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


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          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-
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            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-
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          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-
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              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-
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                 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-
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           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 -
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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 -
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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.



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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



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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.)


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           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;


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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;



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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.


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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



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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 -
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        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 -
