Invega and Gynecomastia, Growth of Male Breast Tissue
Parker Waichman LLP is a national personal injury firm that represents clients in lawsuits over allegedly defective drugs and medical devices. Currently, the firm is investigating possible lawsuits on behalf of individuals who took Invega (known generically is paliperidone), an antipsychotic medication marketed by Johnson & Johnson’s Janssen unit, and developed gynecomastia. The firm continues to offer free legal consultations to individuals with questions about filing an Invega gynecomastia lawsuit.
Invega lawsuits closely resemble Risperdal lawsuits. Both drugs are antipsychotic medications manufactured by Janssen, but Invega is newer and slightly different in chemical composition. The U.S. Food and Drug Administration (FDA) approved Risperdal in 1993, whereas Invega was approved in 2006. Invega and Risperdal lawsuits allege that the drugs caused gynecomastia, or the development of male breast tissue, mostly when taken by children for behavioral issues. Janssen is accused of knowing about the risks but failing to warn patients or their physicians.
While Risperdal/Invega-induced gynecomastia usually does not cause any serious health risks, plaintiffs often allege psychological damage. Risperdal gynecomastia lawsuits frequently allege that the abnormal growth of breast tissue caused the adolescent boys to be bullied by their peers. In some cases, lawsuits are filed on behalf of individuals who underwent surgery to remove the breast tissue.
Research has linked Invega and Risperdal to an increased risk of gynecomastia. In 2014, scientists presented findings at the American Association for Geriatric Psychiatry (AAGP) 2014 Annual Meeting showing that older men who used Risperdal or Invega were more likely to develop gynecomastia compared to non-users. Researchers found that use of these antipsychotic medications was associated with a 69 percent increased risk of gynecomastia compared to men who did not use Risperdal or Invega.
“This is the first and largest epidemiologic study on this question using data from 1 million men in the United States,” said lead author Mahyar Etminan, PharmD, to Medscape Medical News. Etminan is a drug safety researcher in the Therapeutic Evaluation Unit at Provincial Health Services Authority of British Columbia and an assistant professor at the University of British Columbia, Vancouver, Canada.
“There has been a lot of interest on the risk of gynecomastia with Risperdal, mainly in adolescent boys but also in older men. There have been reports to the FDA [US Food and Drug Administration] and case reports from academics,” Etminan said. “So we wanted to see if there was actually a risk with Risperdal that is over and beyond the other antipsychotics. We do know that these drugs in general can cause gynecomastia because of the way they change the hormones in the body. But we weren’t really sure whether Risperdal does it more than the others.”
Janssen Sued over Risperdal Gynecomastia Claims
Parker Waichman notes that Janssen is facing substantial lawsuits alleging Risperdal caused gynecomastia. According to a 2016 filing with the U.S. Securities and Exchange Commission (SEC), at least 13,000 Risperdal product liability lawsuits have been filed against the company.
J&J recently settled a Risperdal gynecomastia lawsuit slated for trial. The lawsuit would have been the sixth case to be heard by jurors. The previous Risperdal gynecomastia lawsuit that went to trial resulted in a $70 million verdict. The lawsuit was filed on behalf of a plaintiff who began taking Risperdal in 2002; he was five years old at the time. He developed gynecomastia, allegedly due to Risperdal side effects, and alleges that his condition caused him to be bullied by his peers. At trial, jurors were shown a video deposition given by former FDA Commissioner David Kessler, who said that J&J manipulated clinical data to hide the risks of gynecomastia with Risperdal. Kessler testified that J&J diluted the data to downplay the risks of Risperdal.
In addition to individual lawsuits, there is also a Risperdal gynecomastia mass tort consolidated in Philadelphia. When the first bellwether case in the mass tort went to trial, the jury handed down a verdict of $2.5 million. Bellwether cases are the first cases to go to trial; their outcome is used to gauge the remaining litigation. The lawsuit alleged that Risperdal caused gynecomastia in a boy who started taking the drug in 2002 at the age of eight. According to the complaint, the plaintiff stopped taking Risperdal when the label was updated to include the risk of gynecomastia. As with other Risperdal gynecomastia lawsuits, the plaintiff alleged that J&J knew about the risks but failed to warn patients or the medical community.
Another Risperdal gynecomastia verdict was handed down in November 2015, when jurors awarded $1.75 million to the plaintiff.
J&J Invega, Risperdal Off-Label Marketing Settlement
In November 2013, J&J reached a $2.2 billion settlement with the federal government to resolve allegations of off-label marketing with Risperdal, Invega and other medications. The term “off-label” means that a drug or medical device is being used in a manner not approved by the FDA. Physicians can prescribe off-label but it is illegal for companies to promote off-label use.
The federal government alleges that J&J promoted Risperdal off-label to elderly patients with dementia and to children. The company allegedly marketed these indications even though they were not approved by the FDA and knew 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. 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.”
Invega was also part of the settlement. The DOJ release states, “Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.”
Filing an Invega Gynecomastia Lawsuit
If you or someone you know developed gynecomastia, or male breast growth after taking the antipsychotic drug Invega, 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).