Fraud on the FDA Complaint Fails to Show Any Missing Clinical Data was Material to Approval of Medical Devices; United States District Court for the District of Minnesota No. 11-cv-2453 (JNE/TNL), U.S. ex rel. Steven Higgins v. Boston Scientific Corp.

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The district court dismissed a qui tam case alleging the defendant made material misstatements and omitted necessary information when it submitted medical devices for approval to the FDA and therefore obtained approval for the devices through fraud. The court found that some of the alleged misstatements and omissions were disputable, but held that the relator […]
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