"Fraud-on-the-FDA" Failure to Warn Claims Are Preempted by Federal Law


The extent to which federal law preempts state law claims is an issue that has been in the forefront of drug and medical device litigation throughout the past few years. In the context of medical device litigation, the U.S. Supreme Court rendered its seminal Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), decision determining that federal law preempts state law causes of action based on a medical device manufacturer's alleged fraudulent representations to the Food and Drug Administration (FDA). Since that decision, federal courts have been considering whether the Buckman analysis applies more broadly to all claims asserting allegations of "fraud-on-the-FDA," or simply just to causes of action titled "fraud-on-the-FDA." Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), with Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff'd by an equally divided court sub nom. Warner-Lambert Co., LLC v. Kent, 552 U.S. 440, 128 S. Ct. 1168 (2008). The Fifth Circuit Court of Appeals is the most recent court to weigh in on this issue in Lofton v. McNeil Consumer & Specialty Pharm., et al, 2012 WL 579772 (5th Cir. Feb. 22, 2012).

In 2000, shortly after taking over-the-counter Motrin for a fever, Christopher Lofton died from a rare disease known as Toxic Epidural Necrolysis (TEN). Around the time when labeling changes were implemented requiring that ibuprofen labels contain a warning regarding the symptoms of TEN, and a citizen's petition was filed seeking additional labeling requirements on ibuprofen products, Lofton's family filed suit against McNeil asserting claims of common law negligence and strict products liability. McNeil moved for summary judgment.

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