Affected Patients of Risperdal File Lawsuits Against Johnson & Johnson

In 1993, Risperdal was approved by the U.S. Food and Drug Administration (FDA) for the treatment of psychotic disorders, such as schizophrenia. Later on, Risperdal was prescribed for other uses. Unfortunately, several doctors have prescribed Risperdal for unapproved uses, with some resulting in serious health complications. As a result, lawsuits against Johnson & Johnson (J&J) and its Jannsen unit are pursued by the affected patients. Some of the patients seek assistance through http://www.risperdalinjuryfirm.com/ .

The FDA has been investigatingRisperdal sales practices since 2004, including allegations that the company marketed the drug for unapproved uses.  As a result a number of settlements have been dealt by the company through the years.

A number of lawsuits have been filed in the recent years with plaintiffs claiming that the use of the antipsychotic medication caused patients to suffer a variety of serious side effects, specifically gynecomastia  or the abnormal breast growth among males. According to legal resources, majority of the lawsuits have been filed as individual claims, rather than Rispderal class action lawsuits.

In 2013, J&J tried to protect itself against the threat of being a target of litigation by paying the victims at least $2 billion for the damages. Experts say that this is one of the largest penalties ever levied for misbranding a drug.

The FDA originally approved Risperdal for psychotic disorders including schizophrenia. It was later approved for other uses. However, the agency began receiving information in January 2012 about Janssen’s efforts to market Risperdal for other uses aside from schizophrenia. J&J made $34 billion onRisperdal sales after its introduction.

Risperdal's global sales peaked at $4.5 billion in 2007 and declined after the company lost patent protection. It generated $3.4 billion in sales in 2008, or 5.4 percent of J&J’s revenue, according to company filings. Sales of the drug fell to $527 million in 2010, according to earnings reports.

The issue of Risperdal is a considered a medical fraud because the drug was found to be misbranded or mislabeled and was indicated for unapproved uses. In addition, J&J was also discovered of paying kickbacks or extra fees to physicians, healthcare providers and the company named Omnicare Inc.

References:

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

medscape.com/viewarticle/571416_6

ehealthme.com/ds/risperdal/gynecomastia

Issue Behind Risperdal Lawsuits Considered as Medical Fraud

Legal reports have it have that a number of the filed lawsuits against Risperdal are due to the breast enlargement in men (gynecomastia). Before it became available as a generic medication in 2008, Risperdal was a best-seller drug. However, Johnson & Johnson (J&J) and its Janssen unit have faced wide legal problems over their Risperdal promotions. 

Furthermore, the issue of Risperdal is a considered a medical fraud because the drug was found to be misbranded or mislabeled and was indicated for unapproved uses. In addition, J&J was also discovered of paying kickbacks or extra fees to physicians, healthcare providers and the company named Omnicare Inc.

As a matter of fact, J&J has been scheduled for early trial dates, called “bellwether” cases. The detailed and full terms of these lawsuits have not been reported yet. Some lawsuits claims that J&J failed to thoroughly investigate on the effects of their medication and warn the consumers about the link between Risperdal and gynecomastia.

References:

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

medscape.com/viewarticle/571416_6

ehealthme.com/ds/risperdal/gynecomastia

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