J-A19031-19

                               2019 PA Super 348

 A.Y. AND BILLIE ANN YOUNT               :   IN THE SUPERIOR COURT OF
                                         :        PENNSYLVANIA
              v.                         :
                                         :
 JANSSEN PHARMACEUTICALS INC.,           :
 JOHNSON & JOHNSON, JANSSEN              :
 RESEARCH & DEVELOPMENT, LLC;            :
 EXCERPTA MEDICA, INC., AND              :
 ELSEVIER INC.                           :   No. 3058 EDA 2016
                                         :
                                         :
 APPEAL OF: JANSSEN                      :
 PHARMACEUTICALS INC., JOHNSON
 & JOHNSON, JANSSEN RESEARCH &
 DEVELOPMENT, LLC

          Appeal from the Judgment Entered September 8, 2016
   In the Court of Common Pleas of Philadelphia County Civil Division at
                    No(s): April Term, 2013 No. 2094

 A.Y. AND BILLIE ANN YOUNT               :   IN THE SUPERIOR COURT OF
                                         :        PENNSYLVANIA
                   Appellant             :
                                         :
                                         :
              v.                         :
                                         :
                                         :
 JANSSEN PHARMACEUTICALS INC.,           :   No. 3059 EDA 2016
 JOHNSON & JOHNSON, JANSSEN              :
 RESEARCH & DEVELOPMENT, LLC;            :
 EXCERPTA MEDICA, INC., AND              :
 ELSEVIER INC.                           :

          Appeal from the Judgment Entered September 8, 2016
   In the Court of Common Pleas of Philadelphia County Civil Division at
                    No(s): April Term, 2013 No. 2094


BEFORE:   PANELLA, P.J., KUNSELMAN, J., and STEVENS*, P.J.E.

OPINION BY STEVENS, P.J.E.:                   FILED NOVEMBER 26, 2019




____________________________________
* Former Justice specially assigned to the Superior Court.
J-A19031-19



      Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC,

and Johnson & Johnson Company (collectively, “Defendants/Appellants” or

“Janssen”) appeal from the judgment of $70 million entered on September 8,

2016, after a jury found in favor of A.Y. and his mother, B.A.Y. (collectively,

“Plaintiffs/Appellees”) and against Janssen in this pharmaceutical failure to

warn case. In addition, Plaintiffs/Appellees have filed a cross-appeal from the

June 10, 2016 order granting partial summary judgment in favor of

Defendants/Appellants on Plaintiffs/Appellees’ punitive damages claim.

      On Defendants/Appellants’ appeal, we affirm. On Plaintiffs/Appellees’

cross-appeal, we reverse and remand for the trial court to consider conflict-

of-law principles with respect to New Jersey and Appellees’ home state of

Tennessee in a manner consistent with this decision.

      The trial court opinion aptly sets forth the record-based procedural

history and relevant facts, as follows:

                           PROCEDURAL HISTORY

      On April 15, 2013, Plaintiffs A.Y. and [B.A.Y., “Mother,”] filed a
      Complaint against Defendants Janssen Pharmaceuticals Inc.,
      Johnson & Johnson, Janssen Research & Development, LLC,
      Elsevier, Inc., and Excerpta Medica Inc. Appellees’ Complaint
      alleged the following thirteen causes of action: (1) negligence,
      (2) negligent-design defect, (3) fraud, (4) strict product liability –
      failure to warn, (5) strict product liability – design defect, (6)
      breach of express warranty, (7) breach of implied warranty, (8)
      violation of Pennsylvania Unfair Trade Practices and Consumer
      Protection Law, 73 P.S. § 201-1 et seq., (9) unfair and deceptive
      trade practices, (10) conspiracy, (11) punitive damages, (12)
      medical expenses incurred by parent, and (13) loss of consortium.




                                      -2-
J-A19031-19


     By Order dated May 2, 2014, the Honorable Arnold L. New ruled
     that New Jersey Law applied to the issue of punitive damages and
     that New Jersey law barred the award of punitive damages. On
     June 2, 2014, Plaintiffs filed a Motion for Reconsideration of the
     Honorable Arnold New’s May 2, 2014 Order barring the award of
     punitive damages. On June 9, 2014, Defendants filed an Answer
     to Plaintiff’s Motion for Reconsideration. On July 18, 2014,
     Plaintiff’s Motion for Reconsideration was denied.

     On November 4, 2015, the Honorable Arnold New approved a
     stipulation dismissing the action as to Defendants Excerpta
     Medica, Inc., and Elsevier Inc. On April 14, 2016, remaining
     Defendants, Janssen Pharmaceuticals, Inc., Johnson & Johnson,
     and Janssen Research & Development, LLC, filed a motion for
     summary judgment.

     On May 5, 2016, Plaintiffs filed an Answer to Defendant’s Motion
     for Summary Judgment. On May 11, 2016, Defendants filed a
     Reply.

     On June 10, 2016, the Honorable Arnold New ruled that Tennessee
     Law applies to Plaintiffs’ substantive claims [because Plaintiffs live
     in Tennessee and allege causes of action arising in Tennessee].
     Plaintiffs’ claims for: negligence, negligent design defect, strict
     liability—failure to warn, strict liability—design defect, breach of
     express warranty, breach of implied warranty [were deemed]
     subsumed into two claims: (a) Product Liability action because
     Risperdal was defective and (b) Product Liability action because
     Risperdal was unreasonably dangerous.[]

     The Honorable Arnold New further ruled that Defendants’
     Summary Judgment [motion] was granted as to the following
     causes of action: (A) product liability action because Risperdal
     was defective, (B) fraud, (C) Pennsylvania’s Unfair Trade Practices
     and Consumer Protection Law, (D) unfair and deceptive trade
     practices (under the Tennessee Consumer Protection Act), (E)
     conspiracy, and (F) loss of consortium. Defendant’s Motion for
     Summary Judgment was denied as to all other causes of action.

     On June 16, 2016, a jury trial commenced in this matter; the
     Honorable Paula A. Patrick presided. On July 1, 2016, the jury
     returned a verdict in favor of the Plaintiffs. The jury found that
     Defendants negligently failed to adequately warn Plaintiffs of the
     risk of gynecomastia associated with Risperdal™ use and

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J-A19031-19


     Defendants’ negligence was a cause in bringing about A.Y.’s
     gynecomastia.      The jury awarded Plaintiffs compensatory
     damages in the amount of $70,000,000.00 (seventy million
     dollars). On July 5, 2016, the jury’s verdict was entered.

     On July 8, 2016, Plaintiffs filed a Post-Trial Motion for Delay
     Damages. On August 10, 2016, Plaintiffs’ Motion for Delay
     Damages was granted. Plaintiffs were awarded $6,661,027.40 in
     Delay Damages. The jury verdict of $70,000,000.00 was molded
     to add Delay Damages of $6,661.027.40 for a total verdict of
     $76,661,027.40. On September 7, 2016, judgment was entered
     in this matter.

     On September 9, 2016, Defendants filed an Appeal to the Superior
     Court from decisions dated July 1, 2016, July 5, 2016, July 25,
     2016, and August 10, 2016. On September 13, 2016, Plaintiffs
     filed a cross-appeal to the Superior Court from decisions dated
     May 2, 2014, July 18, 2014, and July 25, 2016. On September
     22, 2016, Plaintiffs filed a Statement of Errors Complained of on
     Appeal pursuant to Pa.R.A.P. 1925(b). On October 12, 2016,
     Defendants filed a Statement of Errors Complained of on Appeal
     pursuant to Pa.R.A.P. 1925(b).

                         FACTUAL BACKGROUND

     Risperdal (risperdone) is an antipsychotic medication belonging to
     a class of drugs which [has] become known as “atypical” or
     “second generation” (“SGA”) antipsychotics.           Risperdal was
     originally developed and approved for use in the treatment of
     symptoms associated with schizophrenia. The adverse effects
     associated with       Risperdal are:         rapid weight gain,
     hyperprolactinemia, gynecomastia (abnormal development of
     breasts in males), galactorrhea (lactation), pituitary tumors,
     microadenomas of the pituitary gland, breast cancer,
     osteoporosis, decreased bone mineral density, metabolic
     syndrome, dyslipidemia, hypertension, diabetes mellitus, diabetic
     ketoacidosis (DKA), hyperosmolar coma, hyperglycemia, glucose
     dysregulation,    insulin    insufficiency,    insulin    resistance,
     pancreatitis, tardive dyskinesia, extrapyramidal symptoms,
     involuntary movement disorders, dyskinesia, dystonia, akatisia,
     parkinsonism, neuroleptic malignant syndrome (NMS) and/or
     other related conditions. Risperdal is designed, developed, tested,
     labeled, packaged, distributed, marketed, and sold throughout the
     United States by the Janssen Defendants.

                                     -4-
J-A19031-19



     On December 29, 1993, Janssen obtained approval from the Food
     and Drug Administration (“FDA”) to market Risperdal oral tablets
     for the treatment of “manifestations of psychotic disorders”
     (schizophrenia) in adults. In September 2000, the FDA requested
     that the label be changed to more clearly indicate that Risperdal
     was only approved for use in treating schizophrenia in adults. In
     October 2006, Risperdal was approved for the treatment of
     irritability associated with autistic disorder in children and
     adolescents (between the ages of 5 and 16), including symptoms
     of aggression towards others, deliberate self-injuriousness,
     temper tantrums and quickly changing moods. Risperdal has not
     been approved for children younger than 5 or those older than 16
     years old for irritability associated with autistic disorder.

     The prescribing of drugs “off-label” occurs when a drug is
     prescribed by a medical professional for use beyond those
     contained in the drug’s FDA-approved uses.          This includes
     prescribing a drug for a condition not indicated on the label,
     treating the indicated condition at a different dose or frequency
     than specified in the label, or treating a different patient
     population. An example of off-label use is the treatment of a child
     with the drug when the drug is approved to treat adults.[]

     Plaintiff A.Y. was born in 1999. [A.Y.] was diagnosed with
     Attention Deficit Hyperactivity Disorder (ADHD) and Oppositional
     Defiant Disorder (ODD). In August of 2003, when A.Y. was four
     and a half years old, he was prescribed Risperdal by Dr. Deniz
     Eker, a pediatric psychiatrist. Eker Dep. 2/8/16, at 31-32. At the
     time Dr. Eker prescribed Risperdal to A.Y., she did not warn A.Y.’s
     mother about the risk of gynecomastia. Dr. Eker stated that she
     would have warned A.Y.’s mother, but Dr. Eker did not know at
     the time that there was such a significant risk of gynecomastia
     from elevated prolactin. Id. at 56, 61.

