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December 2, 2007

Supreme Court Will Hear Importand Medical Device Preemption Case

On Tuesday, December 4th, the U.S. Supreme Court will arguments in an important products liability case in which a medical device manufacturer argues that a plaintiff's state common law tort claims of negligent design and warning are preempted by the Medical Device Amendments to the Food, Drug and Cosmetics Act (MDA).  Riegel v. Medtronic is a suit on behalf a patient who was injured by the use of a balloon catheter device while undergoing an angioplasty.  The trial court ruled that the plaintiff's negligent design and warning claims were preempted but that manufacturing defect and breach of express warranty claims survived.  The Court of Appeals for the Second Circuit upheld that ruling and the plaintiff later lost the manufacturing defect case.  The lower courts' rulings were based on the language in section 360k(a) of the MDA preempting conflicting state law "requirements" for medical devices that have been approved after undergoing the Food & Drug Administration's extensive "pre-market approval" (PMA) process.  In Medtronic v. Lohr, a 1996 preemption decision concerning the MDA, the court ruled that there was no preemption of state law claims with respect to a device that had only been subjected to the FDA's much more abbreviated approval process under section 510k of the MDA.  See Chrisopher Snowbeck's article for the Saint Paul Pioneer Press.

JDP

December 2, 2007 | Permalink

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