Fifth Circuit Delivers Knockout Punch To Drug Claims

Under Texas law, a products liability action involving a "medicine" has a statutory rebuttable presumption that the "health care provider, manufacturer, distributor, and prescriber" are not liable if the warnings or information that accompanied the product were approved by the Food and Drug Administration (FDA). See Tex. Civ. Prac. & Rem. § 82.007(a)(1). The statute provides five grounds for rebutting this presumption, including "Fraud-on-the-FDA" – the defendant withheld from or misrepresented to the FDA (i) "required information" that was (ii) material and relevant to the performance of the product and (iii) causally related to the claimant's injury. See Tex. Civ. Prac. & Rem. § 82.007(b)(1). On February 22, 2012, in Lofton v. McNeil, the Fifth Circuit significantly limited plaintiffs' ability to use Fraud-on-the-FDA to rebut the no liability presumption under Texas law, finding the claims preempted under federal law. In June 2000, Mr. Lofton died from Toxic Epidermal Necrolysis ("TEN"), allegedly resulting from ingesting ibuprofen. Plaintiffs claimed the manufacturers failed to warn consumers about the risk of severe autoimmune allergic reactions and asserted common law negligence and strict products liability claims. The manufacturers moved for summary judgment on all claims, asserting that the failure to warn claims require proof of Fraud-on-the-FDA and are preempted under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S. Ct. 1012 (2001). In Buckman, the Supreme Court rejected a private right to bring an action sounding in Fraud-on-the-FDA because the state law claim would "conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives." 531 U.S. at 350. The Court stated "that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration." Id. at 348. Not only does federal law provide administrative tools to punish and deter fraud, but the agency's decision to employ those tools implicates its discretion and special competence. Among the factors that make FDA enforcement a somewhat delicate balance of statutory objectives are the need for administrative efficiency and the possibility that tort liability based on inadequate disclosures would create an incentive to submit a deluge of information. Id. at 351. The Court concluded that authorizing tort liability for failure to comply with FDA disclosure requirements "would exert an...