Boehringer Ingelheim, a German drug company and maker of the blood thinner Pradaxa, must pay the federal government $95 million in compensation for defrauding Medicare.
The government charged that Boehringer Ingelheim promoted their drug “off label” meaning for uses they had not received regulatory approval by the U.S. Food and Drug Administration (FDA). Doctors may prescribe “off label” but drugmakers may not advertise that use.
The actions were brought to light by a former Florida employee of Boehringer. Robert Heiden was Florida-based in the 14 years he worked for the company. He alerted authorities when he felt patients may be endangered by the reckless marketing of four off-label drugs.
He filed his so-called Qui Tam lawsuit against the company in federal court in Baltimore about seven years ago.
Aggrenox had been approved by the FDA to prevent secondary strokes, however Heiden saw it was being promoted by the drug company to reduce the risk for heart attack and heart conditions, even though there was no evidence supporting that use. Attrovent and Combivent were being pushed as a cold, cough and asthma remedy in children, but the drug had never even been tested for use in children.
A Qui Tam lawsuit is filed by a private individual with insider information who assists in putting together part of the case. In exchange, they can receive 15 to 25 percent of any recovered damages. Heiden wore a wire to help the Federal Bureau of Investigation confirm the allegations and he combed over millions of pages. For his work, Heiden and his attorneys will receive about $20 million.
Boehringer Ingelheim’s current blockbuster drug, Pradaxa, is used to treat atrial fibrillation.
Ever since December of last year, reports have been coming into the FDA about serious bleeding incidents among those patients taking Pradaxa. The agency has listed Pradaxa among the top drugs for adverse event calls coming into the FDA.