetic Act.’"
Talbott, 63 F.3d at 29 (quoting Mendes v. Medtronic, 18
F.3d at 19 n.4).
The First Circuit also relied on recent decisions
from the Third and Eleventh Circuits rejecting this argument. See Lohr v.
Medtronic Inc., 56 F.3d 1335, 1343 (11th Cir. 1995) ("[T]he MDA cannot be
defeated by a common-law suit alleging a violation of the [federal] statutory
standards"), petition for cert. filed, 64 U.S.L.W. 3360 (Nov. 13, 1995) (No.
95-754); Michael, 46 F.3d at 1329 (same).
FIFRA Case To The Contrary
This position has not met with universal acceptance,
however. At least one other court of appeals has endorsed a contrary position in
a case involving FIFRA, a statute that, like the MDA, preempts state labeling
requirements that are "in addition to or different from" labeling requirements
imposed by federal law.
See 7 U.S.C. §136v(b) (forbidding states to "impose
or continue in effect any requirements for labeling or packaging" of federally
registered pesticides that are "in addition to or different from" federal
In Worm v. American Cyanamid Co., 970
F.2d 1301 (1992), the Fourth Circuit held that "if the Maryland common law
recognizes a tort based on breach of a federally imposed standard, the
[plaintiffs] would be able to pursue that claim without conflicting with federal
law." Id. at 1308.
The Fourth Circuit explained that states remain free
to impose identical standards through their tort law "even if the state law
provides compensation or other remedies for a violation." Id. at
See also Moss v. Parks, 985 F. 2d 736,
740 (4th Cir.) (reaching same result under the differently worded preemption
clause of the Federal Hazardous Substances Act, 15 U.S.C. §1261), cert. denied,
113 S. Ct. 2999 (1993).
The Fourth Circuit would almost certainly apply this
reasoning to a case involving the MDA. See Duvall v.
Bristol-Myers-Squibb Corp., 65 F.3d 392, 400-01 & n. 8 (4th Cir.
1995) (declining in MDA case to distinguish subsequent opinion in Worm
because the "in addition to or different from" language of FIFRA and MDA are
"virtually identical"), petition for cert. filed, 64 U.S.L.W. 3439 (Dec. 22,
1995) (No. 95-1010).
The Eighth Circuit, moreover, recently relied on
Worm and Moss in an MDA preemption case involving a tampon, a
Class II medical device subject to less extensive regulatory oversight than
Class III devices. See National Bank of Commerce v. Kimberly-Clark
Corp., 38 F.3d 988 (8th Cir. 1994).
The Eighth Circuit agreed that, "when a statute [such
as the MDA] preempts state requirements that are different from and in addition
to those imposed by federal law, plaintiffs may still recover under state tort
law when defendants fail to comply with the federal requirements." Id. at
993. See also id. at 992 n.2 (explaining that "the FDA regulations simply
serve as the standard by which to measure defendant's
At least one of the panel members, however, was of
the view that this rule would not apply to a Class III device. See id. at
994 (Heaney, J.) (stating that if tampons were reclassified as Class III
devices, this would "preempt any possible claim for failure to comply [with
federal regulations] under state law").
The remaining two members of the panel went on to
conclude that the plaintiff's claims for failure to warn and inadequate labeling
were preempted because there had been no violation of federal law: the
FDA had in fact approved Kimberly-Clark's labeling. Id. at 998-99
(Loken, J., joined by Fagg, J., concurring).
That disposition arguably rendered unnecessary the
Eighth Circuit's discussion of whether preemption might apply to a claim based
on a violation of a federal requirement.
Even more important, the Seventh Circuit recently
endorsed the analysis of National Bank of Commerce and expressly
disagreed with the holding of Talbott and Lohr.
In Mitchell v. Collagen Corp., 67 F.3d
1268 (7th Cir. 1995), the court of appeals had this to say about the First
Circuit's reasoning in Talbott:
When the claim is that a particular product is
adulterated because it does not comply with standards explicitly established by
the FDA or that a particular label does not comply with standards explicitly
established by the FDA, the correctness of this approach is not self-evident. In
such circumstances, the existence of the FDA-approved paradigm appears to ensure
that state law cannot impose requirements "different from or in addition to"
federal law. The Eighth Circuit has stated that, "when a statute only preempts
state requirements that are different from and in addition to those imposed by
federal law, plaintiffs may still recover under state tort law when defendants
fail to comply with the federal requirements." . . . In the absence of more
explicit legislative or regulatory direction, we hesitate to say, therefore,
that an adulteration claim based on a product's failure to meet PMA
standards—standards that have been explicitly set forth by the FDA — does not
survive MDA preemption. Such a claim seeks merely to enforce the federal
standard, not to add requirements "different from, or in addition to"
Id. at 1281-1282. (footnote omitted). The
court went on, however, to uphold summary judgment in the defendant's favor on
these claims. Id. at 1282-83.
