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A Johnson & Johnson employee who wore a wire to internal meetings at the pharmaceutical giant has been rewarded with nearly $30 million in whistleblower compensation following a government settlement reached by the company over illegal marketing and kickback schemes associated with the antipsychotic Risperdal.
Judy Doetterl wore a recording device to marketing presentations that the federal government say proved that Johnson & Johnson conspired to market Risperdal for uses that were not approved by the FDA, which is illegal. Doetterl and several other employees filed whistleblower lawsuits and encouraged the government to investigate their employer because of things they saw occurring from inside the company.
The result of the investigation led the U.S. Department of Justice (DOJ) to pursue charges against Johnson & Johnson for illegally marketing Risperdal and other drugs, indicating that the company was engaged in an illegal kickback scheme where it paid doctors to push the powerful antipsychotic.
In November, the DOJ and Johnson & Johnson announced a $2.2 billion agreement to settle the government’s Risperdal marketing claims, including $485 million in criminal fines and forfeitures, as well as civil settlements of $1.72 billion between the federal government and states, who say the company committed Medicare fraud due to the illegal tactics.
Doetterl and the other whistleblowers are entitled to a receive portion of the civil settlement under the quit tam provisions of the False Claims Act, since they brought the case to the government’s attention and waited for the government to investigate before going public. The sales rep, who once made $150,000 a year, and some other whistleblowers will receive about $29 million from the recent settlement. Others will receive about $20 million.
According to a report by Bloomberg News, Doetterl said she agreed to gather evidence for the government not for the money, but because she felt what Johnson & Johnson was doing was wrong. Doetterl indicates that she was personally urged to push Risperdal off label to treat dementia and that sales reps were compensated for off-label sales. In 2004, federal agents placed a recording device on her before she attended a meeting in Dallas with other sales representatives.
Investigators say that the illegal marketing led to the unnecessary and risky use of Risperdal, which may put dementia patients’ lives at risk.
The DOJ began investigating Johnson & Johnson’s marketing of Risperdal in 2004, looking into an alleged kickback scheme between the drug maker and Omnicare, the nation’s largest provider of drugs to nursing homes. In 2009, Omnicare reached a settlement with DOJ over kickback charges. DOJ investigators indicated that Johnson & Johnson paid Omnicare millions to push off-label use of Risperdal to nursing home doctors and hid the kickbacks as data fees, education fees and payments to attend Omnicare meetings.
In January 2010, the DOJ filed a civil False Claims Act complaint againstJohnson & Johnson, which also accused the drug maker of illegally promoting Risperdal for use among children prior to obtaining FDA approval for such use.
Johnson & Johnson and its Janssen subsidiary face a growing number of Risperdal injury lawsuits brought in recent years on behalf of boys and young men who were given the drug as children, alleging that use of the antipsychotic as young boys increased the risk of developing a medical condition known as gynecomastia, which causes the breast growth in males.
The complaints allege inadequate warnings were provided for consumers or the medical community about the risk of boys developing breasts from side effects of Risperdal. In some cases, plaintiffs have alleged that boys developed breasts measuring as large as a 38D cup size after using the medication, with many cases resulting in the need for breast removal surgery.
The psychological effects of Risperdal breast growth can have a devastating impact on the boys, greatly impacting their overall quality of life. Lawsuits allege that Johnson & Johnson placed their desire for profits before the health of consumers by withholding information about this potential risk for young males prescribed Risperdal.