Boehringer to Pay $13.5M to Settle States' Off-Label Marketing Claims
Boehringer Ingelheim Pharmaceuticals Inc. will pay $13.5 million to settle allegations by attorneys general in all 50 states and the District of Columbia that the company marketed some of its drugs for unapproved uses.
December 20, 2017 at 05:49 PM
3 minute read
Boehringer Ingelheim Pharmaceuticals Inc. will pay $13.5 million to settle allegations by state attorneys general that the company marketed some of its drugs for uses not approved by the U.S. Food and Drug Administration.
Attorneys general in 50 states and the District of Columbia, including Florida Attorney General Pam Bondi, announced Wednesday a settlement to resolve claims that the German pharmaceutical giant improperly promoted its anti-stroke drug Aggrenox, its chronic obstructive pulmonary disease drugs Atrovent and Combivent, and its hypertension drug Micardis for “off-label” uses.
According to the states, Boehringer, a Delaware corporation headquartered in Ridgefield, Connecticut, marketed Aggrenox, for example, to treat conditions such as heart attacks and congestive heart failure, and claimed that the drug was superior to Plavix, without substantive evidence to that effect. The company also misrepresented that Micardis protected patients from early-morning heart attacks and strokes, the AGs alleged. The allegedly unlawful conduct occurred from 1996 to 2008, according to court documents.
In addition to the claims about Aggrenox and Micardis, Boehringer also falsely stated that Atrovent and Combivent could be used at doses that exceeded the maximum dosage recommendation in the product labeling, the AGs alleged.
Boehringer did not admit wrongdoing as part of the states' settlement, which requires the company to take several steps to ensure that its marketing and promotional practices do not unlawfully promote the drugs. These requirements include limiting the sending of samples of the four drugs to health care providers whose clinical practice is consistent with the product labeling, and refraining from offering financial incentives for sales that may indicate off-label use of any of the four drugs.
A spokesperson for Boehringer did not immediately respond to an emailed request for comment on Wednesday afternoon.
The consent judgment, which is still subject to judicial approval, comes more than five years after the company agreed to pay $95 million to resolve similar claims of off-label marketing and deceptive and misleading representations involving the same four drugs in a suit brought by the U.S. Department of Justice.
“Drug companies that misrepresent their products dangerously jeopardize patients' health in order to increase profits,” said New York Attorney General Eric Schneiderman. “Consumers should be able to trust that the advertised benefits of prescription drugs are supported by scientific evidence, not exaggerated claims.” New York stands to net $500,000 from the settlement, according to the AG's Office.
Attorneys J. Sedwick Sollers III, Mark Jensen, Brandt Leibe and Daniel Sale from King & Spalding represented Boehringer in the settlement, according to court documents.
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