Stange, T. v. Janssen Pharmaceuticals

J. A10042/17
2018 Pa. Super. 4
TIMOTHY STANGE : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
v. :
:
JANSSEN PHARMACEUTICALS, INC.; :
JOHNSON & JOHNSON; JANSSEN :
RESEARCH & DEVELOPMENT, LLC; :
EXCERPTA MEDICA INCORPORATED :
AND ELSEVIER, INC. :
:
APPEAL OF: JANSSEN :
PHARMACEUTICALS, INC.; : No. 739 EDA 2016
JOHNSON & JOHNSON; JANSSEN :
RESEARCH & DEVELOPMENT, LLC, :
Appeal from the Judgment Entered February 10, 2016,
in the Court of Common Pleas of Philadelphia County
Civil Division at No. April Term 2013 No. 1984
TIMOTHY STANGE : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
v. :
:
JANSSEN PHARMACEUTICALS, INC.; :
JOHNSON & JOHNSON; JANSSEN :
RESEARCH & DEVELOPMENT, LLC; :
EXCERPTA MEDICA INCORPORATED :
AND ELSEVIER, INC. : No. 1549 EDA 2016
:
APPEAL OF: TIMOTHY STANGE :
Appeal from the Judgment Entered February 10, 2016,
in the Court of Common Pleas of Philadelphia County
Civil Division at No. April Term 2013 No. 1984
BEFORE: PANELLA, J., DUBOW, J., AND FORD ELLIOTT, P.J.E.
J. A10042/17
OPINION BY FORD ELLIOTT, P.J.E.: FILED JANUARY 08, 2018
Timothy Stange (“Stange”), plaintiff in the court below, and
defendants, Janssen Pharmaceuticals, Inc. (“Janssen”), Johnson & Johnson,
and Janssen Research & Development, LLC,1 have taken cross-appeals from
the judgment entered in favor of Stange in the amount of $535,106.17.
Stange, who suffers from Tourette’s syndrome, was prescribed Risperdal2
and subsequently developed female breasts, a condition known as
gynecomastia. Eventually Stange had to have surgery to remove his
breasts. Stange alleged that Janssen negligently failed to adequately warn
of the risk of gynecomastia associated with Risperdal use. Stange is one of
over 5,500 claimants from around the country who chose to file suit in the
Court of Common Pleas of Philadelphia County. Stange’s case was
coordinated in Philadelphia’s Complex Litigation Center as a member case
under the master docket captioned In Re: Risperdal Litigation, March
Term 2010 No. 296, Case Management Order 1, docketed May 26, 2010. All
of the cases in this mass tort involve male plaintiffs who allege they
developed gynecomastia as a result of ingesting Risperdal. After careful
1 Janssen is a wholly owned and independently managed subsidiary of
Johnson & Johnson. For ease of discussion, we will refer to the defendants
collectively as “Janssen.”
2 Risperdal is the trade name for the generic medication risperidone.
-2-
J. A10042/17
review, we affirm in part, reverse in part, and remand for further
proceedings.
The trial court has briefly summarized the facts and procedural history
of this case as follows:
In January 2006, Mr. Stange was twelve years
old and living in Wisconsin. At that time, he began
seeing Edward H. Kovnar, M.D. (“Dr. Kovnar”), a
pediatric neurologist, for his Tourette syndrome. On
February 7, 2006, Dr. Kovnar prescribed Risperdal to
Mr. Stange. In February 2009, Dr. Kovnar
discontinued Mr. Stange’s use of Risperdal.
In August 2007, Mr. Stange’s mother,
Mrs. Stange, called his pediatrician, David Mueler,
M.D. (“Dr. Mueler”) to report that Timothy Stange
was experiencing a stabbing pain in his left nipple.
In April 2011, Dr. Mueler diagnosed Mr. Stange with
gynecomastia and referred him to a plastic surgeon.
In 2011, Dr. John H. Jensen (“Dr. Jensen”), a plastic
surgeon, saw Mr. Stange and diagnosed him with
gynecomastia. On July 16, 2012, Dr. Jensen
performed a bilateral mastectomy on Plaintiff. The
surgery was successful; however, Mr. Stange has
permanent scars and has experienced pain in his
chest. Prior to his surgery, Plaintiff was often teased
by his classmates about having breasts.
In October 2006, the Federal [Food and] Drug
Administration (“FDA”) approved Risperdal, an
antipsychotic drug, in pediatric and adolescent
populations for symptoms associated with Autism.
Prior to 2002, the Risperdal label did not convey a
risk of gynecomastia. In 2002, the label indicated
that Risperdal elevated prolactin levels but that,
although disturbances such as gynecomastia may
occur, the clinical significance is unknown for most
patients. The ADVERSE REACTIONS section of the
label indicated that gynecomastia was rare. In
October 2006, the Risperdal label was updated as it
was approved for children and adolescents. The
-3-
J. A10042/17
label did not mention gynecomastia in the
WARNINGS section. In the PRECAUTIONS section,
the label indicated that Risperdal is “associated with
higher levels of prolactin elevation than other
antipsychotic agents.” The label stated that
gynecomastia has been “reported in patients
receiving prolactin-elevating compounds.” In August
2007, this information was included in the
WARNINGS section. In both the October 2006 and
August 2007 labels the “Pediatric Use” section
stated: “In clinical trial in 1,885 children and
adolescents with autistic disorder and other
psychiatric disorder treated with risperidone . . .
gynecomastia was reported in 2.3% of
risperidone-treated patients.”
Janssen knew that Risperdal elevated prolactin
in children and adolescents and caused
gynecomastia. In November of 2000, the interim
results of one long-term open label trial (RIS-INT-
41) established that 3.75% of boys taking Risperdal
developed gynecomastia. In August 2001, the final
results of RIS-INT-41 established that 5.5% of boys
taking Risperdal developed gynecomastia. In
September 2002, in a related study (RIS-INT-70),
which was a year extension of RIS-INT-41, 12.5% of
boys in the trial reported new or ongoing
gynecomastia. These results indicated that
gynecomastia was a frequent adverse event.
In 2002, Janssen conducted a post hoc
meta-analysis of five trials studying prolactin levels
in children and adolescents, including RIS-INT-41.
In May 2002, as put forth in Table 21 of this
meta-analysis (hereinafter, “Table 21”), the data
showed that there was a statistically significant
association (p=0.0158) at weeks 8-12 of Risperdal
use in children and adolescents whose prolactin
levels were above the upper limit of normal with the
risk of subsequently developing gynecomastia. The
findings contained within Table 21 were included in
the July 2002 draft of the article but were excluded
from a subsequent draft of the article in October
2002 after the “statistical documentation protocols”
-4-
J. A10042/17
were changed. The changed protocols resulted in
the disappearance of a statistically significant
association. The final article, published in November
2003, stated that there was “no correlation found
between SHAP and prolactin levels even when male
gynecomastia during puberty was
included.”[Footnote 1]
[Footnote 1] “SHAP” refers to “side
effects hypothetically attributable to
prolactin.”
Janssen did not report the information in
Table 21 to the FDA in its application process.
Instead, the Defendants reported that there was no
specific or significant finding of concern relating to
prolactin elevation. Prior to Risperdal’s indication for
use in adolescents in 2006, the Defendants
promoted the use of Risperdal in children and
adolescents. Following the FDA’s approval for
Risperdal in pediatric and adolescent populations in
October of 2006, sales representatives were
instructed to give out brochures referred to as
“Leave-Behind” material. The Leave-Behind material
discussed the new autism approval in children but
failed to contain the new safety information from the
updated label, and actually contained information
contrary to the 2006 label.
Trial court opinion, 5/23/16 at 2-5 (citations to the record omitted).
On April 12, 2013, Plaintiff, Timothy Stange
(“Mr. Stange”), commenced the above-captioned
action by filing an Abbreviated Individual Complaint
for Risperdal Litigation and Adoption by Reference
(“Short-Form Complaint”), which alleged that
Defendants, Janssen Pharmaceuticals, Inc.
