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In re Risperdal Litigation

Supreme Court of Pennsylvania

November 20, 2019


          ARGUED: May 16, 2019

          Appeal from the Judgment of Superior Court entered on November 13, 2017 at No. 576 EDA 2015 (reargument denied January 16, 2018) affirming the Judgment entered on February 12, 2015 in the Court of Common Pleas, Philadelphia County, Civil Division at No. 00183 February Term, 2014, No. 296 March Term, 2010

          Appeal from the Judgment of Superior Court entered on November 13, 2017 at No. 590 EDA 2015 (reargument denied January 16, 2018) affirming the Judgment entered on February 10, 2015 in the Court of Common Pleas, Philadelphia County, Civil Division at No. 01170 March Term, 2014, 296 March Term, 2010




         In this consolidated appeal, Appellants Jonathan Saksek ("Saksek") and Joshua Winter ("Winter") challenge the ruling of the Superior Court affirming the trial court's grant of summary judgment in favor of Appellees Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research and Development, LLC (collectively, "Janssen"). Saksek and Winter are two of a large number of men who have filed suit against Janssen alleging that they developed gynecomastia (enlarged breasts in men) as a result of their ingestion of Risperdal, an antipsychotic drug manufactured by Janssen. In 2014, Janssen filed two motions for summary judgment, which, although nominally directed at Saksek's and Winter's cases, were couched in terms directed at all of the Risperdal plaintiffs - seeking a global ruling that all claims accrued for statute of limitations purposes no later than October 31, 2006, when Janssen changed the Risperdal label to reflect a greater association between gynecomastia and Risperdal. The trial court ruled that all Risperdal-gynecomastia claims, including those of Saksek and Winter, accrued no later June 31, 2009. The Superior Court disagreed, ruling that all such claims accrued no later than Janssen's preferred date (October 31, 2006). Concluding that the Superior Court erred in granting summary judgment at all in Saksek's and Winter's cases, we vacate its decision and remand to the trial court for further proceedings consistent with this decision.


         A. Risperdal

         Risperdal®, also known in its generic form as risperidone, is a second-generation antipsychotic prescription medication. It is manufactured and sold by Janssen Pharmaceuticals, Inc., a wholly owned and independently managed subsidiary of Johnson & Johnson Company. The federal Food and Drug Administration ("FDA") first approved Risperdal in 1993 for certain adult uses, like schizophrenia. At the time that Risperdal was prescribed to Saksek and Winter, it was for an "off label" use because the FDA had not approved its use either for children generally or for any condition from which they were suffering. The FDA subsequently approved Risperdal for a number of other diseases and patient populations, including in 2003 for bipolar disorder in adults, in 2006 for irritability associated with autistic disorder in children and adolescents aged 5-16 years, and in 2007 for schizophrenia in adolescents aged 13-17 years and bipolar disorder in children and adolescents aged 10-17.

         Gynecomastia is an endocrine disorder that is characterized by "swelling of the breast tissue in boys or men, caused by an imbalance of the hormones estrogen and testosterone." Enlarged Breasts in Men (Gynecomastia), Mayo Clinic, (last visited Oct. 28, 2019). Janssen does not dispute that Risperdal sometimes causes hyperprolactinemia, an elevation of prolactin, a hormone secreted by the pituitary gland. Prolactin sometimes suppresses testosterone, which in turn boosts estrogen, both of which may result in the development of breast tissue. Stange v. Janssen Pharmaceuticals, Inc., 179 A.3d 45, 54-55 (Pa. Super. 2018).

         In the prescribing insert (sometimes referred to as the drug's "label") for Risperdal prior to 2006 (during the time when Saksek and Winter were taking the drug), there was no mention of hyperprolactinemia or gynecomastia in either its 'WARNINGS" or "ADVERSE REACTIONS" sections. In the "PRECAUTIONS" section, the label provided as follows:

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. . . . Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients.

         Saksek's Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 4 at 7. In a section entitled "Other Events Observed During the Pre-Marketing Evaluation of Risperdal," gynecomastia was identified as an endocrine disorder and a "rare" adverse event. Id. at 19.

         When the FDA approved Risperdal for pediatric use in October 2006, the label was changed to provide:

Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
* * *
Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin elevating compounds.
* * *
In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorder treated with risperidone, galactorrhea was reported in 0.8% of risperidone-treated patients and gynecomastia was reported in 2.3% of Risperdal-treated patients.

Id. Ex. 6 at 15, 24.

