In Re: Risperdal Litig., Appeal of: Winter, J. ( 2019 )

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IN THE SUPREME COURT OF PENNSYLVANIA
EASTERN DISTRICT
SAYLOR, C.J., BAER, TODD, DONOHUE, DOUGHERTY, WECHT, MUNDY, JJ.
IN RE: RISPERDAL LITIGATION : No. 22 EAP 2018
JONATHAN SAKSEK, :
: Appeal from the Judgment of Superior
Appellant : Court entered on November 13, 2017
: at No. 576 EDA 2015 (reargument
: denied January 16, 2018) affirming
v. : the Judgment entered on February
: 12, 2015 in the Court of Common
: Pleas , Philadelphia County, Civil
JANSSEN PHARMACEUTICALS, INC., : Division at No. 00183 February Term,
JOHNSON & JOHNSON COMPANY, : 2014, No. 296 March Term, 2010
JANSSEN RESEARCH AND :
DEVELOPMENT, LLC, : ARGUED: May 16, 2019
:
Appellees :
IN RE: RISPERDAL LITIGATION : No. 23 EAP 2018
JOSHUA WINTER, :
: Appeal from the Judgment of Superior
Appellant : Court entered on November 13, 2017
: at No. 590 EDA 2015 (reargument
: denied January 16, 2018) affirming
v. : the Judgment entered on February
: 10, 2015 in the Court of Common
: Pleas , Philadelphia County, Civil
JANSSEN PHARMACEUTICALS, INC., : Division at No. 01170 March Term,
JOHNSON & JOHNSON COMPANY, : 2014, 296 March Term, 2010
JANSSEN RESEARCH AND :
DEVELOPMENT, LLC, : ARGUED: May 16, 2019
:
Appellees :
OPINION
JUSTICE DONOHUE DECIDED: November 20, 2019
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.
I. RELEVANT BACKGROUND
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
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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,
https://www.mayoclinic.org/diseases-conditions/gynecomastia/symptoms-causes/syc-
20351793 (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:
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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
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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-
1 Saksek’s and Winter’s complaints were consolidated as part of the In re: Risperdal
Litigation mass tort programs in the Court of Common Pleas of Philadelphia County.
2 While these claims have statutes of limitations of varying lengths and although both
Winter and Saksek took Risperdal when they were minors, neither of them contests that,
absent tolling by the discovery rule, all of their claims would be untimely given the dates
of the filing of their complaints in relation to the dates on which they turned eighteen. See
Fancsali v. Univ. Health Center of Pittsburgh, 761 A.2d 1159, 1164 (Pa. 2000) (“[T]he
period within which a minor’s action must be commenced is measured not from the time
the cause of action accrues, but from the time he or she turns eighteen.”).
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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
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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
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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
3 Judge Fitzgerald concurred only in the result.
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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.
II. THE ARGUMENTS OF THE PARTIES
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
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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.
III. APPLICABLE LAW
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
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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
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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
4 In their responses to Janssen’s motions for summary judgment, Saksek and Winter
described the motions as “premature” and noted that our Superior Court has recognized
that motions for summary judgment should not be considered until the adverse party has
had a full opportunity to develop a claim or defense after all relevant discovery has
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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
occurred. See, e.g., Saksek’s Response in Opposition to Motion for Summary Judgment,
8/18/2014, at 4 n.3 (citing Anthony Biddle Contrs. v. Preet Allied Am. St., L.P., 28 A.2d
916, 928 (Pa. Super. 2011) and Burger v. Owens Illinois, Inc., 966 A.2d 611, 618 (Pa.
Super. 2009)). Neither Saksek nor Winter, however, asked the trial court to deny
summary judgment based upon the allegedly premature nature of Janssen’s filings.
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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 critical knowledge of an injury,
gynecomastia. The Superior Court assumes Winter’s and Saksek’s knowledge of the
latter (gynecomastia).
There is no evidence of record to support such an assumption. Moreover, there is
significant evidence of record in the affidavits of Winter and Saksek to support an
5 Relatedly, the trial court found that paragraph 173 of the long-form complaints
(incorporated into the filed short-form complaints) included a judicial admission by Winter
and Saksek that they should have known of the link between Risperdal and gynecomastia
no later than October 2009. Winter, 2015 WL 4578416, at *9 & n.7 (citing paragraph 173
of the Second Amended Master Long-Form Complaint as alleging that Janssen
“deliberately withheld [information concerning the link between Risperdal and
gynecomastia] from prescribing physicians and the public until at least October 2006,
when it appeared in the label for Risperdal and/or Invega”) (emphasis in original). The
trial court reasoned that “[l]ogically, if the information was ‘hidden from the public until at
least October 2006,’ the information must have been available after October 2006;
otherwise, the insertion of a specific time, October 2006, was superfluous.” Id.
We do not agree that paragraph 173 constitutes a judicial admission. “[A]n admission is
not conclusively binding as a judicial admission unless the testimony is clear and
unequivocal[.]” Greater Val. Terminal Corp. v. Goodman, 176 A.2d 408, 410 (Pa. 1962).