(“Janssen”) and Johnson & Johnson, failed to provide
an adequate warning as to certain risks associated
with the use of Risperdal, a brand name for the
prescription drug risperidone. Plaintiff pled various
theories and counts, including negligence for design
defect, and fraud, strict product liability for failure to
warn and design defect, breach of express and
-5-
J. A10042/17
implied warranties, violation of the Pennsylvania
Unfair Trade Practices and Consumer Protection Law,
violation of the Wisconsin Deceptive Trade Practices
Act, and conspiracy.
On September 22, 2015, Judge Arnold New
granted summary judgment in favor of Defendants
and against Plaintiff on all of Plaintiff’s claims except
for negligent failure to warn and strict product
liability for failure to warn claims.
A jury trial commenced on October 15, 2015,
which was presided over by the Honorable
Kenneth J. Powell, Jr. On December 11, 2015, the
jury returned a verdict finding that the Defendants
negligently failed to warn adequately of the risk of
gynecomastia associated with Risperdal use and that
the Defendants’ negligence was a cause in bringing
about Mr. Stange’s gynecomastia. The jury awarded
compensatory damages in the amount of
$500,000.00.
All parties filed Post-Trial Motions, which this
Court denied on January 5, 2016. That same day,
this Court granted Plaintiff’s Motion for Delay
Damages and molded the jury’s verdict to add delay
damages in the amount of $35,106.17 for a total
verdict of $535,106.17. On February 10, 2016, this
Court approved the parties’ stipulation that Plaintiff
will not seek to execute on the judgment during the
pendency of the appeal, and judgment was entered
in favor of the Plaintiff in the amount of
$535,106.17.
On March 7, 2016, the Defendants filed a
timely Notice of Appeal. On March 8, 2016, this
Court ordered the Defendants to submit a Statement
of Matters Complained of on Appeal pursuant to
Pa.R.A.P. 1925(b). On March 10, 2016, Plaintiff filed
a Notice of Appeal. On March 17, 2016, this Court
ordered Plaintiff to submit a Statement of Matters
Complained of on Appeal pursuant to
Pa.R.A.P. 1925(b). On March 28, 2016, Plaintiff
-6-
J. A10042/17
submitted a timely Statement. On March 29, 2016,
Defendants also submitted a timely Statement.
Id. at 1-2.
We will address Janssen’s claims on appeal first. Janssen has raised
the following issues for this court’s review:
1. Did the trial court abuse its discretion by
allowing an expert opinion that Risperdal® was
the medical cause of Plaintiff’s gynecomastia,
where no evidence supported the expert’s
speculation that Risperdal® caused Plaintiff’s
gynecomastia by raising his prolactin to
abnormally high levels, and the expert failed to
use a scientific method to rule out puberty as a
potential alternative cause?
2. Did the trial court abuse its discretion by
refusing to grant judgment to Defendants,
where the prescribing physician, Dr. Kovnar,
acknowledged: (a) he was aware of the risk of
gynecomastia and high prolactin associated
with drugs such as Risperdal® at the time he
first prescribed for Plaintiff in February 2006;
and (b) he did not recall reading the
Risperdal® labeling that was updated in
October 2006, which would have provided him
additional information about those potential
risks?
3. Did the trial court commit legal error when
instructing the jury on combined negligence,
which gave the misimpression that Defendants
could be held solely liable even if the jury
found the prescriber contributed to Plaintiff’s
injury by prescribing with knowledge of the
risks, or by failing to read the updated
gynecomastia risk information?
Janssen’s brief at 5.
-7-
J. A10042/17
In its first issue on appeal, Janssen argues that it was entitled to
judgment non obstante veredicto (“JNOV”) because the trial court erred in
admitting the expert testimony of Dr. Mark Solomon. Janssen contends that
Dr. Solomon’s methodology, as applied, was not generally accepted in the
relevant field, and that his conclusions were speculative. We disagree.
A motion for judgment n.o.v. is a post-trial motion
which requests the court to enter judgment in favor
of the moving party. There are two bases on which
the court can grant judgment n.o.v.:
[O]ne, the movant is entitled to
judgment as a matter of law and/or two,
the evidence is such that no two
reasonable minds could disagree that the
outcome should have been rendered in
favor of the movant. With the first, the
court reviews the record and concludes
that even with all factual inferences
decided adverse to the movant the law
nonetheless requires a verdict in his
favor, whereas with the second, the
court reviews the evidentiary record and
concludes that the evidence was such
that a verdict for the movant was beyond
peradventure.
Polett v. Public Communications, Inc., 83 A.3d
205, 212 (Pa.Super. 2013)[, reversed on other
grounds, 126 A.3d 895 (Pa. 2015]. In an appeal
from the trial court’s decision to deny judgment
n.o.v.,
we must consider the evidence, together
with all favorable inferences drawn
therefrom, in a light most favorable to
the verdict winner. Our standard of
review when considering motions for a
directed verdict and judgment
notwithstanding the verdict are identical.
-8-
J. A10042/17
We will reverse a trial court’s grant or
denial of a judgment notwithstanding the
verdict only when we find an abuse of
discretion or an error of law that
controlled the outcome of the case.
Further, the standard of review for an
appellate court is the same as that for a
trial court.
Id. at 211.
Drake Mfg. Co., Inc. v. Polyflow, Inc., 109 A.3d 250, 258-259 (Pa.Super.
2015).
“Concerning any questions of law, our scope of
review is plenary. Concerning questions of credibility
and weight accorded the evidence at trial, we will not
substitute our judgment for that of the finder of
fact. . . . A JNOV should be entered only in a clear
case.” [Advanced Telephone Systems, Inc. v.
Com-Net Professional Mobile Radio, LLC, 846
A.2d 1264, 1279 (Pa.Super. 2004), appeal denied,
859 A.2d 767 (Pa. 2004) (citation omitted)]. “[T]he
entry of a judgment notwithstanding the verdict . . .
is a drastic remedy. A court cannot lightly ignore the
findings of a duly selected jury.” Education
Resources Institute, Inc. v. Cole, 827 A.2d 493,
497 (Pa.Super. 2003), appeal denied, 577 Pa. 721,
847 A.2d 1286 (2004) (citation omitted).
Growall v. Maietta, 931 A.2d 667, 670 (Pa.Super. 2007), appeal denied,
951 A.2d 1164 (Pa. 2008).
Rule 702 of the Pennsylvania Rules of Evidence
provides no particular rules for the qualification of
experts. Instead, pursuant to Rule 702 an expert
may be qualified to testify so long as he or she has
“scientific, technical or other specialized knowledge
beyond that possessed by a layperson” that will in
some manner assist the jury in understanding the
evidence presented. Whether or not an expert
witness is qualified to testify is usually a matter left
-9-
J. A10042/17
to the sound discretion of the trial court. See, e.g.,
Jacobs v. Chatwani, 922 A.2d 950, 956 (Pa.Super.
[2007]), appeal denied, 595 Pa. 708, 938 A.2d
1053 (2007).
Daniel v. Wyeth, 15 A.3d 909, 925-926 (Pa.Super. 2011), appeal
dismissed as improvidently granted, 82 A.3d 942 (Pa. 2013).
According to Janssen, Dr. Solomon failed to meet the standard set
forth in Frye v. United States, 293 F. 1013 (D.C.Cir. 1923), for admission
of expert testimony. We disagree.
As we held [] in Trach v. Fellin, 817 A.2d 1102
(Pa.Super. 2003) [(en banc), appeal denied, 577
Pa. 725, 847 A.2d 1288 (2004)], the Frye test sets
forth an exclusionary rule of evidence that applies
only when a party wishes to introduce novel scientific
evidence obtained from the conclusions of an expert
scientific witness. Trach, 817 A.2d at 1108-1109.
Under Frye, a party wishing to introduce such
evidence must demonstrate to the trial court that the
relevant scientific community has reached general
acceptance of the principles and methodology
employed by the expert witness before the trial court
will allow the expert witness to testify regarding his
conclusions. Id., 817 A.2d at 1108-1109, 1112.
However, the conclusions reached by the expert
witness from generally accepted principles and
methodologies need not also be generally accepted.
