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June 27, 2007

Supreme Court Agrees to Hear Preemption Decision Regarding Medical Devices

The U.S. Supreme Court has agreed to review the Second Circuit's determination in Reigel v. Medtronic that federal regulation of medical devices, particulaly when done through the stringent pre-market approval process, generally preempts state products liability claims.  The suit arose when a ballon catheter burst during Reigel's angioplasty.  The Second Circuit's opinion, which is in line with most federal cases which have considered this issue, noted that a medical device manufacturer cannot alter their products once on the market without FDA approval placing them in a difficult position if different state juries reached differing conclusions regarding the product's design.  See stories in the Chicago Tribune and Boston Globe.


June 27, 2007 | Permalink


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