The paragraph states only that Janssen had knowledge of the relationship between
Risperdal and gynecomastia prior to October 2006, which it disclosed in October 2006.
The paragraph does not convey that Winter or Saksek actually received the information
on the revised label, either in October 2006 or at any time thereafter.
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alternative possibility. At all relevant times, weight gain was a reported risk of Risperdal.
Saksek’s Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 4 at
16; id. Ex. 6 at 23. In their affidavits, both Winter and Saksek reported that they
experienced significant weight gain while on Risperdal. Winter’s Response in Opposition
to Motion for Summary Judgment, 8/18/2014, Ex. 3 at 2; Saksek’s Response in
Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 3 at 2. Winter and Saksek
both contend that weight gain provided a normal and reasonable explanation for the
breast growth – both understood that their enlarged breasts reflected the addition of fatty
tissue in their breasts, a condition that would alleviate itself over time when they were
able to lose the increased weight. Winter/Saksek Brief at 29.
Their affidavits provide further support for this explanation. Both attested that they
had never heard of the term “gynecomastia” and their physicians had never discussed
the condition with them or suggested that the ingestion of Risperdal (or any other drug)
could cause the growth of female breast tissue in males. To the contrary, both Winter
and Saksek attested that they had no specialized medical or scientific training and thus
had no understanding of how the endocrine system worked. As such, they had no idea
that an endocrine system disorder could result in the growth of female breast tissue in
males – the entire concept was foreign to them. Both further indicated that over time they
were under the care of physicians who they relied upon to provide treatment and medical
advice, none of whom ever diagnosed them with gynecomastia.
In his dissenting opinion, Chief Justice Saylor takes a contrary view with regard to
Saksek’s and Winter’s awareness of weight gain while taking Risperdal, arguing that it
should have put Saksek and Winter on inquiry notice sufficient to require them to consult
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with their physicians regarding gynecomastia. Dissenting Op. at 2-4. While it may (or
may not) have been useful for treatment purposes for Saksek and Winter to ask their
physicians whether their weight gain was caused by Risperdal or some other cause (e.g.,
overeating), it is not at all clear, and the Chief Justice does not explain, how their weight
gain put either of them on inquiry notice of a possible causal link between their ingestion
of Risperdal and the development of a pathological endocrine condition resulting in the
growth of female breast tissue. As indicated above, supra at 14, weight gain was at all
relevant times listed on the Risperdal label as a known side effect of ingestion of the drug,
and thus even if it is assumed that Saksek and Winter linked the weight gain to the drug,
this would not in any way be indicative of any other more serious abnormality. To the
contrary, it could be argued that knowledge of weight gain as a side effect tempered
inquiry into other explanations for the physical changes to their bodies.
At bottom, the Chief Justice effectively posits that if an individual experiences one
potential (but not unexpected) side effect from consuming a drug, he or she is therefore
placed on inquiry notice for every other potential side effect that could possibly result
from consumption of that same drug (even one, like gynecomastia, which the pre-2006
label recognized as a "rare adverse event”). No case law from any jurisdiction supports
this contention. The only case cited by the Dissent, Ridenour v. Boehringer Ingelheim
Pharm., Inc., 679 F.3d 1062 (8th Cir. 2012), provides no such support. In that case, the
plaintiff began experiencing compulsive behaviors and asked his physician if there was a
possible relationship between those compulsive behaviors and his ingestion of Mirapex.
Id. at 1066. The court ruled that the plaintiff’s question placed him on inquiry notice of a
possible claim against the manufacturer of Mirapex for causing his compulsive behaviors
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(the precise condition he understood himself to be experiencing). Id. In the present case,
even if Saksek and/or Winter understood there to be an association between Risperdal
and weight gain (the condition they themselves acknowledged that they were
experiencing), no reason exists to explain how this circumstance would, as a matter of
law, have placed them on inquiry notice with respect to an entirely different side effect of
Risperdal – gynecomastia, a pathological endocrine condition that neither Saksek or
Winter even knew existed at the time that they were prescribed Risperdal.6 At best, the
argument developed by the Dissent is one for Janssen to posit to a jury for its
consideration.
