Products Liability Law Daily Risperdal®-related claims should not have been deemed time-barred
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Friday, November 22, 2019

Risperdal®-related claims should not have been deemed time-barred

By Georgia D. Koutouzos, J.D.

The record in two consolidated cases provided no substantial basis to conclude that the patients knew or should have known that the adverse side effects they had suffered were attributable to the drug by the claims’ accrual dates established by either the trial court or the appellate court.

A Pennsylvania appellate panel erred in affirming a trial court’s grant of summary judgment favoring the manufacturer of the prescription drug Risperdal® in actions by two patients who sued the company several years after having developed gynecomastia, the commonwealth’s highest court held, vacating and remanding the decisions for further proceedings. Reiterating a narrow interpretation of the discovery rule to permit the tolling of Pennsylvania’s two-year statute of limitations for tort claims only if a reasonable person exercising reasonable diligence could not have determined the cause of his or her injury, the high court nevertheless concluded that material issues of fact remained as to when the patients could have known that their gynecomastia was related to their ingestion of Risperdal (In re Risperdal Litigation (Saksek v. Janssen Pharmaceuticals, Inc. and Winter v. Janssen Pharmaceuticals, Inc.), November 20, 2019, Donohue, C.).

Two adolescent males who allegedly had developed weight gain and gynecomastia (enlarged breasts) in the late 1990s or early 2000s after having taken the prescription antipsychotic Risperdal as off-label treatment for anger management issues, attention deficit hyperactivity disorder, and bipolar disorder filed separate suits asserting products liability and other claims against the medication’s manufacturer, Janssen Pharmaceuticals, Inc., as well as Janssen’s parent and sister companies, Johnson & Johnson Co. and Janssen Research and Development, LLC. The two complaints were consolidated into the mass tort action over Risperdal filed in Pennsylvania’s Court of Common Pleas for Philadelphia County.

In connection with the filing of their complaints in 2014, both patients submitted affidavits swearing that: (1) they had filed their complaints after having been informed by their mothers who had viewed a television commercial in 2013 describing the relationship between gynecomastia and Risperdal; (2) they were not medical professionals and did not know anything about Risperdal other than that it had been prescribed to them; (3) they had followed their doctors’ instructions in taking Risperdal; (4) no doctor had told them or their parents that their breast growth and weight gain could have been caused by anything to which they had been exposed or had ingested; (5) no doctor ever had told them or their parents that Risperdal was the cause of their breast growth and weight gain; and (6) they subsequently understood that their breast growth is referred to as gynecomastia—a term that they had never heard of until shortly before signing their affidavits.

Summary-judgment motion. The drug maker moved for partial summary judgment that, while nominally directed at the two above-mentioned cases, was couched in terms directed at all Risperdal plaintiffs. The motion sought a global ruling that all claims accrued for statute of limitations purposes no later than October 31, 2006, when the Risperdal label was changed to reflect a greater association between gynecomastia and taking the medication. Patients were on constructive and/or inquiry notice for the potential connection between use of the medication and gynecomastia as of that date, the manufacturer maintained.

Lower courts’ decisions. The trial court ruled that all Risperdal-based gynecomastia claims—including those of the two individual patients—accrued no later than June 30, 2009. A commonwealth appellate panel affirmed the trial court’s ruling but concluded that in conjunction with Risperdal’s 2006 label change expressly linking usage of the drug to gynecomastia, the unexplained weight gain and breast development allegedly experienced by the two patients was sufficient to establish that the statute of limitations on their claims began to run no later than October 2006. Thus, the patients’ separate actions filed against the drug manufacturers in 2014 exceeded Pennsylvania’s two-year limitations period for tort claims, the panel held [see Products Liability Law Daily’s November 14, 2017 analysis].

Arguments before the supreme court. The two patients argued that the record did not provide any basis for concluding, as a matter of law, that they knew or should have known that their gynecomastia had not been the result of excessive weight gain but, rather, was the result of the abnormal growth of female breast tissue caused by their ingestion of Risperdal. The drug maker countered that both patients alleged that they developed gynecomastia more than ten years before they filed suit, and that Pennsylvania’s discovery rule has been interpreted narrowly to permit the tolling of the statute of limitations only if a reasonable person exercising reasonable diligence could not have determined the cause of his or her injury. Because neither patient had exercised any diligence, the court should affirm the October 31, 2006 date of the drug’s label change as the accrual date of all Risperdal-related gynecomastia claims, the company contended.

Discovery rule. Under applicable case precedent, Pennsylvania’s formulation of the discovery rule represents a narrower approach than that mandated in other jurisdictions. It places a greater burden on plaintiffs because the commencement of the limitations period is grounded on "inquiry notice" that is tied to "actual or constructive knowledge of at least some form of significant harm and of a factual cause linked to another’s conduct, without the necessity of notice of the full extent of the injury, the fact of actual negligence, or precise cause."

In that regard, 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/her injury and its cause, the high court explained, finding that the record in the patients’ two consolidated cases provided no substantial basis for that conclusion. To the contrary, other than the pleadings and briefs filed by the parties, the evidence in the record consisted primarily of the "Plaintiff’s Fact Sheets" prepared by the two patients and the above-mentioned affidavits that each patient had filed.

