Boehringer Ingelheim will pay the federal government $95 million to settle charges that it improperly marketed off-label uses for four of the company’s drugs.
The U.S. Department of Justice is accusing Boehringer of paying kickbacks to doctors to induce them to prescribe the four drugs—the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease (COPD) drugs Atrovent and Combivent, and the hypertension drug Micardis. Boehringer and DoJ have also settled charges that the company caused false claims to be submitted to government health programs as a result of its actions.
As part of the settlement, Boehringer agreed to enter into a Corporate Integrity Agreement that requires procedures and reviews intended to avoid and promptly detect similar conduct.
“This civil settlement by Boehringer demonstrates that such conduct will not be tolerated,” Stuart Delery, acting assistant attorney general for DoJ’s Civil Division, said in a statement.
According to the federal complaint, Boehreinger promoted Aggrenox for reducing the risk of heart attacks and other cardiovascular events such as myocardial infarction and peripheral vascular disease.
Atrovent and Combivent were marketed for use by children to treat asthma and coughs associated with a cold or flu when the drugs had not been tested on kids, DoJ alleged, while Micardis was promoted for early diabetic kidney disease and medical conditions that increase the risk for heart disease and stroke, such as insulin resistance.
The complaint also alleged that Boehringer knowingly promoted the sale and use of Atrovent and Combivent at doses above those covered by federal health care programs, and that Boehringer knowingly made unsubstantiated claims that Aggrenox was superior to Plavix. The anti-clotting drug is sold jointly by its co-developers Sanofi and Bristol-Myers Squibb, but as of Jan. 1 Sanofi alone will sell Plavix outside the U.S. and Puerto Rico, with BMS receiving royalties on sales through 2018, plus a final payment that year of $200 million.
The federal government said it will obtain $78,455,048 of the settlement, with the remaining $16,544,952 going to state Medicaid programs. However, more than $17 million of the federal portion—more than 21%—will go to the whistleblower who tipped off authorities to Boehringer’s actions.
Robert Heiden, who worked 14 years as a sales representative for the company in Florida, filed a “qui tam” whistleblower lawsuit in U.S. District Court for the District of Maryland in 2005, accusing Boehringer of violating the False Claims Act. He aided the federal investigation of his claims in part by wearing a wire and recording conversations at government request, and by arranging for an undercover FBI agent to attend a Boehringer marketing lecture that promoted Micardis for unapproved uses.
The False Claims Act entitles whistleblowers whose cases result in recoveries for the federal government to a reward of 15% to 25% of recovery proceeds.
DoJ said it has recovered more than $13.8 billion from pharma companies and others accused of fraud against federal healthcare programs through the False Claims Act since January 2009.
The biggest recovery was the $3 billion fine GlaxoSmithKline agreed to pay DoJ last July after pleading guilty to charges that it improperly promoted its Paxil and Wellbutrin antidepressants for unapproved uses, and failed to report safety data about the diabetes drug Avandia. In addition, Johnson & Johnson paid $2 billion, and Abbott Laboratories, $1.6 billion following charges of improper marketing.