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December 20, 2017

States Reach $13.5 Million Settlement with Boehringer Ingelheim Pharmaceuticals Inc. Over Off-Label Promotion of Four Prescription Drugs

All 50 states allege BIPI misrepresented uses, approvals and benefits of Micardis, Aggrenox, Atrovent, and Combivent; company to pay Iowa $178,000

(DES MOINES, Iowa) Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) will pay $13.5 million to all 50 states, including $178,000 to Iowa, to resolve allegations the drugmaker engaged in off-label marketing and deceptive and misleading representations in its promotion of four prescription drugs.

The state attorneys general allege BIPI misrepresented the drugs Micardis, Aggrenox, Atrovent, and Combivent, including:

  • Misrepresenting that its antiplatelet drug, Aggrenox, is effective for many conditions “below the neck,” such as heart attacks and congestive heart failure, and that it is superior to Plavix without evidence to substantiate that claim
  • Misrepresenting that Micardis protects patients from early morning strokes and heart attacks and treated metabolic syndrome
  • Misrepresenting that patients could use Combivent as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD)
  • Falsely stating that patients could use Atrovent and Combivent at doses that exceed the maximum dosage recommendation in the product labeling and that they are essential to treat COPD

The settlement, through a consent judgment filed today in Polk County District Court, resolves a consumer fraud petition also filed today. The agreement requires BIPI to ensure that its marketing and promotional practices do not unlawfully promote these prescription drug products.

Under the agreement, 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
  • Provide that requests for off-label information regarding any of the four drugs are referred to BIPI’s medical division

The company’s payment to Iowa will go to the state’s consumer education and litigation fund.

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