Id., 817 A.2d at 1112. Thus, a court’s inquiry into
whether a particular scientific process is “generally
accepted” is an effort to ensure that the result of the
scientific process, i.e., the proffered evidence, stems
from “scientific research which has been conducted
in a fashion that is generally recognized as being
sound, and is not the fanciful creations [sic] of a
renegade researcher.” See id., 817 A.2d at 1111
(quoting Blum v. Merrell Dow Pharms., Inc., 564
Pa. 3, 9-10, 764 A.2d 1, 5 (2000) (Cappy, C.J.,
dissenting)).
- 10 -
J. A10042/17
Reading Radio, Inc. v. Fink, 833 A.2d 199, 208 (Pa.Super. 2003), appeal
denied, 847 A.2d 1287 (Pa. 2004) (emphasis deleted).
[A]s to the standard of appellate review that applies
to the Frye issue, we have stated that the admission
of expert scientific testimony is an evidentiary
matter for the trial court’s discretion and should not
be disturbed on appeal unless the trial court abuses
its discretion. See Commonwealth v. Zook, 615
A.2d [1] at 11 [(1992), cert. denied, 507 U.S. 974
(1993)]. An abuse of discretion may not be found
merely because an appellate court might have
reached a different conclusion, but requires a result
of manifest unreasonableness, or partiality,
prejudice, bias, or ill-will, or such lack of support so
as to be clearly erroneous. Paden v. Baker
Concrete Constr., Inc., 540 Pa. 409, 658 A.2d 341,
343 (1995).
Grady v. Frito-Lay, Inc., 839 A.2d 1038, 1046 (Pa. 2003). “[W]e
emphasize that the proponent of expert scientific evidence bears the burden
of establishing all of the elements for its admission under Pa.R.E. 702, which
includes showing that the Frye rule is satisfied.” Id. at 1045. “[I]n
applying the Frye rule, we have required and continue to require that the
proponent of the evidence prove that the methodology an expert used is
generally accepted by scientists in the relevant field as a method for arriving
at the conclusion the expert will testify to at trial.” Id., citing
Commonwealth v. Blasioli, 713 A.2d 1117, 1119 (Pa. 1998).
Dr. Solomon is a plastic and reconstructive surgeon with extensive
experience operating on the breast. (Notes of testimony, 10/27/15,
a.m. session at 10, 14.) He is familiar with gynecomastia and has diagnosed
- 11 -
J. A10042/17
and operated on young men with that condition. (Id. at 10, 15.)
Dr. Solomon used differential diagnosis, a generally accepted scientific
process, to conclude that Risperdal caused Stange’s gynecomastia. (Notes
of testimony, 10/27/15, p.m. session at 27-28.) Dr. Solomon explained,
Let’s break it down. First, I think you asked
me the relationship between Risperdal as an agent
creating a rise in prolactin, and that’s very
well-documented.
Prolactin is a hormone secreted by the pituitary
gland. I’m not sure if the jury heard about all of
this. Pituitary gland is a gland that sits in your brain,
and we know Tim’s pituitary was normal because he
had an MRI before he started on the medication.
I think that’s important, as we talk about this
process.
So Risperdal is well-known to stimulate the
production of this hormone, prolactin. Prolactin has
several ways it acts on the breast.
It will cause the breast to grow. Then, in
women -- and in men, it can do this too -- it will
cause the breasts to secret[e] milk. That’s the direct
effect.
There’s also an indirect effect that’s discussed,
where it suppresses the testosterone, which boosts
estrogen, which also acts upon the breast almost
synergistically, meaning, the two together are a
bigger punch than either one alone.
So if you look at the data, what I see, the
internal documents are also published, but the
internal documents break down in a graphic way,
patient takes the drug. Prolactin goes up and
typically, at a period after some weeks of exposure
to the drug, patient starts developing breasts.
- 12 -
J. A10042/17
Id. at 24-25.
There are table after table of these [sic]
history of Tim, where he was given the drug in ‘06.
Mom talks about change -- talks about changes in
‘06. We have photos in ‘07 that are certainly
consistent with gynecomastia, even though no one
had made a diagnosis. It’s plain as day.
This is all consistent that that, plus the history,
plus the subsequent finding of breast tissue, is all
consistent with the fact that Risperdal was the
insinuating agent to elevate prolactin, which has a
direct effect on breast tissue which gave Tim
gynecomastias.
Id. at 25-26.
There is nothing scientifically novel about using differential diagnosis
to conclude that Stange’s gynecomastia was caused by Risperdal. Certainly
differential diagnosis is a generally accepted methodology; indeed, Janssen
does not dispute the validity of differential diagnosis generally. See
Cummins v. Rosa, 846 A.2d 148, 151 (Pa.Super. 2004) (Frye did not
apply where the methodology employed by the plaintiffs’ medical experts
was generally accepted among the medical community for diagnosis and
treatment; plaintiffs’ experts analyzed plaintiff-wife’s medical records and
relied upon their personal expertise to reach a conclusion regarding the
source of her injuries).
Janssen complains that Stange’s prolactin levels were never tested
while he was taking Risperdal and that Dr. Solomon could not rule out
puberty as the cause of Stange’s gynecomastia. However, Dr. Solomon
- 13 -
J. A10042/17
testified that prolactin testing was not necessary in order to render an
opinion within a reasonable degree of medical certainty that Risperdal was
responsible for Stange’s gynecomastia:
Because in anywhere from 25 times the control
to up to 80 some percent of patients, depending
upon the doses of Risperdal, prolactin goes up. In all
the agents of this class of drugs, Risperdal is the
greatest offender at increasing prolactin.
So as part of my job as a physician is to take a
set of the facts and come to a conclusion. If I can
get an ancillary test -- and it’s easy to get, you can
certainly get it -- part of the thing that most of us
are taught is it’s not going to change our opinion.
It’s not even essential to do it.
Here, we have a young man on a drug known
to cause prolactin elevations who has gynecomastia.
On top of that, there’s no -- nothing in the
package insert that says you should follow it along.
Whereas certain drugs, they say you should check a
blood sugar, a potassium, those are in that big red
book there, the Physicians Desk Reference, package
incident [sic].
We can make a diagnosis using our
fundamental knowledge as physicians and be
absolutely certain that it’s a clear correlation
between taking the drug, prolactin, breast growth.
Notes of testimony, 10/27/15, p.m. session at 26-27. See also trial court
opinion, 5/23/16 at 22-23 (“However, the Defendants knew that Risperdal
elevated prolactin and chose not to recommend that prescribing doctors
monitor prolactin levels of patients taking their medication. *** Now the
Defendants wish to benefit from their own concealment by alleging that the
- 14 -
J. A10042/17
Plaintiff’s doctors’ differential diagnosis is insufficient because of a failure to
perform prolactin monitoring.”).
Regarding pubertal changes, Dr. Solomon was able to rule that out in
this case because Stange’s breast tissue was extensive, remained after
puberty, and was not affected by weight gain or loss:
So yes, there’s something called pubertal
gynecomastia. The time cause is self-limited. That’s
the majority of patients that I see as a plastic
southern [sic] who are adolescents, boys with
breasts.
We encourage the family to be patient,
because we know that pubertal gynecomastia will
resolve with time and age. The breast tissue as the
hormonal environment changes in puberty. That
stimulus goes away, the breast tissue goes away.
That’s the vast majority of puberty
gynecomastia. A small percentage may exist. But in
a circumstance where you have a patient who took a
drug that’s known to be an offending agent,
developed breast tissue in a reasonable time course
in relation to that agent, lost his pubescent changes,
his weight sort of went up and went down, but the
breast tissue remained.
And the breast tissue, as I have said before,
was dysmorphic, in excess of his body shape. The
cause of his gynecomastia was the drug, without a
doubt in my mind.
Notes of testimony, 10/25/17, p.m. session at 28-29.
Janssen’s arguments really go to weight and not admissibility. As
stated above, differential diagnosis is a standard well-established
methodology and is routinely used by doctors. The weight to be afforded
- 15 -
J. A10042/17
Dr. Solomon’s testimony and whether to accept his conclusions was for the
jury. The trial court did not abuse its discretion in permitting Dr. Solomon to
testify regarding causation.