Saksek’s and Winter’s lack of medical training is significant. In another case on
the In re: Risperdal Litigation master docket, Murray v. Janssen Pharmaceuticals, Inc.,
180 A.3d 1235 (Pa. Super. 2018), Janssen argued that a physician could not have
6 In this regard, the Chief Justice suggests that because both weight gain and
gynecomastia may result in an enlargement of male breasts, if Saksek and/or Winter had
consulted with physicians regarding their weight gain, then perhaps their gynecomastia
could have been diagnosed at that time. Dissenting Op. at 3-4. In their fact sheets,
however, both Saksek and Winter identified multiple physicians with whom they consulted
for their medical needs during and after the periods of time when they were prescribed
Risperdal. Saksek, for example, listed four physicians who provided medical care for his
ADD, ADHD and bipolar disorder during and after the time that he was prescribed
Risperdal, and three additional physicians who provided him with primary care during the
relevant time periods. Janssen’s Motion for Summary Judgment (Saksek), 8/18/2014,
Ex. 1 at 7-8. In their affidavits, both Saksek and Winter testified that none of their doctors
ever diagnosed them as having gynecomastia or suggested that their breast growth could
have been caused by Risperdal. These facts, taken together and in the light most
favorable to Saksek and Winter as the non-moving parties, establish for summary
judgment purposes that both plaintiffs were under the supervision and care of physicians
while taking Risperdal and that none of these physicians diagnosed them as suffering
from gynecomastia. See Nicolaou, 195 A.3d at 893 (citing Wilson, 964 A.2d at 365) (while
inquiry notice does not require knowledge of “the full extent of the injury,” nevertheless “a
layperson is only charged with the knowledge communicated to him or her by the medical
professionals who provided treatment and diagnosis”).
[J-52A-2019 and J-52B-2019] - 17
diagnosed the plaintiff as suffering from gynecomastia caused by the ingestion of
Risperdal based upon viewing a photograph. Id. at 1242. Janssen insisted that a
physician’s examination of a patient “is essential to distinguish between gynecomastia –
enlarged breasts due to the presence of breast tissue, and pseudo-gynecomastia –
enlarged breasts due to the accumulation of fat tissue[.]” Id. Janssen argued that a
photograph could not be relied upon to determine “the cause of enlargement.” Id. This
contention at least suggests that Janssen agrees that breast enlargement may be
explained by weight gain (pseudo-gynecomastia) as an alternative to the existence of a
pathological endocrine disorder (gynecomastia) resulting in the growth of female breast
tissue in males. With no specialized medical knowledge or training, it is unlikely (at best)
that either Winter or Saksek could have, solely through self-examination, reached any
conclusion that their conditions resulted from the growth of female breast tissue rather
than fatty tissue, particularly where they testified in their affidavits that they had no
understanding that the growth of female breast tissue in males was even a possibility as
a result of ingesting a drug.
As explained hereinabove, the discovery rule tolls the running of the applicable
statute of limitation until the plaintiff discovers, through the exercise of reasonable
diligence, that he is injured and that the injury has been caused by another party’s
conduct. Wilson, 964 A.2d at 361. Importantly, however, 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. As this Court made clear
in Fine, “there must be some reason to awaken inquiry and direct diligence in the channel
to which it would be successful. This is what is meant by reasonable diligence.” Fine,
[J-52A-2019 and J-52B-2019] - 18
870 A.2d at 858; see also id. (stating that reasonable diligence 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.”). If, as Winter and Saksek contend, they believed that their
condition was merely the result of weight gain rather than a pathological endocrine
disorder caused by the conduct of another, then the requirement to exercise due diligence
may never have been awakened. If so, then Winter and Saksek had no legal obligation
to seek an alternative explanation for the condition – including, as the Superior Court
insisted, a requirement to seek medical advice concerning their breast growth. In re:
Risperdal Litig., WL 5256400, at *6. To the contrary, having no reason to believe that
they were suffering from an abnormal pathological condition, they thus arguably had no
reason to consult with their physicians regarding a potential diagnosis.
We do not suggest that Janssen’s contention that Winter and Saksek were aware
of their injuries in 2002 and 1998 is incorrect. Rather, 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.
We likewise disagree with the Superior Court’s determination that the landscape
for discovery changed by October 31, 2006 when Janssen changed the Risperdal label
to report the results of clinical trials which reported the incidence of gynecomastia in 2.3%
of Risperdal-treated patients. The Superior Court found that “by that date, ‘reasonable
minds would not differ in finding that’ Appellants knew, or should have known, of their
[J-52A-2019 and J-52B-2019] - 19
injuries and the cause of those injuries by this point.” Id. Again, however, the certified
record does not support this conclusion, for several reasons.
First, the argument presumes that Winter and Saksek were aware of and should
have appreciated that their breast growth was caused by the conduct of another when
they first experienced breast growth. In other words, this argument suggests that Winter
and Saksek should have been seeking to identify the cause of their condition, including
through examination of the drug label for Risperdal, rather than believe their condition
was adequately explained as a normal byproduct of excessive weight gain. Moreover,
Winter stopped taking Risperdal in 1998 and Saksek did so in 2004. As a result, neither
were still taking Risperdal at the time of the label change in 2006.7 No evidence in the
certified record explains how either would have even known that the label for a drug they
were no longer taking had changed. The record does not reflect that under this
circumstance, their doctors would have had a reason to provide them with updated labels.
