AG Jepsen, DCP: Conn. Joins $13.5 Million Multistate Settlement with Boehringer Ingelheim
Attorney General George Jepsen and state Department of Consumer Protection Commissioner Michelle H. Seagull today announced that Connecticut is joining with 49 other states and the District of Columbia in a $13.5 million settlement with Boehringer Ingelheim Pharmaceuticals, Inc. to resolve allegations that it engaged in off-label marketing and made deceptive and misleading representations in its promotion of four prescription drugs.
The attorneys general alleged that Boehringer Ingelheim made misrepresentations about the drugs and claimed that they had approval, characteristics, ingredients, benefits, uses, or qualities that they did not have. Specifically, the states alleged that the company misrepresented that:
• Micardis, a hypertension medication, protected patients from "early morning risks" of strokes and heart attacks and treated metabolic syndrome when, in fact, the company had no evidence to substantiate those claims.
• Aggrenox, an antiplatelet drug, was effective for many conditions "below the neck" – such as heart attacks and congestive heart failure – and that it was superior to a better-known competitor, Plavix, without evidence to substantiate those claims.
• Combivent, a medication used to treat chronic obstructive pulmonary disease (COPD) and asthma, could be used as a first-line treatment for bronchospasms associated with COPD, when Combivent is not indicated as a first-line treatment; and
• Atrovent, also used to treat COPD and asthma, and Combivent could be used at doses that exceeded the maximum dosage recommendation in the product labeling and that they were essential for treatment of COPD.
"Companies are prohibited under state law from making false or deceptive claims about the products they produce and sell," said Attorney General Jepsen. "In the case of drug companies, the products they create and sell, and the representations they make about those products, have a direct impact on the health and well-being of patients, which makes it all the more important that those representations be truthful. Allegations of false representations about a drug's safety or effectiveness will not go unaddressed."
"When companies misrepresent their products to consumers, not only are they acting irresponsibly, but they betray the public's trust," said Commissioner Seagull. "This becomes much more serious when it affects health care products and medication. Protecting public health and safety is our number one charge, and we take that very seriously. Companies who make untrue claims about health care products in our state will face the appropriate consequences."
The settlement requires court approval before it is final. If approved by the court, Connecticut's share of the settlement funds will be $186,357.19 and will be deposited into the state's General Fund.
In addition to the settlement funds, Boehringer Ingelheim will be required to ensure that its marketing and promotional practices do not unlawfully promote these prescription drugs. The company will limit product sampling of the four drugs to healthcare providers whose clinical practice is consistent with the product labeling and will refrain from offering financial incentives for sales that may indicate off-label use of the four drugs. Additionally, Boehringer Ingelheim will ensure that clinically relevant information is provided in an unbiased manner that is distinct from promotional materials.
The multistate investigation was led by the attorneys general of Kansas and Pennsylvania.
Assistant Attorneys General Jonathan Blake and Lorrie Adeyemi, head of the Consumer Protection Department, assisted the Attorney General with this matter.
Please click here to view the complaint and settlement documents.
Jaclyn M. Severance