Calif. Appeals Court Overturns Preemption Ruling in Risperdal Gynecomastia Cases

LOS ANGELES — A California appellate court has reinstated the eligibility of thousands of Risperdal and Invega gynecomastia cases, finding the failure-to-warn claims are not preempted because there is clear evidence that the FDA would have allowed Janssen Pharmaceuticals Inc. to change the drug’s label via the Changes Being Effected process.

In a May 8 opinion, the California Court of Appeal, 2nd District, agreed with plaintiffs that when seeking approval for its antipsychotic drug Risperdal (risperidone), Janssen failed to submit evidence showing that boys taking the drug were at greater risk of developing enlargement of breast tissue.

Specifically, a data …