Next, Janssen argues that Stange failed to prove proximate cause,
i.e., that an inadequate warning was the cause of Stange’s injuries. Janssen
argues that Stange’s treating physician, Dr. Edward Kovnar, M.D., knew that
neuroleptics such as Risperdal were capable of increasing prolactin levels
and prescribed it anyway. Janssen contends that Dr. Kovnar was aware that
all neuroleptics, including Risperdal, were associated with gynecomastia.
(Janssen’s brief at 33-34.) Janssen also claims that beginning in October
2006, the Risperdal label cautioned prescribers that it was associated with
higher levels of prolactin elevation than other antipsychotic agents, and that
Dr. Kovnar could not remember reading the label. (Id. at 35-36.)
Therefore, Janssen argues that it was entitled to JNOV where Stange failed
to prove that additional risk information would have changed Dr. Kovnar’s
prescribing decision. (Id. at 36.)
To support [his] claim of negligence, [Stange] must
establish that [Janssen] breached its duty to warn,
and that the breach caused [his] injuries. See
Gracyalny v. Westinghouse Elec. Corp., 723 F.2d
1311, 1316-17 (7th Cir. 1983) (claim of negligence,
unlike claim of strict liability, requires plaintiff to
prove specific acts of causal negligence); Dippel v.
Sciano, 37 Wis. 2d 443, 459-60, 155 N.W.2d 55
(1967). With respect to the adequacy of a warning,
the initial inquiry under both strict liability and
negligence analyses is the scope of the
manufacturer[’]s duty to provide a warning.
- 16 -
J. A10042/17
Gracyalny, 723 F.2d at 1318. Although the
adequacy of a warning often presents a factual issue
for a jury, that is not always so. Compare id. at
1321, with Alvarado v. Sersch, 2003 WI 55, 29,
262 Wis. 2d 74, 662 N.W.2d 350 (summary judgment
in negligence is proper where no reasonable jury,
properly instructed, could find defendant was
negligent).
Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis.App. 2004),
review denied, 684 N.W.2d 137 (Wis. 2004) (bracketed information
added).3
A plaintiff who has established both a duty and a
failure to warn must also establish causation by
showing that, if properly warned, he or she would
have altered behavior and avoided injury. Mazur
[v. Merck Co.], 742 F.Supp. [239] at 262 [(E.D.Pa.
1990)]; see also Staymates v. ITT Holub Indus.,
364 Pa.Super. 37, 527 A.2d 140, 147 (1987)
(evidence must support a reasonable inference that
the existence of an adequate warning may have
prevented the injury). Even in the event that a
warning is inadequate, proximate cause is not
presumed. Mazur, 742 F. Supp. at 262. Absent
proof that a more complete or explicit warning would
have prevented [Stange’s] use of [Risperdal], [he]
cannot establish that [Janssen’s] alleged failure to
warn was the proximate cause of [his] injuries.
Id. (bracketed information added).
In cases involving the failure to warn of risks
associated with prescription drugs, Pennsylvania
courts apply the “learned intermediary doctrine.”
Under the learned intermediary doctrine, a
manufacturer will be held liable only where it fails to
exercise reasonable care to inform a physician of the
3 It is agreed that the substantive law of the State of Wisconsin governs the
claim in this case. (Janssen’s brief at 32 n.12.)
- 17 -
J. A10042/17
facts which make the drug likely to be dangerous.
The manufacturer has the duty to disclose risks to
the physician, as opposed to the patient, because it
is the duty of the prescribing physician to be fully
aware of (1) the characteristics of the drug he is
prescribing, (2) the amount of the drug which can be
safely administered, and (3) the different
medications the patient is taking. It is also the duty
of the prescribing physician to advise the patient of
any dangers or side effects associated with the use
of the drug as well as how and when to take the
drug.
Czimmer v. Janssen Pharm., Inc., 122 A.3d 1043, 1057 (Pa.Super.
2015), quoting Gurley v. Janssen Pharm., Inc., 113 A.3d 283, 292-293
(Pa.Super. 2015), in turn quoting Cochran v. Wyeth, Inc., 3 A.3d 673, 676
(Pa.Super. 2010), appeal denied, 20 A.3d 1209 (Pa. 2011).4
There was ample testimony regarding the inaccurate and misleading
nature of Janssen’s warning labels. There was substantial evidence that
Janssen intentionally downplayed the risk of gynecomastia for adolescent
boys using Risperdal. The trial court aptly summarized:
Here, the pre-October 2006 label stated that
certain endocrine disorders like gynecomastia are
“rare.” The 2007 label stated, in the “USE IN
SPECIAL POPULATIONS” section under “Pediatric
Use,” that “[i]n clinical trials . . . gynecomastia was
reported in 2.3% of RISPERDAL®-related patients.”
The 2007 label also reported that gynecomastia
occurred in less than 1% of adult patients and less
than 5% of pediatric patients treated with Risperdal.
4 There is no conflict between Pennsylvania and Wisconsin law on the scope
of the learned intermediary doctrine. (Janssen’s brief at 32 n.12; notes of
testimony, 10/19/15, p.m. session at 3.) The trial court applied the law of
Pennsylvania on the learned intermediary doctrine, and neither party
challenged this determination. (Id.)
- 18 -
J. A10042/17
Both of these warnings were inaccurate based on the
scientific evidence that the Defendants possessed.
Between 2000 and 2003, the Defendants had
evidence from three studies that showed that
3.75%, 5.5%, and 12.5% of boys taking Risperdal
developed gynecomastia. These results indicated
that gynecomastia was a frequent adverse event, not
“rare” as the pre-October 2006 label stated.
Additionally, the 2.3% incidence rate reported in the
2007 label was based on the Defendants’ having
exercised a heavy hand with the data. These
warnings were not accurate, strong, or clear.
Instead, the warnings, to the extent they warned at
all, were inaccurate and misleading about the risks of
gynecomastia.
Trial court opinion, 5/23/16 at 16 (citations to the record omitted).
Furthermore, Dr. Kovnar, Stange’s pediatric neurologist, testified that
although he knew that all neuroleptic drugs increased prolactin levels, he
understood this condition to be rare and temporary and that he would not
have prescribed Risperdal to Stange had he been aware of the increased
risk. Dr. Kovnar did not know that Risperdal elevated prolactin levels
significantly more than other neuroleptic drugs. Dr. Kovnar testified:
Q. Did you know that as a class these second-
generation antipsychotics in general had some
increase of prolactin levels?
A. I was aware all of the neuroleptics were
capable of increasing prolactin levels.
Q. And were you aware that all of them had some
association occasionally with the condition
gynecomastia?
A. Yes, I was aware of that.
- 19 -
J. A10042/17
Q. Was this any secret to you or in the practice of
medicine?
A. No, it was -- it was well-known. My
understanding, however, was that it was rare,
and hopefully, temporary.
Notes of testimony, 10/20/15, a.m. session at 48-49.
Q. Did you spend your evenings and nights
reading pharmaceutical labels?
A. No, I did not. We have a number of readily
accessible sources of information about
pharmaceuticals. One is called the PDR and
the other is an online reference called
Epocrates.
Id. at 50.
Q. Did you know anything from PDR or Epocrates
when you made this choice to prescribe this
drug that there was a significant incidence of
gynecomastia, like five percent? Did you know
anything like that?
A. No, I did not.
Q. And you mentioned that at the time you
believed the drug was -- the condition was
rare; is that correct?
A. Yes.
Q. And having looked at the PDR, is that what the
PDR said back then?
A. I’ve had the opportunity to look back at that
PDR that was available at the time, and what I
think stands out is the comment that
gynecomastia is a rare adverse effect.
Id. at 50-51.
- 20 -
J. A10042/17
Q. Did you know that at the time that the drug
increased prolactin levels more significantly
than other -- than other drugs of the class?
A. No, I didn’t. I knew that every medication that
blocks the effects of dopamine, which is the
underlying mechanism of the drug, is capable
of elevating prolactin levels. But I was
unaware that there was anything special or
unique about Risperdal that caused greater
elevation of prolactin.