Other State And Federal
Other state and federal courts have reached the same
conclusion with respect to the validity of this third variant of the
At least one district court recently cited
National Bank of Commerce with approval in a case involving a Class II
device (a tampon) and held that "plaintiffs may maintain a claim for inadequate
warnings so long as such claim is premised on the warning requirements
established by the FDA." Forrester v. Playtex Family Products
Corp., 1995 U.S. Dist. LEXIS 13371, at *14 (N.D. Ill. Sept. 12,
In addition, a California intermediate appellate
court has held that "[s]tate actions which echo or attempt to enforce federal
standards" under the MDA "are not preempted" and that such violations of federal
requirements qualify as negligence "per se" under California law. Evraets
v. Intermedics Intraocular, Inc., 29 Cal. App. 4th 779, 792, 34 Cal.
Rptr. 2d 852, 859 (2d Dist. 1994). But see Scott v. Ciba Vision
Corp., 38 Cal. App. 4th 307, 324, 44 Cal. Rptr. 2d 902, 911-12 (6th Dist.
1995) (disagreeing with Evraets on this point).
The FDA itself has interpreted Section 360k as not
preempting "State or local requirements that are equal to, or substantially
identical to, requirements imposed by or under the act." 21 C.F.R. §808.1(d)(2)
Notably, the vast majority of the courts that have
considered the third version of the noncompliance argument have overlooked this
FDA interpretation. But see Mitchell, 67 F.3d at 1282 n. 9;
Evraets, 29 Cal. App. 4th at 792, 34 Cal. Rptr. 2d at
Assuming that a court should defer under
Chevron to an agency's interpretation of an express preemption clause
(see note 8, supra), this aspect of the FDA's interpretation of Section
360k (like some others, see note 3, supra) would not warrant deference
because it departs from the plain language of the MDA's preemption
There is simply no way, for example, to reconcile
with the statutory language the FDA's statement that a state requirement can
survive preemption if it is substantially identical to a federal
requirement applicable to a medical device.
A "substantially" identical requirement would be
"different from" the federal requirement and thus preempted under Section
Equally untenable is the FDA's view that a state
requirement that is "equal to" a federal requirement is spared from preemption
under Section 360k. For several reasons, that interpretation of the preemption
clause — and the conclusions of the courts in National Bank of Commerce,
Mitchell, Worm, and Moss — are open to serious
Most importantly, the FDA's interpretation is
inconsistent with the plain language of the statute. Section 360k(a) preempts
"any [state] 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(a) (emphasis added).
But a state law that embodies a standard identical to
a federal standard clearly imposes a requirement "in addition to" the federal
requirement (just as, for example, a second coat of paint of the same color as
the first would be "in addition to" the first coat).
The manufacturer's obligation or duty to comply is
completely independent of any federal-law obligation.
A contrary interpretation, moreover, would read the
phrase "in addition to" out of Section 360k(a), since the companion phrase
"different from" already accomplishes the preemption of all qualifying state
requirements that are not identical to the federal requirements. See generally
United States Department of Treasury v. Fabe, 113 S. Ct. 2202,
2210 n.6 (1993) (each word of a statute must be given meaning).
Alternative Basis for Rejecting
There is another textual basis in the statute for
rejecting this variation of the noncompliance argument. As noted previously, the
MDA preemption clause permits states to apply to the FDA for an exemption from
preemption. 21 U.S.C. §360k(b).
The statute recognizes two possible grounds for such
an exemption. The first is where the state requirement "is more stringent than a
requirement under this chapter which would be applicable if an exemption were
not in effect under this subsection." Id. §360k(b)(1).
The second basis on which an exemption may be
obtained is for a state requirement that is both (1) "required by compelling
local conditions" and (2) such that "compliance with the requirement
would not cause the device to be in violation of any applicable requirement
under this chapter." Id. at §360k(b)(2).
But whenever a state requirement is "identical" to a
federal requirement, the latter condition will be satisfied.
