Attorney General J.B. Van Hollen Announces Settlement Agreement with Boehringer Ingelheim Pharmaceuticals

MADISON — Attorney General J.B. Van Hollen has announced that Wisconsin 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 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 terms of the agreement provide that the state will receive $329,721.76 as part of $773,922.66 attributable to Wisconsin Medicaid. The federal and state governments jointly fund Medicaid, a health care assistance program for the needy and disabled.

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.

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.