Boehringer Ingelheim Pharmaceuticals will pay $95 million to settle a False Claims Act charge brought to the government’s attention by a sales representative-turned-whistleblower. The whistleblower, Robert Heiden, who filed a whistleblower lawsuit in 2005, detailed allegations in the lawsuit about Boehringer Ingelheim’s kickback programs and off-label marketing of certain drugs for unapproved uses. Heiden will receive a $17 million fee under the Act for bringing the case to the government’s attention. Rod J. Rosenstein, U.S. Attorney for the District of Maryland, had this to say:
Pharmaceutical companies cannot market drugs for unapproved uses, make unwarranted claims about their benefits, or pay kickbacks to doctors who prescribe them. Drugs should be marketed only for purposes for which they are deemed safe and effective, and a doctor’s decision to prescribe a drug should not be influenced by his personal financial interest.
Heiden wore a wire and recorded conversations at the government’s request, analyzed 1.5 million pages of documents and more than 2 million call notes that sales representatives kept after each visit with a doctor or doctor’s office, and prepared background notebooks to assist the government with interviews of at least 15 witnesses. He also arranged for an undercover FBI agent to attend a marketing lecture sponsored by Boehringer Ingelheim where the speaker discussed and encouraged uses of the drug Micardis that hadn’t been approved and weren’t supported by research. Colette G. Matzzie, a lawyer with Phillips & Cohen, who represented Heiden, stated:
Rob Heiden was an exceptionally committed whistleblower who led the charge to stop the marketing of prescription drugs for uses that hadn’t been approved and could endanger patients’ health. Even the FBI was impressed with his help, particularly that he was able to get an undercover FBI agent into a Boehringer Ingelheim marketing seminar after Rob had already left the company.
The drug company promoted 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. The company promoted 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 children, and promoted the use of excessively high, unapproved doses of Atrovent and Combivent in patients where only lower dosages were approved and considered safe.
Boehringer Ingelheim marketed 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. Heiden, who worked as a sales representative for Boehringer Ingelheim for 14 years in Florida, stated:
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 qui tam lawsuit was filed in Baltimore under seal as required by the False Claims Act. The government investigated the allegations and joined the case, which was unsealed after the settlement was reached. As part of the settlement, Boehringer also agreed to enter into a corporate integrity agreement that provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to the settlement. Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services, had this to say:
Fraudulent marketing of drugs through off-label promotion and kickbacks to doctors undermines trustworthy medical decision-making, and FDA’s protections in the drug approval process. Such conduct – as alleged in this case – poorly serves patients and taxpayers alike. OIG is overseeing a corporate integrity agreement to improve the transparency of company relationships with physicians and accountability of Board members and corporate executives.
Lawsuits brought by whistleblowers under the False Claims Act have been an effective tool in the effort to keep drug companies honest and to protect the public. It’s extremely important to encourage “whistle blowing” when fraud or cheating by corporations has been taking place. Then – one of these days – those corporations will learn their lesson and change their ways.
Source: Corporate Crime Reporter
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.