Product Liability Claims Allege Antipsychotic Caused Male Breast Growth
Parker Waichman LLP personal injury attorneys comment that Risperdal lawsuits continue to mount against Johnson & Johnson’s Janssen unit. In a recent filing with the U.S. Securities and Exchange Commission (SEC), the company revealed it is facing at least 13,000 product liability claims over the antipsychotic medication. Plaintiffs in the litigation allege that Risperdal causes abnormal and excessive male breast growth, a condition known as gynecomastia. Plaintiffs allege that J&J failed to disclose this risk to patients and the medical community.
Parker Waichman represents numerous clients in product liability lawsuits. The firm continues to offer free legal consultations to individuals who are interested in filing a Risperdal gynecomastia lawsuit.
According to Risperdal lawsuits, Janssen was aware that the antipsychotic could increase levels of prolactin, a hormone that triggers breast development and milk production. Plaintiffs allege that the manufacturer did not adequately warn of this risk when they started taking Risperdal.
When Janssen gained clearance for Risperdal in 1993, the U.S. Food and Drug Administration (FDA) had only approved the drug to treat schizophrenia in adult patients. The Risperdal gynecomastia lawsuits are filed on behalf of plaintiffs who usually began taking the drugs as children for autism, behavioral problems, and other issues. The FDA did not approve Risperdal in pediatric patients until 2006, when its indications were expanded to include irritability associated with autism. In 2007, the FDA approved Risperdal to treat schizophrenia in patients between the ages of 13 and 17 and bipolar disorder in patients between the ages of 10 and 17.
“Off-label” is a term indicating that a drug is being used in a manner not approved by the FDA. Physicians can prescribe off-label if they decide it will benefit the patient but pharmaceutical companies are prohibiting from engaging in off-label marketing. In the past, the federal government has alleged that J&J promoted certain drugs, including Risperdal, for uses not approved by the FDA.
The current prescribing information for Risperdal describes gynecomastia as a potential side effect. This risk is based on clinical trials where Risperdal “has been shown to elevate prolactin levels in children and adolescents as well as in adults”. The rate of gynecomastia in a trial of 1,885 children and adolescents taking Risperdal was 2.3 percent. Data also showed that 49 percent of Risperdal users had elevated levels of prolactin compared to 2 percent of patients taking a placebo.
Clinical trial data showed that 49 percent of patients taking Risperdal had elevated levels of prolactin compared to 2 percent of patients taking a placebo.
Risperdal Litigation Update: Verdicts and Settlements
So far, five Risperdal gynecomastia lawsuits have gone to trial. Recently, a sixth lawsuit was slated for trial but the case was settled before the lawsuit reached court. J&J settled the Risperdal gynecomastia case for an undisclosed amount. The last Risperdal gynecomastia lawsuit that went to trial resulted in a $70 million verdict.
In July, jurors ordered J&J to pay $70 million to a plaintiff who began taking Risperdal in 2002 at the age of 5. The lawsuit alleged J&J failed to warn the plaintiff or his physician about the risk of gynecomastia. According to his lawsuit, the breast growth caused the plaintiff to be bullied by his peers.
Attorneys for the plaintiff showed jurors, among other things, a video deposition given by former FDA Commissioner David Kessler. Kessler testified that J&J obscured clinical data in order to minimize the risk of gynecomastia with Risperdal. He cited a trial where, allegedly, the company excluded boys over the age of 10 from the number of participants who developed gynecomastia. The total number of participants however, still included these individuals. He also claims that the company diluted the data further by adding 103 girls without gynecomastia to the total number of study participants. Plaintiffs claim that data manipulation prevented the FDA from observing the real rate of gynecomastia with Risperdal.
Some 2,000 Risperdal gynecomastia claims have been consolidated into a mass tort in Philadelphia, Parker Waichman notes. The first lawsuit in the Philadelphia litigation to go to trial resulted in a $2.5 million verdict for the plaintiff. Jurors found that the company failed to disclose the risk of gynecomastia with Risperdal. The suit was filed on behalf of a boy who started taking Risperdal to treat behavioral symptoms related to autism in 2002. He was eight years old at the time. According to his lawsuit, he stopped taking Risperdal when the label was updated to reflect a risk of gynecomastia.
A Risperdal gynecomastia verdict was also issued in November 2015. Jurors ordered J&J to pay $1.75 million to the plaintiff.
J&J Off-label Marketing Settlement with Risperdal, Other Drugs
J&J has faced allegations of off-label marketing in the past. The federal government previously accused the company of misbranding certain products, including Risperdal. The company agreed to a $2.2 billion settlement in November 2013. Among other things, the government alleged that J&J approved Risperdal for uses not approved by the FDA, including elderly patients with dementia and children with behavioral issues.
According a press release issued by the Department of Justice, the government also accused J&J of paying illegal kickbacks to physicians and pharmacists.
J&J settled allegations that it marketed Risperdal off-label despite knowing that the antipsychotic “posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.” the DOJ release states.
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania according to the release. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”
More Information about Filing a Risperdal Gynecomastia Lawsuit
If you or someone you know developed gynecomastia, or male breast growth after taking the antipsychotic drug Risperdal, you may have valuable legal rights. The drug side effect attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).