Court Opinion

ID: 4326335
Source: CourtListenerOpinion
Date Created: 2018-10-31 20:38:17.961537+00
Date Added: 2024-06-11T14:19:39.007207
License: Public Domain

J-A18037-18

                             2018 PA Super 398

PHILLIP PLEDGER, BY BENITA               :     IN THE SUPERIOR COURT OF
PLEDGER, AS GUARDIAN OF HIS              :           PENNSYLVANIA
PERSON AND CONSERVATOR OF HIS            :
ESTATE,                                  :
                                         :
                Appellee                 :
                                         :
               v.                        :
                                         :
JANSSEN PHARMACEUTICALS, INC.,;          :
JOHNSON & JOHNSON; AND JANSSEN           :
RESEARCH & DEVELOPMENT, LLC,             :
                                         :
               Appellants                :     No. 2088 EDA 2016

              Appeal from the Judgment Entered June 8, 2016
            in the Court of Common Pleas of Philadelphia County
              Civil Division at No(s): April Term, 2012 No. 1997

PHILLIP PLEDGER, BY BENITA               :     IN THE SUPERIOR COURT OF
PLEDGER, AS GUARDIAN OF HIS              :           PENNSYLVANIA
PERSON AND CONSERVATOR OF HIS            :
ESTATE,                                  :
                                         :
               Appellant                 :
                                         :
                     v.                  :
                                         :
JANSSEN PHARMACEUTICALS, INC.,           :
JOHNSON & JOHNSON CO., AND               :
JANSSEN RESEARCH &                       :
DEVELOPMENT, LLC,                        :
                                         :
               Appellees                 :     No. 2187 EDA 2016

              Appeal from the Judgment Entered June 8, 2016
            in the Court of Common Pleas of Philadelphia County
                Civil Division at No(s): 1997 April Term, 2012

BEFORE: STABILE, J., STEVENS, P.J.E.* and STRASSBURGER, J.**

* Former Justice specially assigned to the Superior Court.

** Retired Senior Judge assigned to the Superior Court.
J-A18037-18

OPINION BY STRASSBURGER, J.:                       FILED OCTOBER 31, 2018

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

and Johnson & Johnson Company (collectively, Janssen)1 appeal from the

judgment of $2.5 million entered on June 8, 2016, after a jury found in favor

of Phillip Austin Pledger (Austin), and his mother, Benita Pledger (collectively,

the Pledgers), and against Janssen in this pharmaceutical failure to warn case.

In addition, the Pledgers appeal from the July 11, 2014 order granting partial

summary judgment in favor of Janssen on the Pledgers’ punitive damages

claim.2   After review, we affirm in part, reverse in part, and remand for

proceedings consistent with this opinion.

      We provide the following background.       Austin was born in 1994.     In

2000, Austin, who was living with his parents about an hour outside of

Birmingham, Alabama, was diagnosed as having autism.3 “In April 2002, Mrs.

Pledger took Austin to meet Dr. Jan Mathisen, a pediatric neurologist in

1“Janssen Pharmaceuticals, Inc. and Janssen Research & Development, LLC,
are wholly owned companies of Johnson & Johnson.” Murray v. Janssen
Pharmaceuticals, Inc., 180 A.3d 1235, 1238 n.1 (Pa. Super. 2018). For
ease of discussion, we will refer to these entities collectively as Janssen.
2 The Pledgers have filed an application for leave to file a post-submission
communication. Janssen has filed a response to that motion setting forth
objections. Upon review of the motion and response, and based upon our
conclusions infra, we deny the application as moot. The information provided
in the motion was not used, nor was it needed, to aid us in our disposition.
3 “Autism is a developmental disorder that impairs the ability of a child to
communicate. It also results in impairment in social interactions, and it can
cause a lot of behavioral issues.” N.T., 1/26/2015 (p.m.), at 38.

