As I wrote in Let’s All Support Stephen Sheller’s FDA Petition to Revoke the Pediatric Approval of Risperdal, Stephen Sheller’s law firm (Sheller, PC), which represents hundreds of boys who were prescribed Risperdal and then grew breasts (gynecomastia) as a result, filed a petition with the Food and Drug Administration (FDA) to change the label and revoke its approval for use on children. During the course of discovery for litigation in its Risperdal cases, Sheller became privy to documents not provided to the FDA that showed Johnson & Johnson hid the problem. However, Sheller is prohibited in those court cases from disclosing these documents. Therefore, Sheller also asked the FDA to order Johnson & Johnson to release him from the confidentiality requirements so he could provide them to the FDA.
The FDA’s response, denying Sheller’s petition last November, demonstrates both how unconcerned the FDA is about the massive harm to children caused by Risperdal — most of which is paid for by the federal government — and its “don’t confuse me with the facts” attitude.
Then, when Sheller appealed to the United States District Court for the District of Pennsylvania, in Sheller PC v. Food and Drug Administration et al., the United States Department of Justice moved to dismiss (throw the case out of court) on the grounds that Sheller did not have any right to appeal because he was not personally harmed:
“Sheller appears to assume that the purported injuries suffered by the children it represents in the personal injury litigation against J&J suffice as injuries to Sheller for purposes of this case.”
Just last Friday, May 1, 2015, Sheller, PC filed its First Amended Complaint in which Sheller says it is harmed because Johnson and Johnson is using the FDA’s denial of its petition in Sheller’s court cases to argue they should be dismissed on the grounds the FDA has found that young boys growing breasts is not a serious adverse effect.
The only real disagreement I have with Sheller, PC’s approach is that it argues adolescents should be switched to other neuroleptics in order to reduce the risk of gynecomastia. While Risperdal probably is the worst for gynecomastia, all of the neuroleptics are so harmful they should not be given to children or adolescents and for that matter should rarely, if ever, be given to adults. Certainly, they should never be forced upon people.
In any event, this proceeding starkly illustrates that the FDA is indifferent to harm caused by drugs it approves, and is not even pretending to be interested in learning the facts.
Sadly, this is not news.
Another thing this proceeding illustrates is just how hard it is to use the legal system to get the FDA to do its job. Sheller is to be commended for taking this on.
This is a very important case. If it is successful, it will give hope of forcing the FDA to follow its mandate to protect the public from harmful drugs.