Attorney Urges FDA to Seek Sealed Court Documents Regarding Risperdal Side Effects

Balkin & Eisbrouch, LLC reports an important development that could influence the outcome of pending Risperdal litigation against Johnson and Johnson.

According to a July 11 Pharmalot article, the attorney who represented 21 year-old Aaron Banks in a Risperdal lawsuit(Banks vs. v. Janssen Pharmaceuticals, Philadelphia Court of Common Pleas, January Term 2010, No. 00618), is urging the FDA to seek documents that may reveal adverse side effects caused by the antipsychotic medication, Risperdal. The documentation at issue was sealed by a Philadelphia judge who is overseeing the ongoing litigation against Risperdal manufacturer, Johnson & Johnson (In Re: Risperdal litigation, March Term 2010 No. 00296.) Plaintiff Aaron Banks alleged that Risperdal caused him to grow breasts, resulting in severe psychological trauma. Johnson & Johnson admitted no wrongdoing, but settled the case for an undisclosed sum.

“In light of published research that links Risperdal use with an increased risk of gynecomastia in young males, we have been investigating a number of claims alleging adverse events caused by risperdone ,” said Charles Balkin, founding partner of Balkin & Eisbrouch, LLC, a national law firm representing people injured by dangerous drugs. Click here to read more about Risperdal side effects.

As detailed in the Pharmalot article, the attorney petitioned that the sealed court documents – which are referred to in a 92-page deposition submitted by former FDA commissioner, David Kessler – be disclosed so that federal regulators can review Kessler’s analysis and corroborating documents that allegedly contain data regarding pediatric use and risks of Risperdal.

In September 2012, Bloomberg News reported that more than 420 plaintiffs had filed Risperdal lawsuits, with at least 120 of those claims involving allegations of gynecomastia – the development of enlarged breast tissue in males. Johnson & Johnson had been criticized for allegedly promoting Risperdal for off-label uses and agreed to pay $181 million to resolve claims made in 36 states that the company inappropriately marketed its controversial antipsychotics, Risperdal and Invega.

As first reported in the Philadelphia Enquirer, David Kessler says that Johnson & Johnson and its Janssen unit violated the Federal Food, Drug, and Cosmetic Act when it promoted Risperdal for unapproved uses in children and adolescents. In his report Kessler wrote,"Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."

According to Pharmalot, a Citizen’s Petition was filed in August of 2012 urging the FDA to place a black box warning on Risperdal and its generic counterparts to indicate a lack of long-term safety data for use in children and adolescents. The FDA claims that it has been actively reviewing the petition.

Meanwhile, the number of product liability lawsuits alleging gynecomastia from exposure to Risperdal continues to build in court rooms throughout the country. “We believe that the off-label usage of Risperdal has exposed too many kids to a health risk that was deliberately downplayed by the drugmaker in its marketing to doctors,” says co-founding Balkin & Eisbrouch partner David Eisbrouch. “We hope that the FDA will take last year’s petition seriously and require the medication to be sold with all appropriate warnings.”

The trial attorneys at Balkin & Eisbrouch, LLC have extensive experience litigating cases involving drug-related injuries, and are presently offering confidential Risperdal lawsuit evaluations nationwide. Learn more about gynecomastia and Risperdal litigation on their website at

About Balkin & Eisbrouch
Charles Balkin and David Eisbrouch offer more than 40 years of collective legal experience helping victims of dangerous drugs and defective medical devices. Balkin & Eisbrouch, LLC – a leading products liability firm – is headquartered in New York and has affiliate offices throughout the country. They are currently accepting new cases involving Risperdal side effects.

Release ID: 18509