Another pharmaceutical giant recently agreed to return millions of dollars to federal and state governments for causing false claims arising out of off-label marketing its pharmaceutical products. In this latest False Claims Act qui tam settlement, Boehringer Ingelheim Pharmaceuticals paid $95 million to resolve allegations relating to its promotion of the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease (COPD) drugs Atrovent and Combivent, and the hypertension drug Micardis. In addition, the company settled allegations that it paid kickbacks to health care providers to further induce them to prescribe these drugs. The qui tam relator received a reward of more than $17 million.
Of particular note, the United States Department of Justice also cited the company for knowingly making “unsubstantiated claims about the efficacy” of Aggrenox, including that it was superior to Plavix. The federal Food, Drug, and Cosmetics Act (“FDCA”), 21 U.S.C. §§ 331, specifically prohibits pharmaceutical companies from making misleading claims as to the drug’s safety or effectiveness. False inflating the efficacy of a drug such as Aggrenox, in effect, misbrands the product, in violation of the FDCA.
The whistleblower in this case was a Boehringer Ingelhemim sales representative, who was forced to off-label market the company’s products to unsuspecting health care providers. Ultimately, he decided to stand up himself and for patient safety.
More information for whistleblowers is located at the Nolan Auerbach website.