PREEMPTION AFTER BUCKMAN: STATE LAW FAILURE TO WARN CLAIMS BASED ON LACK OF DISCLOSURE TO THE FDA.

• Author: Zogaib, Grace M.

INTRODUCTION

Amidst cries for tort reform (1) and the ongoing "preemption war" that has taken the courts by storm, (2) an atmosphere of unease has settled over the American public regarding the rise of the administrative state and the expansive power of federal bureaucracies. (3) The subject of intense controversy, the scope of administrative agency control stretches beyond abstract theoretical and political debate, generating practical ramifications against the backdrop of a shocking increase in medical device injuries over the turn of the twenty-first century. (4) At the convergence of these seemingly independent issues lies an unassuming point of contention: state tort failure to warn claims based on lack of disclosure to the Food and Drug Administration (FDA). (5)

As a federal administrative agency, the FDA oversees the operation of the national regulatory system for medical devices, promulgating a set of reporting requirements that manufacturers must comply with prior to gaining product approval. (6) Such compliance is not always forthcoming, however, and numerous manufacturers have submitted reports containing fraudulent material to the FDA. (7) Such was the case presented in the seminal Supreme Court case, Buckman Company v. Plaintiffs' Legal Committee. (8) Therein, the Court concluded that the plaintiffs' cause of action for "fraud-on-the-FDA" was impliedly preempted under the Medical Device Amendments. (9) Lower courts have subsequently grappled with application of Buckman's rationale to state tort failure to warn claims premised, in part, on lack of disclosure to the FDA. (10) This application has come to yield inconsistent results, leading to a split amongst the federal circuit courts as to whether these failure to warn claims based on lack of disclosure are impliedly preempted under Buckman. (11)

This Note demonstrates that these state tort claims cannot be impliedly preempted under Buckman. Evaluation of the Supreme Court's opinion in Buckman reveals that its preemption analysis ought to be narrowly construed to apply only to fraud on the FDA claims, which are distinct from state law failure to warn claims based on lack of disclosure. (12) Acceptance of this proposition is consistent with broader policy considerations, namely, the critical role tort liability plays with regards to medical device users and manufacturers, and the preservation of the separation of powers as established by constitutional design. (13)

Part I will provide an overview of the relevant Supreme Court jurisprudence, including a brief explanation of the doctrine of federal preemption, the specific preemption framework under the Federal Food, Drug, and Cosmetic Act (FDCA), and the Supreme Court's opinion in Buckman.

Part II will examine the present circuit split and the corresponding rationales of the federal courts from both sides of the preemption divide.

Part III argues that the split ought to be resolved in favor of not preempting state law failure to warn claims premised on lack of disclosure to the FDA, supported by both the legal argument and the broader policy considerations. This section will conclude by addressing and subsequently dismissing competing policy concerns.

1. RELEVANT SUPREME COURT JURISPRUDENCE

   1. The Doctrine of Federal Preemption

      The Supremacy Clause of the United States Constitution lies at the heart of the doctrine of federal preemption, invalidating "state laws that 'interfere with, or are contrary to,' federal law." (14) The preemption analysis rests upon two fundamental "cornerstones:" first, that "the purpose of Congress is the ultimate touchstone in every pre-emption case;" (15) second, "all pre-emption cases, and particularly in those in which Congress has 'legislated... in a field which the States have traditionally occupied,'" require that the analysis begin "with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." (16) The principle necessitating this assumption is protection of "the federal-state balance," ensuring that it will be neither inadvertently upset nor needlessly disrupted by Congress and the Judiciary. (17)

      Because the purpose of Congress may be explicitly promulgated through statutory language, or implicitly manifested through a statute's structure and design, (18) the Supreme Court has come to identify two main types of preemption: express and implied. (19) Express preemption arises "when Congress specifies in a federal statute... the extent to which it intends that the statute... is to oust state power." (20) Implied preemption, which takes on multiple forms, (21) exists where state and federal law are incompatible, nullifying state law "to the extent that it actually conflicts with federal law." (22) Notably, administrative agency action qualifies as federal law for purposes of preemption, (23) effectively permitting unelected administrative officials to specify the degree to which agency regulation will undercut and thereby invalidate state law.

   2. Preemption Framework under the FDCA

      In response to "public outcry" for increased regulation of medical devices following a tragic "series of medical device failures in the early 1970s," Congress enacted the Medical Device Amendments (MDA) with the goal of providing greater consumer protection. (24) The MDA functions as an amendment to the FDCA, (25) giving the FDA the authority to develop and maintain a regulatory system for medical devices. (26) Within the MDA is an express preemption provision, 21 U.S.C. [section] 360k(a), which provides that the states may not establish any requirement that is "different from, or in addition to," any applicable MDA requirements. (27) The Supreme Court has also read [section] 337(a) of the Act to impliedly preempt state law, holding out the provision as "clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government." (28) Specifically, this MDA provision states that "all... proceedings for the enforcement... of this [chapter] shall be by and in the name of the United States." (29) Thus, state law claims that rest solely on noncompliance with the MDA are impliedly preempted because authorization to file such suits lies with "the Federal Government rather than private litigants." (30) In other words, implied preemption operates to bar a claim that "seek[s] to privately enforce... dut[ies] owed to the FDA," regardless of how the litigant labels such a claim. (31) A state law claim may, however, escape both forms of preemption where the plaintiff sues "for conduct that violates a federal requirement (avoiding express preemption)," but does not sue "only because the conduct violates that federal requirement (avoiding implied preemption)." (32)

   3. Buckman Company v. Plaintiffs' Legal Committee

      In 2001, the Supreme Court in Buckman Company v. Plaintiffs' Legal Committee undertook the challenge of applying the federal preemption doctrine to a newly emerging (33) state law tort claim: fraud on the FDA. (34) In Buckman, the plaintiffs suffered injuries from implantation of orthopedic bone screws and sought to hold the manufacturer's consulting company liable. (35) Specifically, the plaintiffs claimed that the consulting company made fraudulent representations to the FDA in order to gain market approval for the screws. (36) These representations, in turn, caused the plaintiffs' injuries. (37) In other words, "[h]ad the representations not been made, the FDA would not have approved the devices, and plaintiffs would not have been injured." (38) Despite the noticeable absence of relief for the plaintiffs injured as a result of fraudulent representations to federal agencies, (39) the Court ultimately found that such claims are impliedly preempted. (40) Placing great emphasis on the federal and statutory framework under which the FDA operates, the Court laid out four main considerations in support of its conclusion. (41)

      First, it observed that the FDA is vested with ample authority "to punish and deter fraud against the Agency...." (42) Not only does the comprehensive application process include disclosure requirements designed to "detect[], deter[], and punish[] false statements made during... [the] approval processes," but the FDA also has a "variety of enforcement options," such as injunctive relief, civil and criminal penalties, or even seizure of the medical device. (43)

      Second, the Court highlighted the need for flexibility and discretion in employing these enforcement options within the "statutory and regulatory framework" so as to maintain a "delicate balance of statutory objectives." (44) It reasoned that state law fraud on the FDA claims would hinder the FDA's ability to "police fraud consistently with the Agency's judgment and objectives," an apparent conflict warranting implied preemption. (45)

      Third, the Court noted that as a "practical matter," allowing fraud on the FDA claims would increase the burdens on both medical device applicants and the FDA itself, (46) which was contrary to Congressional intent. (47) Permitting each state to determine the adequacy of an applicant's disclosure would expose applicants who had gained FDA approval to "unpredictable civil liability." (48) Further, in an effort to avoid liability, applicants may "submit a deluge of information" to the FDA, leading to greater burdens on the FDA and impedance of the evaluation process. (49)

      Fourth, the Court homed in on the fact that state law fraud on the FDA claims "exist solely by virtue of FDCA disclosure requirements," rather than "traditional state tort law which had predated the federal enactments in question[]." (50) Consequently, fraud on the FDA claims would effectively permit private enforcement of FDCA provisions, a function to be exercised exclusively by the United States, as evidenced by the statutory text of 21 U.S.C. [section] 337(a). (51)

      Notably...