Kathleen G. Kane - Pennsylvania Office of Attorney General - Protecting Pennsylvanians

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November 15, 2012

Connecticut pharmaceutical company agrees to pay $95 million to resolve allegations of off-label marketing

HARRISBURG ? Attorney General Linda Kelly today announced that Pennsylvania will receive more than half a million dollars as part of a $95 million national settlement against a Connecticut pharmaceutical company.

Kelly said the settlement resolves allegations that Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) violated the Federal False Claims Act and various state false claims acts, by engaging in off-label marketing campaigns that improperly promoted four drugs: Atrovent, Combivent, Micardis and Aggrenox.

According to the settlement BIPI unlawfully marketed these drugs for a variety of non-FDA approved indications, including Aggrenox for certain cardiovascular diseases 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.
Kelly said that BIPI also promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs as well as made unsubstantiated claims about the efficacy of Aggrenox.

Kelly said the settlement also resolves allegations that BIPI paid kickbacks to health care professionals as encouragement to prescribe these drugs to their patients.

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.

More than $34 million of the total $95 million settlement will go to the Medicaid programs. Pennsylvania will receive more than $513,000.

The suit was filed in U.S. District Court in Maryland. A National Association of Medicaid Fraud Control Units Team participated in the investigation and conducted the settlement negotiations with BIPI on behalf of the states and included representatives from Offices of the Attorneys General for the states of Ohio, Florida, Virginia, South Carolina, and Oregon.

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