Risperdal is an antipsychotic medication used to treat schizophrenia and bipolar disorder in adults and children, and behavioral disorders caused by autism in children. At one time it was the number one antipsychotic used in the United States with more than one million prescriptions for the medication written within three years of its release, including many for unapproved, off-label uses. Today, Risperdal continues to earn more than $3 billion annually for its manufacturers Janssen Pharmaceuticals and Johnson & Johnson.
Despite its popularity, Risperdal has faced controversy from the beginning, with users experiencing negative side effects and accusing the company of inappropriate marketing techniques shortly after the drug hit the market. As a result, Janssen has paid billions of dollar in fines, penalties, and lawsuit settlements throughout the life of the medication.
Gynecomastia and Risperdal Lawsuits
One of the most common side effects of Risperdal use is the development of breasts in young male users. The condition is known as gynecomastia and it is a permanent change that requires reconstructive surgery to correct. Medical experts believe Risperdal triggers gynecomastia because the drug stimulates the production of prolactin, a hormone that is usually found in pregnant or nursing women.
A 2006 study confirmed the risk of gynecomastia with Risperdal use and also showed evidence Risperdal triggers early breast development in young female users. The drug was also shown to cause lactation in girls, boys with gynecomastia, and in women who were not pregnant or nursing. A 2007 report in the Wall Street Journal reported up to 70% of children with gynecomastia developed the disorder because of Risperdal use.
Inappropriate Marketing Accusations
In addition to the health side effect associated with Risperdal, Janssen has also been accused of inappropriate marketing techniques regarding the drug. Lawsuits claims the drug was marketed for unapproved uses in children and adults, including for the treatment of ADHD, chemical restraint, and schizoaffective disorder. Harm caused from the misuse of the drug dates back to 2001, and Janssen and Johnson & Johnson have already paid more than $5 billion in settlements and fines regarding inappropriate marketing and use.
It should be noted that it is legal for doctors to prescribe medications for off-label, unapproved uses, but it is illegal for drug manufacturers to promote or market the drug for such uses.
There is also evidence the FDA was aware of the medical study data that showed how dangerous Risperdal was and still approved the drug for treating schizophrenia and bipolar disorder.
FDA Warnings and Risperdal Lawsuits
After years of problems, Janssen Pharmaceuticals was forced by the FDA to add a black box warning to Risperdal in 2005, but the warning only addressed the risk for elderly dementia patients using the drugs, despite more than 1200 adverse event reports (31 of which were fatal), regarding children’s health.
In 2008, an FDA advisory meeting concluded no further warnings were needed regarding the drug. There have been numerous instances regarding chemical contamination of Risperdal that led to recalls, but the FDA did nothing beyond the existing black box warning.
By 2010, the first Risperdal lawsuit was filed by a 21 year old man who used Risperdal for at least five years and developed gynecomastia. A former Johnson & Johnson CEO was due to testify in the trial, but the company settled the case on the first day of trial for an undisclosed amount.
Later that year, Johnson & Johnson was fined $1.2 billion in an Arkansas court for improper marketing that downplayed the risks of the drug. The fine also included more than 240,000 cases of medical fraud.
Since those first events, Johnson & Johnson and Janssen have faced abundant legal action regarding Risperdal, including:
$181 million settlement in 36 states and the District of Columbia for improper marketing
$327 million settlement in South Carolina
$258 million settlement in Louisiana
$158 million settlement in Texas
$2.2 billion in fines and penalties levied by the US Department of Justice to avoid prosecution for misbranding
420 lawsuits including claims of gynecomastia in 100 cases, six of which were due to call the FDA Commissioner to testify in the trial, but were settled for an undisclosed amount instead
Janssen Pharmaceuticals and Johnson & Johnson are still under investigation and continue to face hundreds of lawsuits regarding serious and life-threatening events caused by Risperdal.