Failure-to-warn claims preempted in Texas unless the FDA finds fraud

5th Circuit decision deepens circuit split on fraud-on-the-FDA statute preemption

A Feb. 22 decision deepened the split among circuit courts on whether federal law preempts state fraud-on-the-Food & Drug Administration (FDA) statutes. The 5th Circuit ruled in Lofton v. McNeil Consumer & Specialty Pharmaceuticals that federal law preempts Texas’ statute, unless the FDA itself finds fraud.

The family of Christopher Lofton, who contracted the rare skin disease toxic epidermal necrolysis and died after taking Motrin, sued Motrin’s maker, alleging common law negligence and product liability. The company moved for summary judgment, asserting that the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Comm. preempted the family’s failure-to-warn claims, which they brought under Texas law. The Buckman decision held that federal law preempts state fraud-on-the-FDA claims because they “conflict with the FDA’s responsibility to police fraud.” Under the Texas statute in question in Lofton, plaintiffs bringing failure-towarn claims have to assert that drug manufacturers misrepresented information to the FDA.

Choosing Sides

Join the Conversation

Advertisement. Closing in 15 seconds.