Fifth Circuit Concludes That U.S. Supreme Court's "Fraud-on-the-FDA" Federal Preemption Precedent Has Broad Application


The Lofton decision deepens the split among the U.S. circuit courts on whether or not the U.S. Supreme Court's "fraud-on-the-FDA" preemption decision in Buckman applies broadly and forcefully to all claims that, either explicitly or implicitly, include an allegation that a drug or medical device manufacturer did not appropriately satisfy its disclosure obligations vis-à-vis the FDA.

On February 22, 2012, the U.S. Court of Appeals for the Fifth Circuit unanimously affirmed the U.S. District Court for the Northern District of Texas' granting of a defendant drug manufacturer’s motion for summary judgment on all claims, including the plaintiffs' failure-to-warn claims, in Lofton v. McNeil Consumer & Specialty Pharmaceuticals, No. 10-10956, slip op. (5th Cir. Feb. 22, 2012). At issue was whether, under Texas law, "a drug manufacturer enjoys a rebuttable presumption that it is not liable for failure to warn if the FDA has approved 'the warnings or information' accompanying the product alleged to have harmed the plaintiff."

The defendant drug manufacturer asserted as an affirmative defense the rebuttable presumption that it had complied with all U.S. Food and Drug Administration (FDA) requirements governing its product's labeling. Under Texas law, a defendant drug manufacturer is afforded a rebuttable presumption defense against failure-to-warn claims if "the FDA has approved 'the warnings or information' accompanying the product alleged to have harmed the plaintiff." Pursuant to Texas law, the affirmative defense may be rebutted if the plaintiff can establish the defendant drug manufacturer "withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury." Tex. Civ. Prac. & Rem. Code § 82.007(a)(1).

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Published In: Administrative Agency Updates, Civil Procedure Updates, Conflict of Laws Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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