7 The trial court rejected the date of the label change (October 31, 2006) as the accrual
date for Risperdal-related gynecomastia claims on the following basis:
Viewing the facts in the light most favorable to [Winter], it is
possible that immediately after he noticed his injuries, [Winter]
conducted a diligent search into the cause of his injuries, was
unable to find evidence of the link between his injuries and his
Risperdal use, and by 2006 his diligent search had become
stale. When viewed in the light most favorable to [Winter], it
would be unreasonable to expect him to have continued
checking the Risperdal label until October 2006 even though
he stopped taking Risperdal in 1998. Put another way, the
October 2006 change to the Risperdal label may have been,
standing alone, insufficient to have awakened [Winter’s] inquiry
concerning the link between Risperdal and his injuries.
Winter, 2015 WL 4578416, at *6.
[J-52A-2019 and J-52B-2019] - 20
Even if they had, for some unexplained reason, sought access to the updated label, the
certified record does not demonstrate how they would have known where to obtain it.
Moreover, if they had gained access to the updated label, it is questionable
whether either of them could have, given their lack of medical training, understood the
complex and specialized discussion of the relevant clinical trials. The revised 2006 label
arguably did not provide any of the basic terms and information necessary to understand
the label’s review of the clinical trials, including, for instance, what specifically
gynecomastia is, that it is caused by an endocrine disorder, or even that the 2.3%
incidence of gynecomastia revealed by the trials was statistically significant, higher than
had been expected, or greater than the incidence of the disorder in the general
population. Winter’s and Saksek’s 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 Winter and Saksek had consulted with their physicians regarding
the contents of the 2006 revised label, the certified record contains no evidence to support
the conclusion that their physicians would have told them that the label confirmed a causal
link between Risperdal and gynecomastia. To the contrary, in deposition testimony
attached as an exhibit to Winter’s and Saksek’s responses to the motions for summary
judgment, a Janssen causation expert emphatically denied that the 2006 label
established any such causal link and further opined that the incidence of gynecomastia
in Risperdal-taking patients could be explained by mere coincidence:
Q: Let me ask you, how would you interpret it? Can you agree
with me that based on what I just read that Risperdal is
associated with gynecomastia?
[J-52A-2019 and J-52B-2019] - 21
A: No. No. No. No. What you just read to me is that in a
population of children and in adolescents taking risperidone,
that 2.3 percent of those patients were found to have
gynecomastia. And I posit based on the medical literature
that, you know, if you just do a cross-sectional surveys of
adolescent boys, you will find that between, you know, as low
as 4 percent and as high as - in the literature, you know, 65,
66 percent of boys will have gynecomastia. If you look at your
own expert's testimony, Dr. Goldstein in his blog, he estimates
it at 90 percent.
So the fact of the matter is you have a population of patients
that are going to have pubertal gynecomastia and they just
happen to be taking Risperdal. And they go through puberty
and they develop gynecomastia, you cannot really make the
association that the risperidone caused the gynecomastia.
This in most instances is going to be just simply pubertal
gynecomastia.
Q. Come on, Dr. Braunstein. A doctor that reads this is going to
come away with, you know, 2.3 percent of risperidone-treated
patients - that's evidence of causation; isn't it?
A. No.
Q. That's evidence of an association, would you agree?
A. No more than my example of drinking coffee and later dying.
Winter’s Response in Opposition to Motion for Summary Judgment, 8/18/2014, Ex. 9 at
70-71.
The contents of the label are consistent with this testimony, as it provides that
Risperdal may elevate prolactin levels and is “associated with higher prolactin levels than
other antipsychotic agents,” and also that various endocrine disorders, including
gynecomastia, “have been reported in patients receiving prolactin-elevating compounds.”
Id. Ex. 6 at 15. The label does not, however, indicate that the ingestion of Risperdal may
cause gynecomastia. If Janssen’s causation expert, based upon his review of the 2006
label, did not conclude that said label reflected a causal link, then it cannot be said,
[J-52A-2019 and J-52B-2019] - 22
contrary to the Superior Court’s determination, that “reasonable minds would not differ in
finding that” Winter and Saksek knew or should have known that their injuries were
caused by their ingestion of Risperdal based upon Janssen’s issuance of the 2006
revised label.
Again, Janssen may certainly argue to the jury that the 2006 label change would
have established for Winter and Saksek knowledge of the injury and its cause if they had
exercised more vigorous diligence. We conclude only that on this record, Janssen was
not entitled to summary judgment as a matter of law, as material issues of fact remain for
a jury’s determination.
B. June 30, 2009 Accrual Date
Janssen’s motions for summary judgment were based entirely on the evidentiary
predicate that the accrual date for Winter’s and Saksek’s causes of action was no later
than October 2006.8 The trial court rejected this accrual date. Instead of ending its inquiry
with the denial of the pending motion for summary judgment, the trial court, sua sponte,
developed an alternative basis for summary judgment based on an accrual date of no
later than June 30, 2009. On appeal, the Superior Court disagreed with the trial court’s
rejection of the 2006 accrual date and noted without analysis that the record supported
both the 2006 and 2009 accrual dates, the latter being irrelevant given its decision. In re:
Risperdal Litig., 2017 WL 5256400, at *6 n.8.
