In a highly anticipated decision in In re: Risperdal Litigation, a divided Supreme Court of Pennsylvania has ruled that questions relating to when Risperdal patients knew or should have known of a connection between Risperdal and abnormal breast growth must be decided on a case-by-case basis. The court’s decision will likely resurrect thousands of potentially time-barred claims in the mass tort litigation.

By rejecting Risperdal manufacturer Janssen’s argument that all plaintiffs should be held to a global accrual date for Risperdal-related claims, the justices reopened the courthouse doors, at least temporarily, to thousands of Risperdal plaintiffs.

The Risperdal Litigation

Risperdal is an antipsychotic drug manufactured by Janssen (a wholly owned subsidiary of Johnson & Johnson Co.) for the treatment of schizophrenia in adults. The Food and Drug Administration (FDA) approved the drug in 1993 for adult use only, but doctors routinely prescribed Risperdal for “off label” use by children to address, among other conditions, irritability associated with autism and bipolar disorder. As originally approved, Risperdal’s label did not mention gynecomastia, which is characterized by the swelling of breast tissue and abnormal breast growth in boys, in either its warnings or adverse reactions sections. In 2006, the FDA approved Risperdal for certain uses in children along with a change to Risperdal’s label that reflected a greater association between Risperdal and gynecomastia.

In early 2014, the appellants, Jonathan Saksek and Joshua Winter, filed their respective complaints against Janssen alleging that Risperdal caused them to develop gynecomastia more than 10 years earlier. Saksek started using Risperdal in 1998 when he was 11 to treat bipolar disorder. Winter started using Risperdal in 1997 when he was 17 to address anger management issues. Saksek and Winter both discontinued their use of Risperdal long before FDA’s 2006 approval of its use in children and adolescents and before the Risperdal label included a warning about gynecomastia.

In May 2014, Janssen filed a motion for summary judgment seeking a global order that all Risperdal-related claims accrued on or before October 31, 2006 – the date when Janssen changed the label to reflect an association between Risperdal and gynecomastia. The trial court granted Janssen’s motion but extended the global accrual date to June 30, 2009, based upon what it described as the cumulative effect of publicly available information about Risperdal in medical literature, newspaper articles and attorney advertising. The Pennsylvania Superior Court affirmed the trial court but moved the global accrual date back to Janssen’s preferred date of Oct. 31, 2006.

In Pennsylvania, a cause of action generally accrues at the time an injury is inflicted. Pennsylvania’s “discovery rule” operates to toll the statute of limitations when an injury or its cause are not reasonably knowable. Whether an injury or its cause are “reasonably knowable” is measured by an objective standard that asks not what the plaintiff actually knew of the injury or its cause, but “what he might have known by exercising the diligence required by law.” See Gleason v. Borough of Moosic

In reaching its conclusion that Saksek and Winter did not fail to exercise reasonable diligence to determine the cause of their respective injuries during the 10-year period that preceded their lawsuits, the court found persuasive that:

(1) Saksek and Winter had never heard of gynecomastia while they were taking Risperdal;

(2) The appellants did not have any medical background or training;

(3) They did not receive any description of gynecomastia (or its symptoms) from their physicians when they were prescribed Risperdal;

(4) They had stopped taking Risperdal by the time Janssen changed the label to disclose the risk of gynecomastia, and

(5) They had mistakenly attributed their development of breasts to weight gain, which has always been listed as a potential side effect on Risperdal’s label, as opposed to gynecomastia.

In a ruling that erodes certain protections of Pennsylvania’s statute of limitations, the Supreme Court held that “[t]he mere experience of a physical condition does not trigger any obligation to actively seek out further information, including whether it is the result of another person’s conduct.” In other words, even though Saksek and Winter knew and understood that they had developed breast tissue, Saksek and Winter may not have had a duty to investigate the underlying cause because they reasonably believed that it was caused by weight gain associated with their use of Risperdal. As such, according to the court, there was no reason for Saksek and Winter “to awaken inquiry and direct diligence in the channel to which it would be successful.” See Fine v. Checcio.

The majority rejected the dissent’s argument that the experience of one side effect of a drug places an individual on inquiry notice for every other potential side effect that could result from taking the same drug. The court concluded that the specific factual question of when Saksek and Winter knew or should have known that their breast growth was caused by gynecomastia (and not weight gain) was one for a jury to determine, not the court.

Key Takeaways

In light of the court's ruling, pharmaceutical companies may be able to limit potential exposure by carefully reviewing drug labeling and adopting proactive measures to ensure that:

• Label disclosures and warnings are as inclusive as reasonably possible under the circumstances
• Any labeling changes are promptly communicated to healthcare providers
• Health care providers are directed to establish a system to communicate labeling changes to patients, including patients who no longer use the drug

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