A law firm is going head-to-head with the Food and Drug Administration (FDA) over documents the agency refused to make public about specific side effects in children taking the antipsychotic drug Risperdal.
Sheller PC claims it was stifled in its efforts to advocate on behalf of children injured by Risperdal when it was barred from turning over to the FDA confidential documents it had obtained through discovery in litigation against the makers of the drug. The firm petitioned the FDA in November to change the safety labels on Risperdal and revoke its pediatric indication because of reports that the drug caused gynecomastia, a condition in which boys grow female breasts. But, the agency refused, saying there wasn’t sufficient data to make those changes.
Since November, two juries in Philadelphia have found Risperdal makers Johnson & Johnson and its unit Janssen Pharmaceuticals guilty of not adequately warning doctors of patients of the gynecomastia risk with Risperdal.
Among the documents that in question was an analysis by former FDA commissioner David Kessler that contradicted a study by Robert L. Findling, which is often cited by Johnson & Johnson and Janssen to quell claims of gynecomastia with Risperdal use in boys. Both the Findling study and testimony from Kessler were presented at both Philadelphia trials.
In April, the FDA filed a motion to dismiss its case against the law firm stating that there was not enough evidence for the firm to argue that its clients had been harmed by the FDA’s denial of the petition to change the drug’s label, or its refusal to remove the pediatric indication, or its refusal not to release the firm from the confidentiality agreements.
Sheller said this week that the firm was, in fact, injured by the FDA’s denial because it made it more difficult for the law firm to win cases for its clients.
Risperdal contains the active ingredient risperidone. It is approved to treat adults and children with schizophrenia, bipolar disorder and irritability with autism. It is also prescribed off-label to treat other conditions including ADHD and ADD.