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Birmingham[,]” in an effort to “relieve behavioral symptoms including temper

tantrums.” Trial Court Opinion, 8/11/2017, at 3; see N.T., 1/26/2015 (p.m.),

at 44. Dr. Mathisen first saw Austin on April 22, 2002, and Dr. Mathisen and

Mrs. Pledger discussed Austin’s autism diagnosis and the potential for

medication that may help him. At Austin’s next visit, on June 17, 2002, Dr.

Mathisen prescribed Risperdal4 to Austin.5 Dr. Mathisen warned Mrs. Pledger

“that weight gain was possible” as a side effect of taking Risperdal. Trial Court

Opinion, 8/11/2017, at 4 (citing N.T., 1/26/2015 (p.m.), at 57. Mrs. Pledger

believed, however, that “this [risk] was acceptable because she thought

[weight gain] could be mitigated by diet.” Id.

      Austin did indeed gain weight, and Mrs. Pledger noticed that about two-

and-a-half months after Austin began taking Risperdal, he “started getting

heavy around his nipples.” N.T., 2/6/2015 (a.m.), at 71. A 2005 photograph

4 Risperdal, also known by its generic name, risperidone, is an “atypical
antipsychotic []. It was initially released for the treatment of schizophrenia in
adults with psychosis, and then that evolved into treatment of bipolar
disorders, and then eventually it was approved for the use in children with
autism.” N.T., 1/26/2015 (p.m.), at 43. Risperdal was developed, marketed,
and sold through Janssen.
5 Risperdal was not approved by the Federal Drug Administration (FDA) for
use in children in 2002. However, according to Dr. Mathisen, such “off-label”
use began happening within a few years of Risperdal’s release into the market
in 1993. N.T., 1/26/2015 (p.m.), at 43. Dr. Mathisen testified that he was
among “a large group of pediatric practitioners who were using [Risperdal] to
treat children with a variety of conduct disorders.” Id. at 54. Risperdal was
approved for use for children with autism in October 2006.

                                      -3-
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of Austin with his shirt off reveals enlargement in his chest area. See Plaintiff’s

Exhibit 71.

      Around November 2006, Mrs. Pledger sought to switch Austin to a

different doctor, Dr. Donald Paoletti. Dr. Paoletti discontinued Austin’s use of

Risperdal in April 2007. The last time Austin saw Dr. Mathisen was in October

of 2006, and Dr. Mathisen’s last refill for Austin’s Risperdal occurred on

January 19, 2007.

      Around October 2011, Mrs. Pledger saw a commercial on television

about the potential for Risperdal to cause a condition called gynecomastia.6

She called the telephone number for the law firm on the television, and then

sent in pictures of Austin as she was asked to do. It was at that time she

learned that there may be a connection between Austin’s Risperdal use and

his large breasts.

      In April 2012, the Pledgers filed a complaint against Janssen, which

included claims asserting inter alia, Janssen’s negligence in failing to warn

physicians and patients that Risperdal could cause gynecomastia.7             That

6 Gynecomastia is “a condition where female breast tissue grows in males.”
Murray, 180 A.3d at 1238. Gynecomastia can be caused by an increase in
levels of the hormone prolactin (hyperprolactinemia), which can lead to the
development of breast tissue in males.
7 The Pledgers’ case was filed in Philadelphia County, and coordinated with
Philadelphia’s Complex Litigation Center as a member case in the mass tort
program captioned at In re Risperdal Litigation, March Term 2010, No. 296.
“[Austin] is one of over 5,500 claimants from around the country who chose
to file suit in the Court of Common Pleas of Philadelphia County…. All of the
cases in this mass tort involve male plaintiffs who allege they have developed

                                       -4-
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complaint also contained a count for punitive damages.           On February 10,

2014, Janssen filed a global motion for partial summary judgment with respect

to several of the claims common to all cases, including the punitive damages

claim. On July 11, 2014, the trial court granted partial summary judgment on

inter alia, the punitive damages claim as to all cases.

