Since 2009, plaintiffs in pharmaceutical product liability suits have had a predictable and largely successful three-word response to defendants’ preemption arguments: Wyeth versus Levine. 555 U.S. 555 (2009). The Supreme Court’s 2011 and 2013 generic-drug preemption decisions forced generic-drug plaintiffs back on their heels, but plaintiffs’ Wyeth v. Levine mantra continued forcefully in brand-name drug litigation. A recent First Circuit decision could change that.

Earlier this year, the First Circuit held that Wyeth v. Levine’s reach has its limits, even in brand-name drug litigation. The FDA alone has the power to approve a drug to enter the market, and the First Circuit found that state law cannot impose liability for what is essentially disagreement with the FDA’s finding of safety and efficacy when it exercises its drug approval power. This article examines the consequences of the First Circuit’s recognition of the FDA’s exclusive power over the approval process and approval decisions. To learn more, click here.