WASHINGTON (Legal Newsline) - The U.S. Department of Justice announced a $95 million settlement on Thursday with the Connecticut-based Boehringer Ingelheim Pharmaceuticals Inc. resolving allegations of the improper promotion of three types of drugs.
Boehringer allegedly engaged in the improper promotion of the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drugs Combivent and Atrovent and the hypertension drug Micardis. The U.S. Food and Drug Administration has approved Aggrenox for the prevention of secondary strokes, Combivent for continued bronchospasm symptoms in patients with COPD who are on a bronchodilator and Micardis for hypertension.
The settlement resolves allegations that the company improperly marketed the drugs and enabled the submission of false claims to government health care programs.
Boehringer allegedly promoted the drugs for uses that were not covered by federal health programs and were not medically accepted indications. The company allegedly promoted Aggrenox for cardiovascular events, including peripheral vascular disease and myocardial infarction, Combivent for use prior to another bronchodilator in the treatment of COPD and Micardis for early diabetic kidney disease.
Boehringer also allegedly knowingly promoted the use and sale of Atrovent and Combivent at doses exceeding the doses covered by federal health care programs, knowingly made unsubstantiated claims about the efficacy of Aggrenox, including purported superiority to Plavix, and paid kickbacks to healthcare professionals to induce them to prescribe the drugs.
Under the terms of the settlement, the federal government will obtain $78,455,048 and Medicaid programs for the states will get $16,544,952. Boehringer will also enter into an expansive corporate integrity agreement as part of the settlement to provide for reviews and procedures that will quickly detect unlawful conduct related to the allegations.
Boehringer did not agree to any liability under the terms of the agreement.
The settlement also resolves a False Claims Act lawsuit filed by Robert Heiden, a former Boehringer sales representatives. As part of the whistleblower, or qui tam, provisions of the act, a relator is permitted to obtain part of the proceeds gained by the federal government. Heiden will receive more than $17 million as part of the resolution.