     In January 2004, four months after [A.Y.] began taking Risperdal,
     A.Y.’s mother went to Doctor Eker and expressed concern that
     A.Y’s breasts were enlarging. Id. at 65. Dr. Eker then began
     tapering the Risperdal because she was concerned about
     gynecomastia. Id. at 66.

     In February 2005, after the initial tapering, Dr. Eker noted that
     A.Y.’s breasts were getting big and that she was discontinuing
     Risperdal because A.Y. had gynecomastia. Id. Dr. Eker testified

                                    -5-
J-A19031-19


     that when she first noticed gynecomastia, she began tapering off
     from the Risperdal but would have stopped it immediately if she
     had been properly informed about the risk of gynecomastia from
     Risperdal. Id. Dr. Eker believed gynecomastia was much less
     frequent and that A.Y.’s development of female breasts (at five
     years old) was a rare occurrence. When Dr. Eker believed the
     gynecomastia had gone down, she put A.Y. back on Risperdal. Id.
     at 76-77.

     Dr. Eker transferred A.Y.’s psychiatric care to Dr. Michael Hughes
     in the first half of 2005. Id. at 78. Dr. Hughes testified that the
     idea to put A.Y. on Risperdal originated with Dr. Eker, and he was
     simply continuing the treatment. Id. at 279-80.

     Dr. Hughes could not say that he would have put A.Y. on Risperdal
     at all if Dr. Eker had not prescribed it first. Id. Dr. Hughes
     testified that if he had known that there was a statistically
     significant association between prolactin elevation from Risperdal
     use and gynecomastia this information would have had a
     significant impact in his thinking with regard to prescribing
     Risperdal. Id. at 266-267. Dr. Hughes stated that he would have
     pushed against Risperdal use if he had known of the additional
     significant concerns. Id. at 83-84. Dr. Hughes treated A.Y. from
     May 2005 through May 2011. Id. at 228-29. Dr. Hughes
     discontinued Risperdal at the request of A.Y.’s mother because
     A.Y. was gaining so much weight. Id. at 161-62.

     Dr. Brian Bonfardin, a psychiatrist, began treating A.Y. in June
     2011. Id. at 16. In June of 2012, A.Y. was struggling, and A.Y.’s
     mother suggested trying Risperdal again to Dr. Bonfardin. At that
     time, Dr. Bonfardin’s prescription of Risperdal had already
     plummeted because he had learned prior to 2012 that Risperdal
     increased prolactin levels more than other antipsychotics. Id. at
     48-49.

     Dr. Bonfardin testified that he did not know of [Janssen’s own
     clinical] studies showing a 5.5% and 12.5 % frequency of
     gynecomastia among children who used Risperdal. If he had such
     information, he would have warned A.Y.’s mother about this
     significant risk. Bonfardin Dep., 2/11/16, at 16.

     A.Y.’s care was transferred to Dr. Gordon Greeson in October of
     2012. Dr. Greeson took A.Y. off Risperdal once he took over care
     because A.Y. gained quite a bit of weight and had hypertension in

                                    -6-
J-A19031-19


      the short period he had been put back on Risperdal. A.Y.’s mother
      requested he be put back on Risperdal [the] next month.

      In 2013, A.Y.’s mother saw an advertisement discussing
      gynecomastia from Risperdal use. A.Y. Mother Dep., 12/14/15,
      at 6-8. She got in contact with an attorney and then went to talk
      to A.Y.’s treating physicians about the problem. Id. Dr. Greeson
      learned of the gynecomastia from A.Y.’s mother in March 2013.
      Dr. Greeson immediately decided he needed to stop Risperdal
      because he feared making the problem worse.

Trial Court Opinion, 6/20/18, at 1-7.

      Appellants raise the following questions for our consideration:

      1. Were Defendants/Appellants entitled to JNOV because federal
         law preempts Plaintiffs’/Appellees state-law failure-to-warn
         claim?

      2. Were Defendants/Appellants entitled to JNOV because
         Plaintiffs/Appellees failed to establish any inadequate warning
         was the proximate cause of A.Y.’s Risperdal use and
         gynecomastia?


      3. Is a new trial required because the trial court erroneously
         excluded: (1) testimony of a treating doctor who continued to
         prescribe Risperdal for A.Y. at his mother’s request and after
         she filed this lawsuit, which called into question whether a
         different warning would have changed the prescribing decision;
         and (2) testimony and evidence establishing A.Y.’s serious
         mental illness and the significant benefit of Risperdal therapy
         for him, which was relevant to the benefit/risk analysis made
         by A.Y.’s prescribers?


      4. Is a new trial required because the trial court did not instruct
         the jury that under Tennessee’s “learned intermediary” rule,
         the jury had to assess whether the warnings were adequate to
         warn A.Y.’s doctors, to whom Janssen owed a duty to warn?


      5. Is a new trial or remittitur required because the trial court failed
         to apply Tennessee’s $750,000.00 cap for non-economic
         damages?

                                       -7-
J-A19031-19




      6. Is a new trial or remittitur required because the jury’s
         $70,000,000.00   compensatory-damages      award    was
         excessive?

Appellants’ brief, at 6-7.

      In their first two issues, Appellants contend they were entitled to

judgment non obstante veredicto (“JNOV”) because federal law preempts

Plaintiffs/Appellees’ state failure-to-warn claim that Tennessee law required

Janssen to change labeling to reflect juvenile Risperdal users’ heightened risk

of gynecomastia.     We set forth our standard of review from the denial of a

motion for judgment n.o.v.:

      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, 633 Pa. 445,
      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

                                     -8-
J-A19031-19


           verdict and judgment notwithstanding the verdict are
           identical. 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,
           580 Pa. 687, 859 A.2d 767 (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, 597 Pa. 717, 951 A.2d 1164
           (2008).   Rule 702 of the Pennsylvania Rules of
           Evidence.

Stange v. Janssen Pharmaceuticals, Inc., 179 A.3d 45, 52-53 (Pa. Super.

2018).

      “Federal ‘preemption is an affirmative defense on which [the] defendant

bears the burden of proof.’” Aaron v. Wyeth, 2010 WL 653984, at *3 (W.D.

Pa. Feb. 19, 2010) (quoting Cambridge Literary Props., Ltd. v. W. Goebel



                                     -9-
J-A19031-19



Porzellanfabrik G.m.b.H. & Co. KG., 510 F.3d 77, 102 (1st Cir. 2007), cert.

denied, 555 U.S. 815, 129 S.Ct. 58, 172 L.Ed.2d 25 (2008); citing Wyeth v.

Levine, 555 U.S. 555, ––––, 129 S.Ct. 1187, 1193, 173 L.Ed.2d 51 (2009)

(characterizing a manufacturer's argument that federal drug law preempted

the plaintiff's claims as a defense)) (hereinafter “Wyeth”).         Our courts

acknowledge a presumption against such a defense:

     We recognize a presumption against federal pre-emption of state
     law. Dooner v. DiDonato, 601 Pa. 209, 971 A.2d 1187 (2009)
     (citing Altria Group, Inc. v. Good, 555 U.S. 70, 129 S.Ct. 538,
     172 L.Ed.2d 398 (2008)). In Kiak v. Crown Equipment Corp.,
     989 A.2d 385, 390 (Pa.Super. 2010), this Court attributed that
     presumption to the “dual jurisdiction” which “results from reasons
     of comity and mutual respect between the two judicial systems
     that form the framework of our democracy.” Fetterman v.
     Green, 455 Pa.Super. 639, 689 A.2d 289, 292 (1997); see also
     Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct.
     2608, 120 L.Ed.2d 407 (1992). As the United States Supreme
     Court noted in Altria Group, Inc., supra: When addressing
     questions of express or implied preemption, we begin our analysis
     “with the assumption that the historic police powers of the States
     [are] not to be superseded by the Federal Act unless that was the
     clear and manifest purpose of Congress.” Rice v. Santa Fe
     Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 91 L.Ed. 1447
     (1947). That assumption applies with particular force when
     Congress has legislated in a field traditionally occupied by the
     States. [Medtronic Inc. v.] Lohr, 518 U.S. at 485, 116 S.Ct.
     2240, 135 L.Ed.2d 700; see also [Lorillard Tobacco Co. v.]
     Reilly, 533 U.S. at 541–542, 121 S.Ct. 2404, 150 L.Ed.2d 532
     [(2001)] (“Because ‘federal law is said to bar state action in a field
     of traditional state regulation,’ namely, advertising, we ‘work on
     the assumption that the historic police powers of the States are
     not to be superseded by the Federal Act unless that is the clear
     and manifest purpose of Congress’” (citation omitted)). Thus,
     when the text of a pre-emption clause is susceptible of more than
     one plausible reading, courts ordinarily “accept the reading that
     disfavors pre-emption.” Bates v. Dow Agrosciences LLC, 544



                                    - 10 -
J-A19031-19


      U.S. 431, 449, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005). Altria
      Group, Inc., 555 U.S. at 77, 129 S.Ct. 538.

Hassett v. Dafoe, 74 A.3d 202, 210 (Pa.Super. 2013). Accord, Lake v.

Memphis Landsmen, LLC, 405 S.W.3d 47, 56 (Tenn. 2013)



      In their preemption argument, Appellants insist Janssen’s labeling at all

relevant times was adequate as a matter of Tennessee law. Nevertheless,

they posit that even if Tennessee law required Janssen to change labeling as

Appellees propose, the federal law doctrine of “impossibility preemption”

applies to Plaintiffs/Appellees’ state-law negligent failure-to-warn claim,

because it was “impossible for Janssen simultaneously to comply with its

federal and state-law obligations” regarding Risperdal labeling of pediatric

gynecomastia risks.    See Appellants’ brief, at 27 (quoting Strayhorn v.

