(Aaron Couture)

The plaintiffs in Philadelphia’s Risperdal mass tort are belatedly changing their legal argument in an effort to sway a judge to reconsider his ruling denying the plaintiffs a chance at punitive damages, Risperdal maker Janssen Pharmaceuticals argued in a court filing this week.

“After strenuously (and repeatedly) arguing that Pennsylvania law should govern the issue of punitive damages (based on the strategic decision that Pennsylvania does not have a statutory cap on punitive damages), plaintiffs now maintain that the court should determine the availability of punitive damages on a ‘case-by-case basis,’” Janssen said in its opposition to the plaintiffs’ motion for reconsideration.

Several hundred Risperdal plaintiffs argued earlier this month that Philadelphia Court of Common Pleas Judge Arnold L. New mistakenly determined that New Jersey law applied to the cases and that the New Jersey Product Liability Act and New Jersey case law bars punitive damages in cases involving U.S. Food and Drug Administration-approved drugs.

The plaintiffs said it didn’t matter where the drug’s warning label was created, but rather where the drug was marketed. The plaintiffs said in their motion that Risperdal was marketed off-label in many states and that those states may have a greater interest in seeing their laws on punitive damages applied than New Jersey would. The plaintiffs further argued that even New Jersey law would allow punitive damages to apply in certain of the cases in which the drug was marketed for uses that were not approved by the FDA.

The plaintiffs said all of those circumstances required the court to determine the availability of punitive damages on a case-by-case basis.

“In an effort to evade this court’s order granting partial summary judgment in favor of Janssen as to plaintiffs’ demand for punitive damages … plaintiffs raise arguments under the guise of a motion for reconsideration and request for certification for interlocutory appeal that they ignored, overlooked, or strategically avoided in their failed opposition to Janssen’s earlier motion,” Janssen said in its opposition brief.

Stephen A. Sheller of Sheller P.C., who is representing the plaintiffs along with Kline & Specter, said Tuesday that Pennsylvania law should apply to the punitive damages claims because that is where the defendant is incorporated, and that is where the plaintiffs outline much of the conduct took place.

“But the alternative to that is to apply the law of the state where the plaintiff was injured and where the off-label and kickbacks occurred,” Sheller said. “That’s your second option, and either way, it certainly shouldn’t be New Jersey [law], unless it’s a New Jersey resident involved.”

Janssen further argued these cases are about Risperdal’s warning label and not about what the plaintiffs asserted was the company’s off-label marketing of the drug to children. Janssen said there has been no evidence to show its business decisions about the creation of Risperdal’s warning label occurred anywhere other than New Jersey. In a footnote to its brief, Janssen said the plaintiffs conceded in their motion in opposition to Janssen’s request for summary judgment that the Risperdal label did not have the necessary warnings.

By focusing on the multistate marketing campaign of Risperdal, the plaintiffs are moving the relevant punitive damages inquiry from the place where corporate decisions are made to individual state activities.

“Stated another way, plaintiffs focus on implementation of corporate decisions rather than the location where company decisions are made,” Janssen said.

Janssen also took issue with the plaintiffs’ argument that some of their claims for punitive damages could survive if they were prescribed the drug before it was FDA-approved for certain off-label uses.

One of the main injuries asserted in the lawsuits is gynecomastia, or the development of breasts in adolescent boys. Risperdal, an antipsychotic medication, wasn’t approved by the FDA for use in children until October 2006. The plaintiffs argue those who took the drug as a minor before October 2006 were not taking an FDA-approved drug as was contemplated in the New Jersey Product Liability Act.

“Consistent with the plain text of the statute, courts consistently have found that the punitive damages bar applies whenever the FDA has approved the medicine at issue,” Janssen countered in its opposition brief.

Sheller said if a drug is not approved by the FDA for a specific use, that means it is not approved for that use.

“If [Janssen] think[s] that preempts everything under the New Jersey punitive damages statute, then they should agree to allow the immediate appeal, which they refuse to do,” Sheller said.

Janssen said the plaintiffs’ arguments didn’t fall within the proper grounds for granting a motion for reconsideration. Janssen said there was no new evidence presented, nor was there any change in controlling law. The company also argued against the plaintiffs’ request for a determination that New’s May 2 order granting partial summary judgment as to punitive damages was either a final order that could be appealed or an interlocutory order that could be certified for appeal.

“There is no compelling reason that the single issue of punitive damages should delay this mass tort litigation,” Janssen argued.

Kenneth Murphy of Drinker Biddle & Reath filed the opposition brief on behalf of Janssen, a subsidiary of Johnson & Johnson, in In re Risperdal Litigation. Murphy wasn’t immediately available for comment.

Gina Passarella can be contacted at 215-557-2494 or at gpassarella@alm.com. Follow her on Twitter @GPassarellaTLI. •