The issue of whether a state law “fraud-on-the-FDA” claim is preempted by federal law will find its way back to the Sixth Circuit in the matter of Tiefenthal v. Genentech, Inc. et seq., in which the plaintiff seeks review of a decision from the District Court for the Western District of Michigan holding that the “fraud-on-the-FDA” exception to the immunity afforded pharmaceutical manufacturers under Michigan’s products liability statute (Mich. Comp. Laws § 600.2946) is impliedly preempted by the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.

The District Court’s decision raises an important question that has deeply divided the circuits and previously made its way to the Supreme Court.  The issue is this:  in  Buckman Co. v. Pl.’s Legal Comm., 531 U.S. 341, 350 (2001), the Supreme Court held “[s]tate law fraud-on-the-FDA claims inevitably conflict with the FDA’s responsibility to police fraud consistently with the Agency’s judgment and objectives.”  Several states, including Michigan, have statutes that preempt tort liability for pharmaceutical companies, except in cases where the company committed a fraud on the FDA.  Previously, the Sixth Circuit held that under Michigan’s statute, Buckman foreclosed tort claims against pharmaceutical companies.  See Garcia v. Wyeth v. Ayerst Laboratories, 385 F.3d 961, 965-66 (6th Cir. 2004) (“Buckman teaches that state tort remedies requiring proof of fraud committed against the FDA are foreclosed since federal law preempts such claims.”)  The Second Circuit disagreed in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).  The Supreme Court granted certiorari in Desaiano to resolve the circuit split, but split 4-4, resulting in affirmance.

In Tiefenthal, the District Court held that Buckman, and therefore Garcia, prohibit a plaintiff from invoking the exceptions on the basis of state court findings of fraud; however, the State statutory exception would still apply where a federal determination of fraud had been made.  With Tiefenthal on appeal, the Sixth Circuit will once again have the opportunity to weigh in on this issue, to which the pharmaceutical industry will be paying close attention.