Merck Serono Pays $44M To Settle Kickback Charge

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whistle-two1Two units of the Merck KGgA have agreed to pay $44.3 million to settle allegations the drugmaker submitted false claims to Medicare and Medicaid between January 2002 and December 2009 in connection with the marketing of its Rebif multiple sclerosis treatment, according to the US Department of Justice.

The Serono Laboratories and EMD Serono units allegedly made payments to doctors for hundreds of speaker training meetings and programs, as well as payments for attending consultant, marketing and advisory board meetings, all at upscale resorts and other locations, the feds allege in a statement.

The source of the charges came from a whistleblower lawsuit filed by Tim Amato, who was hired by Serono as a regional business director in 2003. He had complained internally about so-called ‘funneling’ of payments of as much as $25,000 and $30,000 to doctors who wrote a lot of prescriptions for MS meds. The drugmaker ‘funneled’ these payments through the Consortium of Multiple Sclerosis Centers, a non-profit that educates the public about MS, according to the whistleblower lawsuit (read it here).

There were other checks issued to CMSC, such as one for $70,000 to pay for a visiting scientist, according to the lawsuit (see the check). The feds allege numerous such payments were made to influence Rebif prescribing, as well as other Merck/Serono dugs. After Amato complained, he was fired and filed a wrongful termination lawsuit and, in 2005, the whistleblower lawsuit (here is the settlement agreement).

This is the second time that Merck’s Serono operation has run afoul of the law. In 2005, Serono and various US subsidiaries agreed to pay $704 million to resolve criminal charges and civil charges in connection with illegal schemes to promote and market the Serostim AIDS med (see here). As a result, the existing corporate integrity agreement was extended by three years, and there are now “enhanced provisions,” including a requirement that company directors and senior executives take responsibility for ensuring and monitoring compliance with federal law.

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