If identical state requirements are exempt from
preemption, it is difficult to see why Congress would have required states to
take the trouble of seeking an exemption and of making the further showing that
the identical state requirement is "required by compelling local
Preserving State-Law Claims
Congress, moreover, clearly knows how to preserve
from preemption state-law claims that impose requirements identical to those in
See, e.g., Radiation Control for Health and
Safety Act, 21 U.S.C. §360ss ("Whenever any [federal] standard prescribed . . .
with respect to an aspect of performance of an electronic product is in effect,
no State or political subdivision of a State shall have any authority either to
establish, or to continue in effect, any standard which is applicable to the
same aspect of performance of such product and which is not identical to the
Federal Standard.") (emphasis added); National Traffic and Motor Vehicle
Safety Act, 49 U.S.C. §30103(b) (formerly 15 U.S.C. §1392(d)) ("When a motor
vehicle safety standard is in effect under this chapter, a State or a political
subdivision of State may prescribe or continue in effect a standard applicable
to the same aspect of performance . . . only if the standard is identical to
the standard prescribed under this chapter.") (emphasis added); Federal Boat
Safety Act, 46 U.S.C. §4306 ("Unless permitted by the Secretary . . ., a State
or political subdivision of a State may not establish, continue in force, or
enforce a law or regulation establishing a recreational vessel or associated
equipment performance or other safety standard . . . that is not identical to
a regulation prescribed under section 4302 of this title.") (emphasis
added); see also 15 U.S.C. §§1476(a), §2075(a), 2617(a)(2)(B); 21 U.S.C.
But see Moss, 985 F.2d at 740 & n. 3
(stating that these two formulations are coextensive); Duvall, 65 F.3d at
Congress did not include similar language in the
preemption clause of the MDA (or FIFRA). Indeed, an earlier version of the MDA's
preemption clause (contained in a bill that Congress did not enact) did spare
from preemption state requirements that were "identical to the Federal
See S. 510, §704, 94th Cong., 1st Sess. (passed
Senate Apr. 17, 1975). Congress's rejection of this language in favor of the
broader language contained in the MDA militates strongly against the plaintiffs'
Damages As 'Requirements'
In addition, even if a state tort duty imposes a
standard that is absolutely identical to that embodied in a federal safety
requirement, a private lawsuit seeking to force a defendant to pay
damages plainly imposes a requirement that is "different from, or in
addition to" requirements imposed by federal law.
Given the absence of a private right of action under
the MDA, federal law imposes no requirement similar to the obligation to
Thus, a private tort action cannot, by its terms,
impose requirements that are identical to those imposed by the FDA's
regulations. But see Worm, 970 F.2d at 1307 (holding that states remain
free under FIFRA to impose identical standards through their tort law "even if
the state law provides compensation or other remedies for a
As the First Circuit in Talbott recognized,
moreover, the fact that Congress declined to recognize a private right of action
under the MDA undermines as well the argument that Congress meant to exempt from
preemption state requirements that are identical to federal
Congress's failure to include any private right of
action reflects a determination to vest in "the FDA and other agencies of the
United States government" the exclusive authority to assert a claim that federal
standards have been violated. Talbott, 865 F. Supp. at
It is most unlikely that Congress intended to
foreclose private enforcement of federal norms but to allow states to permit
such private enforcement of identical norms under state law.
In any event, there is no guarantee that a lay jury
or state judge resolving ambiguities concerning the precise scope or
applicability of an identical state norm would reach the same conclusions as
would the FDA concerning the identical federal requirement.
Finally, interpreting Section 360k as exempting
"identical" state requirements would give rise to far greater practical
difficulties than does a similar exemption under statutes (such as FIFRA) that
preempt only labeling and packaging requirements (or for that matter under
statutes that allow states to enforce identical performance and safety
In the latter situations, it is relatively easy to
identify a label or warning or design feature mandated by federal law and to
permit state failure-to-warn or design defect claims based on the manufacturer's
noncompliance with the federal requirement.
See also Mitchell, 1995 U.S. App. LEXIS 27709,
at *32 (using as examples of kinds of claim where problems of administrability
do not arise (1) state-law defective warning claims that are based on warnings
identical to those required by federal law, and (2) design defect cases based on
federal safety standards).
The Talbott case is significant because it
illustrates the kinds of arguments that are increasingly being made in
preemption cases for exceptions based on a defendant's noncompliance with
otherwise-preemptive federal requirements.
The case is also an important doctrinal advance
because it establishes in the First Circuit that these arguments are lacking in
merit. But as the foregoing discussion makes clear, the courts are in
disagreement over the validity of the various "noncompliance" exceptions to
preemption under the MDA.
The fact that the United States government filed an
amicus brief in Talbott in support of one version of the
noncompliance argument is significant because it may reflect either a decision
to press this theory in other preemption contexts or a disagreement with the
broad preemptive reading given by most courts to the MDA.
In any event, it suggests that the validity of
noncompliance exceptions will continue to be litigated in the state and federal
Kenneth Geller is the managing partner of the
Washington, D.C. office of Mayer, Brown & Platt. In Talbott v. C.R. Bard, Inc., 63 F.3d
25, 23 PSLR 880 (1st Cir. 1995), the authors submitted a brief on behalf of the
Product Liability Advisory Council, Inc. as amicus curiae in support of
the prevailing device manufacturer. Back to
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