8 See Janssen’s Motion for Summary Judgment (Saksek), 8/18/2014, at 13 (“[I]n sum,
[Saksek] brought his suit almost nine years after he reached the age of eighteen, more
than eleven years after he learned of his alleged injuries, and more than seven years after
the latest date on which he should be charged with constructive knowledge or inquiry
notice of the purported cause of his injuries, October 31, 2006.”).
[J-52A-2019 and J-52B-2019] - 23
The trial court concluded that Winter’s and Saksek’s claims accrued no later than
June 30, 2009 based upon the environment created by the cumulation of medical journal
articles, media reports, and an instance of lawyer advertising. Winter, 2015 WL 4578416,
at *8. As part of the environment, the trial court identified three “high volume, national,
medical publications”9 dating from 2003-2004 that “reference a link between Risperdal
use and increased prolactin production, as well as the fact that increased prolactin
production may result in gynecomastia.” Id. at 7.10 11
With respect to media reports, the trial court referenced various newspaper articles
and television news broadcasts that it represented contained disclosures of “Risperdal
causing adolescent boys to develop breasts.” Winter, 2015 WL 4578416, at *7.
According to the trial court, publicity of the connection between Risperdal and
gynecomastia began in 2001, with three articles appearing in the Miami Herald. 12 The
9 Donna A. Wirshing et al., Update On Atypicals: Practical Tips To Manage Common
Side Effects, 2 Current Psychiatry 49-57 (2003); Choice Of An Antipsychotic, 45 The
Medical Letter 102-04 (2003); Peter M. Haddad & Angelika Wieck, Antipsychotic-Induced
Hyperprolactinemia: Mechanisms, Clinical Features And Management, 64 Drugs 2291,
2292, 2296, 2298-2300 (2004).
10 Here again, the trial court presupposes that Winter and Saksek were aware that their
breast enlargement was an injury (gynecomastia) rather than a physical condition
resulting from weight gain.
11 Winter and Saksek argue that these articles discuss the relationship between Risperdal
and gynecomastia only in general terms and do not provide any detailed analysis to
support a causal connection between them. Winter’s Brief at 43-46. Winter and Saksek
further contend that in 2004 Janssen “poisoned the proverbial well” on this issue in the
scientific community by commissioning and publishing an article that concluded, falsely,
that there was no significant correlation between high prolactin levels and gynecomastia.
Id. at 44.
12 Foster Kids Describe Drugs' Effects Prescribed Psychiatric Medications Made
“Everything a Blur” for One Girl, Miami Herald (April 23, 2001) at 1A,
http://poundpuplegacy.org/node/33599 (last visited October 28, 2019); Shocking Tale
[J-52A-2019 and J-52B-2019] - 24
trial court next reported that in 2004 Janssen sent “Dear Doctor” letters to prescribing
physicians concerning certain potentially fatal complications relating to the ingestion of
Risperdal, which resulted in articles in four major newspapers.13 Id. While the Dear
Doctor letters were unrelated to any correlation between Risperdal and gynecomastia,
the four articles mentioned the link in a single sentence. Then, in 2008, the New York
Post and the Philadelphia Inquirer published articles that “mentioned the link between
Risperdal and gynecomastia.”14 Later in 2008, Fox Television and CBS Evening News
Fails to Register, Miami Herald (April 24, 2001) at 1B,
http://nl.newsbank.com/nlsearch/we/Archives?p_action=doc&p_docid=0EBC6E5CEB1C58B4&p_docnum
=1&s_dlid=DL0119080516355500373&s_ecproduct=SBK-
W3&s_ecprodtype=NORENEW&s_trackval=&s_siteloc=MH&s_referrer=&s_subterm=Subscription%20un
til%3A%2008%2F12%2F2019&s_docsbal=&s_subexpires=08%2F12%2F2019&s_docstart=3&s_docsleft
=0&s_docsread=3&s_username=switalec&s_accountid=AC0119072516341302898&s_upgradeable=no,
(last visited October 28, 2019); Investigation Urged on Antipsychotic Drugs Given to Disabled
Floridians, Miami Herald, (May 11, 2001) at 23A, http://nl.newsbank.com/nl-
search/we/Archives?p_actiondoc&p_docid=0EBF52C804F9D5A1&p_docnum=1&s_dlid=DL01190805163
12004604&s_ecproduct=SBK-W3&s_ecprodtype=NORENEW&s
trackval=&s_siteloc=MH&s_referrer=&s_subterm=Subscription%20until%3A%2008%2F12%2F2019&s_d
ocsbal=Docs%20remaining%3A%201&s_subexpires=08%2F12%2F2019&s_docstart=3&s_docsleft=1&s
_docsread=2&s_username=switalec&s_accountid=AC0119072516341302898&s_upgradeable=no (last
visited October 28, 2019).
