Risperdal Gynecomastia Lawsuit
Janssen Pharmaceuticals’ antipsychotic drug Risperdal (risperidone) was first approved by the FDA in 1993 for the treatment of adult schizophrenia. In 2006, other indications of the drug were approved for use in children to manage schizophrenia, bipolar disorder, and behavioral disorders caused by autism, but often led to unwanted side-effects.
Risperdal belongs to a class of drugs called atypical antipsychotics, similar to Zyprexa, Seroquel, Abilify, and others. Risperdal quickly gained popularity as an alternative to older antipsychotic drug Haldol (haloperidol). In 2007, the Johnson & Johnson subsidiary generated $4.5 billion in sales from the blockbuster drug. Since its entry into the market, Risperdal has earned nearly $40 billion for the pharmaceutical company.
But now, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals (“Janssen”) face multiple lawsuits accusing the drug giant of “off-label” marketing, or promoting Risperdal for uses not approved by the FDA—including for ADHD, depression, obsessive-compulsive disorder, anxiety, and other disorders. Janssen is further accused of marketing Risperdal to children after its initial request for approval for use in children was denied by the FDA due to a lack of clinical evidence.
Since at least 1999, Risperdal has been linked to permanent, abnormal breast development in males, or gynecomastia. Risperdal stimulates the pituitary gland, which causes increased levels of prolactin (a hormone common in pregnant and nursing women) and often leads to growth of the breast tissue. In 2009, a study published in the Journal of Clinical Psychopharmacology found that Risperdal treatment can cause elevated levels of prolactin in the body for up to two years. Published in 2006 by the Journal of Clinical Psychology, researchers from Switzerland warned Risperdal should be only administered to children and adolescents with extreme caution due to its effects on prolactin blood levels that can lead to gynecomastia. While particularly alarming and developmentally disturbing amongst young boys, causing psychological trauma, gynecomastia can also affect adults as well. Gynecomastia can occur in one or both breasts, and may require surgery to remove the excess tissue.
The first gynecomastia lawsuit was filed against Janssen in 2012 by a 21-year old male who took Risperdal for five years, starting at age nine—long before the drug was approved for use in juveniles in 2006. In February 2015, the first Risperdal suit to go to trial concluded with a $2.5 million verdict in favor of the plaintiff, who developed breasts after taking Risperdal at age seven in 2002 to treat autism. Now, Janssen and Johnson & Johnson face numerous other lawsuits accusing the drug companies of hiding evidence related to Risperdal’s propensity to cause gynecomastia.
$2.2 Billion Risperdal Settlement
In November 2013, Johnson & Johnson agreed to pay $2.2 billion in civil and criminal fines to settle claims that it marketed Risperdal inappropriately and that it, according to then-Attorney General Eric Holder, “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly and the disabled”. Most of the misconduct reportedly occurred from 1999 through 2005.
What Does This Mean for You?
If you or your son developed breasts while taking Risperdal, you may be legally entitled to compensation. It’s not too late to investigate your claim.
Want to Know if You Have a Valid Legal Claim?
Experienced attorneys are investigating the risks of Risperdal and are monitoring all developments. If you or your son developed breasts while taking Risperdal, please contact us by submitting the form or by calling us at 888-931-4335 for a confidential evaluation of your potential claim.