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Dana McSherry represents clients in health care, securities and other government enforcement matters, both civil and criminal. Dana also assists clients in conducting internal investigations and counsels clients across the health care industry on compliance and risk management issues. Read Dana McSherry's full bio.

Second Circuit Deals Blow to Off-Label Marketing Claims


By and on May 26, 2016
Posted In Pharmaceuticals

On May 17, the United States Court of Appeals for the Second Circuit affirmed the dismissal of a relator’s False Claims Act (FCA) claims predicated on allegations that Pfizer “improperly marketed Lipitor, a popular statin, as appropriate for patients whose risk factors and cholesterol levels fall outside the National Cholesterol Education Program (NCEP) Guidelines.”  In...

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FCA Claims Based on Average Wholesale Price (AWP) Theory Barred by Public Disclosure Bar


By on Feb 17, 2016
Posted In Public Disclosure Bar

On January 20, 2016, the U.S. District Court for the Eastern District of Missouri dismissed a complaint based on allegations of Average Wholesale Price (AWP) fraud under the False Claims Act (FCA) against CSL Behring, LLC (Behring) and specialty pharmacies Accredo Health, Inc., (Accredo) and Coram LLC (Coram).  See United States ex rel. Lager v....

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Court Again Rejects Alleged ‘Fraud on the FDA’ Theory of Implied Certification Liability


By on Jun 22, 2015
Posted In Pharmaceuticals

On June 12, 2015, the U.S. District Court for the Northern District of California granted Gilead Science’s second motion to dismiss Relators’ False Claims Act (FCA) claims premised on Gilead’s alleged failure to obtain timely supplemental approval from the U.S. Food and Drug Administration (FDA) for use of a new unapproved manufacturing source. See U.S....

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