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Judge Wields Pre-emption To Dismiss Medtronic Fidelis Claims

This article was originally published in The Gray Sheet

Executive Summary

A Minnesota federal judge on Jan. 5 categorically 1dismissed on grounds of federal pre-emption all 21 claims in a multidistrict personal injury lawsuit against Medtronic for its Sprint Fidelis implantable defibrillator leads

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Another Fidelis dismissal

Minnesota state judge dismisses more than 600 personal injury suits, including 14 distinct liability claims, against Medtronic related to its discontinued 7-French Sprint Fidelis defibrillator lead. The Oct. 20 dismissal 1order cites federal pre-emption protection for the FDA-approved product and follows a similar ruling in January in federal multi-district litigation (2"The Gray Sheet" Jan. 12, 2009). In both cases, the judges rejected plaintiffs' arguments that their claims were "parallel" to rather than in addition to FDA requirements and that the Class I recall of Fidelis invalidated its PMA supplement approval. Legislation to reverse the 2008 U.S. Supreme Court decision that forms the basis of these rulings is still pending in Congress (3"The Gray Sheet" Aug. 10, 2009)

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