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Orthopedic and Dental Industry News Complete Archive »

Supreme Court to Hear Medtronic Case; Charite Liability Claims Dismissed in CA BY LAUREN UZDIENSKI, JUNE 26, 2007

The Supreme Court announced yesterday that it will hear a Medtronic case involving a failed balloon catheter. The decision could have broader implications for the FDA's authority and product liability.

The lawsuit emerged from a catheter failure during Charles Riegel's angioplasty. Riegel sued, and the case was dismissed; on appeal, the court also dismissed the case, adding in their decision that medical device manufacturers cannot alter marketed products without FDA approval. Since different juries could reach different conclusions on whether a product is safe, with which opinion should a manufacturer be obligated to comply?

Traditionally, the answer to that question has been the FDA. The agency's approval protects companies from lawsuits in most cases; in line with that precedent, the Bush administration discouraged the Supreme Court from hearing the Metronic case, and Depuy Spine announced this morning that a California court dismissed most product liability claims regarding its Charite Artificial Disc on the grounds that FDA approval was preemptive.

Federal preemption was challenged in an earlier draft of MDUFMA II, which passed in a House committee last week, but that provision was excised following industry opposition.

Reigel v. Medtronic will be heard when the Court opens its next term this fall.

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