Wyeth Pharm., Inc., 887 F.Supp. 2d 799, 809-10 (W.D. Tenn. 2012)

(“Impossibility preemption is a type of implied conflict preemption which

occurs when ‘state and federal law conflict [and] it is impossible for a private

party to comply with both state and federal requirements.’”), aff’d, 737 F.3d

378 (6th Cir. 2013) (quoting PLIVA, Inc. v. Messing, 564 U.S. 604, 618

(2011)).

      We have previously discussed controlling decisional law characterizing

impossibility pre-emption as “a demanding defense.” Hasset, 74 A.3d at 210

(quoting Wyeth, 129 S.Ct. at 1199). Similarly, Tennessee has observed:

      The United States Supreme Court has identified two fundamental
      principles that must guide any preemption analysis. First, no
      matter what type of preemption is at issue, “the purpose of

                                     - 11 -
J-A19031-19


      Congress is the ultimate touchstone.” Wyeth, 555 U.S. 555, 565,
      129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (quoting Medtronic, Inc.
      v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700
      (1996)). Second, in conducting any preemption inquiry, courts
      must “start with the assumption that the historic police powers of
      the States were not to be superseded by [federal law] unless that
      was the clear and manifest purpose of Congress”—particularly
      when the federal law in question pertains to “a field which the
      States have traditionally occupied.” Id. (quoting Medtronic, 518
      U.S. at 485, 116 S.Ct. 2240) (internal quotation marks omitted);
      see also Leggett, 308 S.W.3d at 854; Morgan v. Ford Motor
      Co., 224 W.Va. 62, 680 S.E.2d 77, 83 (2009) (“Preemption of
      topics traditionally regulated by states—like health and safety—is
      greatly disfavored in the absence of convincing evidence that
      Congress intended for a federal law to displace a state law.”).

Lake, 405 S.W.3d at 56.

      In Wyeth, the United States Supreme Court held that impossibility

preemption did not apply to state claims based on a failure to warn of the risk

of gangrene from Phenergan delivered by an IV-push method, where it was

within the power of the defendant manufacturer, Wyeth, to comply with both

state and federal law by unilaterally strengthening the label’s warning. In so

holding, the Court explained that the Federal Food, Drug and Cosmetic Act

[“Act”] is premised upon the expectation that manufacturers are primarily

responsible for drug safety through proper labeling. The presumption follows,

the Court continued, that compliance with both state and federal labeling

requirements is possible unless there exists clear evidence that the FDA would

block a proposed change to the label.

      With regard to Wyeth, it has been observed:

      In holding that the FDA's approval of Wyeth's label did not provide
      a complete defense to the plaintiff's failure to warn claim under a
      federal preemption theory, the Wyeth Court emphasized that it

                                    - 12 -
J-A19031-19


     was Congress' intent that state law act as a “complimentary form
     of drug regulation” because “manufacturers have superior access
     to information about their drugs, especially in the postmarketing
     phase as new risks emerge.” Wyeth at 1202. The Court further
     emphasized:

            State tort suits uncover unknown drug hazards and
            provide incentives for drug manufacturers to disclose
            safety risks promptly. They also serve a distinct
            compensatory function that may motivate injured
            persons to come forward with information. Failure-to-
            warn actions, in particular, lend force to the [Federal
            Food, Drug and Cosmetic Act's] premise that
            manufacturers, not the           FDA,     bear     primary
            responsibility for their drug labeling at all times. Thus,
            the FDA long maintained that state law offers an
            additional, and important, layer of consumer
            protection that complements FDA regulation.

     Id.

     Moreover, the Court found no Congressional intent to vest the FDA
     with the sole authority to ensure drug safety and effectiveness, as
     would result from the preemption of state tort actions. Id. at
     1200. Wyeth, however, does not render state law failure-to-warn
     claims immune to preemption in every case. The Supreme Court
     recognized that “some state-law claims might well frustrate the
     achievement of congressional objectives” in the federal regulation
     of drug labeling. Wyeth, 129 S.Ct. at 1204. To prevail here,
     Wyeth “faces an exacting burden to establish preemption of state
     law claims because compliance with both state and federal
     requirements for drug labeling is not impossible ‘absent clear
     evidence that the FDA would not have approved a change’ in the
     drug's labeling.” Forst v. Smithkline Beecham Corp., 639
     F.Supp.2d 948, 953–954 (E.D.Wis.2009) (quoting Wyeth, 129
     S.Ct. at 1198).

Aaron, 2010 WL 653984, at *5.

     According to Appellants, however, federal law set forth in the Act at 21

C.F.R. §§ 201.57(e) and 312.32 provides that only the Food and Drug

Administration (“FDA”) may require a warning concerning a risk of an off-label


                                     - 13 -
J-A19031-19



or non-approved use, and even then only in the case of a “serious” risk,

namely, one that threatens life or normal life functions, or requires

hospitalization. Appellants acknowledge the regulations provide an exception

to this general restriction, the “changes being effected,” or “CBE” exception

articulated at 21 C.F.R. §§ 314.70(c)(6)(iii)(A), but they maintain the facts do

not bring the present case within the bounds of the exception.

       Specifically, the CBE exception permits a manufacturer to change

labeling without prior FDA approval only if (1) the manufacturer had newly

acquired information about the drug (2) that showed a causal association (3)

between the drug and an effect that warranted a new or stronger warning. 21

C.F.R. §§ 314.70(c)(6)(iii)(A).           “[N]ewly acquired information is data,

analyses, or other information not previously submitted to the [FDA that]

reveal risks of a different type or greater severity or frequency than previously

included in submissions to FDA.” 21 C.F.R. § 314.3; see also Wyeth, 129

S.Ct. 1197 (quoting 73 Fed.Reg. 49607).

       Appellees argue that Janssen’s extensive clinical studies culminating

with data compiled in its “Table 21,”1 discussed at length in the testimony of

expert witness David Kessler, M.D., see infra, brought them within the
____________________________________________


1 Expert witness Dr. David Kessler, FDA commissioner from 1991-1997,
testified that by the year 2000 or 2001, Janssen had collected data at Table
21 showing a statistically significant increase in both prolactin levels in
children taking Risperdal for at least 8 to 12 weeks and in prolactin-related
gynecomastia in children. Janssen, however, never shared this information.
In his expert opinion, by the year 2000 or 2001, Janssen was marketing
Risperdal for children and adolescents, and was, thus, obligated to share their
studies at this time. N.T. 5/19/2015, at 88-127.

                                          - 14 -
J-A19031-19



contours of the CBE regulations, as the studies supplied the manufacturer with

newly acquired information showing a causal association between Risperdal

and more frequent and severe gynecomastia in juvenile boys than had been

observed in the adult male population.

       Appellants, however, dispute that Janssen had the authority to change

labeling to inform that: Risperdal is associated with higher prolactin levels

than    other   antipsychotic   medications;     elevated    prolactin   “causes”

gynecomastia in the pediatric population; and clinical studies show sufficiently

higher rates of gynecomastia in the pediatric population to qualify the

condition as “frequent” in that population, as differentiated from the “rare”

occurrence reported in adults. This is so, they claim, because Risperdal was

not approved for pediatric use—it was an “off-label” use—and only the FDA

had the authority to warn about off-label uses.

       Plaintiffs/Appellees assail Appellants’ “off-label use” defense as also

being inconsistent with governing statutory law as it existed at the time A.Y.

began taking Risperdal. Specifically, Appellees accurately point out that 21

C.F.R. § 201.57(f)(9)(i), which pertained to “pediatric care,” was in effect in

2003 and provided that any “specific hazard” associated with an unapproved

pediatric use “shall be described in this subsection of the labeling. . . .” Id.

       Appellants’ position is out of step with controlling jurisprudence on drug

manufacturers’ responsibilities to act on their unique access to product

information by adequately warning consumers of newly discovered heightened

risks of injury associated with the drug. Indeed, as the United States Supreme

                                      - 15 -
J-A19031-19



Court has recently reiterated, the CBE regulation contemplates that drug

manufacturers bear ultimate responsibility to provide adequate descriptions

of a drug’s newly discovered risks to ensure consumer safety.2        This was

particularly so prior to 2007—the relevant period in the case sub judice—when

the FDA lacked authority to order manufacturers to revise their labels:

       We also observed that “through many amendments to the FDCA
       and to FDA regulations, it has remained a central premise of
       federal drug regulation that the manufacturer bears responsibility
       for the content of its label at all times.” Wyeth, at 570–571, 129
       S.Ct. 1187. A drug manufacturer “is charged both with crafting
       an adequate label and with ensuring that its warnings remain
       adequate as long as the drug is on the market.” Id., at 571, 129
       S.Ct. 1187. Thus, when the risks of a particular drug become
       apparent, the manufacturer has “a duty to provide a warning that
       adequately describe[s] that risk.” Ibid. “Indeed,” we noted,
       “prior to 2007, the FDA lacked the authority to order
       manufacturers to revise their labels.” Ibid. And even when
       “Congress granted the FDA this authority,” in the 2007
       Amendments to the FDCA, Congress simultaneously “reaffirmed
       the manufacturer’s obligations and referred specifically to the CBE
       regulation, which both reflects the manufacturer’s ultimate
       responsibility for its label and provides a mechanism for adding
       safety information to the label prior to FDA approval.” Ibid.

Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1677, 203 L.

Ed. 2d 822 (2019).


____________________________________________


2While the Wyeth Court acknowledged FDA regulations generally provide that
a manufacturer may change a drug label only after FDA approval of a change
application, as we note supra, it interpreted the misbranding provision of the
regulations as proscribing not labels that enhance warnings but, instead, those
that fail to include adequate warnings. Indeed, on this point, the High Court
stated frankly, “And the very idea that the FDA would bring an enforcement
action against a manufacturer for strengthening a warning . . . is difficult to
accept.” Wyeth, 129 S.Ct. at 1197.