         B. The Saksek and Winter Claims

         Saksek was born in 1987. He grew up in and continues to reside in Hazelton, Pennsylvania. In 1998, at age 11, his psychiatrist prescribed Risperdal in connection with diagnoses for attention deficit hyperactivity disorder and bipolar disorder. Janssen's Motion for Summary Judgment (Saksek), 8/18/2014, Ex. 1 at 5. He discontinued the use of Risperdal in 2004. Id. On February 4, 2014, Saksek filed a short-form complaint, id. Ex. 2, which in turn incorporated by reference a master long-form complaint developed and amended over time by the plaintiffs in the mass-tort litigation.[1] Id. Ex. 11. The master long-form complaint asserts twelve claims based on state common law, products liability and deceptive trade practices, [2] all based upon the allegation that Janssen failed to warn plaintiffs and their prescribers about the risks associated with Risperdal. Id. In a "Plaintiff's Fact Sheet" attached as an exhibit to the long-form complaint, Saksek reported that in 2001 through 2002, he became aware, through "visual observation," of increased breast size, extreme weight gain, and psychological and emotional distress. Id. Ex. 1 at 7.

         Winter was born in May 1980 in Harrisburg, Pennsylvania and continues to reside there. In 1997, Winter began taking Risperdal to control anger management issues. Janssen's Motion for Summary Judgment (Winter), 8/18/2014, Ex.1 at 4. He stopped using Risperdal in 1998. Id. In his short-form complaint, Winter represented that he suffered from weight gain and diabetes while taking Risperdal. Id. Ex. 5 at 2-4. In his "Plaintiff's Fact Sheet," Winter reported that in 1998, he perceived, through "self- observation," that he was experiencing breast development and psychological and emotional distress. Janssen's Motion for Summary Judgment (Winter), 8/18/2014, Ex.1 at 6.

         In connection with the filing of their complaints, both Saksek and Winter submitted affidavits swearing that, inter alia, (1) they filed their complaints after being informed by their mothers who had viewed a television commercial in 2013 describing the relationship between gynecomastia and Risperdal; (2) they are not medical professionals and did not know anything about Risperdal other than that it had been prescribed to them; (3) they followed their doctors' instructions in taking Risperdal; (4) no doctor told them or their parents that their breast growth and weight gain could have been caused by anything to which they were exposed or ingested; (5) no doctor ever told them or their parents that Risperdal was the cause of their breast growth and weight gain; and (6) they now understood that their breast growth is referred to as gynecomastia, a term they had never heard of until shortly before signing their affidavits. Saksek's Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 3; Winter's Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 3.

         C. Janssen's Partial Motions for Summary Judgment

         On May 19, 2014, Janssen filed a motion for partial summary judgment on the issue of the statute of limitations on a global basis (without naming any individual plaintiffs). Therein, Janssen asked the trial court to enter an order holding, inter alia, that all plaintiffs were on constructive and/or inquiry notice of a potential connection between Risperdal use and gynecomastia by no later than October 31, 2006, and that for any gynecomastia injury prior to October 31, 2006 any applicable tort or product liability statute of limitations began to run no later than October 31, 2006. Janssen's Motion for Partial Summary Judgment as to the Affirmative Defense of the Statute of Limitations, 5/19/2015, Proposed Order. The parties fully briefed this global motion, but the trial court did not issue a ruling.

         On August 18, 2014, Janssen filed motions for summary judgment in the Winter and Saksek cases. Janssen incorporated by reference the arguments in its global summary judgment motion into these motions. Janssen's Motion for Summary Judgment (Winter), 8/18/2014, at 8 n.10; Janssen's Motion for Summary Judgment (Saksek), 8/18/2014, at 8 n.9. In its moving papers, Janssen contended that both plaintiffs were placed on inquiry notice of their potential Risperdal claim by no later than October 31, 2006 as a result of the drug's label change. On January 13, 2015, the trial court entered an order and opinion granting Janssen's motion for summary judgment in the Winter case, ruling in the opinion that any claim filed after June 31, 2009 must be dismissed on statute of limitations grounds based upon the cumulative effect of medical literature, newspaper articles and attorney advertising present by that point in time. Winter v. Janssen Pharmaceuticals, Inc., 2015 WL 4578416, at *8 (Pa.Com.Pl. Jan. 13, 2015). On January 31, 2015, the trial court also granted Janssen's motion for summary judgment in the Saksek case, referring in its accompanying opinion that it was doing so for the reasons set forth in its Winter opinion. In a new case management order, the trial court placed approximately twenty percent of all cases on the Risperdal master docket in suspense, indicating that if "the appellate courts affirm this [c]ourt's analysis in Winter regarding the accrual date for Risperdal claims under Pennsylvania's discovery rule," then summary judgment would be entered in all of the suspended cases on statute of limitations grounds. Case Management Order #10, 9/22/2015, at 1-2.