Evidentiary deficiencies. Because the drug maker’s goal had been to obtain a global accrual date of October 31, 2006, for all Risperdal-related claims, the company filed the two summary-judgment motions at issue before any case-specific discovery occurred. As such, although the cases involved malformations of the patients’ bodies, the record contained no photographs depicting the nature and extent of those malformations; evidence that could be essential to a determination of the reasonableness of the patients’ actions (or lack thereof) in response thereto. Furthermore, the record contained no medical records regarding the interactions between the patients and their treating physicians, nor were there any depositions of the patients, their parents, or their treating physicians (none of whom apparently had diagnosed either patient with gynecomastia until at least 2013).

Patients’ knowledge. Despite the absence of that evidence, the trial court found that the two patients repeatedly acknowledged that they had developed gynecomastia in 1988 and 2002, respectively. However, those were not binding admissions with respect to what the two men knew as adolescents back in those years; namely, that they had developed gynecomastia. Thus, the trial court conflated what the patients knew upon filing their suit with what they knew at the time when they were taking Risperdal. Thus, the trial court appeared to assume that the patients knew or should have known that their breast growth was an outward manifestation of an endocrine disorder known as gynecomastia (and triggering their duty to investigate its underlying cause).

Even if weight gain had been listed on Risperdal’s label as a known side effect of ingesting the drug and even assuming that both patients had linked their weight gain to the drug, those facts were not indicative of any other, more serious abnormality, the high court instructed. To the contrary, it could be argued that knowledge of weight gain as a side effect tempered the patients’ inquiry into other explanations for the physical changes to their bodies. While the discovery rule tolls the running of the applicable statute of limitations until the plaintiff discovers, through the exercise of reasonable diligence, that he/she is injured and that the injury has been caused by another party’s conduct, the 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, the high court explained.

Instead, there must be some reason to awaken inquiry and direct diligence in the channel to which it would be successful, the high court instructed. If the two patients believed that their condition merely had been the result of weight gain rather than a pathological endocrine disorder caused by the conduct of another, then the requirement to exercise due diligence never may have been awakened. If so, then the patients had no legal obligation to seek an alternative explanation for the condition—including a requirement to seek medical advice concerning their breast growth.

Inquiry notice. In fashioning its accrual date, the trial court cited the environment created by the cumulation of medical journal articles, media reports, and an instance of lawyer advertising referencing a link between Risperdal and gynecomastia. Based on that publicity, the patients’ inquiry should have been awakened at that point, the trial court said, concluding that as a matter of law, the discovery rule could toll the statute of limitations only until a maximum date of June 30, 2009, for plaintiffs who had ingested Risperdal prior to October 2006. The trial court’s contention was that the cumulative effect of the above-discussed medical journal articles and media reports gave rise to inquiry notice.

Noting that the media reports relied on by the trial court did not discuss any causal link between the ingestion of Risperdal and gynecomastia sufficient to place the two patients on notice of their claims against the drug manufacturer, the supreme court said that it could not be concluded as a matter of law that the case at bar involved the degree of publicity required to place the two patients on notice of their injury and its cause.

Label change. The high court also disagreed with the appellate panel’s determination that the landscape for discovery changed on October 31, 2006—the date when the manufacturer changed the Risperdal label to report the results of clinical trials that reported the incidence of gynecomastia in 2.3 percent of patients who took the drug. Although the panel found that reasonable minds would not differ in finding that the patients knew or should have known of their injuries and those injuries’ cause by that date, the high court said that the record did not support those conclusions.

For one thing, neither patient was still taking the drug at the time of the label change in 2006, and no evidence explained how either would have known that the label for a drug that they no longer were taking had changed. Moreover, if they had gained access to the updated label, the patients’ lack of medical training made it unlikely that their review of the 2006 label would have provided them with any relevant information about their potential claims.

Finally, even if the patients had consulted with their physicians regarding the contents of the 2006 revised label, the record contained no evidence to support the conclusion that their physicians would have told them that the revised label confirmed a causal link between Risperdal and gynecomastia. Consequently, the drug maker was not entitled to summary judgment with respect to the application of the discovery rule. Rather, it was for the jury to decide the material issues of fact remaining for resolution, the supreme court concluded.

Concurrence. Joining the majority in that conclusion, Justice Max Baer wrote separately to reiterate his concerns with respect to Pennsylvania’s continued adherence to the narrow approach to the discovery rule. Noting that the narrow approach places a greater burden on plaintiffs as compared with the so-called "liberal" approach applied by most other states, Justice Baer queried whether the court should align its discovery rule jurisprudence with the broader paradigm adopted by most other states but conceded that the issue was not before the court in the case at bar. Justice Donohoe joined in Justice Baer’s concurring opinion.

Dissent. In his dissenting opinion, Chief Justice Thomas Saylor agreed with the majority that intermediate and trial courts should not have credited the manufacturers’ efforts to establish global accrual dates broadly applicable to all Risperdal cases, but differed with the majority’s conclusion that, in the two instant cases, the drug maker had failed to sufficiently negate the presence of issues of material fact concerning whether there was "reason to awaken inquiry and direct diligence in the channel to which it would be successful."

The case is Nos. 22 EAP 2018 and 23 EAP 2018.

Attorneys: Stephen A. Sheller (Sheller, PC) for Jonathan Saksek. Christopher R. Boisvert (Dechert LLP) for Janssen Pharmaceuticals, Inc., Johnson & Johnson Co., Janssen Research and Development, LLC.

Companies: Janssen Pharmaceuticals, Inc., Johnson & Johnson Co., Janssen Research; Development, LLC

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