                                          - 16 -
J-A19031-19



      Moreover, the High Court emphasized that impossibility preemption

under the relevant regulatory scheme requires the manufacturer to have fully

disclosed the need for the additional warning, only to be met with FDA refusal:

      The underlying question for this type of impossibility pre-emption
      defense is whether federal law (including appropriate FDA actions)
      prohibited the drug manufacturer from adding any and all
      warnings to the drug label that would satisfy state law. And, of
      course, in order to succeed with that defense the manufacturer
      must show that the answer to this question is yes. But in Wyeth,
      we confronted that question in the context of a particular set of
      circumstances. Accordingly, for purposes of this case, we
      assume—but do not decide—that, as was true of the warning at
      issue in Wyeth, there is sufficient evidence to find that Merck
      violated state law by failing to add a warning about atypical
      femoral fractures to the Fosamax label. In a case like Wyeth,
      showing that federal law prohibited the drug manufacturer from
      adding a warning that would satisfy state law requires the drug
      manufacturer to show that it fully informed the FDA of the
      justifications for the warning required by state law and that the
      FDA, in turn, informed the drug manufacturer that the FDA would
      not approve changing the drug’s label to include that warning.

Merck Sharp & Dohme Corp., 139 S. Ct. at 1678. In the present matter,

Janssen did not make such a showing of full disclosure to the FDA during the

relevant time.

      The FDA surely possesses the authority under the statutory scheme to

reject a revised label submitted by Janssen or any other manufacturer. This

fact, alone, however, does not insulate a manufacturer from state failure to

warn claims where the CBE scheme is available to enable compliance with

state law:

      Of course, the FDA reviews CBE submissions and can reject label
      changes even after the manufacturer has made them. See §§
      314.70(c)(6), (7). And manufacturers cannot propose a change

                                    - 17 -
J-A19031-19


       that is not based on reasonable evidence. § 314.70(c)(6)(iii)(A).
       But in the interim, the CBE regulation permits changes, so a drug
       manufacturer will not ordinarily be able to show that there is an
       actual conflict between state and federal law such that it was
       impossible to comply with both.

Id., 139 S. Ct. at 1679.

        As such, viewing Appellants’ defense in light of the above authority,

we disagree that the regulatory scheme would have “clearly” prevented it from

warning about the statistically significant increase in frequency and severity

of gynecomastia in boys taking Risperdal.          In fact, we view Appellants’

“misbranding avoidance” argument offered to justify Janssen’s withholding of

additional warnings to be of the type effectively rejected in Wyeth and its

progeny.     Because Appellants, therefore, have not carried their burden of

proof applicable to their preemption defense, we find that federal drug labeling

laws did not preempt Appellees’ Tennessee tort law claim.

       In Appellants’ next issue, they contend JNOV was required because

Plaintiffs/Appellees failed to establish that the lack of a gynecomastia warning

specific to juvenile risk was the proximate cause of A.Y.’s harm.3 According
____________________________________________


3Proximate causation was but one of two forms of causation—cause-in-fact
being the other—Plaintiffs/Appellees bore the burden of establishing at trial.
See infra. The Tennessee Supreme Court has explained the distinction
between the two causations, as follows:

       The distinction between cause in fact and proximate, or legal,
       cause is not merely an exercise in semantics. The terms are not
       interchangeable. Although both cause in fact and proximate, or
       legal, cause are elements of negligence that the plaintiff must
       prove, they are very different concepts. Cause in fact refers to
       the cause and effect relationship between the defendant's tortious



                                          - 18 -
J-A19031-19



to Appellants, even if the Risperdal warnings were inadequate—a supposition

they deny—the evidence showed that the label Plaintiffs/Appellees’ advocated

at trial would not have prevented A.Y. from taking Risperdal and developing

gynecomastia.

       A.Y.’s physicians were aware of a potential risk of gynecomastia when

they decided to prescribe Risperdal for A.Y., Appellants maintain, and his

parents either continued with or returned to Risperdal despite having learned

of its causative role in A.Y.’s gynecomastia diagnosis. Moreover, Appellant

posits that a plaintiff cannot prove the causation element when he or she

elects to continue a medication after raising a failure-to-warn claim.         It is

undisputed that A.Y. continued to take Risperdal after filing the present action.



____________________________________________


       conduct and the plaintiff's injury or loss. Thus, cause in fact deals
       with the “but for” consequences of an act. The defendant's
       conduct is a cause of the event if the event would not have
       occurred but for that conduct. In contrast, proximate cause, or
       legal cause, concerns a determination of whether legal liability
       should be imposed where cause in fact has been established.
       Proximate or legal cause is a policy decision made by the
       legislature or the courts to deny liability for otherwise actionable
       conduct based on considerations of logic, common sense, policy,
       precedent and “our more or less inadequately expressed ideas of
       what justice demands or of what is administratively possible and
       convenient.”

White v. Lawrence, 975 S.W.2d 525, 529 (Tenn. 1998) (quoting Snyder v.
Ltg. Lufttechnische GmbH, 955 S.W.2d 252, 256 n. 6 (Tenn.1997)
(citations omitted)).    Appellants, however, challenge only Appellees’
proximate causation proffer at trial.



                                          - 19 -
J-A19031-19



      To establish proximate causation in a pharmaceutical failure-to-warn

case, under Tennessee law, a plaintiff must show that “had additional

warnings been given, the plaintiff[] would not have sustained [his] injuries.’

King v. Danek Med., Inc., 37 S.W.3d 429, 453 (Tenn.Ct.App. 2000).

Because the flow of information in this context, however, runs through the

treating physician, the law applies a "learned intermediary" doctrine, whereby

the plaintiff must show that the absent warning, if given, would have altered

the prescribing physician's actions and, thereby, averted the patient's injury.

The purpose of the learned intermediary doctrine is to ensure that makers of

“unavoidably unsafe products” with a duty to give warnings may “reasonably

rely on intermediaries [often physicians] to transmit their warnings and

instructions.” Pittman v. Upjohn Co., 890 S.W. 2d 425, 429 (Tenn. 1994).

      With respect to a plaintiff’s burden to prove causation under the learned

intermediary doctrine, the Tennessee Court of Appeals has held:

      In order to recover for failure to warn under the learned
      intermediary doctrine, a plaintiff must show:        (1) that the
      defendant failed to warn the physician of a risk associated with
      the use of the product not otherwise known to the physician; and
      (2) that the failure to warn the physician was both a cause in fact
      and proximate cause of the plaintiff’s injury.

Harden v. Danek Med., Inc., 985 S.W.2d 449, 451 (Tenn. Ct. App. 1998).

      Appellants' learned intermediary argument asserts that Appellees

presented insufficient evidence that A.Y.'s treating physicians would have

refrained from using Risperdal had Janssen issued a different warning. To




                                    - 20 -
J-A19031-19



support this position, Appellants provide numerous citations to the record,

albeit it without any accompanying explanation of the testimony involved.

      Our review of this record, however, brings us in accord with the trial

court and its determination that Appellant's physicians amply testified they

would have chosen a different course of treatment had Janssen disclosed on

the Risperdal label the significantly heightened risk of prolactin-related

gynecomastia that existed for juvenile boys. To that end, we adopt the trial

court opinion’s salient discussion of how Dr. Eker’s and Dr. Hughes’ respective

reliance on inadequate Risperdal information supplied by Janssen, coupled

with their lack of independent knowledge about juvenile, prolactin-related

gynecomastia, defeated Janssen’s learned intermediary defense. Additionally,

the extensive videotaped deposition testimony of Dr. Kessler regarding

Janssen’s breach of duty to inform physicians under the learned intermediary

rubric also supports the trial court’s conclusion on proximate causation. See

N.T., 5/19/15, at 15-317; N.T.,5/20/15, at 333-656.

      Nevertheless, we discuss briefly the testimony pertinent to the issue of

proximate causation.     To carry its evidentiary burden with respect to

causation, Plaintiffs/Appellees presented the testimony of, inter alia, A.Y.'s

treating physician, pediatric psychiatrist Dr. Deniz Eker, treating phyisican,

pediatric psychiatrist Dr. Michael Hughes, M.D., and expert David Kessler,

M.D., who, as mentioned supra, served as Commissioner of the FDA between

1990 and 1997.




                                    - 21 -
J-A19031-19



     Specifically, Dr. Eker testified that she first prescribed Risperdal to A.Y.

in August of 2003 to treat A.Y.'s ADHD and oppositional defiant disorder. She

maintained she did not warn A.Y.’s mother about the risk of gynecomastia at

the time because she was unaware there was such a significant risk from

elevated prolactin. Eker Dep. 2/8/16, at 56, 61. Though Dr. Eker could not

remember whether she had consulted the Risperdal label thirteen years ago,

she testified that she would have checked the Physician’s Desk Reference

(PDR), which relies in part on drug labeling, for potential side effects

associated with Risperdal. Id. at 100.

     Had Dr. Eker known of the risk, she testified, she would have warned

A.Y.’s mother. Id. at 61. A.Y.'s parents confirmed Dr. Eker did not discuss

gynecomastia with them, and they testified they never would have agreed to

the use of Risperdal if they had known the true risk of gynecomastia. N.T.,

6/29/16, at 238-40,317; N.T., 6/24/16, at 23-24, 48. Dr. Hughes, who

assumed care of A.Y. starting in 2005, also expressed in his deposition

testimony the importance of knowing the actual risk of juvenile gynecomastia

stemming from hyperprolactinemia in his making his prescription decision.

Hughes Dep. 3/10/16, at 66-69. Furthermore, both doctors denied having

meaningful training or experience with, or independent knowledge of,

gynecomastia. N.T., 2/8/16, at 126-28; N.T., 3/10/16, at 91, 122-24.

     At the time Dr. Eker first prescribed Risperdal to A.Y., according to the

testimony of Dr. Kessler, Janssen already knew that Risperdal posed an




                                    - 22 -
J-A19031-19



increased risk of gynecomastia to juveniles.       See fn. 1, supra.   Yet, the

Risperdal label failed to warn of this increased risk.

      Specifically, Dr. Kessler testified in his video deposition that in August

of 2003, the Risperdal label indicated the drug's effect on prolactin levels was

consistent with other drugs in its class, that hyperprolactinemia had unknown

clinical significance, and that gynecomastia was a "rare" occurrence associated

with Risperdal use, occurring in fewer than 1 in 1000 patients, compared to a

"frequent" occurrence, defined as more than 1 in 100 patients. Kessler Tr.

