PENNSYLVANIA RECORD

Parties involved in the consolidated Pennsylvania litigation involving the drug Risperdal will convene on Sept. 16 at 2 p.m. at the Philadelphia Court of Common Pleas to discuss claims filed against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc.

According to Bernstein Liebhard LLP, a firm representing a large number of the plaintiffs, items likely to be included on the meeting's agenda will be cases that allege new-onset male breast development caused by the medication, a condition referred to as gynecomastia.

There are approximately 700 product liability cases involving Risperdal now filed in the Philadelphia Court of Common Pleas, many of which claim the need for a mastectomy, liposuction and other surgical intervention to repair the male breast growth complications was allegedly caused by use of Risperdal.

Risperdal is an antipsychotic medication approved to treat schizophrenia and bipolar disorder in adults and adolescents between the ages of 10 and 17. The drug is also cleared by the U.S. Food and Drug Administration (FDA) to treat irritability in children ages 5-to-16 years old with autistic disorder. According to research, Risperdal is also frequently prescribed off-label for symptoms associated with ADHD.

According to a study published on Aug. 6 in the Journal of Clinical Psychopharmacology, 27 out of 174 men exposed to risperidone, the active ingredient in Risperdal, developed male breasts within 60 days. The research was led by scientists from the University of British Columbia and involved health records of more than 82,000 men from 2001 to 2011. The men were aged between 40 and 85 years old.

The Risperdal lawsuits filed in the Philadelphia Court of Common Pleas claim that Johnson & Johnson and Janssen failed to adequately warn men and their doctors about the risk for gynecomastia and other side effects. The companies have also been accused of marketing the drug for off-label uses.

In November 2013, Johnson & Johnson agreed to a $2.5 million settlement with the U.S. Department of Justice involving claims that Risperdal and several other medications were promoted for uses not approved by the FDA.

In the case for Risperdal, this may involve promotion of the drug's marketing in children before it was cleared for pediatric uses in 2006. The federal government also accused Johnson & Johnson and Janssen of withholding information about Risperdal's side effects, which may include its association with gynecomastia.