As we reported earlier, Wyeth v. Wimbush was one of the first cases interpreting the Supreme Court’s decision in Wyeth v. Levine, and the first to extend Levine beyond failure to warn claims. Wyeth has now filed an en banc petition (pdf) challenging that decision.
Wyeth argues that the claim that it was negligent during the FDA approval process is no different from the “fraud-on-the-FDA” claims that the Supreme Court found preempted in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Buckman held that “fraud-on-the-FDA claims” would “cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the [FDA], will later be judged insufficient in state court,” leading to a “deluge” of information that the FDA “neither wants nor needs.” Id. at 351. Wyeth argues that there is some conflict between the panel’s decision and Buckman. Other FDA-regulated companies will be eager to see whether the full court tackles the question.
Wyeth also argues that the panel should not have addressed preemption because of two alternative arguments. One is that Ohio common law does not recognize a “negligent-bringing to market” claim, and the other is that plaintiff did not present evidence of negligence. These arguments are likely aimed at achieving a panel rehearing, since they are not usually a basis for en banc review. See 6 Cir. R. 35(c) (“Alleged errors in the determination of state law or in the facts of the case (including sufficient evidence) . . . are matters for panel rehearing but not for rehearing en banc.”).
Although the Sixth Circuit does not keep statistics what percentage of en banc petitions are granted, a statistical study by Pierre Bergeron in the Tennessee Law Review finds the number to be about two percent.