13 Warning on Schizophrenia Drug, New York Times (July 25, 2004) at 117,
https://www.nytimes.com/2004/07/25/us/warning-on-schizophrenia-drug.html (last visited
October 28, 2019); Maker of Schizophrenia Medicine Clarifies Risks, Washington Post
(July 25, 2004), https://www.washingtonpost.com/archive/politics/2004/07/25/maker-of-
schizophrenia-medicine-clarifies-risks/0f06be62-0dbb-412b-af7d-
6f21314120be/?utm_term=.e18b8a5ca72f (last visited October 28, 2019); Drug Firm Admits
Misleading Claims, Charleston Newspapers (July 25, 2004) at 8; Medicine Maker Admits
Deception It Downplayed Possibly Fatal Safety Risks, Kansas City Star (July 25, 2004),
https://kansascity.newsbank.com/doc/news/104140855AD42619?search_terms (last
visited October 28, 2019).
14 Medicaid Kids in Psych-Rx $urge, N.Y.Post (February 3, 2008) at 7,
https://nypost.com/2008/0203/medicaid-kids-in-psych-rx-urge (last visited October 28,
2019); Karl Stark, Tarnished View of Wonder Drugs, Philadelphia Inquirer, February 17,
[J-52A-2019 and J-52B-2019] - 25
discussed a possible link between Risperdal and gynecomastia, and on June 15, 2009,
counsel for Winter and Saksek uploaded a video on an internet platform (YouTube)
discussing the issue.15 Id. at 8. Based on this publicity, the trial court concluded that “by
June 30, 2009, [Winter’s] inquiry should have been awakened,” and that “as a matter of
law, the discovery rule can only toll the statute of limitation until a maximum date of June
30, 2009 for plaintiffs who ingested Risperdal prior to October 2006.” Id.
Before proceeding to analysis of the trial court’s contentions, we note that only
some of the media reports cited by the trial court are included in the certified record on
appeal. The New York Post and the Philadelphia Inquirer articles published in 2008, the
cited Fox and CBS television shows, and the YouTube video were referenced by Janssen
in a footnote regarding lawyer advertising in its global motion for partial summary
judgment (on which the trial court did not issue a ruling). Janssen’s Motion for Partial
Summary Judgment as to the Affirmative Defense of the Statute of Limitations, 5/19/2015,
at 22 n.27. Because Janssen incorporated by reference the arguments in its global
summary judgment motion into its motions for summary judgment in the Winter and
Saksek cases, 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, these items are
fairly considered to be in the certified record here. However, the three Miami Herald
articles, see supra note 12, and the four articles related to the “Dear Doctor” letters, supra
2008 at E01,
https://www.inquirer.com/philly/business/20080217_Tarnished_View_of_Wonder_Drugs.html (last
visited October 28, 2019).
15 Sheller PC, Risperdal®: Has your son experienced breast growth while taking this
drug? Youtube (uploaded June 25, 2009), http://www.youtube.com/watch?v=L_wj6-LINIg
(last visited October 28, 2019).
[J-52A-2019 and J-52B-2019] - 26
note 13, were not part of either the global record or the summary judgment records of
Winter or Saksek. The identification of these seven articles is the apparent result of sua
sponte research conducted by the trial court, which, having rejected October 31, 2006 as
the final accrual date, proceeded to fashion its own alternative accrual date.
In a footnote, the trial court indicated that “a court may take judicial notice of press
releases[,] news articles and published analyst reports in determining what the market
knew,” citing to a single decision of a federal district court. Id. at *7 n.9 (citing Landow v.
Wachovia Securities, LLC, 966 F. Supp. 2d 106, 119 (E.D.N.Y. 2013)) (in case involving,
inter alia, allegations of financial fraud, federal district court took judicial notice of certain
court filings and media reports “not for the truth of the matters asserted therein, but rather
to establish the fact that the information in those materials was publicly available”). We
note that in taking judicial notice, it is unclear whether the trial court considered the
requirements of Rule 201 of the Pennsylvania Rules of Evidence, entitled “Judicial Notice
of Adjudicative Facts.”16 For example, Rule 201(b)(1) directs that judicial notice may be
16 Rule 201 provides as follows:
Rule 201. Judicial Notice of Adjudicative Facts
(a) Scope. This rule governs judicial notice of an adjudicative fact only, not
a legislative fact.
(b) Kinds of Facts That May Be Judicially Noticed. The court may judicially
notice a fact that is not subject to reasonable dispute because it:
(1) is generally known within the trial court's territorial
jurisdiction; or
(2) can be accurately and readily determined from sources
whose accuracy cannot reasonably be questioned.
(c) Taking Notice. The court:
[J-52A-2019 and J-52B-2019] - 27
taken of an adjudicative fact if it is not subject to reasonable dispute that the fact is
generally known within the trial court’s jurisdiction. Relevant to summary judgment in
these cases, whether the facts judicially noticed by the trial court were generally known
goes to the heart of the inquiry notice issue. 17
Moreover, it is unclear under our rules whether a trial court may take judicial notice
of certain facts and then grant summary judgment to the moving party on those same
facts. Pursuant to Rules 1035.1–1035.5 of the Pennsylvania Rules of Civil Procedure,
the “record” for purposes of motions for summary judgment consists of the pleadings,
(1) may take judicial notice on its own; or
(2) must take judicial notice if a party requests it and the court
is supplied with the necessary information.
