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Risperdal Lawyer Pushes for Court Order to be Lifted

A Risperdal lawyer is lobbying the FDA to publish documents that purportedly reveal undisclosed side effects caused by the controversial antipsychotic, but are currently classified under a court order. The documents were sealed by a Philadelphia judge as part of the ongoing litigation against drug maker Johnson & Johnson, in which hundreds of Risperdal lawsuits allege the medication causes gynecomastia, the medical term for male breast development.

A 92-page report submitted in 2012 by former FDA commissioner David Kessler makes reference to a deposition placed under a protective order by the court. Since the publication of the main report – which criticizes Johnson & Johnson’s misleading marketing tactics – Risperdal lawyer Stephen Sheller has been trying to convince the FDA that publishing the remainder of the documents is a matter of public interest. He also filed a Citizen’s Petition requesting that the FDA demand a “black box” Risperdal side effects warning be added to the drug labeling.

The FDA has said they are “actively reviewing” Sheller’s petition.

There are currently more than 420 Risperdal lawsuits filed in courts across the country, with plaintiffs alleging Johnson & Johnson concealed the risk of side effects from the public – most notably gynecomastia. In some cases, the condition allegedly required patients to undergo mastectomies.

Risperdal studies sponsored by Johnson & Johnson

Sheller’s communication with the FDA makes reference to Kessler’s review of a 2003 study of Risperdal, published in the Journal of Clinical Psychiatry. The study, which concluded that long-term use of Risperdal in children with autism and schizophrenia did not increase the risk of gynecomastia, was funded and co-authored by Johnson & Johnson. According to Kessler’s report, the involvement of the drug maker discredits the research. Kessler alleges the company altered results by ignoring data that did not show the drug in a favorable light, claiming they omitted adverse events reported in post-pubescent boys.

But Sheller says Kessler went into greater detail, and is demanding the full report be made available. In a plea to the FDA earlier this month, the Risperdal lawyer stated:

“Dr. Kessler was recently deposed on the subjects of his expert report, including his criticism of the meta-analysis. Although confidential, the FDA has no bar or impediment in its way and can simply ask J&J for a copy of the transcript to review.”

Johnson & Johnson deny wrongdoing

In response to Sheller’s overtures, Johnson & Johnson maintain that the FDA has been provided with “extensive clinical data” regarding the use of Risperdal in children, including “retrospective surveys, post-marketing reviews… [and] reports from external investigator-initiated studies.”

A spokesperson from Johnson & Johnson said the data was provided after Sheller’s petition was filed in August 2012, and stated that the company continues to “adhere to FDA guidelines and regulations.”

Risperdal lawsuits allege deceptive marketing

In a string of high-profile lawsuits, Johnson & Johnson stand accused of marketing Risperdal to children prior to winning FDA approval. Granted permission by the FDA for sale to adult bipolar sufferers in 2003, Risperdal was approved as a treatment for children with autism in 2006, and for children with schizophrenia in 2007.

But a Risperdal lawsuit filed last year included testimony from a former Johnson & Johnson sales manager who claimed staff were encouraged to promote the medication to pediatricians as early as 2003. The firm was accused of paying doctors to recommend the “off-label” use of Risperdal as a treatment for irritability in autistic children.

In another case, a Risperdal lawyer representing a teenager who developed gynecomastia claimed Johnson & Johnson knew that the drug could promote male breast growth, and said it was “illegally marketed to kids.”