        Austin’s case proceeded to a jury trial beginning January 20, 2015, and

did not conclude until February 24, 2015. There were numerous issues in the

case, all of which were vigorously contested by both the Pledgers and Janssen.

By way of overview, the Pledgers sought to prove that Janssen “had

discovered a significant risk of gynecomastia among boys who ingested

Risperdal for eight through twelve weeks and had demonstrated elevated

prolactin levels while taking the drug.”8 Trial Court Opinion, 8/11/2017, at 5.

According to the Pledgers, despite Janssen knowing that information, it did

not communicate this risk to the FDA or to doctors prescribing Risperdal. In

support of this claim, the Pledgers presented testimony of their expert, Dr.

David Kessler, Federal Drug Administration (FDA) commissioner from 1991-

1997.

        Dr. Kessler testified that data collected at Table 21 showed [a]
        statistically significant side effect among children taking Risperdal
        between 8 and 12 weeks. In Dr. Kessler’s opinion, Table 21

gynecomastia as a result of ingesting Risperdal.” Stange v. Janssen
Pharmaceuticals, Inc., 179 A.3d 45, 49-50 (Pa. Super. 2018).

8 As part of their evidence, the Pledgers presented a study by Janssen that
“was summarized in a chart known at trial as ‘Table 21’ and marked into
evidence as P34(A).” Trial Court Opinion, 8/11/2017, at 5.

                                        -5-
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     showed that children taking Risperdal within this time period, and
     had elevated prolactin levels, were 7.8 percent more likely to
     develop gynecomastia than children taking Risperdal whose
     prolactin level had remained normal.

Id. at 5-6 (citing N.T., 1/29/2015 (p.m.), at 30-35).

     Janssen acknowledged that Table 21 was never shared with the FDA.

N.T., 2/11/2015 (p.m.), at 114.     Moreover, because this information was

never shared with the FDA, and was not on Risperdal’s label in 2002 at the

time Dr. Mathisen prescribed Risperdal to Austin, Dr. Mathisen believed “any

association between Risperdal and gynecomastia was rare” and never checked

“Austin’s prolactin levels” or examined him for gynecomastia. Trial Court

Opinion, 8/11/2017, at 6 (citing N.T., 1/26/2015 (p.m.), at 104).         Dr.

Mathisen further testified that “he would have discussed the relationship

between Risperdal and gynecomastia with Mrs. Pledger had he known of the

data in Table 21.” Id. In addition, Mrs. Pledger testified that had she known

about the risk of gynecomastia, she would not have permitted Austin to take

Risperdal. N.T., 2/6/2015 (a.m.), at 58-59.

     Janssen also vigorously contested causation; in other words, Janssen

claimed that Austin’s large chest area was not caused by his taking Risperdal.

In order to prove that Austin did indeed have gynecomastia caused by

Risperdal, the Pledgers presented the testimony of Dr. Mark Solomon.9

9It is the series of events leading up to Dr. Solomon’s testimony, along with
Dr. Solomon’s testimony itself, that form the primary basis of this appeal.
These issues will be discussed in detail infra.

                                    -6-
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           Dr. Solomon explained his medical opinion that the
     diagnosis of [] gynecomastia depends on the presence of breast
     tissue and he explained that breast tissue is biologically not the
     same as fat tissue. He showed the jury the difference using
     medical slides. Dr. Solomon stated breast tissue growth does not
     go away on its own since it does not come from obesity which is
     characterized by fat cells that grow and recede depending on
     weight. Dr. Solomon testified that his own physical examination
     of Austin confirmed the presence of breast tissue inside Austin’s
     breasts. Dr. Solomon said Austin had been on Risperdal for
     several years and his medical records had reported no other
     causal agent. He said female breasts in boys develop from the
     center and then spread outwards. The areola grows first and then
     breast tissue multiplies around the areola to form gynecomastia.
     Dr. Solomon told the jury that a picture of Austin shows what he
     termed “end stage growth.” Pointing at the 2005 picture of 11[-
     ]year[-]old bare[-]chested Austin coming out of a swimming pool,
     Dr. Solomon testified, “That’s a full breast. That’s not a little
     nipple out pouch. In 2005, he was 11 that would be the beginning
     of puberty. So if it were pubertal in origin, you would see a little
     pouch of a nipple, not an outline of a breast.” (N.T., 2/9/[20]15,
     [at] 66.)

