With 900 pending Multi-District Litigation cases in Philadelphia, the first bellwether trial concerning Risperdal’s side effects started on Monday.
The Nov. 3 trial (Re: Risperdal Litigation, Case No: 100300296, in the Philadelphia Court of Common Pleas) is the start of three to determine how the jury will respond. The second has been scheduled for January 2015, and the third for February 2015. All cases concern gynecomastia, diabetes, and other life-threatening side effects in younger patients.
A day after the first trial began, Johnson & Johnson and subsidiary Janssen Pharmaceuticals reached a $2.2 billion settlement concerning its illegal marketing practices. Charged with criminal misdemeanor, the company had been pushing the atypical antipsychotic to elderly dementia patients; however, no studies supported this off-label usage.
At the same time the trial started, a new study concerning the relationship between Risperdal usage and developing gynecomastia came out. Published in the Journal of Clinical Psychopharmacology, it states that men prescribed the drug have a 69-percent chance of developing the condition. As well, there’s a 40-percent chance of breast development associated with Risperdal when compared to other atypical antipsychotics. The study examined 8,000 men between the ages of 40 and 85, with 83,000 similar control subjects between 2001 and 2011.
Along with these findings, a doctor’s testimony at the Vermont’s Mental Health Oversight Committee last month revealed that medical professionals may be giving children higher dosages of Risperdal than recommended. Dr. David C. Rettew, Director of the Pediatric Psychiatry Clinic at University of Vermont’s College of Medicine, explained that doctors follow the American Academy of Child and Adolescent Psychiatry’s recommendations 51 percent of the time and the FDA’s recommendations 27 percent of the time.
On the market since 1993, Risperdal was approved by the FDA in 2003 for adult treatment of schizophrenia and, not long after, for bipolar disorder. By 2006, it had been approved for children’s autism and, a year later, bipolar disorder in those under 16.
Yet, beyond gynecomastia, Risperdal is associated with multiple serious side effects: diabetes, stroke risks, and harmful muscle movement conditions like neuroleptic malignant syndrome (NMS) and tardive dyskinesia.