The Pennsylvania Supreme Court declined to hear Janssen Pharmacuetical’s request for an appeal of a lower courts decision to reinstate the lawsuit of a Texas man who took Risperdal as a child. The Pennsylvania Superior Court’s decision to allow Tommy Moroni’s suit against Janssen, a subsidiary of Johnson & Johnson, to go back to trial will stand.

July 2019, the Pennsylvania Superior Court overturned a trial courts mid-trial decision to dismiss Moroni’s suit stating the plaintiff’s expert medical witnesses did not meet Texas’ strict standards for proving a link between Risperdal and gynecomastia, a condition that causes boys to grow breast tissue. However, the appellate court found that weighing expert testimony is a procedural question, not a substance question, therefore Pennsylvania’s looser standards apply. The panel of judges found that the plaintiff’s experts had in fact proven “to a reasonable degree of medical certainty, that Risperdal caused [Moroni’s] gynecomastia.” 

The plaintiff’s experts, Dr. Mark Solomon, a plastic surgeon familiar with gynecomastia, and Dr. David Kessler, former commissioner of the FDA, pediatrician and biostatistician. Kessler testified that Janssen knew of Risperdal’s link to gynecomastia and failed to warn doctors and patients of the possible side effect. 

Using Janssen’s internal studies and communications, Kessler was able to trace the history of Risperdal to show the pharmaceutical giant should have seen red flags in their own data that would put the risk of gynecomastia in children at 2.3% – 12.5% when taking Risperdal. A finding that Janssen should have shared with physicians who were known to be prescribing the drug off-label to children, but failed to do so. Instead, Janssen downplayed the risk and  manipulated the study results presented to the FDA which resulted in the 2006 approval for the use of the antipsychotic drug in children.

Moroni began using Risperdal in 2004 at the age of seven to treat attention deficit hyperactivity disorder (ADHD). At the time Risperdal was not approved for use in children, although Janssen was encouraging doctor’s to prescribe the antipsychotic drug to children off-label. Moroni took the drug for about four years and was diagnosed with gynecomastia about 2 years after discontinued use of the drug.

There are more than 7,000 pending Risperdal suits in Pennsylvania courts and more than 13,000 cases nationwide. Sheller PC has represented plaintiff’s with notable verdicts including $500,000 to $70 million for compensatory damages, and an $8 billion punitive damages jury verdict which was reduced to $6.8 million by the trial judge, a decision that will be appealed.

Risperdal Breast-Growth Trial Won’t Go To Pa. Supreme Court, Law360, March 17, 2020