(d) Timing. The court may take judicial notice at any stage of the
proceeding.
(e) Opportunity to Be Heard. On timely request, a party is entitled to be
heard on the propriety of taking judicial notice and the nature of the fact to
be noticed. If the court takes judicial notice before notifying a party, the
party, on request, is still entitled to be heard.
(f) Instructing the Jury. The court must instruct the jury that it may, but is not
required to, accept as conclusive any fact judicially noticed.
Pa.R.E. 201.
17 The propriety of judicial notice aside, the trial court did not, and could not, discuss
whether Winter and/or Saksek had any reasonable access to these media reports.
Because the evidence in this regard is non-existent, it is not even clear whether Winter
and/or Saksek had access to the internet or the skill to search effectively, especially since
the articles typically lacked certain terms (e.g., gynecomastia or breast growth) that would
have been useful in constructing searches designed to locate them. The record also does
not establish that, at the relevant points in time, these articles could have been accessed
without subscriptions to the publications in question. The Court ascertained, in
connection with its efforts to gain access (for citation purposes) to certain of the websites
listed supra, that paid subscriptions are currently required for two of the Miami Herald
articles in footnote 12 and the Kansas City Star article in footnote 13.
[J-52A-2019 and J-52B-2019] - 28
depositions, answers to interrogatories, admissions, affidavits, and reports signed by an
expert witness that would, if filed, comply with Rule 4003.5(a)(1), whether or not the
reports have been produced in response to interrogatories. Pa.R.C.P. 1035.1–1035.5.
These rules do not indicate that a trial court may also take judicial notice of other facts
and thus consider them part of the record when ruling on a motion for summary judgment.
The manner in which the trial court proceeded and the information it considered have not
been challenged,18 however, and we will not decide the issue here. We thus review the
merits.
The media reports relied on by the trial court do not discuss any causal link
between the ingestion of Risperdal and gynecomastia sufficient to place Winter and
Saksek on notice of their claims against Janssen. None of the nine cited newspaper
articles reference gynecomastia in their titles, and only one of the nine even uses the term
in the text. Five of the nine do not refer to breast growth at all, but rather only the
development of lactating breasts in boys, a condition never reported by Winter or Saksek.
Finally, and perhaps most importantly, the articles only mention breast growth and/or
18 In a reply brief, Saksek and Winter note that the seven articles are not in the certified
record on appeal, indicating that the “trial court found them through independent
research.” Saksek/Winter Reply Brief at 15 n.1; see also Saksek/Winter Brief at 47 (The
trial court sua sponte referenced these articles in its opinion, presumably based on
independent research.”).
On this point, we note, parenthetically, that Rule 2.9(C) of the Pennsylvania Code of
Judicial Conduct provides “[a] judge shall not investigate facts in a matter independently,
and shall consider only the evidence presented and any facts that may properly be
judicially noticed.” Comment 6 to Rule 2.9(C) makes clear that electronic media, i.e., the
internet, is a prohibited source of independent research of facts.
This case does not implicate an analysis of any potential violation of this Rule. Instead,
we use this opportunity to caution the bench against resorting to this practice.
[J-52A-2019 and J-52B-2019] - 29
lactation anecdotally, typically referring to a single boy (or a “handful” of boys) suffering
from the side effects of ingesting Risperdal at issue here.
As indicated, the trial court also referred to two television news shows and a
YouTube video. One of the television news shows was a Fox News broadcast on
November 20, 2008.19 At the end of the broadcast there was a short segment introduced
as follows: “Thousands of children are taking them, dozens have died as a result of side
effects. So, should doctors stop prescribing antipsychotic drugs to children. A new
warning from a government panel[.]” Janssen’s Motion for Partial Summary Judgment as
to the Affirmative Defense of the Statute of Limitations, 5/19/2015, Ex. AA at 8. The
segment included a brief interview with a young woman who complained that Risperdal
caused her to gain “so much weight” that it affected her moods and made her depressed.
Id. at 9. A short interview with Attorney Stephen Sheller (now counsel for Saksek and
Winter) followed. Attorney Sheller was introduced by the show’s host as “a lawyer in
Philadelphia who represents patients damaged by antipsychotic drugs, including these
boys who had to have mastectomies because they grew breasts on Risperdal.” Id.
Attorney Sheller did not address the subject of his introduction, instead commenting only
that antipsychotic drugs are “a good profit center for the drug industry” and that the FDA
has conflicts of interest that protect the drug companies at the expense of public health.
Id.
