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Federal Preemption and Tort Claims

By Lawrie Demorest and Brendan Krasinski

For medical device manufacturers, federal preemption can be a powerful defense to state tort claims. Although there is some split of authority, most federal courts of appeals that have addressed the issue have held that when a medical device reaches the market via the Food and Drug Administration's (FDA) rigorous “premarket approval” (PMA) process, many state common law claims are expressly preempted by the Medical Device Amendments (MDA) of 1976.

The emergence of new and innovative medical products that combine FDA-regulated devices with either a drug or biologic component, however, raises the question whether manufacturers will be able to successfully assert preemption as a defense to state tort claims arising from these “combination products.” See Laura Lewis Owens and Courtney Carter Fletcher: Combination Products: Is It a Drug, Medical Device, or Biologic? (unpublished manuscript, on file with Laura Lewis Owens, Alston & Bird, LLP). Although conventional wisdom would lead many to conclude that a preemption defense should be successful for many medical device combination products, at least one federal district court decision seems to conclude that the MDA's preemption provision never applies to “combination products.”

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