Id. at 55-56. Dr. Kovnar testified that if he had all of the information in
February 2006, he would have chosen a different medication for Stange.
(Id. at 49-50.) Dr. Kovnar also testified that there was no reason to test
Stange’s prolactin levels, in the absence of a specific directive or warning.
(Id. at 56-57.) Janssen’s sales representatives made visits to his office
several times in the spring and summer of 2007 and never communicated
any increased risk of gynecomastia. (Notes of testimony, 10/21/15,
a.m. session at 65-69.)
The evidence fully supports a conclusion that due to Janssen’s
inadequate labeling and failure to warn, Dr. Kovnar was unaware of the
specific heightened risks associated with the use of Risperdal and would
have prescribed a different drug. It was at least sufficient to create a jury
question on proximate cause. The trial court did not err in refusing to grant
JNOV on this basis. This claim fails.
Finally, in its third issue on appeal, Janssen complains that the trial
court erred in instructing the jury on the concept of combined negligence.
- 21 -
J. A10042/17
According to Janssen, the instruction gave the jury the misimpression that it
could find Janssen liable for inadequate labeling even if it also believed that
Dr. Kovnar contributed to the risk of injury by failing to read the updated
labeling or by deciding to prescribe Risperdal with knowledge of the
increased risks. (Janssen’s brief at 38-39.) Janssen acknowledges that a
combined negligence instruction was appropriate vis-à-vis the three named
defendants and that the instruction accurately reflected Wisconsin law on
joint and several liability. (Id. at 37-38.) Nonetheless, Janssen argues that
the instruction was misleading where Stange never argued that Dr. Kovnar
was negligent and the issue of Dr. Kovnar’s prescribing decision, either
knowing the risks or having failed to read the updated labeling, was central
to Janssen’s defense. (Id. at 38.)
In examining these instructions, our scope of review
is to determine whether the trial court committed
clear abuse of discretion or error of law controlling
the outcome of the case. Williams v. Philadelphia
Transportation Company, 415 Pa. 370, 374, 203
A.2d 665, 668 (1964). Error in a charge is sufficient
ground for a new trial, if the charge as a whole is
inadequate or not clear or has a tendency to mislead
or confuse rather than clarify a material issue.
Glider v. Com. Dept. of Hwys., 435 Pa. 140,
151-52, 255 A.2d 542, 547 (1969). A charge will be
found adequate unless “the issues are not made
clear to the jury or the jury was palpably misled by
what the trial judge said or unless there is an
omission in the charge which amounts to
fundamental error.” Voitasefski v. Pittsburgh
Rys. Co., 363 Pa. 220, 226, 69 A.2d 370, 373
(1949); A reviewing court will not grant a new trial
on the ground of inadequacy of the charge unless
there is a prejudicial omission of something basic or
- 22 -
J. A10042/17
fundamental. Sweeny v. Bonafiglia, 403 Pa. 217,
221, 169 A.2d 292, 293 (1961); Giorgianni v.
DiSanzo, 392 Pa. 350, 356, 140 A.2d 802, 805
(1958). In reviewing a trial court’s charge to the
jury, we must not take the challenged words or
passage out of context of the whole of the charge,
but must look to the charge in its entirety. McCay
v. Philadelphia Electric Company, 447 Pa. 490,
499, 291 A.2d 759, 763 (1972).
Stewart v. Motts, 654 A.2d 535, 540 (Pa. 1995).
The trial court gave the following instruction:
You must decide if the defendants’ negligence
caused the plaintiff’s injury. This question does not
ask about the cause but rather a cause, because an
injury may have more than one cause. Someone’s
negligence caused the injury if it was a substantial
factor in producing the injury. An injury may be
caused by one person’s negligence or by a combined
negligence of two or more people. The negligence of
one person alone may produce an injury or the acts
or omissions on the part of two or more persons or
other conditions beyond anyone’s control may jointly
produce the injury.
Notes of testimony, 12/11/15, a.m. session at 39.
As Janssen concedes, the instruction was an accurate statement of
Wisconsin law. Fischer by Fischer v. Ganju, 485 N.W.2d 10, 17 (Wis.
1992); Wis.J.I.-Civil 1500. Furthermore, the instruction was appropriate
where the trial court denied the motions for nonsuit of Johnson & Johnson
and Janssen Research & Development, LLC, and so all three defendants
remained in the case. As the trial court remarked, “Although the Defendants
attempt to minimize Johnson & Johnson’s involvement in this case, as
discussed infra, both Janssen and Johnson & Johnson acted (at a minimum)
- 23 -
J. A10042/17
negligently in failing to warn of the risks of Risperdal which caused Plaintiff’s
injury.” (Trial court opinion, 5/23/16 at 25.)
Janssen complains that the jury was confused because Janssen’s
defense was that Dr. Kovnar prescribed Risperdal despite knowing the risks
and/or failing to read the updated label. However, the trial court instructed
the jury on proximate cause and the learned intermediary doctrine, and
Janssen was free to argue that Dr. Kovnar violated a duty of care when he
prescribed Risperdal. The trial court did not err in instructing the jury on
combined negligence, in accordance with Wisconsin law.
We now turn to Stange’s issues on cross-appeal. Stange has raised
the following issues for this court’s review:
[1.] Did [Judge New] improperly grant a global
motion [for] summary judgment on the claims
for punitive damages of all Risperdal plaintiffs,
including Timothy Stange, especially where
ample evidence in this case supported a claim
of punitive damages against Janssen and
warranted the submission of that issue to the
jury under either Wisconsin or New Jersey law?
[2.] Did the trial court improperly fail to instruct the
jury that [Stange] was entitled to all of the
damages proximately flowing from Defendants’
negligent acts and on [Stange]’s life
expectancy?
Stange’s brief at 4-5.
With respect to Judge New’s order as coordinating judge,
A trial court may dismiss an action pursuant to
Rule 1035.2 of the Pennsylvania Rules of Civil
Procedure governing summary judgment: After the
- 24 -
J. A10042/17
relevant pleadings are closed, but within such time
as not to unreasonably delay trial, any party may
move for summary judgment in whole or in part as a
matter of law (1) whenever there is no genuine issue
of any material fact as to a necessary element of the
cause of action or defense which could be
established by additional discovery or expert report,
or (2) if, after the completion of discovery relevant
to the motion, including the production of expert
reports, an adverse party who will bear the burden
of proof at trial has failed to produce evidence of
facts essential to the cause of action or defense
which in a jury trial would require the issues to be
submitted to a jury. Pa.R.C.P. 1035.2. A proper
grant of summary judgment depends upon an
evidentiary record that either (1) shows the material
facts are undisputed or (2) contains insufficient
evidence of facts to make out a prima facie cause
of action or defense and, therefore, there is no issue
to be submitted to the jury. Pa.R.C.P. 1035.2 Note.
Where a motion for summary judgment is based
upon insufficient evidence of facts, the adverse party
must come forward with evidence essential to
preserve the cause of action. Id. If the non-moving
party fails to come forward with sufficient evidence
to establish or contest a material issue to the case,
the moving party is entitled to judgment as a matter
of law. The non-moving party must adduce
sufficient evidence on an issue essential to its case
and on which it bears the burden of proof such that a
jury could return a verdict favorable to the non-
moving party. As with all summary judgment cases,
the court must examine the record in the light most
favorable to the non-moving party and resolve all
doubts against the moving party as to the existence
of a triable issue. Upon appellate review, we are not
bound by the trial court’s conclusions of law, but
may reach our own conclusions. In reviewing a
grant of summary judgment, the appellate Court
may disturb the trial court’s order only upon an error
of law or an abuse of discretion. The scope of review
is plenary and the appellate Court applies the same
standard for summary judgment as the trial court.
- 25 -
J. A10042/17
Biernacki v. Presque Isle Condominiums Unit Owners Ass’n, Inc., 828
A.2d 1114, 1115-1116 (Pa.Super. 2003), quoting Grandelli v. Methodist
Hosp., 777 A.2d 1138, 1143-1144 (Pa.Super. 2001) (citation omitted).
