On June 23, 2014, the Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, No. 12-1351, 2014 WL 2807193 (June 23, 2013). In doing so, it declined to resolve a deepening circuit split and let stand an en banc decision by the U.S. Court of Appeals for the Ninth Circuit holding that the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetics Act (FDCA) do not preempt for state-law claims based on a failure to report adverse information to FDA.
In Stengel v. Medtronic, Inc., Plaintiffs alleged that Medtronic had failed to report to the FDA information about known risks associated with one of its devices, even though it was required to do so under the MDA. 704 F.3d 1224, 1226 (9th Cir. 2013) ( en banc). The district court found that the proposed amendment was preempted under Buckman v. Plaintiff's Legal Committee, 531 U.S. 341 (2001), which held that the MDA impliedly preempted state law claims alleging misrepresentations to the FDA. Id. A divided Ninth Circuit panel affirmed. Stengel, 704 F.3d at 1226. But, the Ninth Circuit granted rehearing en banc and reversed. The Ninth Circuit held that Plaintiffs' "failure to report" theory could state a "parallel" claim because it "specifically alleges, as a violation of Arizona law, a failure to warn the FDA [and that] Arizona law contemplates a warning to a third party such as the FDA." Id. at 1233. The court summarily distinguished Buckman stating that Plaintiffs' statelaw claim did not concern the FDA's pre-market approval process at issue in Buckman. Id. A more in-depth analysis of the Ninth Circuit's en banc decision is available here.
By denying certiorari, the Supreme Court rejected an invitation to resolve a significant circuit split. The Fifth and Ninth Circuits have held that Buckman does not preempt claims premised on a failure-to-report adverse events to FDA, but the Sixth and Eighth Circuits have reached the opposite conclusion. Compare id. and Hughes v. Bos. Scientific Corp., 631 F.3d 762 (5th Cir. 2011), with In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) and Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005). Until the Supreme Court weighs in on this issue, medical device manufacturers will face varying law in different parts of the country on this important issue.