The YouTube video referenced by the trial court contains a lawyer advertisement
by Attorney Sheller. Without question it links the ingestion of Risperdal with the incidence
19 Unlike with the Fox News program, Janssen did not attach a transcript of the CBS
News program to its global motion for summary judgment. The website cited by Janssen
(and set forth in the trial court’s opinion) indicates that the video is no longer available.
[J-52A-2019 and J-52B-2019] - 30
of gynecomastia. As it was uploaded on June 25, 2009 and the trial court set June 30,
2009 as the final accrual date for all Risperdal-related gynecomastia claims, this video
was apparently the straw that broke the camel’s back for the trial court, such that any
potential plaintiff’s “inquiry should have been awakened.” Winter, 2015 WL 4578416, at
*8.
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. According to the
trial court, “the link between Risperdal and gynecomastia was so widely discussed in the
mainstream media, and in medical journals, that by June 30, 2009 anyone exercising
reasonable diligence would have discovered the existence of his or her claims against
Janssen. Id. In making this argument, the trial court adopted the reasoning of three
federal district court decisions, each of which determined that the level of publicity
regarding causal links between a particular drug and a particular injury was such that a
potential plaintiff should have been put on notice of his or her claim. See In re Avandia
Mktg., Sales Practices & Products Liab. Litig., 2012 WL 3205620 (E.D. Pa. Aug. 7, 2012)
(federal district court found that a reasonable person would have been on notice to
investigate possible link between heart attack already suffered and the drug Advandia
after New England Journal of Medicine concluded that there was a 43% increased risk of
myocardial infarction, multiple national health associations issued warnings for patients
to consult with physicians, and the FDA required a black box label, all resulting in massive
mainstream media coverage); In re Vioxx Products Liab. Litig., 522 F. Supp. 2d 799 (E.D.
La. 2007) (after a large patient study associated ingestion of the drug Vioxx with
significantly increased risks of serious cardiovascular thrombotic events, the FDA
[J-52A-2019 and J-52B-2019] - 31
required a revised label, the manufacturer withdrew the drug from the market, which
resulted in an “avalanche of media coverage” penetrating local markets nationwide, which
the federal district court found was sufficient to put potential plaintiffs on notice); Burrell
v. Astraeneca LP, 2010 WL 3706584, at *1 (Del. Super. Sept. 20, 2010) (based upon
information published in medical and lay sources regarding a link between the drug
Seroquel and diabetes, a label change and two “Dear Doctor” letters specifically alerting
the medical community of the label change, the federal district court ruled that plaintiffs
were on notice as of the date of their diagnosis with diabetes).
Unlike in these cases, 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. In In re Avandia, the American College of
Cardiology, the American Diabetes Association, and the American Heart Association all
issued statements advising diabetes patients to contact their physicians. In re Avandia,
2012 WL 3205620, at *3. The FDA required a prominent “black box warning” to be
included on the drug label. Id. The district court, in setting the accrual date at the end of
2007, found that local and national media had successfully reported to the general public,
citing statistics indicating that by November 2007 Avandia prescriptions had fallen by
54%. Id. at *4. In the Vioxx litigation, the district court likewise found that when the
manufacturer pulled the drug from the market, an “immediate media blitz” followed which
penetrated both national and local markets. In re Vioxx, 522 F. Supp. 2d at 801. The
district court described the situation as “the largest and most-publicized prescription drug
withdrawal in this country’s history.” Id. at 803. In Burrell, the drug manufacturer had to
issue not just one but two “Dear Doctor” letters alerting the medical community of the
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label change that identified the link between Seroquel and diabetes. Burrell, 2010 WL
3706584, at *6.
It may fairly be questioned as to whether the national attention regarding the link
between Risperdal and gynecomastia compares favorably with the extent of media
coverage in the In re Avandia, In re Vioxx and Burrell cases. In the present cases, the
trial court referenced three medical journal articles (all published in 2003-2004), nine
newspaper articles (spread over eight years), two television news programs in 2008, and
a YouTube video. However, 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.
This is not to say that the publicity (including the medical journal articles) cited by
the trial court in this case was insufficient to place Winter and Saksek on notice (at any
particular point in time) that their ingestion of Risperdal was the cause of their
gynecomastia or that their enlarged breasts were in fact the result of the growth of female
breast tissue and not mere overall weight gain. Rather, 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.
Finally, the scope of the distribution and information linking Risperdal to
gynecomastia in the medical journal articles, media reports and lawyer advertising does
not cumulatively, as a matter of law, lead to the conclusion that Saksek and Winter were
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put on inquiry notice sufficient to establish a June 30, 2009 accrual date for their causes
of action.
We therefore hold that the Superior Court erred in affirming the trial court’s grant
of summary judgment in favor of Janssen. Genuine issues of material fact remain with
respect to Janssen’s statute of limitations defense. We remand these two cases to the
trial court for further proceedings consistent with this decision.
Reversed and remanded.
Justices Baer, Todd, Dougherty, Wecht and Mundy join the opinion.
Justice Baer files a concurring opinion in which Justice Donohue joins.
Chief Justice Saylor files a dissenting opinion.
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