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Whistleblower's extraordinary efforts helped win $95 million settlement with Boehringer Ingelheim
Date:10/25/2012

esult in recoveries for the government are entitled to a reward of 15 percent to 25 percent of the recovery. For the work Heiden and his attorneys did on the case, the government is awarding Heiden over 21 percent.

The allegations involved the off-label marketing of four drugs: Aggrenox, Atrovent, Combivent and Micardis. Pharma companies are prohibited from marketing drugs for uses the U.S. Food and Drug Administration (FDA) hasn't approved, although doctors may prescribe drugs for off-label uses.

The more egregious off-label marketing charges in the whistleblower lawsuit against Boehringer Ingelheim include:

  • Promoting the use of Aggrenox as one of the best drugs to reduce the risk of heart attacks and other cardiovascular risks despite the lack of evidence to support those claims. Aggrenox had been approved by the FDA only for prevention of secondary stroke.
  • Promoting the use of Atrovent and Combivent by children to treat asthma and coughs associated with a cold or flu, when the drugs had not been tested on kids, and promoting the use of excessively high, unapproved doses of Atrovent and Combivent in patients where only lower dosages were approved and considered safe.
  • Marketing Micardis for prevention of "metabolic syndrome" (medical conditions, such as insulin resistance, that increase the risk for heart disease and stroke) and prevention of early kidney disease when the FDA had approved Micardis only for treatment of hypertension.

"I was concerned that doctors were basing their treatment decisions on false information," Heiden said. "Promoting off-label treatments with potential serious consequences just to increase sales is heinous behavior."

"Boehringer Ingelheim's alleged off-label marketing practices helped it grow from a small company to one of the largest, privately held companies in the world," said Peter Chatfield, a Washington, DC, attorney with Phillips &a
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SOURCE Phillips & Cohen LLP
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