The trial court must accept as true all well-pleaded
facts relevant to the issues in the non-moving party’s
pleadings, and give to him the benefit of all
reasonable inferences to be drawn therefrom. A
grant of summary judgment is proper where the
pleadings, depositions, answers to interrogatories,
admissions of record and affidavits on file support
the court’s conclusion no genuine issue of material
fact exists and the moving party is entitled to
judgment as a matter of law.
Goldberg v. Delta Tau Delta, 613 A.2d 1250, 1252 (Pa.Super. 1992),
appeal denied, 626 A.2d 1158 (Pa. 1993) (citations omitted).
The coordinating judge briefly described the procedural history relating
to the global order granting partial summary judgment in favor of the
defendants on the issue of punitive damages as follows:
On February 10, 2014, Moving Defendants filed
a Motion for Partial Summary Judgment arguing
New Jersey law barred the recovery of punitive
damages. Moving Defendants argued a conflict
existed between New Jersey’s Products Liability
Act,[5] which sharply limits the availability of punitive
damages in pharmaceutical products liability cases,
and Pennsylvania law, which permits the recovery of
punitive damages in pharmaceutical products liability
cases. They further argued New Jersey had a
greater interest in the application of its law because
New Jersey is where the “punitive conduct,” i.e. the
corporate decisions about Risperdal’s design,
manufacturing, marketing, selling, and labeling,
allegedly occurred.
5 NJPLA, N.J. Stat.Ann. § 2A:58C-5(c).
- 26 -
J. A10042/17
In response, Plaintiffs made three arguments.
First, Plaintiffs argued the law of the case doctrine
required this Court to apply the law of the state
where Risperdal was marketed, prescribed, and
ingested. Second, Plaintiffs argued if the law of the
case doctrine did not apply, then this Court should
apply Pennsylvania law to the punitive damages
claim. Finally, Plaintiffs argued they could recover
punitive damages under New Jersey law because the
New Jersey precedent relied on by Moving
Defendants is inapplicable to the case sub judice.
By Order dated May 2, 2014, for the reasons set
forth below, this Court granted partial summary
judgment in favor of Moving Defendants on the issue
of punitive damages.
Opinion by Judge New, 10/22/15 at 2-3.
Plaintiffs filed a motion for reconsideration on June 2, 2014, which was
denied. Stange argues that a global order concerning punitive damages was
inappropriate. Stange contends that Pennsylvania law requires a
choice-of-law analysis of what state has the greatest relationship and
interests in each individual plaintiff’s case, which is necessarily
fact-dependent. According to Stange, a Wisconsin resident, a choice-of-law
analysis favors application of Wisconsin law in this case. Stange complains
that rather than entering a global motion, the trial court should have allowed
him to develop facts and state interests important to his particular
circumstances. (Stange’s brief at 55.)
Stange also argues that the New Jersey Product Liability Act, which
allows a prescription drug manufacturer to defend against punitive damages
by demonstrating that its drug was approved by the FDA, does not apply in
- 27 -
J. A10042/17
this case, where the FDA first approved Risperdal for pediatric use in October
2006, and Risperdal was never approved for treatment of Tourette’s
syndrome. Stange argues that because Risperdal was prescribed for an
off-label use, it was not “approved” within the meaning of the NJPLA.
Finally, Stange argues that the global order deprived individual plaintiffs of
significant substantive rights and denied individual plaintiff’s counsel the
opportunity to present responsive argument pertinent to that particular
plaintiff’s case. (Stange’s brief at 67.)
Janssen contends that the issue is waived because Stange’s argument
that Pennsylvania choice-of-law rules required application of Wisconsin
punitive damages law was not preserved in the trial court. Pa.R.A.P. 302(a)
(“Issues not raised in the lower court are waived and cannot be raised for
the first time on appeal.”). In their response to the defendants’ motion for
partial summary judgment, the plaintiffs argued that the law of the case
doctrine required the trial court to apply the law of the state where Risperdal
was marketed, prescribed, and ingested. (Opinion by Judge New, 10/22/15
at 4.) The plaintiffs argued that the coordinating judge was bound by his
decisions in three previous cases, applying the punitive damages law of the
- 28 -
J. A10042/17
state where the injury occurred.6 (Id.) In the alternative, the plaintiffs
argued that Pennsylvania punitive damages law should apply to every case
6 The conflict of law issue arises from three cases decided prior to the global
order entered in the In Re Risperdal® Litigation. Judge New applied the
punitive damages law of the home domicile of the respective plaintiffs. In
resolving the law of the case issue, Judge New stated:
Plaintiffs’ argument fails for two separate, yet
equally important, reasons. First, the law of the
case doctrine only applies to prior decisions in the
same case. King, 999 A.2d at 600. Here, although
they fall under the umbrella of the In Re
Risperdal® Litigation mass tort program, the
Banks, AB, and SB matters are individual, different,
cases. Case Management Order No. 1 makes clear
that each case retains its own identity as an
individual case, and the In Re Risperdal®
Litigation docket was established merely as a
depository for the filing of pleadings and motions
common to all cases. See In Re Risperdal®
Litigation March Term 2010 No. 296, Case
Management Order 1 at § 1. Since Banks, AB, and
SB are separate cases, this Court’s rulings
concerning which state’s law applies to the issue of
punitive damages in those cases has no effect on
this Court’s ruling on the issue sub judice. Second,
assuming arguendo Banks, AB, SB, and In Re
Risperdal® Litigation are considered to be the
same “case” for the purposes of the law of the case
doctrine, the law of the case doctrine would still not
apply because the undersigned issued the Orders in
question in all four matters, Banks, AB, SB, and
In Re Risperdal® Litigation. As the Superior Court
made clear, “[a] trial judge may always revisit his
own prior pre-trial rulings in a case without running
afoul of the law of the case doctrine. Clearwater
Concrete, 18 A.3d at 1216. For both of these
reasons, the law of the case doctrine does not apply
in this matter.
Opinion by Judge New, 10/22/15 at 5 (footnote omitted).
- 29 -
J. A10042/17
in the litigation, where the defendants met repeatedly in Pennsylvania to
make decisions regarding the activities giving rise to punitive damages. (Id.
at 5-10.) The coordinating judge stated:
This Court notes Plaintiffs did not argue a choice of
law analysis requires this Court to apply the law of
the state where Risperdal was marketed, prescribed,
and ingested by the individual plaintiffs. Rather,
Plaintiffs made two separate and distinct arguments:
1) the law of the case doctrine required this Court to
apply the law of the state where Risperdal was []
marketed, prescribed, and ingested, and 2) if this
Court found the law of the case doctrine did not
apply, then Pennsylvania law should apply.
Id. at 6 n.4.
According to Janssen, the plaintiffs’ argument, that Pennsylvania law
required a case-by-case assessment of the competing interests of all
relevant jurisdictions and that the law of each state where Risperdal was
prescribed and ingested should govern each individual case, was not raised
in the plaintiffs’ March 24, 2014 response in opposition to the motion for
partial summary judgment. Janssen contends that the argument was raised
for the first time in the plaintiffs’ June 2, 2014 motion for reconsideration of
the global order granting the defendants’ partial summary judgment motion.
Failure to raise an issue before the trial court,
however, results in waiver of the issue on appeal.
Dollar Bank v. Swartz, 540 Pa. 369, 657 A.2d
1242, 1245 (1995) (citations omitted) (“It is a
fundamental principle of appellate review that we will
not reverse a judgment or decree on a theory that
was not presented to the trial court”). Even if an
issue “was included in [a] subsequently filed motion
for reconsideration, issues raised in motions for
- 30 -
J. A10042/17
reconsideration are beyond the jurisdiction of this
Court and thus may not be considered by this Court
on appeal.” Rabatin v. Allied Glove Corp., 24
A.3d 388, 391 (Pa.Super. 2011) (citation omitted);
accord Pa.R.A.P. 302(a).
Eisbacher v. Maytag Corp., 2017 WL 947606 at *5 (Pa.Super. March 9,
2017).
