J&J and Janssen have settled allegations that basically claim the companies were not only pick-pocketing U.S. taxpayers, but that they were also putting at risk the most vulnerable members of our society: the young, the elderly and the disabled.
New York, New York (PRWEB) November 05, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of individuals against fraud, extols the successful efforts of several whistleblowers who filed lawsuits that helped spur global healthcare giant Johnson & Johnson (J&J) and its Janssen subsidiary to pay more than $2.2 billion to settle allegations related to the off-label marketing of the anti-psychotic drug Risperdal and two other drugs, according to a U.S. Department of Justice press release issued today. A Nov. 4 Bloomberg report noted that J&J’s Janssen unit will plead guilty to one misdemeanor charge for its off-label marketing of Risperdal; that is, the company’s efforts to promote Risperdal for uses not approved by the U.S. Food and Drug Administration (FDA).
Janssen settled civil claims for the off-label marketing of Risperdal to the elderly, children and the mentally disabled, as well as for paying kickbacks to Omnicare Inc., the largest nursing home pharmacy operation, the Bloomberg article noted, adding that civil claims include the off-label marketing of another anti-psychotic drug, Invega, as well as the heart drug Natrecor.
Janssen “accepts accountability” for the actions described in the misdemeanor plea, J&J noted in a statement, as reported by Bloomberg, but added that the settling of the civil allegations “is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations.”
In a press release issued today, the FDA noted that it approved Risperdal in 2002 for the treatment of schizophrenia; and in 2003 it extended its approval to include short-term treatment of acute mania and mixed episodes associated with Bipolar 1 disorder. The release also noted that Janssen began to market the drug as a treatment for dementia in the elderly in March 2002, “representing that Risperdal was safe and effective for this unapproved indication and subpopulation.”
Janssen had also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents, the FDA noted in its release, adding that until late 2006, Risperdal was not approved for use in children for any purpose, and that the FDA had repeatedly advised the company that promoting its use in children was problematic and could be evidence of a violation of the law.
Bloomberg noted that the civil settlement involves 45 states and resolves three lawsuits filed by whistleblowers under the False Claims Act, a Civil War-era law allowing private persons to file lawsuits on behalf of the U.S. government. Such lawsuits are also known as “qui tam” actions. Amendments added to the Act in 1986 and later have further incentivized whistleblowers to take action by raising the amounts awarded for damages and fines. Whistleblowers can obtain millions of dollars, or between 15% and 30% of the amount recovered by the government.
Whistleblowers involved in what is the government’s third-largest settlement with a pharmaceutical company, according to the Bloomberg report, will certainly be sharing one of the largest amounts ever awarded in a qui tam case. According to the Justice Department’s press release, whistleblowers involved in litigation in the Eastern District of Pennsylvania (U.S. v. Janssen Pharmaceuticals, Case No: 13-cr-605, U.S. District Court, Eastern District of Pennsylvania (Philadelphia)) will get about $112 million; whistleblowers in the District of Massachusetts (U.S. v. Janssen Pharmaceuticals, Case No: 1:07-cv-10288-RGS, U.S. District Court, District Of Massachusetts), $27.7 million; and whistleblower in the Northern District of California (U.S. v. Scios Inc., Case No: CR-11-0461-CRB, U.S. District Court, Northern District of California (San Francisco)), $28 million. (See related court documents here.)
“J&J and Janssen have settled allegations that basically claim the companies were not only pick-pocketing U.S. taxpayers, but that they were also putting at risk the most vulnerable members of our society: the young, the elderly and the disabled,” said Parker Waichman LLP.
Victoria Starr, a former Janssen sales representative, is one whistleblower involved in the settlement, Bloomberg reported, adding that her lawsuit was centered on alleged orders from her company to convince doctors to prescribe Risperdal for children with mental-health problems, an unapproved use at the time.
Also named in the Bloomberg report was whistleblower Bernard Lisitza, a former pharmacist for Omnicare who alleged he was fired after complaining about his employer’s switching patients’ prescriptions to J&J drugs.
In recent years many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects. These whistleblowers have helped the federal government recover billions of dollars obtained illegally by pharmaceutical and medical device companies. Whistleblowers also save the lives of countless prescription drug and medical device users who were previously unaware of the side effects of their device or prescription.
Anyone who possesses proof that a pharmaceutical or medical device company has engaged in some form of fraudulent activity against the federal government is encouraged to contact us. Please view our Qui Tam page or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney