Attorney General Fox Reaches $13.5 Million Settlement with Pharmaceutical Company

Attorney General Tim Fox announced today a $13.5 million settlement with Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).  This settlement is in regard to BIPI’s alleged off-label marketing and deceptive and misleading representations made in its promotion of four of its prescription drugs: Micardis®, Aggrenox®, Atrovent®, and Combivent®.

The settlement, reached between the attorneys general of 49 states and the District of Columbia and BIPI, resolves allegations that BIPI  misrepresented four of its prescription drugs.  It claimed the drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities when in fact, they did not.  Specifically, the States allege BIPI falsely claimed: (1) its antiplatelet drug, Aggrenox®, was effective for many conditions “below the neck”, such as heart attacks and congestive heart failure, and was superior to Plavix® without evidence to substantiate that claim; (2) Micardis® protected patients from early morning strokes and heart attacks and treated metabolic syndrome; (3) Combivent® could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD); and (4) that Atrovent® and Combivent® doses could exceed the maximum dosage recommendation in the product labeling and were essential for treatment of COPD.

“When consumers and their doctors don’t know the specific benefits and risks of their prescription medicines, it can cause severe health problems,” Attorney General Tim Fox said. “With such potentially devastating consequences, it’s imperative that pharmaceutical companies refrain from misrepresenting the appropriate uses, doses, and risks of their drugs. I’m pleased Montana joined with all other states and the District of Columbia to send a clear message that deceptive business practices by pharmaceutical companies like BIPI will not be tolerated.”

The states allege that these misrepresentations were unfair and deceptive and that the pharmaceutical company’s actions violated state consumer protection laws, including Montana Code Annotated 30-14-103.  The Consent Judgment filed in the First Judicial District Court requires BIPI to ensure that its marketing and promotional practices do not unlawfully promote these prescription drug products.  Specifically, BIPI will:

• Limit product sampling of the four drugs to health care providers whose clinical practice is consistent with the product labeling;
• Refrain from offering financial incentives for sales that may indicate off-label use of any of the four drugs;
• Ensure clinically relevant information is provided in an unbiased manner that is distinct from promotional materials; and
• Provide that requests for off-label information regarding any of the four drugs are referred to BIPI’s Medical Division.

BIPI also agreed to pay the participating attorneys general a total of $13.5 million, of which Montana’s share is $138,718.  Montana’s settlement money will go to its Office of Consumer Protection.

All 50 states and the District of Columbia are participating in the settlement, which was led by Arizona, the District of Columbia, Illinois, Indiana, Kansas, Nevada, Pennsylvania, Tennessee and Texas.

Click here to read the complaint and consent judgment.