Trial Court Opinion, 8/11/2017, at 27-28.

     Janssen conceded that Austin had gynecomastia, but also contended

that Austin had a condition called pseudogynecomastia, “a disease category

diagnosed by some physicians who link obesity and fat to the development of

feminine looking breasts in boys.” Id. at 28. According to defense expert, Dr.

Tom Vaughn, III, an endocrinologist, Austin had both gynecomastia and

pseudogynecomastia. N.T., 2/18/2015 (a.m.), at 105. Dr. Vaughn testified

that pseudogynecomastia is “obesity … in the chest, and sometimes it can look

very much like breast tissue.” Id. at 104. Dr. Vaughn stated that Risperdal

caused Austin’s weight gain, which caused his pseudogynecomastia. Id. at

107. In addition, Dr. Vaughn testified that he could not tell from the 2005

                                    -7-
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picture whether Austin had gynecomastia or pseudogynecomastia at that

point. N.T., 2/18/2015 (p.m.), at 13.

      In addition to the foregoing, Janssen suggested that even if Austin’s

large chest area at that time were gynecomastia, it was not caused by

Risperdal. Dr. Vaughn testified that Austin’s gynecomastia was not caused by

Risperdal, but instead was caused by puberty. N.T., 2/18/2015 (p.m.), at 33-

37.

      On the other hand, the Pledgers relied upon Dr. Solomon’s testimony.

He testified that

      to a reasonable degree of medical certainty … Austin’s ingestion
      of Risperdal caused his gynecomastia. … Dr. Solomon said he
      based his causation opinion in part by performing a differential
      diagnosis and told the jury why he ruled out other causes. Dr.
      Solomon testified that in his opinion gynecomastia does not
      develop in pre-puberty boys absent an abnormality caused by
      disease or an outside agent such as a medication. Reviewing
      Austin’s medical records, Dr. Solomon saw no evidence of a
      disease causing Austin’s gynecomastia. He specifically ruled out
      other known causes which were not present in Austin’s medical
      history including the absence of Kl[ine]felter’s syndrome, thyroid
      abnormality, or either pituitary or testicular tumors. “Absent
      another cause, another drug, another tumor, another kind of
      anything, a normal 8[-]year[-]old boy has a zero incidence of
      gynecomastia.” (N.T., 2/9/[20]15, [at] 106 []).

            Dr. Solomon testified that in his medical opinion, based on
      all the evidence before him, Risperdal was the only remaining
      variable and he told the jury why:

            [S]o, briefly, Risperdal is a drug that among its side
            effects, it’s a stimulant of prolactin which is this
            hormone that we talked about briefly that’s secreted
            by the pituitary gland and acts on the breast tissue.

                                    -8-
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                   He was exposed to this drug at the age of 8. If
            you review literature, in 8 to 12 weeks from exposure
            to the drug, prolactin goes up, significantly. And his
            response to that significant rise, time related
            according to his mom, was the development of some
            breast buds which she didn’t rightfully connect,
            because she wouldn’t. He stayed on that drug for five
            years. I believe until 2007. So that he had a constant
            stimulus with elevations in prolactin for some
            prolonged period of time that we can – I’m sure
            occurred. I have no reason not to think it occurred
            because of my knowledge of the drug, and therefore,
            it stimulated his breasts to grow.

Trial Court Opinion, 8/11/2017, at 26-27 (quoting N.T., 2/9/2015 (a.m.), at

104-105).

