State Claims Against HPM&B Client, A Maker of MRI Machines, Are Dismissed Under the Federal Preemption Doctrine
Interpreting the Supreme Court’s 2008 decision in Riegel v. Medtronic, Inc., a Westchester County judge has dismissed claims sounding in negligence and product liability following plaintiffs’ decedent’s death from injuries he sustained while undergoing a Magnetic Resonance Imaging (“MRI”) test.
In Colombini v. Westchester County Health Care Corporation, HPM&B’s client was sued under theories of defective design, breach of warranty, and failure to warn for allegedly contributing to the unsafe environment which allowed a ferrous-containing oxygen tank to be drawn into the MRI machine’s powerful magnet. The tank struck and fatally injured plaintiffs’ decedent. The maker provided ample warnings about this specific inherent danger but it did not maintain day-to-day control over the MRI site.
Following Riegel, in which the Supreme Court held that such state tort claims are preempted under the federal 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, the court awarded summary judgment to HPM&B’s client because the MRI machine was the subject of pre-market approval by the Food and Drug Administration.
The court extended Riegel’s holding to products, like the MRI machine at issue, that have been reclassified as Class II devices and thus subject to less stringent FDA oversight following premarket approval. The court held that once a device has entered the market as an approved Class III device, having undergone the rigorous FDA premarket approval process, state tort claims are preempted by the federal Medical Device Amendments regardless of its subsequent reclassification.
Inquiries can be directed to Dan Ratner and Daryl Paxson of HPM&B’s Appellate Practice and Products Liability and Mass Tort Groups. Click here to review the decision.