Bloomberg Law
Jan. 4, 2018, 10:36 PM UTC

Gilead Asks High Court to Stop ‘Dangerous’ False Claims Case

Daniel Seiden

• Gilead wants Supreme Court ruling on false claims materiality defense

• FDA’s approval of Gilead’s drugs despite knowledge of allegations means case must fail, Gilead says

The U.S. Supreme Court should rule that a false claims case against HIV drug maker Gilead Sciences Inc. can’t stand because the Food and Drug Administration always approved its drugs despite knowledge of alleged misrepresentations, the company told the court in its petition.

Multiple appeals courts have ruled in recent years that the government’s continued approval of goods after learning of alleged regulatory violations is strong evidence of immateriality, which is fatal to a false ...

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