         On appeal, a three-judge panel of the Superior Court affirmed in principal part.[3]The intermediate appellate court agreed that the entry of summary judgment against Winter and Saksek was appropriate, but moved the accrual for causes of action related to Risperdal back from June 31, 2009 to October 31, 2006 - the date on which Janssen changed the Risperdal label to reflect, inter alia, the relative rates for gynecomastia in pediatric clinical trials. In re: Risperdal Litig., 2017 WL 5256400, at *6 (Pa. Super. Nov. 13, 2017). The Superior Court held that the 2006 label change sufficiently tied the usage of Risperdal to the incidence of gynecomastia such that Winter and Saksek should have known of their injuries and the relationship between those injuries and Risperdal. Id.

         This Court granted discretionary review to consider whether summary judgment should have been granted in Janssen's favor on statute of limitations grounds. In re: Risperdal Litigation, 189 A.3d 376 (Pa. 2018). An appellate court may reverse a grant of summary judgment if there has been an error of law or an abuse of discretion. Fine v. Checcio, 870 A.2d 850, 857 n.3 (Pa. 2005). "[S]ummary judgment is appropriate only in those cases where the record clearly demonstrates that there is no genuine issue of material fact and that the moving party is entitled to judgment as a matter of law." Atcovitz v. Gulph Mills Tennis Club, Inc., 812 A.2d 1218, 1221 (Pa. 2002); Pa.R.C.P. 1035.2(1). The trial court must take all facts of record and reasonable inferences therefrom in a light most favorable to the non-moving party. Toy v. Metropolitan Life Ins. Co., 928 A.2d 186, 195 (Pa. 2007). In so doing, the trial court must resolve all doubts as to the existence of a genuine issue of material fact against the moving party, and, thus, may only grant summary judgment "where the right to such judgment is clear and free from all doubt." Summers v. Certainteed Corp., 997 A.2d 1152, 1159 (Pa. 2010). Because the issue presented requires us to decide whether there are genuine issues of material fact is a question of law, our standard of review is de novo and our scope of review is plenary. Fine, 870 A.2d at 857 n.3.


         Saksek and Winter argue that the record does not provide any basis for concluding, as a matter of law, that they knew or should have known with the exercise of reasonable diligence that the condition they were experiencing was not the product of excessive weight gain, but rather was the result of the abnormal growth of female breast tissue caused by their ingestion of Risperdal. Saksek/Winter's Brief at 15. They contend that gynecomastia was not described to them when they were prescribed Risperdal or warned that its ingestion could result in gynecomastia. Id. at 14. Neither boy had any reason to believe that they were not experiencing a buildup of fatty tissue but rather were suffering from an endocrine disorder caused by a drug they took for entirely different reasons (psychotic disorders). Id. Since neither of them had any medical background, they had no understanding of changes to hormone levels as a result of prolactin changes, or of the possibility (much less the likelihood) that the development of permanent female breasts in boys could be the result. Id. at 15.

         Conversely, Janssen contends that Saksek and Winter both allege that they developed gynecomastia more than ten years before they filed suit. Janssen's Brief at 17. Janssen argues that Pennsylvania's discovery rule has been interpreted by this Court narrowly, permitting 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. Id. at 12. According to Janssen, not only did Saksek and Winter not exercise reasonable diligence, they exercised no diligence at all. Id. Janssen insists that Saksek and Winter may prevail only if this Court replaces its long-established objective standard for application of the discovery rule with a subjective one tolling the statute of limitations until a plaintiff has individualized knowledge of his or her injury and its precise cause. Id. at 13. As a result, Janssen argues that this Court should affirm the Superior Court's determination that the accrual date for all Risperdal-related gynecomastia claims is October 31, 2006, the date of the label change. Id. at 27.


         Saksek's and Wilson's actions were dismissed based upon their alleged failure to file them in a timely manner. Limitations periods are computed from the time the cause of action accrued. 42 Pa.C.S. § 5502(a). Generally, "a cause of action accrues, and thus the applicable limitations period begins to run, when an injury is inflicted." Wilson v. El-Daief, 964 A.2d 354, 361 (Pa. 2009). "Once a cause of action has accrued and the prescribed statutory period has run, an injured party is barred from bringing his cause of action." Fine, 870 A.2d at 857.

