Boehringer Ingelheim to Pay $95 Million to Resolve False Claims Act Allegations

Government Alleges Company Improperly Marketed Three Drugs Connecticut-based Boehringer Ingelheim Pharmaceuticals Inc. has agreed to pay $95 million to resolve allegations relating to the improper promotion of the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease (COPD) drugs Atrovent and Combivent, and the hypertension drug Micardis. The Food and Drug Administration (FDA) has approved Aggrenox to prevent secondary strokes, Combivent to treat continued symptoms of bronchospasm in patients with COPD who already are on a bronchodilator and Micardis to treat hypertension. The settlement resolves allegations that Boehringer improperly marketed each of these drugs and caused false claims to be submitted to government health care programs. According to the governments allegations, Boehreinger promoted each of the three drugs for uses that were not medically accepted indications and were not covered by federal health care programs. Specifically, the settlement resolves allegations that Boehreinger promoted Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; that Combivent was marketed for use prior to another bronchodilator in treating COPD; and that Micardis was marketed for treatment of early diabetic kidney disease. The uses were not for medically accepted indications and were not covered by federal health care programs. Additionally, the settlement resolves allegations that Boehringer knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs and that Boehringer 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 to induce them to prescribe Aggrenox, Atrovent, Combivent and Micardis. As a result of todays $95 million settlement, the federal government will obtain $78,455,048, and state Medicaid programs will obtain $16,544,952. The settlement resolves a False Claims Act lawsuit filed in the District of Maryland by Robert Heiden, a former sales representative for Boehringer. The whistleblower, or qui tam, provisions of the False Claims Act permit the relator to obtain a portion of the proceeds obtained by the federal government. As part of todays resolution, Mr. Heiden will receive more than $17 million. Also as part of the settlement, Boehringer has agreed to enter into an expansive Corporate Integrity Agreement that provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to the settlement. The claims settled by this agreement are allegations only; there has been no determination of liability.