Thanks to the extraordinary efforts of one whistleblower, along with a thorough investigation conducted by the Health Care Fraud Prevention and Enforcement Action Team (HEAT), another pharmaceutical manufacturer agreed to settle a False Claims Act lawsuit. According to the United States Department of Justice (DOJ), Boehringer Ingelheim Pharmaceuticals Inc. will pay $95 million to resolve allegations it engaged in marketing practices that defrauded Medicare and promoted the off-label use of four of its drugs.
The improper marketing allegations involved the stroke-preventing drug Aggrenox, the chronic obstructive pulmonary disease (COPD) medications Atrovent and Combivent and the hypertension medication, Micardis.
According to the allegations, Boehringer fraudulently marketed Aggrenox, Combivent and Micardis for uses that were not medically accepted nor approved by the FDA and were, therefore, not covered by any federal health care program. The off-label promotion of these drugs caused false claims to be submitted to Medicare and other government sponsored health care programs.
In addition to the allegations that Boehringer knowingly and willfully used improper marketing tactics for these drugs, federal authorities also found pharmaceutical manufacturer illegally promoted the sale and use of its COPD drugs, Atrovent and Combivent. Boehringer allegedly encouraged the use and sale of both drugs at unacceptably high doses, which exceeded the approved dosage amount covered by federal health care programs.
Boehringer was also accused of making unproven claims in relation to its drug Aggrenox. The pharmaceutical manufacturer allegedly made multiple unfounded statements, claiming Aggrenox was a superior to its rival medication, Plavix.
Additional allegations contained within the whistleblower’s lawsuit included:
- Promoting Aggrenox as “one of the best drugs to reduce the risk of heart attacks and other cardiovascular risks.” Boehringer made these claims despite having any evidence to support them, as the FDA only approved Aggrenox for the prevention of a secondary stroke.
- Promoting Atrovent and Combivent as a children’s medication used to treat asthma and coughs associated with the common cold or flu. In reality, neither of these drugs had not been tested on kids.
- Marketing Micardis as a means to prevent “metabolic syndrome” and early kidney disease. The only FDA approved use of Micardis is for the treatment of hypertension.
Allegations of Illegal Kickbacks
According to the whistleblower lawsuit, Boehringer allegedly orchestrated an illegal kickback scheme involving at least 50,000 doctors and multiple hospital purchasers. Boehringer allegedly provided illegal kickbacks to medical professionals through the “free use” of ambulatory blood pressure monitor machines (ABPMs) in their offices. Once the ABPMs were delivered to the doctor’s offices, Boehringer allegedly used “ABPM lunch and learn sessions” to show physicians and their staff how to bill Medicare for use of the monitors, even though they hadn’t been charged for the equipment. Boehringer only provided the “free” ABPMs to those doctors who wrote a certain number of prescriptions for its drugs.
The whistleblower in this case, Robert Heiden, worked as a sales representative for Boehringer for 14 years in its Florida office. After learning of the False Claims Act violations at Boehringer, Heiden made several attempts to voice his concerns to supervisors. After no action was taken, Heiden consulted with a False Claims Act attorney and filed a whistleblower lawsuit in 2005.
“I was concerned that doctors were basing their treatment decisions on false information,” said Heiden. “Promoting off-label treatments with potential serious consequences just to increase sales is heinous behavior.
In order to assist the federal government’s investigation, Heiden went above and beyond his duties as a whistleblower. In order to put a stop to Boehringer’s fraudulent activities, Heiden:
- Agreed to wear a wire to record conversations
- Combed through 1.5 million pages of documentation and an excess of 2 million physician visit notes made by Boehringer’s pharmaceutical sales reps to collect evidence
- Prepared notebooks with background information to help authorities effectively interview more than 15 witnesses in the False Claims Act lawsuit
- Provided a way for an undercover FBI agent to attend a Boehringer marketing lecture, in which the speaker encouraged the off-label use of Micardis
As a result of the $95 million settlement, Heiden will receive a relator’s share of $17 million.