In 2005, a whistle-blower, or qui tam, for Connecticut-based Boehringer Ingelheim Pharmaceuticals let the U.S. Food and Drug Administration know that his employers had kickback programs, as well as off-label marketing of certain drugs for unapproved uses.
As a result, Boehringer will pay $95 million to settle a False Claims Act charge, of which the federal government will receive $78,455,048, and state Medicaid programs will receive $16,544,952. Rod J. Rosenstein, U.S. Attorney for the District of Maryland, said, “pharmaceutical companies cannot market drugs for unapproved uses, make unwarranted claims about their benefits, or pay kickbacks to doctors who prescribe them… A doctor’s decision to prescribe a drug should not be influenced by his personal financial interest.”
The whistleblower recorded conversations by wearing a wire, as well as analyzing over one million documents, call notes made by sales representatives after each visit to the doctors, for which there were at least 15 witnesses. The whistleblower had an undercover FBI agent show up to a marketing lecture, which was sponsored by Boehringer. During the lecture, they suggested, even applauded, using the drug Micardis in ways which, at the time, had not received approval, nor was supported by research.
In return for his help and cooperation, and as a provision of the False Claims Act which permits him to obtain a portion of the proceeds obtained by the federal government, this whistleblower will receive a $17 million fee under the False Claims Act as a result of bringing the case to the government’s attention.
Aggrenox received FDA approval only for the prevention of secondary stroke, yet Boehringer promoted the use of Aggrenox as one of the leading drugs used to reduce heart attacks and other cardiovascular risks. There was no evidence that reinforced such bogus claims, and people relied on this false information, potentially risking their health.
In addition, the company promoted Atrovent and Combivent for children’s use as a treatment for asthma, as well as coughs associated with the flu, despite the fact that the drugs had never been tested on children. They also approved much stronger dosages in patients, when only lower dosages had been approved.
Yet another drug, Micardis, was marketed for the prevention of “metabolic syndrome”, as well as prevention of early kidney disease and stroke, even though the FDA only approved this medication for treating hypertension.
The whistleblower, who was a Boehringer Ingelheim sales representative for 14 years, said, “I was concerned that doctors were basing their treatment decisions on false information. Promoting off-label treatments with potential serious consequences just to increase sales is heinous behavior.”
The whole purpose in these pharmaceutical companies going through the FDA for approval is to create a system of safety for everyone who uses them. When these companies fraudulently market these drugs, or pay doctors to promote these drugs when the reasons for prescribing the drugs have not yet been researched, nor received FDA approval, they are only looking out for their profits, disregarding the safety of the consumer. Is this justice?
For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).