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  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
TO FEDERAL PREEMPTION?

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 objectives.

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 law.

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 statutes.

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 federal requirements.

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 MDA.

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.

The 'Talbott' Case

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 practices.

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.

21 U.S.C. §360k(a).

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 Preemption

The issue of compliance with federal safety standards frequently arises in product liability and other tort litigation.

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 statutory duty.

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 explained:

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 federal law.

Criminal Prosecution

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 malfunctioning.

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 MDA.

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 contexts.

A Fraud-On-The-FDA Exception to MDA Preemption'

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 law.

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.

Id. at 29.

Practical Considerations

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 explained,

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 law.

Talbott, 63 F.3d at 29.

"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 Cases

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. 1994).

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 manufacturing specifications").

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 withheld information.

Would the FDA have deemed the withheld information a violation of its disclosure requirements? Would it have approved the device anyway?

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 law.

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 appeals explained:

[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.

46 F.3d at 1329.

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 innovation.

Affirmative Evidence Of Intent

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 preemption.

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 account.

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 telling.

Effect Of FDA Determination Of Noncompliance

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 30.

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 noncompliance.

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 Rule

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 disclosed.

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 retroactively?

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 admitted.

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 redesigned devices.

Defendants accordingly maintained that the violations of federal law to which Bard pleaded guilty were not relevant to the Talbott litigation.

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 exception.

Complex Inquiry

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 claim.

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 plaintiff's claim.

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 on.

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 case").

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 Identical

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 proof.

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 requirements).

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 1307.

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).

Eighth Circuit Ruling

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 conduct").

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.

Seventh Circuit Ruling

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" it.

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 Courts

Other state and federal courts have reached the same conclusion with respect to the validity of this third variant of the noncompliance argument.

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, 1995).

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).

FDA Interpretation

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) (1995).

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 859.

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 provision.

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 360k.

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 doubt.

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 Argument

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 conditions."

Preserving State-Law Claims

Congress, moreover, clearly knows how to preserve from preemption state-law claims that impose requirements identical to those in federal law.

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. §343-1(a)(1).

But see Moss, 985 F.2d at 740 & n. 3 (stating that these two formulations are coextensive); Duvall, 65 F.3d at 400.

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 requirements."

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' argument.

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 pay damages.

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 violation").

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 requirements.

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 47.

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.

Practical Difficulties

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 standards).

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).

Conclusion

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 courts.


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 Article

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