Products liability – Preemption – MDA

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Where a plaintiff has asserted state-law claims arising from alleged defects in three implanted medical devices that the defendant manufactured and marketed, the plaintiff’s claims are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, so they must be dismissed.

“[Defendant] Medtronic asserts that the MDA preempts Summers’s claims because the devices at issue are Class III medical devices that have been approved through the FDA’s premarket approval (‘PMA’) process. … [Plaintiff Kathleen] Summers concedes that the devices are Class III devices. … She argues that her claims nonetheless may proceed because they are based on state-law tort duties that ‘“parallel,” rather than add to, federal requirements.’ …

“Summers’s breach-of-warranty claims assert that the implants she received were not fit for use. … In substance, these claims allege that the devices are not reasonably safe and effective despite the FDA’s findings to the contrary. Therefore, the MDA preempts Summers’s breach of warranty claims. …

“… The MDA preempts failure-to-warn claims that challenge the adequacy of FDA-approved labeling. … Summers’s negligence claim is thus preempted to the extent it asserts that the FDA-approved warnings that she received were inadequate.

“In her Opposition, Summers argues that her negligence claim is based on ‘Defendants’ duty to monitor its products and inform its customers of aftermarket discovered defects’ and a ‘failure to act post-market, in dereliction of a duty to warn arising from product defects which surfaced some time after implantation of the devices.’ …

“Summers asserts that this aftermarket claim is found in the Complaint’s allegation that ‘Defendants had prior knowledge of the malfunction of the implanted devices but failed to notify Plaintiff of the need to take corrective measures or actions.’ … The Complaint does not allege, however, that Medtronic became aware of device malfunctions after FDA approval. Summers may not add facts through her opposition brief that she did not plead in her complaint. … Where Summers’s Complaint does not allege when Medtronic became aware of device malfunctions, she has failed to state a negligence claim based on a duty to warn of defects that Medtronic discovered after Summers received the implants.”

Summers v. Medtronic, Inc., et al. (Lawyers Weekly No. 02-140-25) (7 pages) (Talwani, J.) (Civil Action No. 1:24-cv-11793-IT) (March 18, 2025).

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