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Medtronic Fraud Case Review Casts Doubt On FDA Tort Challenges – WLF

This article was originally published in The Gray Sheet

Executive Summary

The Cincinnati appeals court's decision to review a lawsuit alleging that Medtronic made false claims to FDA portends a favorable decision for manufacturers, according to the Washington Legal Foundation

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FDA's new-found willingness to invoke the federal preemption doctrine in state tort suits may provide device firms with some solace in the absence of product liability reform legislation, but prospects remain unclear for non-original-PMA devices

Preemption Redemption: FDA Legal Briefs Stand In For Product Liability Law

FDA's new-found willingness to invoke the federal preemption doctrine in state tort suits may provide device firms with some solace in the absence of product liability reform legislation, but prospects remain unclear for non-original-PMA devices

Litigation In Brief

Medinol v. Boston Scientific: Injunction against sales of Boston Scientific Express stents and 30% royalty payments to Medinol on Taxus drug-eluting stents applies only to The Netherlands, Hague district court rules. Court finds device infringes one Dutch counterpart of four European patents asserted by Medinol. Boston Scientific, which will appeal the decision, notes that "neither the injunction nor potential damages will be material," because total 2003 sales of the devices in The Netherlands will be only about $10.6 mil. Meanwhile, Medinol's request for cross-border relief in 16 European countries is denied. The ruling follows a June 24 Dusseldorf, Germany district court finding that Boston Scientific infringed Medinol patents in that country (1"The Gray Sheet" June 30, 2003, p. 22). Related New York federal court litigation between the firms is ongoing (2"The Gray Sheet" Dec. 8, 2003, p. 23)...

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