Nicholas Malfitano Dec. 16, 2015, 9:01am


PHILADELPHIA (Legal Newsline) – If the results of the first trials are any indication, Janssen Pharmaceuticals might find itself with a hefty price tag connected to more than 1,600 Risperdal cases currently pending in Philadelphia, even without the prospect of paying punitive damages - though an appeal might change that.

Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has found itself the subject of lawsuits from male plaintiffs nationwide who were prescribed the drug and claimed to have suffered from gynecomastia, the development of female breast tissue. 

This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.

Statistics recently issued by the Philadelphia County Court of Common Pleas Complex Litigation Center and its director Stanley Thompson stated a total of 1,606 Risperdal cases had been filed in the court system as of the end of November. 

That figure will not be final either. The court will attract more cases in the future, as 95 were filed in November.

Three of the four trials that have concluded have resulted in victories for plaintiffs. Two have exceeded $1 million, and the other victory went for $500,000 - a total of $4.75 million to plaintiffs.

This is despite the fact that punitive damages have been disallowed in the cases, though plaintiffs attorneys have appealed that decision.

Speaking recently on behalf of fellow plaintiff liaison counsel Thomas Kline of Kline & Specter and Stephen A. Sheller of Sheller P.C., Christopher Gomez, also of Sheller P.C. expressed optimism that the ban would be lifted in the future.

“We are confident that at some point punitive damages will be reinstated,” Gomez said.

In February, the first of these cases to make its way through the CLC reached its conclusion. Alabama man Austin Pledger, who was prescribed Risperdal in 2002 as a teenager for treatment of mood swings related to his autism, developed size 46 DD breasts, allegedly as a result of taking the drug. 

In 2002, Risperdal had not yet received Food and Drug Administration (FDA) approval for prescription to adolescents, but it would later receive such designation in 2006 – along with a causation warning that the drug may lead to gynecomastia in some male users. 

Pledger asserted Janssen did not disclose the side effect to his doctors before he was prescribed Risperdal. A Philadelphia jury awarded Pledger $2.5 million in February, and post-trial motions are currently pending in the case.

However, Philadelphia County Court of Common Pleas Judge Arnold New ruled in June of last year that punitive damages were not applicable in cases involving Risperdal. In a post-trial motion in the Pledger case, New reiterated his stance in October of this year that punitive damages would not apply. 

Though Janssen (a Johnson & Johnson subsidiary) is a Pennsylvania corporation, New stated the marketing and development for Risperdal, along with all relevant Food and Drug Administration correspondence regarding it, was addressed to Janssen’s principal business location in New Jersey – and was therefore bound by that state’s Product Liability Act. 

Per that legislation, cases involving pharmaceutical manufacturers are only subject to punitive damages if it could be proven that the manufacturer knowingly concealed information about their product from the FDA. 

In the case of William Cirba, the second plaintiff whose Risperdal case has reached the Philadelphia County Court of Common Pleas, Janssen emerged with a victory. 

Cirba, 19, was prescribed Risperdal when he was six years old for the treatment of oppositional defiant disorder in 2002, and asserted he also grew breasts as a result of taking the drug. 

Cirba added Janssen was aware of the presence of gynecomastia among a percentage of Risperdal users prior to 2006, but allegedly concealed the information from Cirba’s physicians. 

In response, Janssen argued it provided sufficient caution of the risks associated with Risperdal to Cirba’s prescribing doctors and his gynecomastia wasn’t diagnosed until 2014, the year after he filed his lawsuit against Janssen.

In the end, the jury in Cirba’s case concluded his medical condition could not be connected to adverse side effects from Risperdal, though it further determined the company was negligent in warning of the risks of the drug.

A third trial, involving Maryland plaintiff Nicholas Murray, was recently decided in Murray’s favor for $1.75 million. Murray was prescribed Risperdal at the age of nine in 2003, for off-label treatment of symptoms associated with his Asperger’s Syndrome. 

Like Pledger and Cirba, Murray also allegedly contracted gynecomastia as a result. The $1.75 million jury verdict represents damages for “disfigurement and mental anguish.” Post-trial motions in Murray’s case are also currently pending.

Stange v. Janssen Pharmaceuticals reconvened this month and resulted in a $500,000 jury verdict for the plaintiff, Timothy Stange.

Similar to the Cirba case, the jury found Janssen was negligent in failing to provide a warning about the drug. However, in this particular suit and unlike the Cirba case, the jury did conclude that same negligence directly caused Stange’s injuries. Stange is from Wisconsin. 

“There have been three cases tried to jury verdicts. In each case the jury has found that Janssen failed to warn about the risk of gynecomastia in children and adolescents,” Gomez said before the Stange verdict. 

“In two of the cases, there have been multimillion-dollar jury verdicts. We expect this trend to continue.”

When asked if counsel had any settlement talks with Janssen to this point, Gomez stated they had not and intended to continue to proceed with trials in each Risperdal case.

“There are no settlement talks at this time. We are prepared to continue to go and try the cases with Janssen/Johnson & Johnson,” Gomez said.

Gomez said Janssen’s Pennsylvania corporate base made Philadelphia an ideal venue for the cases to be heard.

Gomez explained 12 Risperdal cases are currently in discovery and heading to trial in 2016.

Defense liaison counsel in the Risperdal litigation - Kenneth Murphy of Drinker, Biddle & Reath and Stephen Imbriglia of Gibbons P.C., both of Philadelphia - offered no comment.

In an email statement, Janssen spokesperson Robyn Reed Frenze said the company “will continue to defend this litigation and will try cases where appropriate” regardless of where they were filed, and agreed with New’s decision to apply New Jersey law to these cases on the subject of punitive damages.

Frenze further commented, “Risperdal (risperidone) has helped and is still helping millions of patients with debilitating mental illnesses and neurodevelopmental conditions as part of a comprehensive treatment plan.”

An October Securities & Exchange Commission filing showed Janssen has created a reserve fund regarding pending product liability litigation.

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com

More News