Pennsylvania Record

Thursday, February 20, 2020

Pa. Supreme Court reinstates thousands of Risperdal cases after J&J argued they were filed too late

Attorneys & Judges

By Nicholas Malfitano | Nov 26, 2019


HARRISBURG – According to a pair of majority rulings from the Supreme Court of Pennsylvania, a factual analysis must be undertaken in each individual case involving Johnson & Johnson anti-psychotic drug Risperdal, before a jury can decide when the statute of limitations begins to toll for bringing a claim.

On Wednesday, the state’s top judiciary decided 6-1 on that issue in Risperdal cases filed by plaintiffs Jonathan Saksek and Joshua Winter versus Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals – specifically, on the issues of the tolling of the relevant statute of limitations and when the plaintiffs should have known of the drug’s risks.

The Supreme Court decision reversed a prior ruling from the Superior Court of Pennsylvania, which found favor with the pharmaceutical company, granted it summary judgment and threw out the lawsuits filed by Saksek and Winter, and in effect, those from thousands of other plaintiffs who brought similar suits.

Saksek and Winter were prescribed Risperdal in 1997 and 1998 and allegedly began developing gynecomastia (development of breast tissue) in 1998 and 2002, respectively, but did not file suit against Janssen for damages until 2014. Those plaintiffs brought suit after seeing television advertising connected to Risperdal litigation in 2013.

The defense agreed with the trial court that the statute of limitations mandated the grant of summary judgment, but contended if the discovery rule applied, it would have only tolled the statute of limitations until October 2006, when Risperdal’s prescribing label was changed to include a warning about gynecomastia.

In January 2015, the trial court granted a defense motion for summary judgment and ruled an applicable statute of limitations applied to both Saksek and Winter’s cases, feeling that they should have known of Risperdal’s gynecomastia-related injury risks by June 30, 2009. This decision was also applied to the thousands of other suits.

Both plaintiffs appealed to the Superior Court, which consolidated the appeals, but the Superior Court agreed with the trial court in its ruling. However, the Supreme Court felt differently and heard the case. Their ruling now means those thousands of previously-dismissed cases are now back in play.

Justice Christine Donohue authored the Court’s majority opinion, joined by fellow justices Sallie Updyke Mundy, Kevin Dougherty, Debra Todd, Max Baer and David Wecht. Baer also wrote a concurring opinion, joined by Donohue.

The lone dissent was from Chief Justice Thomas G. Saylor.

Speaking for the majority, Donohue rebuked the trial and appellate courts for taking it upon themselves to decide the issue of when the statute of limitations in Risperdal cases should toll – instead, countering that a jury should decide whether enough media-related awareness and notice of the drug being linked to gynecomastia had been circulated among the general public, to inform them that they may have been injured.

“We cannot conclude, as a matter of law, that the present case involves the degree of publicity required to place Winter or Saksek on notice of the relationship between their injury and its cause,” Donohue said.

“The FDA did not require a black box warning on the Risperdal label, no national health organizations issued warnings to physicians and patients, no statistics regarding decreases in prescriptions have been cited in support of the extent of the media coverage into local markets, there was no national media ‘blitz,’ and Janssen did not issue any ‘Dear Doctor’ letters advising prescribing physicians of the 2006 label change.”

According to Donohue, “We conclude only that reasonable minds could differ, thus requiring that the factual issues relating to Janssen’s statute of limitations defense must be submitted to a jury for resolution.”

The majority ruling reversed both the trial and appellate court decisions, along with remanding the cases back to the trial court for further proceedings consistent with this ruling.

Saylor, meanwhile, dissented and said Saksek and Winter should have been noticed of potential injury when they experienced weight gain as a result of taking Risperdal.

“Appellants all but acknowledge that they had reason to know that their excessive weight gain was ‘the unfortunate result of medical treatment. Moreover, as the majority also relates, ‘at all relevant times, weight gain was a reported risk of Risperdal,'” Saylor said.

“Therefore, it seems to me quite plain that appellants should be charged with inquiry notice to determine whether they might have claims (albeit, that the accrual date for the statute of limitations is properly postponed until the age of their majority),”

As to the notion of plaintiffs experiencing one side effect from a given drug and therefore being noticed on all of them, Donohue replied there was “no case law from any jurisdiction supports this contention.”

Further, the majority agreed there was no connection between the 2006 label change and the tolling of the statute of limitations – and stated for the record that they were not ruling on the merits of the company’s arguments,

“We conclude only that given that the evidentiary record here is entirely undeveloped, and given that in summary judgment proceedings all facts of record and reasonable inferences therefrom must be construed in the light most favorable to the non-moving party, Janssen was not entitled to summary judgment as a matter of law with respect to application of the discovery rule. It is for the jury to decide the material issues of fact remaining for resolution,” Donohue stated.

Johnson & Johnson issued a statement on the Supreme Court’s ruling.

“We are aware of the Pennsylvania Supreme Court’s decision and respectfully disagree with its holding. We are prepared to vigorously defend this litigation going forward and continue to maintain that numerous cases are untimely,” the company said.

“Risperdal is an important U.S. FDA-approved prescription medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions.”

Plaintiff counsel representing Saksek and Winter, Tom Kline and Chip Becker of Kline & Specter, also responded to the decision.

“The Court’s ruling reinstates the legal rights of thousands of people with valid Risperdal claims; combined with the affirmance of three jury verdicts and the reinstatement of the right to punitive damages, this litigation now has all of the legal impediments resolved, enabling a pathway forward for full compensation for those who were injured as a result of Johnson & Johnson’s illegal off-label promotion and marketing of a powerful antipsychotic adult drug to children,” Kline and Becker said.

Nearly 7,100 Risperdal lawsuits – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over asbestos and vena cava filters, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s.

Supreme Court of Pennsylvania cases 75 EAL 2018 and 76 EAL 2018

Superior Court of Pennsylvania case 576 EDA 2015

Philadelphia County Court of Common Pleas cases 140200183 & 140301170

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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