FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gilead Petitions for Rehearing of Overturned FCA Verdict

Sept. 21, 2017
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Gilead Sciences petitioned the Ninth Circuit Court to reconsider its decision allowing a False Claims Act case against the company to proceed.

In July, the court reversed a dismissal of the case. Gilead’s petition argued the ruling conflicts with the materiality test established in Universal Health Services Inc. v. United States. In that decision, the U.S. Supreme Court ruled that to prove liability in a False Claims Act case, the plaintiff must prove the misrepresentation induced the government to pay the claim. Gilead argued a company cannot be considered to have committed a material FCA violation if the government continues to reimburse for products after learning of the violation.

PhRMA, BIO and the U.S. Chamber of Commerce submitted amicus briefs in support of Gilead’s petition.

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