Wednesday, May 4, 2011

EMD Serono pays out $44M to settle false claims suit

By Michelle Lang

EMD Serono Inc., an affiliate of Merk KGaA of Germany, has paid $44.3 million and changed its Corporate Integrity Agreement as part of a civil lawsuit settlement related to allegations that the company paid health-care providers to promote its multiple sclerosis drug Rebif. 

The False Claims Act allegations date back to January 2002 and run through December 2009. Per a news release from the U.S. Department of Justice, the allegations put on EMD Serono include payments for speaker training meetings, as well as marketing, consultant and advisory board meetings; False claims on Rebif were then made to federal health-care programs like Medicare and Medicaid, with doctors allegedly getting a kickback from EMD Serono.

The lawsuit was brought by the U.S. Attorney’s office in Maryland. The update of the Corporate Integrity Agreement must include, according to the Office of the Inspector General, “requiring that company directors and senior executives take responsibility for ensuring and monitoring compliance with federal law.”

“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,” said Thomas Gunning, senior vice president and general counsel at EMD Serono, in a news release issued by the company.

The $44.3 million settlement will be split between the federal government receiving $34.6 million and states getting $9.7 million to settle Medicaid claims.

In April, EMD Serono announced it had awarded a $1.5 million grant to Massachusetts General Hospital to establish a social network for multiple sclerosis-focused researchers, to be called the Multiple Sclerosis (MS) Discovery Forum.