Mass Tort Contains Risperdal Gynecomastia Lawsuits
Lawsuits alleging the antipsychotic drug Risperdal caused gynecomastia continue to mount against Johnson & Johnson’s Janssen unit. In fact, Risperdal litigation accounts for most of the mass tort growth in Philadelphia’s Complex Litigation Center. Risperdal lawsuits are often filed on behalf of males who took the medication as young boys and developed gynecomastia, or the abnormal growth of female-like breasts. Risperdal plaintiffs allege that Janssen was aware of these risks but failed to adequately disclose information about gynecomastia to patients or their physicians.
Parker Waichman LLP is a national law firm that represents many clients in drug injury lawsuits. The firm, which keeps-up-to-date with Risperdal gynecomastia litigation, continues to offer free legal consultations to individuals who are interested in filing a Risperdal gynecomastia lawsuit.
According to The Legal Intelligencer, Risperdal litigation is the second largest mass tort in Philadelphia; the first is Reglan. Reglan and Risperdal mass torts were the only two litigations to show any growth since Philadelphia implemented efforts to reduce its pharmaceutical inventory in 2012. The number of pharmaceutical cases pending totaled 5,601 as of Jan. 1; this is 200 more than the number of pending cases at the start of 2012.
The Risperdal mass tort increased by 39 percent last year, as 550 lawsuits were added to the litigation. The growth can mostly be attributed to the end of a tolling agreement, which is when legal parties agree that statutes of limitations do not apply to a case for a certain period of time. Most Risperdal cases were filed in 2013.
Five Risperdal gynecomastia lawsuits have gone to trial, some producing large verdicts. Risperdal gynecomastia claims have also been cited in government allegations of off-label marketing.
Risperdal Gynecomastia Verdicts, J&J Ordered to Pay $70 Million
Parker Waichman notes that a Risperdal gynecomastia lawsuit went to trial this July, producing a massive verdict of $70 million in favor of the plaintiff. It was the fifth Risperdal case to go to trial. The plaintiff began taking Risperdal in 2002 at the age of five. He developed abnormal breast growth, allegedly due to Risperdal side effects, and alleges that Janssen failed to disclose the risks. As with other Risperdal gynecomastia cases, the plaintiff alleges that his condition caused him to be bullied by his peers, leading to psychological damage.
Former U.S. Food and Drug Administration (FDA) Commissioner David Kessler gave a video deposition for the plaintiffs, which was presented at trial. Jurors heard from Kessler that J&J allegedly manipulated Risperdal clinical data to obscure the risk of gynecomastia.
A filing with the U.S. Securities and Exchange Commission (SEC) shows that Janssen is facing at least 13,000 Risperdal lawsuits.
Other juries have handed down Risperdal gynecomastia verdicts in favor of the plaintiff. The first Risperdal trial in Philadelphia, which ended in February 2015, produced an award of $2.5 million. Verdicts of $1.75 million and $500,000 were handed down in the third and fourth trials, respectively. In the second trial, jurors found for Janssen, but determined that the company did not adequately warn about the risks of Risperdal.
Early this year, Janssen settled a Risperdal gynecomastia case for an undisclosed amount just days before trial. The company settled two other Risperdal lawsuits in November 2016.
The FDA approved Risperdal in 1993 to treat adult patients with schizophrenia. The drug’s indications were later expanded in 2006 to include irritability associated with autism. Risperdal was also later cleared to treat schizophrenia in younger patients, as well as patients with bipolar disorder.
Plaintiffs suing over Risperdal typically allege that the medication labeling failed to sufficiently warn about the risk of gynecomastia at the time, even though Janssen should have been aware of the risks. Lawsuits are generally filed on behalf of individuals who allege that they would not have taken the antipsychotic medication had they been fully aware of the risks.
Risperdal is thought to increase the risk of gynecomastia because it increases levels of prolactin, a hormone that stimulates breast development and milk production.
Gynecomastia is now listed as a potential side effect on the Risperdal medication labeling. The prescribing information states that the drug has been associated with increased prolactin levels in both adults and children taking Risperdal. The document cites clinical trials assessing Risperdal and gynecomastia. One trial showed that the rate of gynecomastia was 2.3 percent; 1,885 children and adolescents participated in the trial. Trials also found increased prolactin levels, which occurred in 49 percent of participants taking Risperdal and 2 percent of participants taking a placebo.
Risperdal and Off-label Marketing Allegations Lead to $2.2B Settlement
Consumers are not the only ones to pursue litigation over Risperdal. In the past, the federal government has alleged that Janssen promoted several drugs, including Risperdal, for uses not approved by the FDA. This type of “off-label” marketing is prohibited among pharmaceutical companies, although physicians themselves are allowed to prescribe off-label if they believe it will help the patient. J&J agreed to pay a $2.2 billion settlement in 2013 to resolve the allegations.
Among other things, the government alleged that Janssen promoted Risperdal to children and elderly patients with dementia even though regulators had not approved these uses at the time. The company engaged in this type of off-label marketing despite being aware that Risperdal “posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production,” a Department of Justice press release states. “Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients,”
“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.”
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).