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Widening A Circuit Split, The Sixth Circuit Expands Preemption For Fraud-On-The-FDA Claims

Posted in Recent Cases

In Marsh v. Genetech, Inc., the Sixth Circuit held that clever pleading of state law fraud-on-the-FDA claims could not get around its precedent on preemption of those claims.  The plaintiff claimed that Genetech did not comply with the FDA’s reporting requirements about the dangerous side effects of its psoriasis drug Raptiva.  Genetech claimed immunity under Michigan’s law that makers of FDA-approved drugs are immune from product liability claims unless the manufacturer intentionally withheld information from the FDA.  While the Sixth Circuit previously held in Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), that fraud-on-the-FDA claims are preempted, the plaintiff tried to get around this by pleading only non-compliance with FDA regulations rather than fraud.

Affirming the district court, Judge Moore’s opinion holds that the failure to submit required reports to the FDA “is arguably a species of fraud on the agency” and that Garica applies to preempt the plaintiffs’ claims.   Even if it were not fraud, the opinion goes on the hold that the plaintiff’s claim “triggers the same concerns that animated Buckman and Garcia.”   In a footnote, the panel acknowledged the growing split with the Second Circuit’s decision in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2007).  The Supreme Court accepted cert in Desinao, but issued only a 4-4 split decision in Warner-Lambert Co. v. Kent, 552 U.S. 440, 441 (2008).  The Fifth Circuit agreed with the Sixth Circuit’s position earlier this year in Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012).