Risperdal is 2nd Largest Mass Tort in Philadelphia
Risperdal lawsuits account for a large portion of the mass tort spike in Philadelphia, where the pharmaceutical inventory is the highest it has been in years. Risperdal litigation is the second largest mass tort in Philadelphia’s Complex Litigation Center, behind Reglan. Johnson & Johnson’s Janssen unit is facing thousands of lawsuits alleging that its antipsychotic medication Risperdal caused gynecomastia, or the abnormal growth of breast tissue, in young boys. Risperdal gynecomastia lawsuits, some of which have produced sizeable verdicts, allege that Janssen knew about the risks but failed to warn patients or the medical community.
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.
As of Jan. 1, there were 5,601 lawsuits against pharmaceutical companies in Philadelphia’s Complex Litigation Center. In 2012, the court started making changes to reduce its mass tort inventory. Since then, The Legal Intelligencer reports, the number pharmaceutical cases has increased by 200. The Risperdal and Xarelto mass tort litigations were the only two that increased last year. All other pharmaceutical mass torts decreased.
According to The Legal Intelligencer, 550 new lawsuits were added to the Risperdal mass tort last year, increasing the inventory by 39 percent.
Reportedly, the Risperdal mass tort mostly grew because Janssen deciding to end a tolling agreement, an agreement in which parties agree to suspend the statute of limitations for a case.
Risperdal Gynecomastia Lawsuits and Jury Verdicts
Parker Waichman comments that Janssen is facing at least 13,000 Risperdal lawsuits, according to a filing with the U.S. Securities and Exchange Commission (SEC). The Risperdal gynecomastia litigation has produced several awards, including a $70 million verdict issued last year.
Additionally, Janssen reportedly settled another Risperdal case before it went to trial for an undisclosed amount; there have been five Risperdal gynecomastia trials so far.
In the most recent trial, jurors found for the plaintiff. The Risperdal lawsuit was filed on behalf of a boy who started taking the antipsychotic in 2002 at the age of five. The plaintiff suffered gynecomastia, allegedly due to Risperdal. The lawsuit alleged that these Risperdal adverse events caused him to be bullied by his peers leading to psychological damage.
From the plaintiff’s party, jurors were shown a video deposition given by former U.S. Food and Drug Administration (FDA) Commissioner David Kessler. In his testimony, Kessler said that J&J manipulated clinical trial data to downplay the risks of Risperdal.
Other Risperdal verdicts have been handed down as well. The first Risperdal lawsuit in the Philadelphia mass tort went to trial and produced a $2.5 million verdict. Another $1.75 million Risperdal gynecomastia verdict was awarded in November 2015. Plaintiffs in the Risperdal litigation allege that Janssen failed to warn patients and their doctors about the risk of gynecomastia with Risperdal. A number of cases are filed on behalf of plaintiffs who underwent surgery to remove the breast tissue.
Janssen gained clearance for Risperdal in 1993. The FDA approved the drug to treat adult patients with schizophrenia. In 2006, the agency expanded Risperdal’s indications to include irritability associated with autism. Later, the drug was approved to treat younger patients with schizophrenia and patients with bipolar disorder.
Risperdal gynecomastia lawsuits allege that the medication label failed to properly disclose the risk of gynecomastia when plaintiffs began taking the drug. Lawsuits allege that, if the potential side effects were properly listed, plaintiffs would have selected a different treatment option.
Risperdal can increase levels of prolactin, a hormone that stimulates breast development and milk production.
The current Risperdal label lists gynecomastia as a potential adverse event. According to the prescribing information, children and adults taking the drug have experienced increased prolactin levels. The documents states that Risperdal “has been shown to elevate prolactin levels in children and adolescents as well as in adults”. In a trial containing 1,885 children and adolescents taking Risperdal, the rate of gynecomastia was 2.3 percent. Additionally, 49 percent of Risperdal users had elevated levels of prolactin compared to 2 percent of patients taking a placebo.
Janssen Pays $2.2B Settlement over Risperdal, Other Drugs
J&J has been involved in large settlements with the United States government, where allegations involved Risperdal. In 2013, the company paid $2.2 billion to settle allegations of off-label marketing with Risperdal and other drugs. The government also alleged that J&J paid illegal kickbacks to doctors and pharmacists to prescribe their drugs.
“Off-label” means that a drug is being used in a manner not approved by the FDA. Pharmaceutical companies are prohibited from off-label marketing, but physicians can prescribe drugs off-label if they believe it will benefit the patient. With Risperdal allegations, Janssen was accused of marketing Risperdal off-label to children and elderly patients with dementia.
According to a press release issued by the Department of Justice, J&J promoted Risperdal for uses not approved by the FDA, including to elderly patients with dementia and to children. The company engaged in this type of off-label marketing, the government alleged, despite knowing the drug “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.”
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).