Dep., 5/19/2015, at 13-29.

      Yet, Dr. Kessler explained, Janssen knew of Risperdal's increased risk

from eighteen clinical studies it had conducted through the 1990's and into

the 2000's to overcome its prior failed efforts to obtain FDA approval to

introduce pediatric dosing information on the label. Two of the studies of boys

ranging from 5 to 18 years old, in particular, showed a frequent occurrence of

gynecomastia.    The first was a long-term clinical study in which patients

underwent a 48-week observation while taking Risperdal. An interim analysis

in 2000 showed a gynecomastia incidence rate of 3.7% (13 cases/266 boys).

The 2002 final analysis for the clinical study revealed an incidence rate of

5.5% (23 cases/419 boys).

      The second study represented a one-year extension of the first study,

by recording the incidence of new and continuing gynecomastia in boys who

had participated in the first study and continued to take Risperdal for a second




                                     - 23 -
J-A19031-19



year. The study found an incident rate of gynecomastia at 12.5%. Dr. Kessler

testified the rate was "frequent.” Id. at 46-72.

      By Janssen's own 2002 internal analysis of its studies, there was a

statistically significant correlation between Risperdal and prolactin-related

gynecomastia in children. Dr. Kessler testified Janssen was obligated to warn

about the risks at this time by submitting the results of its studies to the FDA

as an "important finding," but it did not do so. Id. at 143-77. Instead, in

December 2003, Janssen sought FDA approval of Risperdal for pediatric use

without submitting the new data on gynecomastia risk. When the FDA denied

Janssen's application for safety concerns regarding prolactin elevation,

Janssen responded, "A review of the safety information did not show a

correlation between prolactin levels and adverse events that are potentially

attributable to prolactin."   Dr. Kessler characterized Janssen's response as

misleading. Id. at 177-84.

      Accordingly, we agree with the trial court that the record belies

Appellant's "learned intermediary" defense that A.Y.'s physicians prescribed

Risperdal with knowledge of the heightened pediatric gynecomastia risks

associated with the drug.     See Pittman, supra at 29 (indicating that an

adequate warning to learned intermediaries must convey, inter alia, a warning

with the degree of intensity required by the nature of the risk). See also

Proctor v. Davis, 291 Ill.App.3d 265, 682 N.E.2d 1203, 1214. (Ill.App. 1997)

(holding drug manufacturer Upjohn could not rely on prescribing physicians

as “learned intermediaries” when their off-label use occurred without

                                     - 24 -
J-A19031-19



knowledge of dangerous side effects and was promoted through misleading

information at time Upjohn possessed undisclosed, adverse information about

drug).

      Here, evidence showed that the label not only failed to state with the

correct degree of intensity the nature of the risk, it failed altogether to state

the heightened risk that Janssen, through administration of its own clinical

trials, knew applied to juvenile boys.

      Appellants also posit, however, that Appellees were precluded from

establishing proximate cause because A.Y.’s mother elected to continue with

Risperdal even after knowing about the gynecomastia risk.         Our review of

Appellants' court-ordered Pa.R.A.P. 1925(b) statement, however, reveals that

Appellants did not raise this issue sufficiently to preserve this alternate

argument against Appellees' proximate causation proffer at trial.

      Specifically, Appellants' statement does reference that A.Y.'s mother

acknowledged Dr. Eker told her that breast enlargement was a possible side

effect of Risperdal, and she still requested that A.Y. stay on Risperdal, even

after filing the present lawsuit. See Appellants' Concise Statement of Matters

Complained of on Appeal, Paragraph 5. However, this reference is contained

within a larger passage focused exclusively on the treating physicians'

independent knowledge of Risperdal's risks, and as such appears to be offered

as part and parcel of the argument that Dr. Eker knew of Risperdal's risks and

conveyed them to A.Y.'s mother.




                                     - 25 -
J-A19031-19



      Indeed, the sentence immediately following the reference to A.Y.'s

mother brings the issue to its conclusion by stating, "Where, as here, the

prescribing physicians testified that they understood the risks of a medication

at the time they prescribed it to their patient, they conveyed that risk to the

patient (here the patient's mother), and there is no evidence that either

prescribing physician even read the product label, any alleged deficiency in

the label could not be the proximate cause of A.Y.'s injury. Judgment as a

matter of law therefore should have been granted."          Pa.R.A.P. 1925(b)

Statement, at Issue 5.

      Despite having conducted an exhaustive review of Appellants' Concise

Statement, the trial court did not perceive in Issue 5 the question of whether

Plaintiffs/Appellees were precluded by law from meeting their their proximate

causation burden once A.Y.'s mother decided to continue with Risperdal even

after she filed suit against Janssen.   This was due not to the trial court's

oversight but, instead, to Appellants' vague-at-best drafting of Issue 5, which

appears dedicated solely to the issue of the physicians' knowledge. It is well-

settled that a vague Rule 1925(b) statement fails to preserve a purported

issue contained therein. See M.G. v. L.D., 155 A.3d 1083, 1099 (Pa.Super.

2017) (citing Reinert v. Reinert, 926 A.2d 539 (Pa.Super. 2007) (issue

raised on appeal waived where Rule 1925(b) statement was too vague for trial

court review)). Therefore, we conclude Appellants have waived their claim as

presented in this context.




                                    - 26 -
J-A19031-19



      Nevertheless, Appellants have preserved what amounts to essentially

the same issue in its next Question Presented, where they ask whether a new

trial is required for what they view as the trial court’s erroneous evidentiary

ruling excluding the testimony of one of A.Y.’s treating physicians, Gordon

Greeson, M.D., who prescribed Risperdal to A.Y. in 2012.              According to

Appellants, Dr. Greeson’s testimony was “uniquely important to rebut

Plaintiffs/Appellees’ theory that [A.Y.’s mother] would have refused Risperdal

treatment for A.Y. if she had known it could cause gynecomastia.” Appellant’s

brief, at 41. In that respect, Appellants maintain, the testimony would have

shown the failure to warn was not the proximate cause of A.Y.’s gynecomastia,

for Mother would have continued with Risperdal even had it contained an

accurate statement of risk. We disagree.

      With respect to the grant or refusal to grant a new trial upon allegations

of error in the admissibility of evidence we have stated:

      Decisions regarding the admissibility of evidence are within the
      discretion of the trial court and will be reversed on appeal only if
      the trial court abused its discretion or committed an error of law.
      ... We will grant a request for a new trial based upon a trial court's
      evidentiary rulings only if those rulings not only are erroneous,
      but also are harmful to the complaining party. ... Evidence is
      relevant if it logically tends to establish a material fact in the case,
      tends to make the fact at issue more or less probable, or supports
      a reasonable inference or presumption about the existence of a
      material fact.

Phatak v. United Chair Co., 756 A.2d 690, 691 (Pa.Super. 2000) (citation

omitted).




                                      - 27 -
J-A19031-19



      Dr. Greeson provided deposition testimony that A.Y.’s mother asked to

restart Risperdal in June 2012—more than nine years after A.Y. first developed

gynecomastia and more than one year after A.Y. had discontinued the

medication in large part because of the gynecomastia effect. By March 2013,

Dr. Greeson recommended that A.Y. switch from Risperdal to another

antipsychotic, but Mother declined to follow the doctor’s advice, even though

she indicated she was prompted to file the present lawsuit against the

manufacturer of Risperdal by advertisements pertaining to Risperdal/juvenile

gynecomastia causes of action.    At this point, Dr. Greeson testified in his

deposition that he believed there was “no doubt” Mother was aware of the risk

of gynecomastia from Risperdal at the time she asked him to restart A.Y. on

the medication.

      Appellants argue, “The only rational inference from Dr. Greeson’s

testimony is that a risk of gynecomastia would not cause Mother to refuse

Risperdal—because A.Y.’s actual gynecomastia did not cause her to do so.”

They posit the doctor’s testimony would have contradicted Mother’s testimony

that she resumed Risperdal only because A.Y.’s gynecomastia would not have

resolved even if she discontinued the medication permanently.

      Dr. Greeson explained in his deposition that his advisement to Mother

included his concern that resuming Risperdal could make A.Y.’s gynecomastia

worse. Mother’s willingness to continue Risperdal in the face of this warning

was thus relevant to the proximate cause element to the failure to warn case

at bar, Appellants conclude, for it shows Mother would likely have disregarded

                                    - 28 -
J-A19031-19



any risk-of-gynecomastia warning to obtain the antipsychotic benefits of

Risperdal.

      The trial court responds that Dr. Greeson’s testimony was irrelevant to

Plaintiffs’ failure to warn claim, as Mother’s willingness to resume Risperdal in

2013, after A.Y. had developed irreversible gynecomastia over the previous

10 years, did not have the tendency to make it more or less likely that

Janssen’s failure to warn proximately caused Mother to agree to Risperdal

therapy for her then four-and-one-half year-old son. See Pa.R.E., Rule 401

(“Relevant evidence” means evidence having any tendency to make the

existence of any fact that is of consequence to the determination of the action

more probable or less probable than it would be without the evidence.”);

Hennessey v. Moyer, No. 905 EDA 2019, 2019 WL 4862183, at *6 (Pa.

Super. Ct. Oct. 2, 2019) (“Relevant evidence is admissible if its probative

value outweighs its prejudicial impact.”).      Accord     Tenn. R. Evid. 401

(“‘Relevant evidence’ means evidence having any tendency to make the

existence of any fact that is of consequence to the determination of the action

more probable or less probable than it would be without the evidence.”); Tenn.

R. Evid. 402 (“Evidence which is not relevant is not admissible.”). The court

further notes that the jury heard other evidence pertaining to Mother’s request

to resume Risperdal despite obviously knowing that her son had likely

developed gynecomastia because of the medication.