         The discovery rule is an exception that tolls the statute of limitations when an injury or its cause is not reasonably knowable. Id. The discovery rule will toll the applicable statute until a plaintiff could reasonably discover the cause of his action, including in circumstances where the connection between the injury and the conduct of another are not readily apparent. Wilson, 964 A.2d at 361. Pennsylvania's reasonable diligence standard is objective; the question is 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." Gleason v. Borough of Moosic, 15 A.3d 479, 485 (Pa. 2011). Although objective, the objective reasonable diligence standard is "sufficiently flexible ... to take into account the differences between persons and their capacity to meet certain situations and the circumstances confronting them at the time in question," Fine, 870 A.2d at 858 (citing Crouse v. Cyclops Industries, 745 A.2d 606, 611 (Pa. 2000)), and, as such, "is to be applied with reference to individual characteristics." Wilson, 964 A.2d at 366.

         The requirement of reasonable diligence is not an absolute standard but, rather, is "what is expected from a party who has been given reason to inform himself of the facts upon which his right of recovery is premised." Id. at 858. This Court has stressed that "there are very few facts which diligence cannot discover, but there must be some reason to awaken inquiry and direct diligence in the channel to which it would be successful." Fine, 870 A.2d at 858. In determining whether reasonable diligence has been exercised, a court must determine whether the plaintiff exhibited "those qualities of attention, knowledge, intelligence and judgment which society requires of its members for the protection of their own interests and the interests of others." Id. Because this determination typically involves many fact determinations, it is normally for the jury to decide it. Gleason, 15 A.3d at 485 (quoting Fine, 870 A.2d at 859).

         Pennsylvania's formulation of the discovery rule represents a more narrow approach than is mandated in some other jurisdictions, as 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.'" Nicolaou v. Martin, 195 A.3d 880, 893 (Pa. 2018) (quoting Gleason, 15 A.3d at 484). However, this Court has expressly declined to hold, as a matter of law, that a layperson may be charged with knowledge greater than that which was communicated to her by the medical professionals who provided treatment and diagnosis. Wilson, 964 A.2d at 365.

         IV. ANALYSIS

         A. October 2006 Accrual Date

         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. Gleason, 15 A.3d at 485 (quoting Fine, 870 A.2d at 859). The certified record here provides no substantial basis for such a finding in these two consolidated cases. To the contrary, other than the pleadings and briefs filed by the parties, the evidence in the certified record consists primarily of the "Plaintiff's Fact Sheets" prepared by Winter and Saksek and the affidavits they each filed. Because Janssen's goal was to obtain a global accrual date of October 31, 2006 for all Risperdal-related claims, Janssen filed the two motions for summary judgment at issue here before any case-specific discovery occurred.[4] As such, although these cases involve malformations of their bodies, the certified record contains no pictures of Winter or Saksek, including none that depict the nature or extent of those malformations - evidence that could be essential to a determination of the reasonableness of their actions (or lack thereof) in response thereto. Perhaps even more importantly, the certified record contains no medical records regarding the interactions between Winter and/or Saksek and their treating physicians, and no depositions of Winter, Saksek, their parents, or any of their treating physicians (none of whom, apparently, diagnosed either of them with gynecomastia until at least 2013).

         Despite the absence of any evidence in support, the Superior Court found that "Appellants repeatedly acknowledged that they developed gynecomastia in 1998 [Saksek] and 2002 [Winter]." In re: Risperdal Litig., 2017 WL 5256400 at *5. These "repeated acknowledgements" presumably included answers set forth in their "Plaintiff's Fact Sheets" to the effect that each began to observe swelling of their breasts and increased weight gain at or around the time that they were ingesting Risperdal, and a statement in their responses to Janssen's summary judgment motions to the effect that "[t]his case is about [Winter/Saksek, young men] who ingested [Janssen's] drug, Risperdal, and developed large, female-like breasts as a result …" These are not, however, binding admissions with respect to what Winter and Saksek knew back in 2002 and 1998 (respectively), namely that either of them knew at those times that they had "developed gynecomastia."[5]

         The Superior Court conflates what Winter and Saksek know now, having subsequently been diagnosed with gynecomastia, with what they knew in 2002 and 1998. The Superior Court likewise appears to assume that Winter and Saksek either knew or should have known that their breast growth was an outward manifestation of an endocrine disorder known as gynecomastia (thus triggering a duty to investigate its underlying cause). Importantly, the Superior Court fails to distinguish between knowledge of the physical condition of large breasts and the ...

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