Health Law Daily Class III medical device litigation doesn’t necessarily trigger federal question jurisdiction
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Wednesday, July 10, 2019

Class III medical device litigation doesn’t necessarily trigger federal question jurisdiction

By Rebecca Mayo, J.D.

Federal question jurisdiction is not triggered by the mere presence of an FDA-approved medical device in the action.

A district court found that there was no federal question jurisdiction over state law-based claims against a pacemaker manufacturer simply because pacemaker was a Class III medical device subject to FDA approval. The court held that the federal question at issue was significant to the parties but did not "transcend the parties, affect the government’s operations, or challenge federal law in a manner evidencing importance of the issue to the federal system as a whole," (Lecce v. Medtronic, Inc., July 8, 2019, Lioi, S.).

The claims. A patient received care at a hospital that included interrogation of her pacemaker and immediately after receiving care, experienced complications with her pacemaker. The patient filed claims against the hospital, employees and the pacemaker manufacturer, Medtronic, in the county court of common pleas. Medtronic removed the action to federal district court and asserted that the court would be required to review the design, manufacturing, and programming of a Class III medical device which would necessarily implicate a significant federal issue and turn on substantial questions of federal law. The patient moved to remand the case back to the lower court.

Substantial federal question. Federal question jurisdiction lies over state law claims if a federal issue is necessarily raised, actually disputed, substantial, and capable of resolution in federal court without disrupting the federal-state balance approved by Congress. To determine if the federal issue is substantial, the court looks to the importance of the issue to the federal system as a whole. Here, the court noted that the court would need only determine how federal law affects the parties in this case and the decision would have no bearing on federal law or federal government action and therefore have virtually no importance to the federal system as a whole.

Additionally, federal question jurisdiction should only be extended where Congress did not include a private federal right of action and where it will not materially affect, or threaten to affect, the normal currents of litigation. Here, Congress did not include any private right of action in the Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) but it did allow state courts to award for damages in violations of FDA requirements. The court held that finding federal question jurisdiction simply because the action involved a Class III medical device would open federal courts’ doors to any medical malpractice case involving an FDA-approved medical device, which would materially affect the normal currents of litigation.

The case is No. 1:18CV2720.

Attorneys: Antonios P. Tsarouhas (Perantinides & Nolan, Co. L.P.A.) for Heather Lecce. Christopher F. Swing (Brouse McDowell LPA) for Medtronic, Inc. and Medtronic USA, Inc. Andrew P. Guran (Vorys, Sater, Seymour and Pease LLP) for Nationwide Children's Hospital.

Companies: Medtronic, Inc.; Medtronic USA, Inc.; Nationwide Children's Hospital

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