Although Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Inc. (Janssen), recently settled two lawsuits over the antipsychotic drug Risperdal, they are still facing several thousand lawsuits. The pending cases in Philadelphia alone involve more than 2,000 plaintiffs.
As of January, the juries that have heard the cases have awarded a total of just over $74 million in damages against Janssen in four of the six trials, according to the Jere Beasley Report. Two other Risperdal cases have settled on the eve of trial. However, the drug makers say the recent settlements do not indicate plans to settle additional lawsuits in the future.
Plaintiffs contend Janssen concealed the risk of Risperdal’s most devastating side effect, gynecomastia, or the abnormal growth of breast tissue in young boys.
The drug went on the market in January 1994, shortly after the U.S. Food and Drug Administration (FDA) approved it for treating schizophrenia in adult patients. Four years later Janssen requested, but was denied, FDA approval of Risperdal dosing information for pediatric use.
Despite the fact that Risperdal was not approved for pediatric indications, Janssen aggressively marketed the drug for off-label uses in children and adolescents for the next nine years until it was ultimately approved for pediatric use, according to the Jere Beasley Report. In 2013, Johnson & Johnson agreed to a $2.2-billion settlement with the U.S. Department of Justice (DOJ) over these and other deceptive marketing practices involving Risperdal.
Risperdal-induced gynecomastia often requires invasive surgical procedures such as liposuction or mastectomy to remove the tissue. Righting Injustice explains that elevated levels of prolactin, the hormone that women produce while pregnant and just after childbirth to trigger lactation, is believed to cause gynecomastia.
Medical tests have revealed high levels of prolactin in patients taking Risperdal. Tender and painful breasts and nipple discharge often accompany the disfiguring condition, which also causes emotional and psychological problems.
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If you or a loved one has suffered an injury as a result of taking Risperdal, contact James Lampkin, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at James.Lampkin@beasleyallen.com.
Jere Beasley Report (February 2017)
Jere Beasley Report (October 2012)