Serono to pay $44M in U.S. kickbacks case

Another whistleblower lawsuit has ended with a settlement. Merck Serono has agreed to pay $44.3 million to resolve claims that it paid doctors to prescribe its multiple sclerosis drug Rebif, the Justice Department announced. According to the government, Merck KGaA's Serono Laboratories and EMS Serono spent more than seven years paying providers to prescribe and promote Rebif.

The company does not admit any wrongdoing and denies the lawsuit's allegations. "It is important to note that the settlement contains no claims that unnecessary prescriptions for Rebif were written, no allegations of patient harm and no admission of fault by the company," EMD Serono SVP and General Counsel Thomas Gunning told CBS.

But the government maintains Serono paid doctors for speaker training and for attendance at Rebif-related meetings at upscale resorts, beginning when the product was approved in January 2002 and through the end of 2009. Merck KGaA bought Serono in 2007.

Those payments prompted Medicare and Medicaid claims that were allegedly "tainted by kickbacks," the Justice Department's press release states. "Health care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback," said Maryland U.S. Attorney Rod Rosenstein.

According to CBS News, the lawsuit alleges that one top prescriber of Rebif was paid more than $300,000, often through a New York-based MS clinic. According to the suit, Serono management characterized its relationship with the clinic this way: "[W]e have a whole money laundering thing going on."

- see the Justice Department statement
- get the news from Bloomberg
- read the CBS News piece