iAny brand name drug manufacturer knows the value of a good federal preemption defense: a straightforward disposition of challenges to the design or labeling of a product. It’s also no secret that the U.S. Supreme Court’s 2009 preemption decision in Wyeth v. Levine undercut the value of the preemption defense in brand name pharmaceutical litigation. The court reasoned that failure-to-warn claims for certain types of labeling were not preempted because, under the Food and Drug Administration’s (FDA) Changes Being Effected (CBE) process, the manufacturer can, in some instances, proactively update its label with new information.
That begs the question: What about information that’s not new, such as information that the drug manufacturer and FDA had at the time the drug was first approved? The recent S.D.N.Y. decision in Utts v. Bristol-Myers provides some helpful insight and a very defense-friendly answer: Such claims are preempted, because they do not concern “new” information sufficient to trigger the manufacturer’s power to change the drug label through the CBE process.
In Utts v. Bristol-Myers Squibb Co., plaintiffs alleged that Eliquis – an anticoagulant prescribed to reduce the risk of blood clots – caused severe internal bleeding, that defendants had known of these issues prior to obtaining New Drug Application (NDA) approval, and had relied on a flawed study to obtain FDA approval. Plaintiffs asserted a number of causes of action under California law, including strict liability claims for failure to warn, design defect, manufacturing defect and negligent design.
The New York federal court ruled that the claims were preempted, relying on the logic of the Supreme Court’s decision in Wyeth and its two more recent decisions in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, which held that design-defect and failure-to-warn claims against a generic drug manufacturer were preempted because the generic manufacturer had no authority to alter the design or labeling. Reading these cases together, the Utts court concluded that, although a drug manufacturer in some instances can act proactively when new information comes to light, claims about prior existing information are preempted. The CBE process simply is not available for information that was known at the time the drug was approved. Without the CBE process, the regular rules apply and the manufacturer cannot unilaterally change the label.
The court’s definition of what constitutes new information is particularly interesting. In dismissing plaintiffs’ claims with leave to amend, the court noted that brief allegations in the complaint concerning post-NDA reports about already-known risks were not sufficient alone to constitute “new” information triggering the manufacturer’s CBE authority. Rather, to avoid preemption, plaintiffs had to show that the reports “revealed risks of a ‘different type’ or ‘greater severity of frequency’” than that known by FDA at the time of the approval.
The Utts court also ruled that plaintiffs’ negligent design claim was preempted, because it required the court to speculate about what alternative designs FDA might have approved when it originally reviewed the NDA. That kind of analysis, the court ruled, was foreclosed by Mensing. Alternatively, the court reasoned, to the extent plaintiffs’ claim suggested that there was no safe formulation for the drug and that Bristol-Myers should never have sold Eliquis, that line of reasoning was also preempted by the Supreme Court’s decision in Bartlett. The negligent design defect claim was dismissed without leave to amend.
The reasoning applied in Utts is extensive – a real primer on the NDA process and on recent FDA preemption jurisprudence. It’s also in line with two 2015 appellate decisions from the U.S. Court of Appeals for the First Circuit’s decision in In re Celexa & Lexapro Mktg. & Sales Practices and the U.S. Court of Appeals for the Sixth Circuit’s decision in Yates v. Ortho-McNeil-Janssen Pharm. Inc., which also found preemption of claims against brand name drug manufacturers alleging failure-to-warn and design-defect claims, respectively.
It’s too early to discern the full impact of the Utts decision, but for brand name drug manufacturers, it is promising – and sure to be cited regularly. It’s also indicative of a change in strategy for asserting preemption – an alternative to the “clear evidence” standard from Wyeth and a refocusing on the limitations of the CBE process, itself.
Kristen Richer contributed to this post.
