Elderly patients recently won an epic victory against monolithic health care company Johnson & Johnson, and its subsidiary Janssen and Scios. The case took over ten years for justice to prevail, but on Nov. , 2013 the verdict was finalized with Johnson and Johnson facing $2.2 billion dollars in fines, settlement and retributions penalties. Now begins the next journey for individuals to bring their personal cases to justice. If you or a loved one took Risperdal, Invega or Novector, please contact ginsburg law immediately. Johnson and Johnson was convicted of convincing Doctors and other prescribers of misusing those three drugs.
The Off-label prescription of Risperdal
Risperdal and Invega were only approved for use in patients that had schizophrenia but Johnson & Johnson and their subsidiary company Janssen convinced Doctors to use the drugs in an “off-label” way.
Off-label means that a company feels that the drug though not officially approved by the FDA, has shown merits to be a solution for other symptoms and therefore, begins to market it to doctors touting its values though they are only experimental and not approved. In Johnson & Johnson and Janssen’s case, the Doctors and the Pharmacies also received kickbacks for prescribing the drugs to their elderly patients in the off-label program.
“The lawsuit alleged that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA approved use, treatment for schizophrenia. The company also provided incentives for off-label promotion and intended use by basing sales representative’s bonuses on total sales of Risperdal I their sales areas, not just FDA-approved uses.
In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients. Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million.
The complaint also alleges that Janssen knew that patients taking Risperdal has an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes). “When Janssen receive the initial results of studies indicating Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleged that the company retained outside consultants to re-analyze the study results and ultimately published auricles stating that Risperdal was actually associated with a lower risk of developing diabetics.
The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare” sales force designed to target nursing homes and doctors who treated the elderly in business plans, Janssen’s goal was to “maximize and grow Risperdal’s market leadership in geriatrics and long term care. The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients”. Source
The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.” These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes. Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.” Source
This case is cause for every patient who has been prescribed and taken Risperdal, Invega for off label reasons should be notified. Meaning if they did not have schizophrenia, and took Risperdal or Invega, they should call Ginsburg IMMEDIATELY. Ginsburg Law is a legal expert in medical malpractice and product liability. If you or a loved one has taken one of these drugs, please take immediate action and contact Ginsburg Law. Experienced medical malpractice litigators are critical for a winning case. Ginsburg Law has the experience necessary to see justice be served. Call Now.