Warner-Lambert Co. v. Kent

Statutory Background

Under the Food, Drug, and Cosmetic Act ("FDCA"), before a manufacturer can release a new drug on the market, the manufacturer must file a New Drug Application ("NDA") with the Food and Drug Administration ("FDA"). Brief for Petitioner at 4. The NDA must furnish a full report providing the FDA with the information it needs to determine the drug's safety and effectiveness. Brief for Respondents at 3. The FDA will approve the NDA, unless it finds specific grounds for denying the application.� Id. at 3.� However, the U.S. Supreme Court has found that the FDA has discretion in enforcing the FDCA.� Brief for Petitionerat 9-10.�

In 1995, the State of Michigan enacted Mich. Comp. Law � 600.2946(5)� ("Michigan Statute"), which absolves drug manufacturers of tort liability if the FDA approved the drug and manufacturers complied with all of the terms of the approval. Brief for Respondents at 9.� However, the Michigan Statute withdraws this defense from the manufacturer if the plaintiff proves that (i) the manufacturer intentionally withheld or misrepresented information required under the FDCA and that (ii) the FDA would not have approved the drug application if the manufacturer had accurately submitted the omitted or misrepresented information. Brief for Petitioner at 12.

Applicability of Buckman Co. v. Plaintiffs' Legal Comm.

In Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), the Supreme Court held that state-law claims based on fraudulent misrepresentations to the FDA ("fraud on the FDA claims") are preempted by federal law. 531 U.S. at 341.The Court held that there is no presumption against federal preemption, given the fundamental federal character of the relationship between the FDA and regulated companies. 531 U.S. at 347. Injecting state law would compromise this federal relationship, the Court reasoned, by disrupting the balance of statutory FDA objectives, burdening manufacturers with a patchwork of state tort regimes, and obstructing the FDA's review process through the resulting flood of information. 531 U.S. at 350-52.

In the present case, the courts below disagreed whether Buckman controlled.� The District Court for the Southern District of New York found that federal law preempted the Michigan Statute. Brief for Petitioner at 17. The District Court reasoned that although the Statute did not expressly create a state claim for fraud on the FDA, it implicitly achieved the same prohibited result by authorizing plaintiffs to plead and prove such fraud to a jury. Id. The Second Circuit Court of Appeals reversed, finding that the Michigan statutory exception was not preempted.� Id.� Unlike the statute in Buckman, the Second Circuit argued, the Michigan Statute did not create an independent state claim for fraud on the FDA. Id.; Brief for Respondents at 11. Rather, the Statute only placed a condition on plaintiffs' freedom to recover under traditional state tort law. Brief for Respondents at 11.

The parties also disagree over whether Buckman is controlling in this case. The Michigan plaintiffsclaim that unlike the Buckman statute, the Michigan Statute does not punish or deter fraud against the FDA. Brief for Respondents at 22. However, Warner-Lambert argues that this distinction is insignificant because both causes of action impermissibly permit state courts to infringe on the FDA's exclusive authority over federal disclosure requirements. Brief for Petitioner at 45-46.

Additionally, the Michigan plaintiffs argue that, unlike the Buckman plaintiffs, they are asserting traditional common-law tort claims that pre-date and operate independently from the FDCA. Brief for Respondents at 22. Warner-Lambert responds that the Buckman prohibition controls regardless of whether this action rests theoretically upon a distinct state-law claim. Brief for Petitioner at 43. In practice, Warner-Lambert urges, claims under the Michigan Statute could not go forward without improperly proving fraud on the FDA. Id. at 43.

Presumption Against Preemption

If a field of law falls within traditional state police powers, courts will apply a presumption against preemption by federal law. See e.g., Buckman, 531 U.S. at 347. The Second Circuit found that the Michigan Statute falls within traditional state police powers and therefore applied this presumption. See Brief for Petitioner at 38. Warner-Lambert argues that this presumption should not apply. Id. at 40. According to Warner-Lambert, the Michigan Statute in practice requires courts to monitor fraud against federal agencies, which Buckman found does not fall within states' protected police powers. Id. at 39. The Michigan plaintiffs counter that the Michigan Statute is an entirely separate type of claim than a "fraud on the FDA" claim because the Statute has a different objective. Brief for Respondents at 18-19.� Rather than aiming to police manufacturers' disclosures to the FDA, the Michigan Statute is a defense to an action aimed at protecting consumer health and safety, a traditional object of state police authority. Id. at 18.�

Warner-Lambert further argues that the Second Circuit erred because an anti-preemption presumption cannot apply if state law impedes regulation under a comprehensive federal scheme. Brief for Petitioner at 40. Warner-Lambert points to prior decisions by the Court, finding that there is no presumption that a concurrent regulation is a valid exercise of police power when the subject of regulation has a history of federal control. Id.at 40-41. According to Warner-Lambert, the federal government has a long and significant history of regulating drugs in the United States. Id. at 40. The Michigan plaintiffs counter with the Court's history of applying presumptions against preemption for state statutes that impliedly conflict with federal regulation. Brief for Respondents at 19n.4. Because the Michigan Statute is similar to these "implied conflict cases," the Court should apply the anti-preemption presumption. Id. at 21.�

Implied Preemption

Finally, the parties disagree over whether federal law implicitly preempts the Michigan Statute. Federal law will implicitly preempt state law when the state law conflicts, frustrates the purpose of, or imposes upon the exclusive authority of a federal statute. Brief for Petitioner at 22. Warner-Lambert claims that the Michigan Statute trespasses on the FDA's exclusive enforcement power for federal disclosure requirements. Id. at 23-24. The Michigan plaintiffs respond that the Statute does not impinge on FDA authority because it does not seek to impose liability because of misrepresentations to the FDA. Brief for Respondents at 30. Rather than police for compliance with the FDA, the Michigan Statute provides tort liability immunity if the manufacturer has complied with the FDA, but will not extend this immunity if the process has been corrupted. Id. at 30-31.�

Warner-Lambert argues that if the Court fails to find implied federal preemption, state tort-law claims will interfere with the FDA's ability to enforce the FDCA. Brief for Petitioner at 29. State tort-law litigation will unfairly burden manufacturers, who will submit excessive paperwork to the FDA to avoid liability. Id. at 32. This outcome will obstruct FDA attempts to limit disclosure to information necessary to enforce the FDCA. Id. at 32. The Michigan plaintiffs claim that these fears are misplaced because the Michigan Statute only applies to non-disclosures of information already required by FDCA. Brief for Respondents at 38.