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# 2nd Circuit Strengthens Preemption Law: Attorneys
- URL: https://www.fdaweb.com/2nd-circuit-strengthens-preemption-law-attorneys/
- Published: 2019-03-28T12:00:00.000Z
- Updated: 2026-09-15T01:16:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143724

Attorneys **Lucas Przymusinski** and **Matt Holian** (DLA Piper) say a 2nd Circuit Court of Appeals decision upholding lower court actions in multi-district litigation against Bristol-Myers Squibb and Pfizer over their anticoagulant Eliquis significantly strengthens preemption law. In an online [analysis](https://www.dlapiper.com/en/us/insights/publications/2019/03/significant-preemption-win-for-bristol/?ref=fdaweb.com), they say the appeals court upheld lower court rulings dismissing all of plaintiffs’ complaints on federal preemption and adequacy of warning grounds.

The analysis says the appeals court [said](https://www.courtlistener.com/opinion/4603612/gibbons-v-bristol-myers-squibb-co/?ref=fdaweb.com) that in order to state a failure-to-warn claim that is not preempted by the Federal Food, Drug, and Cosmetic Act, a plaintiff must plead “a labeling deficiency that defendants could have corrected using the changes being effected regulation.” Specifically, the court held, a plaintiff must identify “newly acquired information” that “reveals risks of a different type or greater severity or frequency than previously included in submissions to FDA.”

In the Eliquis case, the court said, despite repeated attempts the plaintiffs failed to allege the existence of any “newly acquired information” that would have allowed the companies to make any relevant change to the drug’s labeling.

The attorneys say the decision strengthens preemption law in two important ways. First, it confirms that, in appropriate circumstances, preemption can be resolved on a motion to dismiss, and that plaintiffs must allege specific newly acquired information that would have warranted a label change using the changes being effected regulation. Second, they write, this appears to be the first decision by an appeals court in any circuit that finds preemption where the alleged safety information at issue involved a branded medication and arose after FDA approval.