Risperdal Jury Affirms J&J Failed to Warn of Drug Risperdal's Risks, but Did Not Cause Male's Breast Growth; Sheller, P.C. Appeals FDA's Denial of Petition to Revoke Use of Risperdal in Children
PHILADELPHIA, March 20, 2015 /PRNewswire/ -- A Philadelphia jury today affirmed by a 10-2 vote that Janssen Pharmaceuticals, a division of Johnson & Johnson, failed to warn of the risk to boys and young men growing female-like breasts, a condition called gynecomastia, as a result of taking the drug Risperdal. On the claim that the drug caused breast growth in the plaintiff, the jury voted in favor of Janssen.
In the three week trial, the drug company argued there was no link between the drug and the plaintiff's breast growth. The plaintiff, prescribed the drug for attention deficit disorder from age six to ten, claimed the drug caused his gynecomastia and that the company knew the risks but obscured them from physicians prescribing the drug. The law firms of Sheller, P.C. and Kline & Specter represented the now 19-year old plaintiff.
Risperdal was originally approved in 1993 to treat schizophrenia and severe psychotic disorders in adults. The U.S. Food and Drug Administration (FDA) approved Risperdal for limited use in children and adolescents in late 2006, the same time the plaintiff stopped taking the drug. Prior to 2006, the drug was prescribed "off label" to children.
Attorney Stephen A. Sheller, the first to investigate the link between Risperdal and gynecomastia, contends the drug should never have been approved for children. "The 'new' 2006 label did not then and does not now adequately warn prescribing physicians, parents and the public about the dangers of Risperdal to protect children and adolescents," says Sheller. "The warnings should be changed radically, right now."
A Sheller and Kline plaintiff with similar claims won a $2.5 million jury verdict against Janssen earlier this month. Although the present verdict favors the drug company, "a second jury in a row determined that Janssen failed to warn of off-label use in adolescents and children," Thomas Kline said in The Legal Intelligencer newspaper, adding that "Janssen cannot defend its abhorrent conduct."
Prior to the two trials, Sheller filed a Citizen's Petition with the FDA to revoke approval for the use of Risperdal in children based on his concern for the safety and efficacy of the drug.The similar antipsychotic Invega was also named in the petition.
According to the petition, documents obtained by Sheller through discovery for his previous Risperdal trial detailed the drug company's knowledge of the severity of the drug's side effects. Sheller knew of the documents but could not provide them as they were under seal and by law could not make them public. He requested the FDA obtain them directly from Janssen. The FDA did not, says Sheller, and denied his petition.
"I find it unconscionable the FDA denied our petition without pressing Janssen for the documents," says Sheller. "All research and documents should be made public. We must protect children, the elderly, and others at risk who don't have resources to challenge the pharmaceutical companies on their own."
Six previous Sheller Risperdal trials for gynecomastia in the Philadelphia Court of Common Pleas ended in settlement. There are more than 1,600 individual Risperdal gynecomastia cases awaiting trial, mostly in Philadelphia.
Sheller and Janssen have squared off in the past over Risperdal. A whistleblower, represented by Sheller contended the company engaged in illegal marketing and False Clams Act violations, resulting in a $2.2 billion settlement between Janssen and the U.S. Department of Justice in 2013.
The case is Cirba et al v. Janssen Pharmaceuticals Inc., case number 130301803, in the Philadelphia County Court of Common Pleas. Christopher A. Gomez of Sheller, P.C. and Thomas R. Kline of Kline & Specter were attorneys of record for the plaintiff.
About Stephen A. Sheller and Sheller, P.C.
Sheller, P.C. represents plaintiffs injured by defective and dangerous drugs, devices, and consumer products nationwide as well as whistleblowers reporting corporate and government fraud. Founded by Stephen A. Sheller and in practice since 1977, Sheller, P.C. has challenged some of the largest corporations in the United States, including pharmaceutical and medical device companies, auto, tobacco and others.
The firm's off-label marketing and federal and state False Claims Act qui tam whistleblower cases have recovered more than $6.4 billion for the U.S. Government and taxpayers to date, including some of the largest in U.S. history.
SOURCE Stephen A. Sheller and Sheller, P.C.
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