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Boehringer Ingelheim Pharmaceuticals, Inc. Pays $95 Million to Resolve Off-Label Marketing Allegations

10/25/2012

(COLUMBUS, Ohio) -- Ohio Attorney General Mike DeWine announced today that Ohio has joined with other states and the federal government to settle allegations that Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) paid kickbacks and engaged in off-label marketing campaigns that improperly promoted four drugs: Atrovent, Combivent, Micardis and Aggrenox.

BIPI, a Connecticut based company, will pay the states and the federal government $95 million, of which $34,468,649.22 will go to the Medicaid programs to resolve civil allegations that the company unlawfully marketed Aggrenox, Combivent, Atrovent and Micardis and thereby caused false claims to be submitted to the government health care programs.

As part of the settlement, Ohio will receive $1,399,566 in restitution and other recovery.

"The accurate marketing of medications is essential for their safe and beneficial use by those in need," said Attorney General DeWine. "It's also vital when it comes to paying for those medications. Anything else is unfair to patients and taxpayers, and illegal."

The settlement resolves allegations that BIPI unlawfully marketed these drugs for a variety of non-FDA approved indications, including Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; Combivent for use prior to another bronchodilator in treating Chronic Obstructive Pulmonary Disease; and Micardis for treatment of early diabetic kidney disease.

Additionally, the settlement resolves allegations that BIPI knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs and that BIPI knowingly made unsubstantiated claims about the efficacy of Aggrenox, including that it was superior to Plavix.  The agreement also resolves allegations that the company paid kickbacks to health care professionals as inducement to prescribe.

As a condition of the settlement, BIPI will enter into a Corporate Integrity Agreement (CIA) with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company's future marketing and sales practices.

The investigation resulted from a qui tam action originally filed in the United States District Court for the District of Maryland under the federal False Claims Act and various state false claims statutes.

A National Association of Medicaid Fraud Control Units (NAMFCU) Team participated in the investigation and conducted the settlement negotiations with BIPI on behalf of the states and included representatives from the Offices of the Attorneys General for the states of Ohio, Florida, Virginia, South Carolina and Oregon.

Media Contacts:

Dan Tierney: 614-466-3840
Jill Del Greco: 614-466-3840