Michigan residents cannot pursue claims in a Philadelphia mass tort alleging the antipsychotic drug Risperdal caused them to grow breasts as young boys, a Pennsylvania appeals court said, agreeing that the Michigan Product Liability Act (MPLA) bars claims over drugs that have been approved by the Food and Drug Administration (FDA). The three-judge panel decision was made despite the knowledge that the medication was being used for indications for which it was not approved.
Philadelphia County Common Please Court Judge Arnold New originally threw out the claims made by Michigan-based plaintiffs in November 2014 after finding that the MPLA ban applied to the cases. The plaintiffs appealed on the grounds that they were prescribed the drug off-label, which they said excluded them from the ban.
Risperdal, made by Johnson & Johnson’s Janssen Pharmaceuticals, contains the active ingredient risperidone. It was first approved by the FDA in the 1990s to treat schizophrenia in adults. In 2006, the agency cleared the drug for use in treating irritability in children with autism.
All but one of the more than dozen Michigan-basted plaintiffs in the mass tort program in Philadelphia County Court of Common Pleas were prescribed Risperdal off-label before the medication was approved for children. About 6,400 claims are pending in Philadelphia, where the mass tort was established in October 2013. Those suing Janssen claim the drug company withheld information that Risperdal could cause adolescent boys to grow female-like breasts, a condition called gynecomastia.