Report Off-Label Drug Marketing, Kickbacks, and Other Pharma Fraud
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If you have non-public information about off-label drug marketing, kickbacks to doctors, or other pharmaceutical fraud, a whistleblower attorney can guide you through the steps that need to be taken. We can help you determine whether you have a case and may be eligible for a whistleblower reward.
Not only are America’s tax dollars at stake, but so is the health and welfare of its citizens. Most forms of drug company fraud not only rob the government’s funds, but also hurt patients.
Although doctors are permitted to prescribe drugs for uses not approved by the FDA, or “off-label” uses, drug companies may not market drugs for such uses. Giving kickbacks to prescribers is also illegal. Because Medicare pays for these drugs, off-label marketing is Medicare fraud.
Under the False Claims Act, those who report pharmaceutical fraud can receive a percentage of any monies the government recovers. Pharmaceutical whistleblowers have helped the government recover billions. Whistleblowers are often drug company employees or individuals that work with drug companies.
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For off label marketing of the drug Depakote, a federal district judge last week ordered Abbott Laboratories to pay a $500 Million criminal fine, to forfeit $198.5 Million, and to pay $1.5 Million to the Virginia Medicaid Fraud Control Unit.
In May, Abbott Laboratories pled guilty to off-label marketing of Depakote for dementia and schizophrenia, uses not approved by the FDA. It also settled allegations that it marketed Depakote for psychiatric illnesses in children, including conduct disorders, attention deficit disorder and autism, and other psychiatric illnesses in adults, including depression, anxiety, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol and drug withdrawal, agreeing to pay $1.6 Billion.
Whistleblowers get a share of these settlements as a reward for reporting fraud under the False Claims Act.
Explains the LA Times:
Lawsuits filed by four groups of whistle-blowers alleged that Abbott marketed the drug for off-label uses, including for treatment of schizophrenia, dementia and autism. The Justice Department intervened in those suits to determine whether the company’s marketing of the drug violated civil and criminal laws, including fraudulently charging Medicare and Medicaid.
Those lawsuits alleged that Abbott encouraged and trained its salespeople to market Depakote off-label to nursing-home directors, geriatric doctors and other long-term-care providers. The company also gave doctors illegal kickbacks to talk about off-label uses of the drug to boost sales, according to the whistle-blower suits, which were filed in federal courts in Illinois, Virginia and the District of Columbia.
Recent Off-Label Drug Promotion Cases
A whistleblower in an off-label marketing case against Boehringer Ingelheim Pharmaceuticals Inc. will receive more than $17 million as a reward. The reward is his share of a $95 million settlement with the government. Whistleblowers get a share of such settlements as a reward for reporting fraud under the False Claims Act.
Robert Heiden, a former sales representative for Boehringer, blew the whistle on the company’s illegal off-label marketing of three different drugs. The three drugs were Aggrenox, Combivent, and Micardis.
The government alleged that Boehreinger marketed these drugs for uses that were not approved by the Food and Drug Administration. Such unapproved uses are not covered by Medicare and Medicaid. Yet these federal health care programs were billed millions.
Boehreinger is also accused of paying kickbacks to doctors for prescribing Aggrenox, Atrovent, Combivent and Micardis.
Pharmaceutical company GlaxoSmithKline has agreed to pay $3 billion in fines to the government in a pharmaceutical whistleblower case. This is the largest pharmaceutical fraud settlement to date, and brings whistleblower lawsuit settlements to a total of $10 billion for 2012. Whistleblowers get a share of these settlements as a reward for reporting fraud under the False Claims Act.
The pharmaceutical whistleblowers were four GSK employees, including a vice president and a senior marketing development manager. The pharmaceutical fraud involved GSK’s conduct regarding Paxil, Avandia, Wellbutrin, and other drugs it manufactures. To get doctors to prescribe the drugs, GSK paid for luxuries like tropical vacations and spa treatments.
According to prosecutors, GSK also promoted the use of Paxil in children, and helped publish a misleading report of a clinical test. It was later warned that Paxil might increase the risk of suicide in teenagers. This is part of a troubling and widespread trend of off-label drug marketing aimed at children.
The government also claims that GSK engaged in off-label drug marketing of Wellbutrin, promoting the drug for treatment of weight loss and sexual dysfunction when it was not approved by the F.D.A. for those uses.
GSK also allegedly failed to report information in had about the safety risks of Avandia to the F.D.A., and overcharged the government for drugs.