Johnson & Johnson Faces Lawsuits and Settlements Over Risperdal Issues

Following reports that the top-selling antipsychotic drug Risperdal may cause gynecomastia or the abnormal breast growth in children and adult males, a number of the affected patients have decided to seek due compensation from the manufacturer, Johnson & Johnson (J&J) and its Janssen unit. Also,this ongoing issue of Risperdal is a considered a medical fraud because the medication was found to be misbranded or mislabeled and was indicated for unapproved uses. In addition, J&J was also found paying kickbacks or extra fees to physicians, healthcare practitioners, and the company named Omnicare Inc. J&J has been shelling out millions of dollars for Risperdal settlements, news reports say.

In the press time, the U.S. Food and Drug Administration (FDA) has not ordered a recall of Risperdal or required that new warnings be posted on the drug.

Throughout the years, J&J has faced various legal problems over their Risperdal promotions. According to reports, the company illegally marketed the Risperdal for off-label uses that were never approved or established as safe and effective by the FDA.  

The FDA approved Risperdal in 1993 for “the management of the manifestations of psychotic disorders.” However, J&J’s Janssen unit soon marketed Risperdal for bipolar disorder, dementia, mood and anxiety disorders and other unapproved uses, according to court documents filed in the Eastern District of Pennsylvania.

Based on media reports, Janssen plead guilty to a misdemeanor criminal charge over misbranding Risperdal for uses not approved by the U.S. Food and Drug Administration (FDA), including treating elderly patients with dementia. Aside from Janssen settling civil claims that it marketed Risperdal without approval for the elderly, children and the mentally disabled; it also settled the claim that the company paid kickbacks to doctors and to Omnicare Inc., a leading pharmacy for nursing homes. 

However, while Janssen “accepts accountability” for the actions explained in the misdemeanor plea, the civil settlement “is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations,” J&J expressed.

The health risks and other side effects brought by Risperdal have been documented by the victimized patients, healthcare groups, legal experts, and the FDA. The Journal of Clinical Psychopharmacology published a research study in 2006 revealing that prolactin levels may significantly increase when Risperdal was taken by adolescent males. Furthermore, in 2009, another study by the Journal of Child and Adolescent Psychopharmacology found that increased prolactin levels remained for as long as two years after the patients stopped taking Risperdal.

References:

healthcentral.com/schizophrenia/h/is-gynecomastia-from-risperdal-reversible.html

medscape.com/viewarticle/571416_6

ehealthme.com/ds/risperdal/gynecomastia