Supreme Court Deadlock on Whether Michigan “Fraud-on-the-FDA” Exception is Pre-empted Under Buckman

March 4, 2008

“The tie goes to the runner” or in this case to the Michigan plaintiffs who are allowed to advance their products liability claims involving the diabetes drug, Rezulin. Yesterday, in a 4-4 split decision, the U.S. Supreme Court affirmed the judgment of the Second Circuit, which found no pre-emption of plaintiffs’ common law claims based on a Michigan statute which requires plaintiffs to prove fraud on the FDA when the drug is FDA-approved or compliant. Warner-Lambert Co. LLC, et al. v. Kent, et al. (formerly Desiano), __S. Ct. __, 2008 WL 552875 (U.S.). This decision is the second in a trilogy of FDA pre-emption cases considered by the Court this term. Chief Justice Roberts’ recusal created the potential for a deadlock.

Although the two-sentence per curiam opinion (handed down just one week after oral argument) provides no precedential value, it heightens the anticipation of the Court’s decision in the third FDA pre emption case that the Court will hear this fall, Wyeth v. Levine, U.S. Supreme Court No. 06-1249. The issue in Levine is whether FDA approval of prescription drug labeling provides a pre-emption defense to state law products liability actions.

The issue presented in Kent was whether implied pre-emption of state-law fraud-on-the-FDA claims articulated in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (“Buckman”) is limited to express claims of fraud-on-the-FDA or whether Buckman extends to traditional tort causes of action that require the fact-finder to determine whether the manufacturer withheld material information from or misled the FDA. Under a Michigan statute, FDA approval provides an absolute defense with an important exception. M.C.L. § 600. 2946(5)(a). If the manufacturer or seller intentionally withholds from or misrepresents to the FDA information that is required to be submitted under the FDCA and the drug would not have been approved or the FDA would have withdrawn approval if the information were accurately submitted, plaintiff may recover under common law. Id. The District Court found that the fraud-on-the-FDA exception to immunity for FDA-approved drugs was pre-empted under Buckman. The Second Circuit reversed, limiting implied pre-emption under Buckman to express “fraud-on-the-FDA” theories of liability. See Desiano, 467 F.3d at 98. Applying a presumption against pre-emption, the Second Circuit held that, absent a clear statement from Congress, the common law claims preserved by the immunity exception are not pre-empted.

The Supreme Court’s split decision in Kent leaves intact the Second Circuit’s no pre-emption ruling.