A lawsuit filed against Gilead Sciences Inc. claims that the company cheated taxpayers by selling contaminated and defective drugs to Medicare and Medicaid. Whistleblowers made these charges in the lawsuit that was unsealed last month in a California federal court. This adds to the sharp increase in fraud litigation over manufacturing violations in the industry. The complaint asserts that Gilead since 2001 has sold at least 10 products – including HIV medications Viread, Truvada and Stribild – that lacked potency or were contaminated with filth, metal or microbes, allegedly rendering them nonreimbursable by government health care programs. Gilead committed “serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” according to the complaint, which says damages at least reach into the hundreds of millions of dollars.
The whistleblowers are Jeff Campie, a former senior director for quality control assurance at Gilead who says he was fired for raising objections, and Sherilyn Campie, who was still working as an associate manager for quality control at Gilead when the complaint was filed earlier this year. While selling drugs of suspect quality violates the False Claims Act (FCA), it’s a theory that’s just beginning to be used in whistleblower cases. It should be noted that some of the larger FCA settlements, including a $750 million deal in 2010 with GlaxoSmithKline PLC and a $500 million accord in 2013 with Ranbaxy Laboratories Ltd., arose over quality lapses.
Jeff Campie is also suing over alleged retaliation in connection with his apparent termination, but Gilead says he hasn’t properly claimed to have been engaged in protected conduct – such as investigation of false claims, as opposed to investigation of GMP violations – or that his dismissal was related to whistleblowing.
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