For Immediate Release - October 26, 2012

AG Coakley Recovers $730,000 for State Medicaid Program in Multistate Settlement with Pharmaceutical Manufacturer

Company Accused of Improperly Promoting Four of its Drugs

BOSTON – A pharmaceutical manufacturer has agreed to pay more than $730,000 to the Massachusetts Medicaid Program (MassHealth) as part of a 50-state settlement resolving allegations of improper off-label marketing of four of its drugs, Attorney General Martha Coakley announced today. 

Boehringer Ingelheim Pharmaceuticals, Inc., a German company with a United States division headquartered in Ridgefield, Connecticut, allegedly engaged in illegal off-label marketing and kickback schemes to promote the sale of four drugs: Aggrenox, Micardis, Atrovent and Combivent. The investigation began with the filing of a whistleblower lawsuit in federal court in Maryland.

“This action is part of our ongoing effort to hold manufacturers accountable for inaccurate marketing and sales practices of medications, especially when people are struggling to pay for them,” AG Coakley said. “The settlement returns money to our MassHealth program and ensures that patient and taxpayer dollars are spent for legitimate, medically necessary purposes.”

The settlement also resolves allegations that Boehringer paid kickbacks to health care professionals as an inducement to prescribe the company’s products. 

Aggrenox is a combination therapy (low dose aspirin and extended release dipyridamole) approved by the U.S. Food and Drug Administration in 2000 for the prevention of secondary stroke and transient ischemic attacks, preventing excessive blood clotting and decreasing the likelihood of stroke in at-risk patients.  The investigation by the U.S. Department of Justice focused on allegations that Boehringer’s marketing personnel made unsubstantiated claims regarding Aggrenox’s superiority over competitor drugs, and improperly promoted it for uses that were not FDA-approved, including the treatment of cardiovascular events.

Micardis is drug approved by the FDA in 1999 for the treatment of hypertension. The investigation claims that Boehringer promoted off-label uses of Micardis for the treatment of conditions such as metabolic syndromes, and to enhance renoprotection (the minimization of adverse effects on renal vasculature). 

Combivent and Atrovent are for the treatment of bronchospasm associated with chronic obstructive pulmonary disease, chronic bronchitis and emphysema. Atrovent is FDA-approved for maintenance treatment, and Combivent is approved for use by patients who receive regular aerosol treatment and require a second bronchodilator. The government investigated allegations that Boehringer engaged in off-label marketing of these drugs by promoting “hyper-dosing” (the use of more medication than indicated as appropriate by the FDA label). 

Under the terms of the multistate settlement, which includes Washington, D.C., Boehringer will pay the state Medicaid programs approximately $34.5 million in compensation for excessive payments made as a result of the alleged illegal conduct, with a recovery for the MassHealth program of $731,529.23.  

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