      We agree with the trial court’s assessment.        The proximate cause

inference Appellants seek to make is simply too attenuated given the

                                     - 29 -
J-A19031-19



significant passage of time and change in circumstances from when A.Y. began

Risperdal treatment in 2003 to when he came under the care of Dr. Greeson

in 2012-2013. Contrary to Appellants’ contention, the proposed testimony

would not have shed light on Mother’s state of mind at the outset of A.Y.’s

treatment, nor would it have “contradicted” Mother’s statement that she

requested continuation of the medication because A.Y. already had severe,

irreversible gynecomastia by 2013. Under our standard of review, we cannot

conclude that the ruling in question was both erroneous and harmful to the

Appellants. Accordingly, we view this claim as meritless.

      Appellants next challenge the court’s evidentiary ruling excluding

specific act evidence of A.Y.’s “biting, hitting, smashing windows out with his

fist, persistent fighting with other children, refusal to follow instructions at

school or at home, and on one occasion breaking a chicken’s back.”

Appellant’s brief, at 44. Appellants also contest the court’s ruling limiting the

testimony of expert medical witness, child psychiatrist Nadine Schwartz, M.D.,

whom Appellants had offered to speak on the Risperdal risk/benefit analysis

conducted by psychiatrists, on her opinions regarding whether A.Y.’s

treatment records reflected any evidence of significant emotional distress from

gynecomastia.

      “The admission of expert testimony is a matter of discretion [for]
      the trial court and will not be remanded, overruled or disturbed
      unless there was a clear abuse of discretion.” Blicha v. Jacks,
      864 A.2d 1214, 1218 (Pa.Super.2004). Indeed, admission of the
      disputed testimony “must be shown to have been not only
      erroneous but also harmful.... Evidentiary rulings which did not


                                     - 30 -
J-A19031-19


      affect the verdict will not provide a basis for disturbing the jury's
      judgment.” Detterline v. D'Ambrosio's Dodge, Inc., 763 A.2d
      935, 940 (Pa.Super. 2000) (quoting Ratti v. Wheeling
      Pittsburgh Steel Corp., 758 A.2d 695, 707 (Pa.Super.2000)).

Helpin v. Trustees of Univ. of Pennsylvania, 969 A.2d 601, 617 (Pa.Super.

2009), aff'd, 10 A.3d 267 (Pa. 2010).

      According to the trial court, it committed no error in its evidentiary

rulings excluding specific act evidence, as it did not preclude Dr. Schwartz

from “testifying about Risperdal generally, the patients for whom Risperdal is

appropriate, and the analysis a prescriber engages in when determining

whether to prescribe Risperdal, including consideration of the risks and

benefits.   As the transcript demonstrates, Dr. Schwartz testified regarding

these matters and more at trial.” Trial Court Opinion, at 59-61.

      The transcript shows the court permitted Dr. Schwartz to testify not only

generally about Risperdal use in child psychiatry but also specifically about the

risk/benefit assessment relevant in A.Y.’s case given his medical and

behavioral history. For example, Dr. Schwartz discussed how a psychiatrist

would approach a risk/benefit analysis, and she applied the approach to

examine A.Y.’s particular case. She explained he had been diagnosed with

ADHD, oppositional defiant disorder, and mood disorder (either depressed or

bipolar) at various points, and offered her opinion that A.Y. exhibited “very

serious symptoms.” She confirmed that the severity of the condition is the

most essential piece to the risk/benefit analysis. Id.

      Dr. Schwartz went on to discuss how Risperdal would have benefitted

A.Y. given his diagnoses.      She primarily emphasized the drug’s mood

                                     - 31 -
J-A19031-19



stabilization properties as a way of helping such a patient with aggressive,

explosive, violent, or impulsive outbursts, which, she opined, can be very

quick and severe. Dr. Schwartz was permitted to restate these behaviors and

the drug’s corresponding benefits several times without objection or

interruption by either opposing counsel or the court. N.T. 6/24/16 at 21-26,

54-56.

      The trial court concludes:

      The above-referenced testimony belies Defendants’ claim that this
      court limited Dr. Schwartz to only discussing the general benefits
      of Risperdal. As the transcript demonstrates, Dr. Schwartz
      testified about Risperdal as a treatment for certain mood
      disorders, the patients for whom Risperdal is appropriate, and the
      factors to be considered when prescribing such a medication. Dr.
      Schwartz also discussed A.Y.’s medical conditions, the seriousness
      of his symptoms, and why the severity of the conditions is relevant
      to a psychiatrist’s risk/benefit analysis.

Trial Court Opinion, at 62.

      We agree with the trial court and discern no error with its evidentiary

rulings precluding specific act evidence, as Appellants still informed the jury,

through expert testimony, that A.Y. demonstrated “very serious symptoms”

and that Risperdal for juveniles with his diagnoses has been shown to help

with highly aggressive, impulsive, explosive, and violent outbursts.        This

expert proffer, therefore, fairly characterized A.Y.’s condition and enabled

Appellants to frame its theory of the case that Mother faced a dilemma

between risking a relapse in A.Y.’s very serious mood disorder from Risperdal

cessation and exacerbating A.Y.’s gynecomastia from Risperdal continuation.



                                     - 32 -
J-A19031-19



As such, we discern neither error with, nor prejudice stemming from, the

court’s ruling precluding testimony regarding A.Y.’s specific acts manifesting

his mood disorder.

      Similarly, we reach the same conclusion with respect to the trial court’s

ruling precluding Dr. Schwartz from inferring from the record whether

Appellant exhibited any evidence of significant emotional distress from his

gynecomastia. Dr. Schwartz never met or treated A.Y. and, therefore, had no

first-hand knowledge of how his gynecomastia affected him emotionally,

psychologically, or socially, leaving her to speculate from records about such

matters.

      Appellants cite to McClain v. Welker, 761 A.2d 155, 156 (Pa.Super.

2000) as supporting its position, but McClain is inapposite, as it addressed

whether the trial court erred when it refused to qualify Dr. Theodore Lidsky,

a neuroscientist, as an expert on plaintiff children's cognitive defects from

ingesting lead paint because he lacked a medical degree. In reversing and

remanding, the panel ordered, "Accordingly, on remand, Dr. Lidsky should be

permitted to render an expert opinion within the guise of Pa.R.E. 702 as to

the causation of cognitive disorders." Id. at 158.

      The expert in McClain, therefore, was permitted to clarify how ingesting

lead can cause the particular cognitive defects exhibited by the plaintiff

children. Such a scientific subject was clearly within the neuroscientist's scope

of expertise. Appellants, in contrast, failed to establish that Dr. Schwartz's

scope of expertise included the ability to interpret another doctor's notes to

                                     - 33 -
J-A19031-19



gauge a patient's level of emotional distress and humiliation from a disfiguring

diagnosis.

        Again, we find the court's evidentiary ruling neither erroneous nor

harmful. Under the circumstances, and with other witnesses expressing direct

impressions of A.Y.’s emotional distress, the court committed no error in

deeming Dr. Schwartz’s inferences on A.Y.’s emotions incompetent for

admission at trial.

        Appellants next assert several challenges to the trial court’s jury

instructions.     Our review of these claims is governed by the following

standard:

        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. Error will be found
        where the jury was probably misled by what the trial judge
        charged or where there was an omission in the charge. 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 a
        fundamental error. In reviewing a trial court's charge to the jury,
        we must look to the charge in its entirety.

Tincher v. Omega Flex, Inc., 180 A.3d 386, 397-98 (Pa.Super. 2018)

(cleaned up).4
____________________________________________


4   We note the parallel standard of Tennessee:

        [T]his Court has held that “[w]hether a jury instruction is
        erroneous is a question of law and is[,] therefore[,] subject to de
        novo review with no presumption of correctness.” Nye, 347
        S.W.3d at 699 (citing Solomon v. First Am. Nat'l Bank of
        Nashville, 774 S.W.2d 935, 940 (Tenn.Ct.App.1989)).              As



                                          - 34 -
J-A19031-19



       Appellants contend that this Court should remand for a new trial because

the trial court declined to instruct the jury on a key aspect to Tennessee’s

Learned Intermediary Doctrine. Specifically, Janssen proposed the following

instruction, which it argued would clarify for the jury that for prescription

medications, unlike other consumer products, the “user” to whom the

warnings are directed is the physician, not the patient:

       In this action, because the product involved is a prescription
       medication that can only be taken with the doctor’s prescription,
       the expected users of Risperdal, for purposes of any warnings, are
       the physicians who prescribed Risperdal for [A.Y.], not [A.Y.] or
       his family. This is because a prescribing physician is in the best
       position to understand the patient’s needs and assess the risks
       and benefits of a particular course of treatment. In order to
       prevail, Plaintiff’s must prove that Janssen failed to warn [A.Y.]’s
       healthcare providers of the risk of gynecomastia and that his
       healthcare providers were not already aware of the risks. If the
       risk of gynecomastia was apparent to [A.Y.]’s physicians, Janssen
       was not negligent even if Janssen gave no warning about it.

Appellants’ First Amended Proposed Points of Charge, Proposed Instruction

No.21, 6/29/16 (emphasis in original).

____________________________________________


       indicated, in determining whether a trial court has imparted
       “substantially accurate” jury instructions, we review the charge in
       its entirety and consider it as a whole; we will not invalidate
       instructions that “‘fairly define[ ] the legal issues involved in the
       case and do[ ] not mislead the jury.’” Id. (quoting Otis, 850
       S.W.2d at 446). Moreover, we may consider the jury instructions
       in conjunction with the verdict form in determining whether the
       issues were presented to the jury “in a clear and fair manner.”
       Hickson Corp. v. Norfolk S. Ry., 260 F.3d 559, 568 (6th
       Cir.2001).

Payne v. CSX Transportation, Inc., 467 S.W.3d 413, 448 (Tenn. 2015).


                                          - 35 -
J-A19031-19



      The trial court opted instead to rely on the Tennessee Pattern Instruction

Civil 10.12 for its instruction. The instruction went as follows:

      Supplier’s duty to warn. A supplier who knows or reasonably
      should know that a product is likely to be dangerous for its
      intended use or foreseeable misuse has a duty to use reasonable
      care to warn of the product’s danger or to reveal its unsafe
      condition.