      Finally, Janssen suggested that even if Austin had gynecomastia that

was caused by Risperdal, Dr. Mathisen was primarily at fault because the label

for Risperdal revealed that ingestion could increase prolactin levels.10 While

Janssen acknowledges that the label in 2002 stated that gynecomastia was

“rare,” that label also stated that Risperdal increased prolactin levels. See

Plaintiff’s Exhibit 10; N.T., 1/26/2015 (p.m.), at 120.   Thus, according to

Janssen, Dr. Mathisen had sufficient knowledge to discuss this risk with Mrs.

Pledger prior to prescribing Risperdal for Austin.

      Nevertheless, on February 24, 2015, the jury returned a verdict in favor

of the Pledgers, concluding that Janssen was negligent in not adequately

warning Dr. Mathisen about the risk of gynecomastia to Austin from his taking

10 This defense, known as the “learned intermediary doctrine,” will be
discussed in greater detail infra.

                                     -9-
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Risperdal, and that this negligence was a cause of Austin’s gynecomastia. The

jury awarded Austin $2.5 million in damages. Janssen timely filed post-trial

motions, which were denied on May 4, 2016. The Pledgers entered judgment

on June 8, 2016, and both Janssen and the Pledgers timely filed notices of

appeal. The trial court filed its opinion on August 11, 2017.11

Appeal of Janssen

      On appeal, Janssen presents several issues for our review. See

Janssen’s Brief at 6-7. We begin with Janssen’s contention that the trial court

erred in denying judgment notwithstanding the verdict (JNOV) because the

Pledgers “failed to prove that any alleged inadequacy in Risperdal’s labeling”

caused Austin’s gynecomastia. Id. at 41. In considering this issue, we set

forth the following. “The standard which we employ when reviewing the denial

of a motion of directed verdict and a motion for [JNOV] is the same. We will

reverse the [trial] court when we find an abuse of discretion or an error of law

that controlled the outcome of the case.” Jones v. Constantino, 631 A.2d

1289, 1292 (Pa. Super. 1993).

            We will review all of the evidence in the light most favorable
      to the verdict-winner and will give that party the benefit of every
      reasonable inference arising from that evidence while rejecting all
      unfavorable testimony and inferences. [JNOV] may be entered
      where: (1) the moving party is entitled to judgment as a matter
      of law and/or (2) the evidence is such that no two reasonable
      minds could disagree that the verdict should have been rendered
      for the moving party. Our scope of review is plenary concerning
      any questions of law. Regarding questions of credibility and the

11The trial court did not order the parties to file concise statements of errors
complained of on appeal pursuant to Pa.R.A.P. 1925(b).

                                     - 10 -
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      weight accorded the evidence at trial, however, we will not
      substitute our judgment for that of the fact-finder. [JNOV] should
      be entered only in a clear case, and any doubts must be resolved
      in favor of the verdict winner.

Murray, 180 A.3d at 1241 (internal quotation marks omitted).

      Under Alabama law,12 in a pharmaceutical failure to warn case as in any

negligence case, a “plaintiff bringing such an action must establish: (1) that

the defendant had a duty; (2) that the defendant failed to provide adequate

warnings of the hazards of a particular product, thereby breaching that duty;

(3) that the breach was the proximate cause of the plaintiff’s harm; [and] (4)

that the plaintiff suffered injury as a result.” Bodie v. Purdue Pharma Co.,

236 F. App’x 511, 518 (11th Cir. 2007) (applying Alabama law).

      Here, Janssen does not contest the fact that it owed a duty to the

Pledgers. However, at trial and on appeal, Janssen contends that it did not

breach that duty.    In considering a breach of duty in the context of a

pharmaceutical failure to warn case, “Alabama courts follow the learned-

intermediary doctrine, and thus, a manufacturer’s duty to warn a consumer

about a drug is limited to an obligation to advise the prescribing physician of

any potential dangers that may result from the drug’s use.” Stephens v. Teva

Pharm., U.S.A., Inc., 70 F.Supp.3d 1246, 1253–54 (N.D. Ala. 2014) (internal

citations and quotation marks omitted). “Additionally, the plaintiffs must show

that the manufacturer failed to warn the physician of a risk not otherwise

12 The parties stipulated that Pennsylvania law governs procedure-related
issues in this case and Alabama law governs liability-related issues.

