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

Attorney General Peter F. Kilmartin today announced that Rhode Island 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 dollars, of which $34,468,649.22 will go to the State 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.

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. As part of the settlement Rhode Island will receive approximately $75,000 in restitution and other recovery.

In 2012, the Office of Attorney General's Medicaid Fraud & Patient Abuse Unit recovered over $9.5 million from investigations and settlements to Rhode Island's state/federal Medicaid program.

"This is yet another example of a major pharmaceutical company engaging in illegal activities in order to improve profits," said Attorney General Kilmartin. "These kinds of practices jeopardize patients' health and violate the public trust. We will continue to vigilantly ensure that drug companies comply with the law in the sales and marketing of drugs sold to the public, and those who do not abide by the rules will be held accountable."

Specifically, this 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. Finally, the agreement 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.

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