The lawsuit was originally filed under the qui tam, or whistle-blower provision, of the False Claims Act by a former senior director for quality control assurance at Gilead and an associate manager for quality control at the company.
In their complaint, the whistle-blowers allege Gilead has sold 10 products that were contaminated or lacked potency since 2001, which rendered the drugs non- reimbursable by Medicare and Medicaid, according to the report.
The whistle-blowers argue the Food and Drug Administration would not have approved Gilead’s products or would have withdrawn approval of the contaminated and defective products if the agency knew how they were being manufactured and sold.
Gilead has filed a motion to dismiss the case, and asserted there is no case law that states a company commits fraud through violations of good manufacturing practices, according to the report.
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10 largest False Claims, Stark Law and Anti-Kickback settlements of 2014
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