                                    - 11 -
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known to the physician and that the failure to warn was the actual and

proximate cause of the patient’s injury.” Id. at 1254. “Hence, the plaintiff

must show not only that an inadequate warning was given, but also that an

adequate warning would have prevented the injury.” Id.

      Janssen contends that it warned Dr. Mathisen adequately of the risks of

Risperdal. First, Janssen claims that “Dr. Mathisen was ‘well aware’ Risperdal

may elevate prolactin and potentially cause prolactin[-]related side effects like

gynecomastia.” Janssen’s Brief at 42.         Thus, according to Janssen, Dr.

Mathisen had all of the information he needed to warn the Pledgers, but he

failed to do so.

      “[T]he causal link between a patient’s injury and the alleged failure to

warn is broken when the prescribing physician had ‘substantially the same’

knowledge as an adequate warning from the manufacturer should have

communicated to him.” Christopher v. Cutter Labs., 53 F.3d 1184, 1192

(11th Cir. 1995). Here, the question then is whether the 2002 Risperdal label

adequately warned Dr. Mathisen of the risk of gynecomastia.

      At the time Dr. Mathisen first prescribed Risperdal to Austin, the warning

label stated that gynecomastia was “rare,” meaning it occurred “in fewer than

1/1000 [(.001%) of] patients.” See Plaintiff’s Exhibit 10. In addition, that

label provided that “[a]s with any other drugs that antagonize dopamine D

                                     - 12 -
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[sic] receptors, risperidone elevates prolactin levels and the elevation persists

during chronic administration.”13 N.T., 1/28/2015 (p.m.), at 23.

      At the time Dr. Mathisen initially prescribed Risperdal to Austin, Dr.

Mathisen had no reason to believe that Risperdal would have any different

effect on Austin’s prolactin level than any other drug in its class. This is clearly

not “substantially the same” knowledge that the risk of gynecomastia was 23

times what Dr. Mathisen reasonably believed it to be.          Thus, viewing the

testimony in the light most favorable to the Pledgers, we conclude that the

trial court did not err in denying JNOV on this basis.

      Janssen also contends that because Dr. Mathisen’s final refill for Austin

occurred in January of 2007, after the updated October 2006 label was

available, it was Dr. Mathisen’s failure to read the updated warning that

actually caused Austin’s gynecomastia. Janssen’s Brief at 43-44.                 In

considering this issue, we point out that Janssen’s own studies revealed that

it was the elevation in prolactin during weeks eight through twelve of

administration that was causally related to gynecomastia. See Trial Court

Opinion, 8/11/2017, at 5. By 2006, Austin was well beyond this point. In

fact, the 2005 photograph shown at trial reveals that Austin already had

13 By way of comparison, the 2006 label provided the following: “In clinical
trials in 1[,]885 children and adolescents with autistic disorder or other
psychiatric disorders treated with risperidone, … gynecomastia was reported
in 2.3% of risperidone-treated patients.” See Plaintiff’s Exhibit 10. In
addition, the label provided that “[r]isperidone is associated with higher levels
of prolactin elevation than other antipsychotic agents.” N.T., 1/28/2015
(p.m.), at 25.

                                      - 13 -
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increased breast size. See Plaintiff’s Exhibit 71. Accordingly, we conclude that

the trial court did not err in denying JNOV based upon Dr. Mathisen’s final refill

for Risperdal because the evidence viewed in the light most favorable to the

verdict-winner, the Pledgers, showed the damage from Risperdal had already

been done to Austin.

      Finally, Janssen argues it is entitled to JNOV because Dr. Mathisen still

prescribes Risperdal to minors today, even though the label has been updated

to identify the additional risks related to elevated prolactin and gynecomastia.

