Stange, T. v. Janssen Pharmaceuticals , 179 A.3d 45 ( 2018 )


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  • 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”
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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-
    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
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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-
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    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
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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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    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 -
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    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
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    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
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    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
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    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;
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    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 6
    9-70.)   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 -