Boehringer Ingelheim Agrees to Pay $95 Million to Settle False Claims Act Allegations

The Department of Justice, on Thursday October 25, 2012, announced its settlement with Boehringer Ingelheim Pharmaceuticals Inc.(Boehringer) to resolve allegations that Boehringer improperly promoted its drugs,  Aggrenox, Atrovent, Combivent and Micardis for uses that were not medically accepted indications; promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs; that Boehringer made unsubstantiated claims about Aggrenox’s efficacy, and that the company paid kickbacks to health care professionals in exchange for prescribing these four named drugs.  As a result of these actions, the government alleged that false claims were submitted to government health care programs for reimbursement for these drugs.

The settlement arose from a qui tam action filed in the District of Maryland by whistle-blower Robert Heiden, a former sales representative for Boehringer. The government and states intervened in the action and settled the alleged claims for $95 million, of which the federal government will obtain $78,455,048 and the state Medicaid programs will share $16.544,952.  Under the provisions of the False Claims Act that permit the whistle-blower to receive a portion of the proceeds, Mr. Heiden will receive more than $17 million.

The Food and Drug Administration (FDA) approved Aggrenox to prevent secondary strokes.  The settlement resolves allegations that Boehringer promoted Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease, neither indication of use was approved by the FDA.  Although doctors may prescribe drugs for uses that the FDA did not approve, or for “off-label” uses, a pharmaceutical company, such as Boehringer, may not market the drugs for such “off-label” uses.

The FDA approved Combivent to treat continued symptoms of bronchospasm in patients with COPD who already are on a bronchodilator.  The government alleged that Boehringer marketed Combivent for use prior to another bronchodilator in treating COPD.  The FDA has not approved this indication of use for Combivent.

Finally, as to the government’s off-label allegations, it was alleged that Boehringer marketed Micardis for treatment of early diabetic kidney disease.  The FDA approved Micardis to treat hypertension.

Additionally, the settlement resolves the allegations that Boehringer knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs.  Furthermore, Boehringer knowingly made unsubstantiated claims about Aggrenox’s efficacy, including that it was a superior drug to Plavix.  Unless a pharmaceutical company has specifically researched and performed specific FDA regulated head to head testing as between two drugs, thus, proving a drug’s superiority over another, the pharmaceutical company is not allowed to make these kind of superiority claims when marketing its drugs.

The settlement also resolves claims that Boehringer paid kickbacks to health care professionals as incentive to prescribe Aggrenox, Atrovent, Combivent and Micardis. Such payments are in violation of the federal and state Anti-Kickback Statutes. Under the recent amendments to the False Claims Act, a violation of the Anti-Kickback Statute is a violation under the False Claims Act.

The government will also enter a Corporate Integrity Agreement with Boehringer that requires the company to put in place procedures, audits and reviews of company behavior and to promptly detect conduct similar to that arising under the settlement.  The average length of such agreements is five years.

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