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Federal Preemption: With What Level of Specificity Must State Law Claims Be Plead to Survive Preemption Under the Medical Device Amendments of 1976?
By Peter M. Durney and Christopher J. Hurst
This article takes a look at the state of the law, including a recent decision, Dunn v. Genzyme Corp., which, while at the state level, most certainly bodes well for defendants arguing for more detailed pleading in medical device lawsuits in Massachusetts, and provides guidance for similar arguments outside the Commonwealth of Massachusetts and in federal courts.
Peter M. Durney
Cornell & Gollub
Insights SPRING2021
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Almost a decade and a half has passed since the United States Supreme Court’s decision in Bell Atlantic v. Twombly, 550 U.S. 544 (2007) changed the federal pleading landscape, yet the application of the more robust Fed. R. Civ. P. 12(b) (6) plausibility standard articulated in Twombly remains inconsistent overall, and unsettled in certain areas of the law. One of those unsettled areas pertains to product liability claims related to medical devices. Only a few U.S. Circuit Courts of Appeal have examined the level of specificity necessary to plead state law claims in order to avoid preemption under the Medical Device Amendments of 1976, leaving the federal district courts and state courts that have adopted the federal plausibility pleading standard with limited guidance in how it should
be applied. This article takes a look at the state of the law, including a recent decision, Dunn v. Genzyme Corp., 486 Mass. 713, 2021 WL 298551 (January 29, 2021) (slip op.) which, while at the state level, most certainly bodes well for defendants arguing for more detailed pleading in medical device lawsuits in Massachusetts, and provides guidance for similar arguments outside the Commonwealth of Massachusetts and in federal courts.
In Dunn, the Massachusetts Supreme Judicial Court held that while the plaintiff’s claims were not preempted by federal law, the “bare-bones” allegations in the complaint—that Genzyme’s FDA-approved knee arthritis injection was “defective” and violated “FDA regulations”—were insufficient to the meet the plausibility standard. Dunn is a significant decision for the medical device community because the court refused to open the door to burdensome and costly discovery, agreeing with Genzyme that a lack of access to information