Boehringer Ingelheim Pharmaceuticals to Pay $95 Million to Settle False Claims Act Charge

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, filed a whistleblower lawsuit in 2005.

The company was represented by Wick Sollers, Elizabeth White and Mark Jensen of King & Spalding in Washington, D.C.

In the lawsuit, Heiden detailed allegations about Boehringer Ingelheim’s kickback programs and off-label marketing of certain drugs for unapproved uses.

Heiden will receive a $17 million bounty for bringing the case to the government’s attention.

“Pharmaceutical companies cannot market drugs for unapproved uses, make unwarranted claims about their benefits, or pay kickbacks to doctors who prescribe them,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland. “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 pharma reps kept after each visit with a doctor or doctor’s office, prepared background notebooks to assist the government with interviews of at least 15 witnesses, and 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.

“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,” said Colette G. Matzzie an attorney with Phillips & Cohen who represented Heiden. “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.”

Heiden alleged that the 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.

He also alleged that 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 kids, and promoting the use of excessively high, unapproved doses of Atrovent and Combivent in patients where only lower dosages were approved and considered safe.

Heiden also alleged that the company 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.

“I was concerned that doctors were basing their treatment decisions on false information,” Heiden said. “Promoting off-label treatments with potential serious consequences just to increase sales is heinous behavior.”

Heiden worked as a sales representative for Boehringer Ingelheim for 14 years in Florida.

Phillips & Cohen filed his qui tam lawsuit in federal district court 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.

“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,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services (HHS).  “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.”

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