Bayer Corporation and its entities (Bayer HealthCare Pharmaceuticals, Bayer HealthCare LLC, and Bayer AG) have agreed to pay $40 million to resolve allegations of kickbacks and false claims in connection with three of its drugs: the antifibrinolytic aprotinin (Trasylol), the statin cerivastatin (Baycol), and the antibiotic moxifloxacin (Avelox), according to the US Department of Justice (DOJ).
The settlement stems from two whistleblower lawsuits filed by Laurie Simpson, a former employee of Bayer, the DOJ said in a statement. In a lawsuit, Simpson alleged that Bayer paid kickbacks to hospitals and physicians to get them to use aprotinin and moxifloxacin; marketed these drugs for off-label uses that were not reasonable and necessary; and downplayed the safety risks of aprotinin.
The lawsuit further alleged that Bayer submitted false claims to the Medicare and Medicaid programs and violated the laws of 20 states and the District of Columbia. In a second lawsuit, Simpson alleged that Bayer knew about, but downplayed, cerivastatin's risks of causing rhabdomyolysis; misrepresented the efficacy of cerivastatin when compared to other statins; and fraudulently persuaded the Defense Logistics Agency to renew certain contracts relating to cerivastatin. For safety reasons, both cerivastatin and aprotinin have been withdrawn from the US market. The company did not respond to requests for comment on the DOJ announcement. "Simpson diligently pursued this matter for almost two decades," Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department's civil division, said in the statement.
This case "highlights the critical role that whistleblowers play in the effective use of the False Claims Act to combat fraud in federal healthcare programs," Boynton added. "As alleged in the complaints, Bayer — one of the largest pharmaceutical companies in the world — engaged in a series of unlawful acts, including paying kickbacks to doctors and hospitals, marketing them off-label, and downplaying their safety risks," Philip R. Sellinger, US attorney for the District of New Jersey, said in the statement. "This resolution should send a message to the pharmaceutical industry that such conduct undermines the integrity of federal healthcare programs and jeopardizes patient safety," Sellinger added. Under the terms of the settlement, Bayer will pay $38,860,555 to the United States and $1,139,445 to the 20 states and the District of Columbia.
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