      Warnings should be given to those persons whom the supplier
      should reasonably expect to use or to handle the product or be
      endangered by its use or handling if the supplier reasonably
      should believe those persons would not realize the danger without
      the warnings. The failure to fulfill this duty is negligence.

N.T. 6/30/16, at 171.

      Furthermore, the court directs us to the questions it presented to the

jury on the verdict sheet, which the court also read to the jury before

deliberation.   According to the court, this reading instructed the jury

specifically that the manufacturer’s warning was required to be directed to

A.Y.’s healthcare providers:

      Now, as you deliberate, you will receive the verdict sheet. I’ll read
      it to you. There are four questions you must answer. The first
      question: Was Janssen negligent by failing to provide an adequate
      warning to [A.Y.’s] healthcare providers about the risk of
      gynecomastia from taking Risperdal? There’s a line to check yes,
      a line to check no. If you answer yes to Question 1, please
      proceed to Question 2. If you answer no to Question 1, plaintiff
      cannot recover. Do not answer any further questions and return
      to this Courtroom.

N.T. 6/30/16, at 182.

      The trial court opines that the explanation provided on the verdict sheet,

coupled with the jury instruction regarding Defendants/Appellants’ duty to



                                     - 36 -
J-A19031-19



warn, accurately reflected the law applicable to the present case. Appellants

disagree, as they claim the court’s instruction and reading of the jury sheet

simply gave the jurors “contradictory” charges that could only have misled or

confused them.

      We disagree with Appellants’ position. Viewing the court’s charge as a

whole, we view no key omission, fundamental error, or inherent conflict, as

the jury was sufficiently apprised of a manufacturer’s duty to direct its warning

to healthcare providers, consistent with the learned intermediary doctrine.

Therefore, Appellant is due no relief on this claim.

      Next, Appellants posit that the trial court committed reversible error

when it failed to apply appropriately the Tennessee Civil Justice Act Damages

Cap of 2011, which imposes a limit on non-economic damages in the amount

of $750,000 per plaintiff. Tenn. Code Ann. § 29-39-102(a)(2), “Civil Actions;

awards” (2018).

      It is undisputed that the cap applies to the present case, but

Plaintiffs/Appellees argued that the facts brought this case under a statutory

exception to the cap. The exception provides:

      (h) The limitation on the amount of noneconomic damages
      imposed by subdivision (a)(2) and subsections (b)-(e) shall not
      apply to personal injury and wrongful death actions:

      …

      (2) If the defendant intentionally falsified, destroyed or concealed
      records containing material evidence with the purpose of
      wrongfully evading liability in the case at issue; provided,
      however, that this subsection (h) does not apply to the good faith


                                     - 37 -
J-A19031-19


         withholding of records pursuant to privileges and other laws
         applicable to discovery, nor does it apply to the management of
         records in the normal course of business or in compliance with the
         defendant’s document retention policy or state or federal
         regulations.

Tenn. Code. Ann. § 29-39-102(h)(2).

         Appellants maintain, without reference to either rules of statutory

interpretation or pertinent authority, that the statute targets only spoliation

of evidence during discovery, and there was no spoliation “in the case at

issue.”

         They note Plaintiffs/Appellees did not allege that Janssen engaged in

falsifying, destroying, or concealing records during the course of discovery in

this case.      Because, they reiterate, the statute in question is aimed at

discovery conduct within a given case and not at alleged pre-litigation

manipulation or concealment of documents from non-party actors, even if the

documents may one day become evidence in a potential future litigation, the

exception does not apply to the present matter.

         The trial court found no merit to Defendants/Appellants’ argument at

trial,   where    Appellants   invoked    the     statute   when   Plaintiffs/Appellees

requested the following instruction:

         You must determine whether the Defendants intentionally
         falsified, destroyed, or concealed records pertaining to this case[.]

         For you to find that Defendants intentionally falsified, destroyed,
         or concealed records pertaining to this case, the Plaintiff must
         prove by a preponderance of the evidence the following elements:




                                         - 38 -
J-A19031-19


     1. That Defendants intentionally falsified, destroyed or concealed
        Defendants’ records to wrongfully evade liability in the case at
        issue; and

     2. That Defendants’ records         contained    material   evidence
        pertaining to this case.

See Plaintiffs’ Amended Proposed Points for Charge, 6/29/16.

     Specifically, Plaintiffs/Appellees provided the following argument in

support of its proposed points of charge:

     [Plaintiffs’ Counsel]: Your Honor, let me give you globally
     what’s going on. This case is going to be decided under Tennessee
     law, and I don’t profess to be a total expert on Tennessee law.
     But the defendants are going to raise an issue, if there’s a jury
     verdict and if it exceeds, I believe, $750,000, they will try to claim
     that there’s some sort of damage cap in Tennessee. [Counsel
     then explains there is an exception in cases of concealment of
     evidence.] So what you see here is the instruction about what
     that means, and then later on in the verdict form we propose a
     question on it.

     So the two issues of concealment, there’s two things they did.
     One is they locked up Table 21 from 2002 until 2015. That’s a big
     part of our case. And then you also have the Bilker issue [referring
     to person Janssen allegedly hired to provide an alternate
     interpretation of the clinical studies discussed, supra]. So there’s
     two issues of concealment because, even though they gave Table
     21 to the FDA in October 2015, our claim goes to 2003. So we
     think this comes in, and we think you need this instruction so that
     we can get a jury finding on this issue in case, you know, we’re
     fortunate enough.

N.T., 6/30/16, at 9-10.


     Appellants countered:

     [Defendants’ Counsel]:         No, but it has to do – falsified,
     destroyed, or concealed to wrongfully evade liability in the case at
     issue. Your Honor, obviously we haven’t had briefing on this, but
     I think it’s clear from the statute and from the instruction itself


                                    - 39 -
J-A19031-19


      that this is about concealing evidence in this litigation. It’s not
      about whether you should or shouldn’t have given facts to other
      people outside litigation. This is just extremely prejudicial, and
      it’s not appropriate to this case. And to be suggesting to this jury
      that we destroyed evidence and kept it out of litigation just is
      irretrievably prejudicial to the defendants.

N.T., 6/30/16, at 12-13.

      The trial court explains it rejected Defendants/Appellants’ argument

and, therefore, read Plaintiffs/Appellees’ proposed charge to the jury, because

ample evidence demonstrated that Appellants intentionally falsified and

concealed records in this case:

      “To reiterate, Plaintiffs presented evidence that Defendants
      concealed Table 21, an internal Janssen document, that
      demonstrated a statistically significant link between Risperdal and
      gynecomastia. Instead of submitting this information to the FDA
      during the approval process, Defendants withheld and concealed
      the results for more than a decade.           In addition, Plaintiffs
      presented evidence that Defendants hired Dr. Warren Bilker, a
      biostatistician, to perform a reanalysis of Table 21. The only
      specifics given to Dr. Bilker, who was under the control and
      direction of Dr. Findling and Dr. Daneman, were to refute the
      results in Table 21. N.T., 6/27/16, at 179. According to Plaintiffs,
      Dr. Bilker intentionally manipulated and retested the data multiple
      ways to get the results Defendants wanted. Once Dr. Bilker was
      able to refute the results in Table 21, the reanalysis was submitted
      as a letter by Dr. Daneman and Dr. Findling to The Journal of
      Clinical Psychiatry and published. These results, according to
      Plaintiffs, were inaccurate, inadequate, and misleading.

Trial Court Opinion, at 85.

      We agree that such intentional conduct, if proven, was fairly

contemplated within the exception set forth in subsection (h) of the statute in

question.   A reasonable inference arises from the record that Appellants

persisted in its alleged concealment of the clinical study results recorded in


                                     - 40 -
J-A19031-19



Table 21 not only with an eye toward future litigation in general but also to

frustrate existing lawsuits such as Plaintiffs/Appellees’. This alleged conduct

was compounded by Appellants’ manipulation of the data collected in Table 21

and publication of the altered results during the relevant time.

      The court, therefore, properly informed the jury that it was to decide a

question of fact whether Plaintiffs proved its allegations of such conduct

occurring after the present lawsuit had commenced, and that if it decided in

the affirmative then the damages cap no longer applied.            As Appellants

develop no persuasive argument to upset the court’s considered interpretation

of the statute, we decline to find error with the instruction at issue.

      Relatedly, Appellants claim the court committed reversible error when it

gave an allegedly incomplete special interrogatory on what Appellants call the

spoliation issue. Specifically, the verdict form read:

      Did Janssen intentionally falsify, destroy, or conceal records
      containing material evidence in this case?

Trial Work Sheet/Verdict Sheet, 7/5/16.

      According to Appellants, the omission of the clause, “with the purpose

of wrongfully evading liability in the case at issue,” deprived the jury of clear

guidance on how to make the proper finding required under the law, and,

therefore, prejudiced Appellants in the process.     Our review of the record,

however, reveals that the court provided the following jury instruction just

minutes earlier:




                                     - 41 -
J-A19031-19


       Trial Court:           Intentional falsification, destruction, or
       concealment.      You must determine whether the defendants
       intentionally falsified, destroyed, or concealed records pertaining
       to this case. For you to find the defendants intentionally falsified,
       destroyed, or concealed records pertaining to this case, the
       plaintiffs must prove, by a preponderance of the evidence, the
       following elements:          Number one, that the defendants
       intentionally falsified, destroyed, or concealed defendant’s records
       to wrongfully evade liability in this case at issue. . . .

N.T., 6/30/16, at 173. (emphasis in original).

       Contrary to Appellants’ contention, the court instructed the jury that it

was required to consider whether Defendants/Appellants had acted in such a

way to wrongfully evade liability in this case. As the record belies Appellants’

assertion, we find it without merit.5

       In Appellants’ final issue, they contend the trial court should have

granted a new trial or remitted what they perceive as an excessive damages

award. We disagree.

