by Ben Vernia | October 26th, 2012
On October 25, the Department of Justice announced that Boehringer Ingelheim has agreed to pay $95 million to resolve a whistleblower’s allegations that the company promoted one of its drugs unlawfully, and thereby caused the submission of false claims. According to DOJ’s press release:
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 Justice Department announced today.
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 government’s 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 today’s $95 million settlement, the federal government will obtain $78,455,048, and state Medicaid programs will obtain $16,544,952.
The government also announced that qui tam relator, a former Boehringer employee, will receive more than $17 million (the division of federal and state recoveries makes it difficult to compute the relator’s share of the federal portion; overall the relator’s share comes to 17.9%).