Issues not raised before the trial court are not
preserved for appeal and may not be presented for
the first time on appeal. Pa.R.A.P. 302(a); Erie
Insurance Exchange v. Larrimore, 987 A.2d 732,
743 (Pa.Super. 2009). While the issue was included
in the subsequently filed motion for reconsideration,
issues raised in motions for reconsideration are
beyond the jurisdiction of this Court and thus may
not be considered by this Court on appeal. Prince
George Center, Inc. v. U.S. Gypsum Co., 704
A.2d 141, 145 (Pa.Super. 1997), appeal denied,
557 Pa. 640, 732 A.2d 1210 (1998), cert. denied,
528 U.S. 810, 120 S. Ct. 41, 145 L. Ed. 2d 37 (1999).
Rabatin, 24 A.3d at 391.
Furthermore,
[a] decision to pursue one argument over another
carries the certain consequence of waiver of those
issues that could have been raised but were not.
This proposition is consistent with our Supreme
Court’s efforts to promote finality, and effectuates
the clear mandate of our appellate rules requiring
presentation of all grounds for relief to the trial court
as a predicate for appellate review.
Id. at 392, quoting Devine v. Hutt, 863 A.2d 1160, 1169 (Pa.Super. 2004)
(footnote omitted).
Stange argues in his reply brief that waiver is inappropriate in the
mass tort context since appointed liaison counsel is not class counsel and
- 31 -
J. A10042/17
does not represent all Risperdal plaintiffs. (Stange’s 4th-step reply brief
at 8 n.1.) Stange argues that Rabatin, Devine, and similar precedent were
developed in “one-off” cases. (Id. at 10.) Stange complains that this was
his first opportunity on his individual record to litigate the question of
punitive damages. (Id. at 8.)
After carefully reviewing the plaintiffs’ response in opposition to the
defendants’ motion for partial summary judgment, we deem the punitive
damages issue to be adequately preserved. While the plaintiffs did cite the
law of the case doctrine and argue that the coordinating judge should follow
his earlier rulings, the plaintiffs argued more generally that the law of the
plaintiffs’ various home states should apply to punitive damages. The
plaintiffs relied on several other decisions applying the punitive damages law
of the state of the injury, ingestion, and marketing of a pharmaceutical drug.
(Plaintiffs’ response in opposition to defendants’ motion for partial summary
judgment, 3/24/14 at 8-10; RR, Vol. 1 at 163-165.) The plaintiffs argued
that although Janssen is a Pennsylvania corporation, the trial court should
recognize the strong interests of the state where the plaintiff’s injuries
occurred, the drug was prescribed, and where the defendant has
affirmatively and actively marketed and sold the drug. (Id.) The plaintiffs
did not limit their argument to the law of the case doctrine. Although the
plaintiffs did ask the coordinating judge to respect his earlier rulings, that
argument was couched within a broader argument that the law of the state
- 32 -
J. A10042/17
where a particular plaintiff was prescribed Risperdal and suffered injury
should apply. We decline to find waiver.7
In addressing which substantive law to apply, we
employ the conflict-of-law principles that our High
Court framed in Griffith v. United Air Lines, Inc.,
416 Pa. 1, 203 A.2d 796 (1964). In Griffith, our
Supreme Court altered its approach in determining
which substantive law to apply in tort cases. Prior to
that decision, Pennsylvania followed the
lex loci delicti rule, which applied the substantive
law of the place where the tort was committed. Id.
at 801. However, the High Court abandoned that
mechanical approach in favor of a methodology that
combined the “government interest” analysis and the
“significant relationship” approach of sections 145
and 146 of the Restatement (Second) of Conflicts,
which we reproduce infra. Id. at 801-06; Troxel v.
A.I. duPont Inst., 431 Pa.Super. 464, 636 A.2d
1179, 1180–81 (1994).
Marks v. Redner’s Warehouse Markets, 136 A.3d 984, 987 (Pa.Super.
2016) (footnote omitted).
Griffith, supra, addressed the choice of law
question in an action brought by the executor of a
Pennsylvania resident killed in a plane crash during a
landing in Denver on a flight from Philadelphia,
Pennsylvania to Phoenix, Arizona. Id. at 797.
Concluding that the plane crash in Colorado was
“purely fortuitous” and that Pennsylvania had a
greater interest in the executor’s recovery, our
7 We do agree with Janssen, however, that the issue regarding whether
Risperdal had been “approved” within the meaning of the NJPLA is waived.
In their motion for reconsideration of the global order granting the
defendants’ partial summary judgment motion, the plaintiffs argued, for the
first time, that the NJPLA did not preclude punitive damages because
Risperdal did not achieve FDA approval for any pediatric use until October
2006. The plaintiffs argued that many cases involved Risperdal ingestion by
minor children before the October 2006 approval. (Plaintiffs’ motion for
reconsideration, 6/2/14 at 5; RR, Vol. 1 at 209.)
- 33 -
J. A10042/17
Supreme Court discarded the lex loci delicti rule for
a flexible methodology that permitted courts to
conduct an “analysis of the policies and interests
underlying the particular issue before the court.”
Griffith, supra at 805.
Id. at 987-988.
Section 145(2) of the Restatement (Second) of
Conflicts sets forth the contacts to be considered in
applying the analysis required under Griffith. They
include:
(a) the place where the injury occurred;
(b) the place where the conduct causing the
injury occurred;
(c) the domicile, residence, nationality, place
of incorporation and place of business of
the parties; and
(d) the place where the relationship, if any,
between the parties is centered.
Restatement (Second) of Conflict of Laws § 145
(1983).
We evaluate these four factors mindful of the
overarching choice-of-law principles enumerated in
§ 6 of the Restatement (Second). Those
considerations include the following:
(a) the needs of the interstate and
international systems;
(b) the relevant policies of the forum;
(c) the relevant policies of the other
interested states and the relevant
interests of those states in determination
of a particular issue;
(d) the protection of justified expectations;
- 34 -
J. A10042/17
(e) the basic policies underlying the
particular field of law;
(f) certainty, predictability and uniformity of
result; and
(g) ease in the determination and application
of the law to be applied.
Id. § 6.
Id. at 988.
As stated in Marks, the first step in our analysis is to decide whether
there is a true conflict between the laws of New Jersey and Wisconsin.
A true conflict occurs where an analysis of the
policies underlying each of the conflicting laws
reveals that, in each case, application of the
respective state’s law would further its corresponding
policy. Id. at 855. If a true conflict exists, we then
proceed to determine which jurisdiction has the
greater interests, considering the qualitative contacts
of the states, the parties and the controversy.
Cipolla, supra at 856.
Id.
Here, a true conflict exists where the NJPLA does not permit the
imposition of punitive damages in pharmaceutical products liability cases
where the drug was approved by the FDA. Wisconsin caps punitive damages
at twice the amount of any compensatory damages or $200,000, whichever
is greater, but does not otherwise limit punitive damages in pharmaceutical
cases. Wis.Stat.Ann. § 895.043(6). Wisconsin clearly has an important
interest in protecting its citizens, such as Stange, against tortious conduct;
- 35 -
J. A10042/17
New Jersey’s Products Liability Act reflects its policy of shielding its
pharmaceutical industry from imposition of punitive damages. As such,
there is a true conflict of law and the trial court must determine which state,
New Jersey or Wisconsin, has the most significant relationship to the parties
and the occurrence to determine which jurisdiction’s substantive law
applies.8
Stange argues that Wisconsin law should apply because he was
prescribed Risperdal in Wisconsin and developed gynecomastia in Wisconsin;
Janssen’s inadequate warnings reached Dr. Kovnar in Wisconsin; Janssen’s
salespeople visited Dr. Kovnar in Wisconsin on multiple occasions over many
years and failed to disclose Risperdal’s actual risks; and his medical and
legal injuries all occurred in Wisconsin. (Stange’s brief at 53.) Stange also
argues that Wisconsin has the greater governmental interests where he is a
Wisconsin resident and Wisconsin has a strong interest in regulating the
activities of pharmaceutical companies that choose to do business within its
borders. (Id. at 54.) Stange contends that Wisconsin’s overriding interest
in regulating corporate entities conducting business there and punishing
outrageous behavior is greater than New Jersey’s interest in maintaining the
profitability of its pharmaceutical industry. (Id.)
