The United States Justice Department recently announced that Boehringer Ingelheim Pharmaceuticals will pay $95 million to settle allegations that it promoted three drugs for uses that were not approved by the Food and Drug Administration (FDA). The settlement comes after Robert Heinden – a former sales representative for Boehringer – brought a federal False Claims Act suit against the company in Maryland.
The FDA had approved the use of Aggrenox to prevent secondary strokes, Combivent to treat bronchospasm in patients with chronic obstructive pulmonary disease who are already on a bronchodilator, and Micardis to treat high blood pressure. According to the Justice Department, however, Boehringer advocated the use of Aggrenox to treat heart attacks and peripheral vascular disease, Combivent to treat those not yet on a bronchodilator, and Micardis for early diabetic kidney disease.
In addition, the Justice Department found that Boehringer had promoted the used of Atrovent, a drug used to treat chronic obstructive pulmonary disease, at dosages higher than those covered by federal health care programs. Furthermore, the settlement with the Justice Department also resolved allegations that Boehringer had paid medical professionals kickbacks in return for prescribing its drugs.
As a result of the settlement, Boehringer agreed not only to pay a fine, but also to implement internal procedures and policies designed to prevent a recurrence of this sort of illegal activity.
Off-Label Marketing Settlements on the Rise
The Justice Department’s settlement with Boehringer is just one of several recent settlements with the pharmaceutical industry involving off-label marketing. In the biggest case to date, GlaxoSmithKline agreed to pay $3 billion to settle allegations that it had promoted the use of two drugs for unapproved uses and had failed to disclose important safety information about a third drug.
False Claims Act an Important Tool
One of the Justice Department’s most important tools in its efforts to ensure that pharmaceutical companies promote their drugs properly is the False Claims Act. The False Claims Act allows whistleblowers to obtain a percentage of the money collected by the federal government as a result of a successful False Claims Act case. In the Boehringer case, for example, Robert Heinden, is set to receive approximately $17 million from the Justice Department’s settlement.
Contact an Experienced Whistleblower Attorney
If you or someone you know is considering filing a False Claims Act suit or would like more information, contact an experienced False Claims Act attorney. A knowledgeable False Claims Act lawyer can assess your case , explain your options and file a successful case on your behalf.