       Under Tennessee law, a trial court “may set aside a jury’s verdict and

order a new trial when justice so requires.” Palanki v. Vanderbilt Univ.,

215 S.W.3d 380, 386 (Tenn.Ct.App. 2006). The role of the trial judge in this

regard is well-settled:


____________________________________________


5 Also germane to this issue is the well-settled legal precept that failure to
object to a flawed jury verdict prior to a jury's dismissal precludes a challenge
to the verdict in post-trial motions. See Stapas v. Giant Eagle, Inc., 198
A.3d 1033, 1041 (Pa. 2018) (holding that where both parties to litigation
approved verdict sheet and did not object to verdict before jury dismissed,
post-trial objections to verdict were waived); Pa.R.C.P. 227.1(b)(1) (“post-
trial relief may not be granted unless the grounds therefore, (1) if then
available, were raised in pre-trial proceedings or by motion, objection ... or
other appropriate method at trial.”).

                                          - 42 -
J-A19031-19


     Although the amount of an award is primarily a consideration for
     the jury to determine, the trial court may suggest a remittitur
     when the amount of the verdict is excessive, beyond the range of
     reasonableness, or is excessive as the result of passion, prejudice,
     or caprice. Poole v. Kroger Co., 604 S.W.2d 52, 54 (Tenn.
     1980). However, there is no precise mathematical formula which
     the court can use to assure that judgments in negligence cases
     are uniform. S. Ry. Co. v. Sloan, 56 Tenn.App. 380, 407 S.W.2d
     205, 211 (1965). Said the Court:

           There is no exact yardstick, or measurement, which
           this court may use as a guide to determine the size of
           verdicts which should be permitted to stand in cases
           of this kind. Each case must depend upon its own
           facts and the test to be applied by us is not what the
           amount the members of the court would have
           awarded had they been on the jury, or what they, as
           an appellate court, think should have been awarded,
           but whether the verdict is patently excessive. The
           amount of damages awarded in similar cases is
           persuasive but not conclusive, and, in evaluating the
           award in other cases, we should note the date of the
           award, and take into consideration inflation and the
           reduced value of the individual dollar.

     S. Ry. Co., 407 S.W.2d at 211.

Palanki, 215 S.W.3d at 386.

     Pennsylvania is largely in accord:

     The assessment of damages is peculiarly within the province of
     the factfinder and an award will not be upset on appeal unless it
     is so excessive as to shock the conscience of the court or it is
     clearly based on partiality, prejudice or passion. De Simone v.
     City of Philadelphia, 380 Pa. 137, 110 A.2d 431 (1955).
     Generally, under Pennsylvania law, damages need not be proved
     with mathematical certainty, but only with reasonable certainty,
     and evidence of damages may consist of probabilities and
     inferences. See, e.g., Morin v. Brassington, 871 A.2d 844, 852
     (Pa. Super. 2005), quoting J.W.S. Delavau Inc. v. Eastern
     America Transp. & Warehousing, Inc., 810 A.2d 672, 685 (Pa.
     Super. 2002); James Corp. v. N. Allegheny Sch. Dist. 938 A.2d
     474, 494 (Pa. Cmwlth. 2007); E.C. Ernst, Inc. v. Koppers Co.,

                                    - 43 -
J-A19031-19


      Inc., 626 F.2d 324, 327 (3d Cir. 1980). Where the amount of
      damages can be fairly estimated from the evidence, the recovery
      will be sustained even though such amount cannot be determined
      with entire accuracy. Mass. Bonding & Ins. Co. v. Johnston &
      Harder, 343 Pa. 270, 22 A.2d 709, 713–14 (1941). We review a
      trial court's decision whether to grant a new trial based on alleged
      excessiveness or inadequacy of the verdict for an abuse of
      discretion. Botek v. Mine Safety Appliance Corp., 531 Pa. 160,
      611 A.2d 1174, 1176 (1992). Judicial reduction of a jury award
      is appropriate only when the award is plainly excessive and
      exorbitant. Haines v. Raven Arms, 536 Pa. 452, 640 A.2d 367,
      369 (1994).

      The refusal of a remittitur is peculiarly within the discretion of the
      trial court and will not be reversed absent an abuse of discretion
      or error of law. Id., citing Scaife Co. v. Rockwell–Standard
      Corp., 446 Pa. 280, 285 A.2d 451, 456–57 (1971).

Bailets v. Pennsylvania Tpk. Comm'n, 181 A.3d 324, 336 (Pa. 2018).

      Appellants contend that such precepts should guide this Court to find

that the verdict in the present case is so excessive relative to the harm

suffered that a remittitur would effectively “destroy the jury’s verdict,” thus

necessitating a retrial.     See Guess v. Maury, 726 S.W.2d 906, 912

(Tenn.Ct.App. 1986).

      Appellants note that, under Tennessee law, “[w]hen asked to determine

whether a verdict should be set aside based on the amount of the damages

award alone, the courts must consider the nature and extent of the plaintiff’s

injuries, the pain and suffering the plaintiff experienced, the expenses the

plaintiff incurred as a result of the injuries, the impact the injuries have had

on the plaintiff’s enjoyment of life, and the plaintiff’s age and life expectancy.”

Duran    v.   Hyundai      Motor   America,    Inc.,   271   S.W.3d    178,    212

(Tenn.Ct.App. 2018).


                                      - 44 -
J-A19031-19



      “Gynecomastia[,]”       Appellants   submit,   “is   not   a   life-threatening

condition, and Plaintiffs presented no evidence of physical pain and suffering.”

Appellants’ brief, at 54. While surgical correction of gynecomastia is possible,

Plaintiffs/Appellees did not choose to pursue this option. Appellants further

stress that Plaintiffs/Appellees similarly presented no evidence of economic

damages, hospital bills, and did not argue that gynecomastia would affect

A.Y.’s future earnings. Id.

      Thus essentially limited to psychological and emotional, non-economic

damages, Appellants continue, Plaintiffs/Appellees’ award of $70,000,000 was

grossly disproportionate to the evidence.       Appellants maintain the extent of

such evidence was that A.Y. was bullied at school and work, teased, and never

went outside without a shirt. They conclude such a proffer simply did not

support a compensatory damages award nearly 30 times larger than the next

largest compensatory verdict in Philadelphia, $2,500,000 in Pledger v.

Janssen Pharmaceuticals, Inc., 198 A.3d 1126 (Pa.Super. 2018).

      The trial court opines that the verdict was not excessive, as the jury was

free to infer from the evidence that A.Y.’s pain and suffering, embarrassment,

loss of enjoyment of life, and the inability to engage in normal activities in the

future was considerable.      In that vein, the court notes that the jury was

charged to consider both economic and non-economic damages, and

Tennessee law holds that a “jury has wide latitude in assessing non-economic

damages.” Meals ex rel. Meals, 417 S.W.3d at 425.




                                       - 45 -
J-A19031-19



      Indeed, the court notes, the jury charge instructed the jury that “no

definite standard or method of calculation is prescribed by law by which to fix

reasonable    compensation    for   pain   and   suffering,   permanent   injury,

disfigurement, and the loss of enjoyment of life, nor is the opinion of any

witness required as to the amount of such reasonable compensation.” Trial

Court Opinion, at 92 (quoting N.T. 6/30/16, at 175-76). Because the courts

have recognized that such damages are not easily quantified and do not lend

themselves to easy valuation, the amount of these damages is appropriately

left to the sound discretion of the jury. Id. (quoting Duran, 271 S.W.3d at

210-211).

      We discern no reversible error with the jury’s award of damages, as we

do not view it as inconsistent with the evidence. A.Y. was just 4 ½ years old

when first prescribed Risperdal, and he has never since known life without

gynecomastia. At sixteen years of age when the jury considered its award,

A.Y. was living with severe and permanent disfigurement. The undisputed

record confirms he has been routinely bullied and teased by peers and is too

humiliated to ever remove his shirt in recreational or social situations where

it would be customary for boys to do so when enjoying ordinary pleasures of

youth.

      The jurors were free to call upon their personal experiences and

sensibilities to assess such intangible harms, and their valuation could reflect

the length of time A.Y. would reasonably be expected to live with this




                                     - 46 -
J-A19031-19



disfiguring, embarrassing condition.      Under such facts, the jury exercised

sound discretion. Accordingly, we will not disturb the damages award.

                           APPELLEES’ CROSS-APPEAL

      In Appellees’ cross-appeal, they contend the trial court erred by granting

Janssen’s motion for partial summary judgment on Appellees’ claim for

punitive damages. In entering its global order granting summary judgment

as to all plaintiffs in the Risperdal litigation, the trial court determined that

New Jersey had a greater interest than Pennsylvania in the application of its

law on the issue of punitive damages, and the New Jersey Products Liability

Act does not permit Plaintiffs to recover punitive damages.

      This   Court   has   subsequently    considered   the   trial   court’s   two

determinations in Murray v. Janssen Pharmaceuticals, Inc., 180 A.3d

1235 (Pa.Super. 2018), Stange, 179 A.3d at 49-50, and Pledger, 198 A.3d

1126 and held in each that we were required to remand for the trial court to

consider conflict-of-law principles with respect to New Jersey and the

respective plaintiff’s home state, which it had not done. See Stange, 179

A.3d at 66-67 (remanding for consideration of conflict between Wisconsin and

New Jersey); Murray (180 A.3d at 1248-49 (remanding for consideration of

conflict between Maryland and New Jersey); Pledger, 198 A.3d at 1148

(remanding for consideration of conflict between Alabama and New Jersey).

      Here, Appellees present the same arguments made by the plaintiffs in

the aforementioned cases, and both parties agree the decisions by our Court

remain binding precedent.     See Marks v. Nationwide Ins. Co, 762 A.2d

                                     - 47 -
J-A19031-19



1098, 1101 (Pa.Super. 2000) (acknowledging as long as a decision by this

Court has not been overturned by our Supreme Court, it remains binding

precedent). Thus, as we have done previously, we reverse the order of the

trial court granting partial summary judgment in favor of Janssen and remand

for proceedings consistent with those in Stange, Murray, and Pledger.

      Judgment affirmed in part, reversed in part, and remanded for

proceedings wherein the trial court shall consider conflict of law principles with

respect   to   Tennessee    and    New    Jersey   and   how    they    bear   on

Plaintiffs/Appellees’ punitive damages claim. Jurisdiction relinquished.


Judgment Entered.




Joseph D. Seletyn, Esq.
Prothonotary



Date: 11/26/19




                                     - 48 -
