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The Pennsylvania Superior Court has reversed Janssen Pharmaceuticals' only defense verdict in the Risperdal mass tort litigation in Philadelphia.

A unanimous three-judge Superior Court panel on Monday reversed Janssen Pharmaceuticals' win in the case W.C. v. Janssen, and ordered a new trial on the issues of causation and damages.

The 22-page precedential ruling hinged on the testimony of Michelle Baker, a physician's assistant who treated the plaintiff for eight years. According to Superior Court Judge Jack Panella, who wrote the court's opinion, the trial court erred by permitting Baker, a lay witness, to essentially offer expert testimony at trial.

“Baker's testimony, in which she opined that appellant's weight gain, rather than his Risperdal usage, caused him to appear to have gynecomastia, was the only causation testimony offered by a witness who personally treated appellant,” Panella said. “This opinion was offered without the proper vetting and safeguards surrounding expert testimony.”

In March 2015, a 12-member jury in Philadelphia determined that, although Janssen failed to warn about the risks of gynecomastia, the plaintiffs also failed prove that the drug caused the plaintiff's gynecomastia, which is a condition where males grow excess breast tissue.

The verdict was the second out of Philadelphia's Risperdal mass tort litigation program, where more than 5,500 cases are pending against the Johnson & Johnson subsidiary over its alleged failure to warn about the link between antipsychotic medication and gynecomastia. More than five Risperdal cases have come before juries in Philadelphia, and, although two cases were tossed out midtrial, the verdict in W.C. was the only defense verdict so far.

In an emailed statement, Kline & Specter attorney Thomas R. Kline, who is representing the plaintiffs, said “It is most noteworthy that in every Risperdal case decided by a jury, including [W.C.], Janssen has been found negligent, and the Superior Court panel, in this precedential opinion has upheld that negligence finding, and directed a new trial as to causation and damages only.”

Janssen spokeswoman Kelsey Buckholtz said the company was disappointed by the ruling, and defense counsel is “reviewing our options going forward.”

Despite winning a new trial, the plaintiffs also failed to convince the same Superior Court panel that the lower court erred when it rejected arguments that the statute of limitations in two cases should have been tolled until 2013.

That ruling, issued in an 18-page memorandum opinion in the cases Saksek v. Janssen Pharmaceuticals and Winter v. Janssen Pharmaceuticals, rejected the argument that the plaintiffs could not know about the link between Risperdal and gynecomastia until they saw a commercial explaining the connection in 2013.

Panella, who also wrote the opinion in Saksek and Winter, noted that the plaintiffs allegedly began growing breasts in 1998 and 2002, but did not sue until 2014.

“Their breasts were there, and had been there, for years. And then, in October 2006, the label on Risperdal changed, expressly linking usage of the drug to gynecomastia,” Panella said. “Accordingly, by that date, 'reasonable minds would not differ in finding that,' appellants knew, or should have known, of their injuries and the cause of those injuries by this point.”

Kline said he expects the ruling to have impact beyond the Winter and Saksek cases.

“We believe yesterday's harsh statute of limitations ruling, which bars the claims of thousands of Risperdal victims who could not possibly have known of their gynecomastia injury and its cause, is wrong both factually and legally,” Kline said. “We plan to appeal further, seeking to reopen the door to the courthouse.”

But Buckholtz stressed the Superior Court's holding that said the plaintiffs should have known about the cause of their injuries by October 2006 at the latest.

“We are pleased the Superior Court affirmed Judge [Arnold] New's ruling,” she said.