8 As stated above, Stange does not argue on appeal that Pennsylvania
punitive damages law should apply.
- 36 -
J. A10042/17
According to Janssen, the critical punitive damage contacts weigh in
favor of New Jersey law because the defendants’ principal places of business
were in New Jersey, the Risperdal labeling was developed and distributed
from New Jersey, Janssen’s overall Risperdal marketing and sales strategy
was developed in New Jersey, and communications with the FDA and the
medical community occurred in New Jersey. (Janssen’s brief at 43.)
Janssen also argues that New Jersey has an interest in preserving its local
economy, protecting its pharmaceutical industry, and policing its own
corporate citizens. (Id. at 45-47.) Janssen characterizes Wisconsin’s
punitive contacts as “minimal” and argues that the coordinating judge
correctly found that New Jersey punitive damages law applies globally, to all
Risperdal cases in the mass tort program.
We disagree. As discussed above, we decline to find that Stange
waived the choice-of-law argument because the plaintiffs’ response to the
defendants’ motion for partial summary judgment included a discussion of
the law of the case doctrine. Stange’s argument on appeal that the law of
Wisconsin, his home state, should apply to the issue of punitive damages in
his particular case is preserved. However, the trial court did not fully
address the issue, finding that the plaintiffs’ argument was limited to the law
of the case doctrine. Therefore, the trial court only considered whether
New Jersey or Pennsylvania law should apply, not the law of the individual
plaintiff’s home state. We agree with Stange that it is necessary to remand
- 37 -
J. A10042/17
for the trial court to allow Stange to develop an individual record on
choice-of-law as it relates to his unique circumstances and to set out the
facts and state interests important to his particular case. As such, it is
necessary to reverse the order granting partial summary judgment for the
defendants on the punitive damages issue and remand for the trial court to
consider the conflict-of-law principles developed in Griffith, supra.9
Finally, Stange contends that the trial court erred in refusing to
instruct the jury on future damages including future emotional distress due
to the bullying and ridicule he endured because of his breasts. Stange
argues that he introduced evidence at trial that he was continually bullied
because of his condition, which was confirmed by medical records.
(Stange’s brief at 69.) Stange’s mother corroborated his testimony
regarding the extreme anguish and embarrassment he suffered for years.
(Id.) According to Stange, this led to a reasonable inference that he would
continue to suffer mental anguish for the rest of his life as a result of the
bullying. (Id. at 69-70.) Therefore, Stange argues that under Wisconsin
law, an instruction on future damages was warranted. (Id. at 70.) The trial
court charged the jury on noneconomic damages, including emotional
9 We note that the recent case of Bristol-Myers Squibb Co. v. Superior
Court of California, U.S. , 137 S. Ct. 1773 (2017), in which the
United States Supreme Court held that out-of-state plaintiffs failed to
establish specific jurisdiction over Bristol-Myers since there was no
significant link between the claims and Bristol-Myers’ conduct in California,
has no impact on this case, where Janssen is a Pennsylvania corporation.
- 38 -
J. A10042/17
distress, but refused Stange’s requested instruction on future emotional
distress, finding that Stange failed to present any evidence of mental
anguish from bullying in the future. (Trial court opinion, 5/23/16 at 9-11.)
The Supreme Court of Wisconsin has set forth the applicable law
regarding future damages, including for future emotional distress
proximately flowing from the defendant’s negligence, as follows:
The law is clear that when the tortfeasor’s conduct
causes bodily harm for which he or she is liable, the
tortfeasor is also liable for mental distress (including
fear and anxiety) resulting from the bodily harm.
Where the “plaintiff can demonstrate physical injury
at the time of the accident, plaintiff may also prove
and collect damages for emotional injury arising from
the accident.” Rennick v. Fruehauf Corp., 82
Wis. 2d 793, 805, 264 N.W.2d 264 (1978). The
burden on the person claiming damages is to
convince the jury, by the greater weight of the
credible evidence to a reasonable certainty, that he
or she has sustained or will sustain the mental
distress and physical harm claimed as a result of the
tortfeasor’s negligent conduct. In other words,
recovery may be had for reasonably certain injurious
consequences of the tortfeasor’s negligent conduct,
not for merely possible injurious consequences.
Thus the jury was instructed in this case that it was
to compensate the plaintiff for worry and mental
distress, if any, which the plaintiff had endured and
was reasonably certain to endure in the future as a
consequence of his injuries. Wis. J.I.-Civil
No. 1750A (1982).
Brantner v. Jenson, 360 N.W.2d 529, 532 (Wis. 1985).
The Supreme Court of Wisconsin affirmed a published decision of the
court of appeals, Brantner v. Jenson, 352 N.W.2d 671 (Wis.Ct.App. 1984),
which articulated a rule that “if there is a reasonable basis for the fear of
- 39 -
J. A10042/17
future harm and the possibility of that harm developing was increased as a
result of the negligently caused injury, the mental distress is compensable.”
Brantner, 352 N.W.2d 671.
The court of appeals articulated a rule setting forth
two elements a victim must establish by a
preponderance of the evidence to prove that he or
she is reasonably certain to endure mental distress
as a consequence of the injury: (1) the possibility of
the feared harm must have increased as a result of
the negligently inflicted injury, and (2) the victim
must have a reasonable basis for the fear of future
harm.
Brantner, 360 N.W.2d at 534.
The two-part test, which is merely another way of
stating the general rules of causation and damages
in negligence law, recognizes the distinction between
damages for reasonably certain anxiety over a
possible future occurrence of the consequence and
damages for the probable future occurrence of that
consequence and looks to the totality of
circumstances surrounding the plaintiff’s alleged
mental distress to determine whether the distress is
reasonably certain.
Id. at 534-535. See also Meracle v. Children’s Serv. Soc’y of
Wisconsin, 437 N.W.2d 532 (Wis. 1989) (plaintiffs could not recover future
damages for medical expenses and emotional distress based upon their fear
that their adopted daughter might contract Huntington’s Disease; she had
only a 25% chance of developing the disease and a plaintiff must
demonstrate that the anticipated damages are reasonably certain to occur).
- 40 -
J. A10042/17
The trial court explained that while Stange testified to past incidents of
bullying, there was no evidence that he currently suffers any mental anguish
or was likely to suffer mental distress in the future:
At trial, Mr. Stange described multiple
instances of his being bullied in high school because
of his breasts. It is clear that the bullying based on
his breasts ceased after Mr. Stange’s surgery and he
is not currently being bullied. Mr. Stange did not
testify that this past bullying caused any permanent
mental problems for him other than the fact that he
has memories of the events. Mr. Stange did not
testify that he currently suffers any mental anguish
from any residual effects of past bullying.
Mr. Stange did not indicate that he believed that he
would suffer any mental anguish from bullying in the
future. Further, [Stange] did not proffer an expert
to opine on the possible long-term effects of bullying
on mental health. Accordingly, [Stange] did not
present sufficient evidence to support a finding that
[he] would suffer mental health problems in the
future; thus, it would be inappropriate for the jury to
award damages. Therefore, this Court did not err in
refusing to instruct the jury that it could award
damages for future emotional distress.
Trial court opinion, 5/23/16 at 11 (references to the transcript omitted;
citation omitted). We agree. Stange’s argument that the jury could make a
“fair inference” that he will continue to experience the effects of past
bullying is too speculative. Stange failed to demonstrate that future
damages for emotional distress were “reasonably certain.” Therefore, the
trial court did not err in refusing to instruct the jury on damages for future
emotional distress.
- 41 -
J. A10042/17
Affirmed in part and reversed in part; remanded for further
proceedings consistent with this Opinion. Jurisdiction relinquished.
Panella, J. joins this Opinion.
Dubow, J. did not participate in the consideration or decision of this
case.
Judgment Entered.
Joseph D. Seletyn, Esq.
Prothonotary
Date: 1/8/18
- 42 -