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1.7.2.1.5 “Fraud on the FDA” and reporting requirements

The Supreme Court also interpreted the statute in 2001 in Buckman Co. v. Plaintiffs’ Legal Committee,233 a case involving a “fraud-on-the-FDA” claim in which the plaintiffs were injured by a device that they claimed the FDA approved only because of false information submitted by the manufacturer. Even though the preemption clause in the statute did not apply, the Court held that such a claim was impliedly preempted because it conflicted with the FDA’s mission to police the medical device market and to maintain the delicate balance between protecting the public from unsafe devices and giving people access to devices that might help them. Buckman may not, however, immunize manufacturers from liability for misrepresentations made to consumers and physicians rather than to the FDA.234

The Eighth Circuit has held that Buckman also bars a claim based on a manufacturer’s failure to report adverse events to the FDA after the FDA had approved the particular medical device.235 The Fifth Circuit, however, allowed a failure to warn claim based on failure to report post-approval adverse events to proceed.236 It stressed that the adverse event reports would have been disseminated to the public, not just the FDA, and that the plaintiff’s claim did not depend on speculation that the FDA would have taken some particular regulatory action in response to the adverse event reports. The Ninth Circuit has agreed that neither Buckman nor the Supreme Court’s other decisions require preemption of a claim based on a manufacturer’s violation of a continuing duty under Arizona law to warn of dangers and report them to third parties such as the FDA, although a concurrence notes the difficulties of proving causation.237

Footnotes

  • 233 {223} 531 U.S. 341, 353, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001). See also Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017) (negligence claim based on failure to report adverse events to FDA is preempted); Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) (claim based on failure to inform patients that FDA had not approved device for certain uses is preempted because facts are tied to scope of FDA approval); Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128, 1144, 1151–1152 (D. Minn. 2011) (Buckman preempts claim based on manufacturer’s securing of FDA approval through incorrect procedural route). Cf. Zimmerman v. Novartis Pharmaceuticals Corp., 889 F. Supp. 2d 757 (D. Md. 2012) (Buckman precludes jury from considering whether manufacturer was liable for punitive damages because of misrepresenting information to FDA, a requirement under state law). But cf. Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006) (common law claim not preempted even though state law made manufacturer immune unless it withheld or misrepresented information to FDA), aff’d by an equally divided court sub nom. Warner-Lambert Co. v. Kent, 552 U.S. 440 (2008) (per curiam).

  • 234 {224} Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017); Rossum v. I-Flow Corp., 2011 WL 3274080 (D. Minn. Aug. 1, 2011); Purcel v. Advanced Bionics Corp., 2010 WL 2679988 (N.D. Tex. June 30, 2010). But cf. McGuan v. Endovascular Technologies, Inc., 106 Cal. Rptr. 3d 277 (Cal. Ct. App. 2010) (claims of fraud on physicians and patients are preempted when FDA had approved the product’s warnings and FDA investigated and found no violation of its regulations).

  • 235 {225} In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200 (8th Cir. 2010). See also Hiesner v. Genzyme Corp., 2010 WL 894054 (N.D. Ill. Mar. 8, 2010) (state law claim that manufacturer should have updated its label to reflect new information about adverse reactions goes beyond FDA regulation that permits, but does not require, manufacturers to do so, and therefore is preempted).

  • 236 {226} Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011).

  • 237 {227} Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc).