BALTIMORE, MARYLAND, Oct. 25, 2012 -- The healthcare fraud case that Boehringer Ingelheim Pharmaceuticals Inc. settled today with the government for $95 million was due in large measure to a former Boehringer Ingelheim sales representative-turned-whistleblower who made extraordinary efforts to stop Boehringer Ingelheim's pharma marketing practices that allegedly defrauded Medicare and other government healthcare programs and promoted uses of its drugs that endangered patients' health.
The whistleblower, Robert Heiden, filed a "qui tam" (whistleblower) lawsuit in 2005 with detailed allegations about Boehringer Ingelheim's kickback programs and "off-label" marketing of certain drugs for unapproved uses. He provided extensive assistance to the government's investigation. For instance, he:
- 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.
- 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.
Ironically, after Heiden left his job with Boehringer Ingelheim because of his concerns about the company's marketing practices, he took a job with Hawthorn Pharmaceuticals Inc. only to discover that his new employer allegedly was marketing unapproved drugs for off-label uses and thereby allegedly defrauding government healthcare programs. He filed a separate qui tam lawsuit against Hawthorn and its chief executive officer, Max Draughn, which Hawthorn and its parent company, Cypress Pharmaceutical Inc., paid the government $2.8 million last March to settle.
"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, a Washington, DC, attorney with Phillips & Cohen LLP, which represents 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."
Under the False Claims Act, whistleblowers whose cases result in recoveries for the government are entitled to a reward of 15 percent to 25 percent of the recovery. For the work Heiden and his attorneys did on the case, the government is awarding Heiden over 21 percent. The allegations involved the off-label marketing of four drugs: Aggrenox, Atrovent, Combivent and Micardis. Pharma companies are prohibited from marketing drugs for uses the U.S. Food and Drug Administration (FDA) hasn't approved, although doctors may prescribe drugs for off-label uses. The more egregious off-label marketing charges in the whistleblower lawsuit against Boehringer Ingelheim include:
- Promoting 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.
- Promoting 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.
- Marketing 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."
The whistleblower lawsuit also alleged that Boehringer Ingelheim implemented a kickback program that would have been difficult for outsiders to figure out: Boehringer Ingelheim provided at least 50,000 doctors and numerous large hospital purchasers "free use" of a machine in their offices that monitored blood pressure (known as "ambulatory blood pressure monitors," or ABPMs), then allegedly encouraged the doctors or their staff through "lunch and learn" sessions to bill Medicare and other healthcare programs for use of the monitors even though they hadn't been charged for the equipment.
The ABPMs were "free" to doctors only if they wrote a certain number of prescriptions for Boehringer Ingelheim drugs, the lawsuit said. Sales reps were encouraged to help doctors interpret the results even though they weren't properly trained and the monitors weren't calibrated regularly, rendering the results unreliable.
The ABPM program was a follow-on to a previous kickback program, "Inspiring Improvement Program" (IIP), where Boehringer Ingelheim provided free spiromenters, which measure lung function, to doctors who wrote numerous prescriptions for Boehringer Ingelheim drugs. Boehringer Ingelheim then allegedly encouraged doctors to bill Medicare and other government healthcare programs for spirometry tests that had been administered by respiratory therapists from local hospitals and healthcare institutions who were paid by Boehringer Ingeleim.
"Boehringer Ingelheim's alleged off-label marketing practices helped it grow from a small company to one of the largest, privately held companies in the world," said Peter Chatfield, a Washington, DC, attorney with Phillips & Cohen. "Many doctors chose Boehringer Ingelheim's products over less-expensive, equally effective drugs as a result of the company's marketing practices."
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.
"Assistant U.S. Attorneys Roann Nichols and Tom Corcoran, former Assistant United States Attorney Jamie Bennett, trial attorney Brian McCabe with the Department of Justice Civil Division and the state team from the National Association of Medicaid Fraud Control Units, in particular, did a tremendous job for the government," said Matzzie.
Invaluable support was provided in the investigation by the FBI, the Office of Inspector General at the Department of Health and Human Services (HHS-OIG), the FDA, the Department of Defense's Tricare program, the Office of Personnel Management and the U.S. Department of Veterans Affairs.