A Pennsylvania Supreme Court ruling may reinstate a number of Risperdal lawsuits brought against Johnson & Johnson, impacting claims over failure to warn about male breast growth side effects that were previously dismissed on statute of limitation grounds.

Johnson & Johnson has faced thousands of product liability lawsuits brought in the Pennsylvania state court system, each raising similar claims on behalf of boys and young men diagnosed with a condition known as gynecomastia, which results in the development of full breasts among males who used the medication as a child.

At issue on appeal were two cases filed on behalf of plaintiffs Jonathan Saksek and Joshua Winter. Their claims were previously dismissed by the trial court, which determined that they waited too long to file their lawsuits under the Pennsylvania statute of limitations, which only provides two years. However, the ruling by the highest court in the state indicates that juries should determine when plaintiffs should have reasonably known about the risks associated with the drug, triggering the start of the statute of limitations period.

According to recent filings with the U.S. Securities Exchange Commission, Johnson & Johnson has faced about 13,000 Risperdal cases brought on behalf of individuals nationwide, with most consolidated as part of a “mass tort” in the Pennsylvania court system.

Thousands of cases have previously been dismissed based on the statute of limitations, after the Court previously determined that the two year statute of limitations period began in each case when Johnson & Johnson added information to the drug label on October 31, 2006, indicating that clinical trials found gynecomastia occurs in 2.3% of patients taking the drug.

In an opinion (PDF) issued on November 20, the Pennsylvania Supreme Court vacated those decisions in a 6-1 ruling, indicating that in this case, it is up to juries to decide when plaintiffs should have known about the link between Risperdal and gynecomastia.

“As indicated, discovery rule determinations are fact-intensive inquiries that should typically be left for juries to decide, and summary judgment is appropriately granted only in cases where reasonable minds would not differ in finding that the plaintiff knew or should have known, based upon the exercise of reasonable diligence, of his injury and its cause,” the majority opinion states. “The certified record here provides no substantial basis for such a finding in these two consolidated cases.”

According to the opinion, a number of factors could be at play in determining what plaintiffs knew and when, such as the extent of their gynecomastia at the time. In addition, the court noted that whether plaintiffs had actually been diagnosed with gynecomastia should also come into play. For example, neither Winter nor Saksek were diagnosed with gynecomastia until at least 2013, the Court noted.

The ruling is likely to have ramifications that extend beyond the two cases, as Johnson & Johnson may now face case-specific statute of limitations analyses in thousands of cases that were previously dismissed based on the now-overturned lower court decision.

This adds to the mounting liability problems Johnson & Johnson faces in the Risperdal litigation, coming about a month after a Pennsylvania jury ordered the drug maker to pay one plaintiff $8 billion in punitive damages for failing to warn consumers and the medical community about the gynecomastia risk.

The verdict is notable not only for its massive size, but also because it is the first Risperdal trial where a jury was allowed to consider awarding punitive damages, after a Pennsylvania Superior Court cleared the way for such damages in a January 2018 ruling.

While the drug maker has reached some individual Risperdal settlements, thousands of cases remain unresolved.