Janssen’s Brief at 42-43. However, the issue is whether an adequate warning

in 2002 would have changed Dr. Mathisen’s prescribing habits. Dr. Mathisen

testified specifically that if he were aware of the 2.3% risk of gynecomastia in

2002, it would not have been a rare event and “[h]e would have brought up

the potential for that problem.” N.T., 1/26/2015 (p.m.), at 80. In fact, Dr.

Mathisen testified that he tells patients about the risk of gynecomastia when

prescribing Risperdal today. Id. at 194, 207. Moreover, Mrs. Pledger testified

that had she been warned of this risk, she would not have permitted Austin to

take Risperdal. See N.T., 2/6/2015, at 58-59. Thus, the record supports the

conclusion that a different warning in 2002 would have changed Dr. Mathisen’s

prescribing behavior and the injury to Austin could have been prevented.

Therefore, we conclude the trial court did not err in denying JNOV in any

respect based upon the conduct of Dr. Mathisen.

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     We now turn to Janssen’s issues with respect to Dr. Solomon. See

Janseen’s Brief at 27-40. In doing so, we provide the following background.

In March of 2014, Dr. David E. Goldstein, “a pediatrician and endocrinology

specialist licensed in Missouri, examined Austin at the request” of his

attorneys. Trial Court Opinion, 8/11/2017, at 15.

           Dr. Goldstein met 19[-]year[-]old Austin and his parents on
     March 5, 2014[,] at a hotel in Birmingham, Alabama, not far from
     the family’s home. He examined Austin and diagnosed him with
     gynecomastia.     Austin’s parents gave Dr. Goldstein an oral
     medical history.

            On March 31, 2014, Dr. Goldstein signed an expert report
     based on the physical examination, the parents’ oral history,
     written medical records and deposition testimony. Dr. Goldstein’s
     report includes his opinion as an expert in pediatric endocrinology
     that “the treatment of children and adolescents with [r]isperidone
     causes gynecomastia”; that Austin has “very enlarged breasts
     primarily due to gynecomastia” and that Austin’s treatment with
     [r]isperidone between 2002 and 2007 is “a substantial
     contributing factor to the development of Austin’s gynecomastia.”

           The [law] firm disclosed Dr. Goldstein’s expert report to
     [Janssen’s] Philadelphia attorneys at Drinker Biddle within the
     case management time frame set by Judge Arnold L. New, Mass
     Torts Supervising Judge. Soon after, on April 16, 2014, Dr.
     Goldstein appeared for a deposition conducted by Janssen
     attorney and Drinker Biddle partner Thomas Campion, Esq. Mr.
     Campion asked Dr. Goldstein whether he was “practicing
     medicine” on March 5, 2014[,] when he examined Austin. Dr.
     Goldstein said that he was “hesitating” in saying he had not been
     “practicing medicine” but only because he had told Austin’s
     parents “a couple of things [he] would recommend they did, but
     not under [his] care, like go to your doctor and do this and do
     that.” (N.T. 4/16/[20]14, p. 43).

Trial Court Opinion, 8/11/2017, at 15-16 (some citations omitted).

                                   - 15 -
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      No issues were raised with respect to Dr. Goldstein’s competency to

testify during the period provided for in the case management order.

However, several days into trial,14 on the morning of Monday, February 2,

2015, one of Janssen’s attorneys, Kenneth Murphy, Esquire, explained to the

trial court that one of the Pledgers’ attorneys, Christopher Gomez, Esquire,

had emailed him on Saturday, January 31, 2015, stating that the Pledgers

intended to proceed with Dr. Goldstein’s trial testimony by way of deposition

de bene esse.15 N.T., 2/2/2015, at 5. The trial court ruled immediately that

it would not permit Dr. Goldstein to testify by deposition. Id.

      Janssen subsequently submitted to the trial court a bench memorandum

explaining why the trial court should exclude Dr. Goldstein’s testimony

altogether.16 See Reproduced Record, Vol. II., at 968a; Bench Memorandum,

14 By this time, motions in limine had been presented and decided, the jury
had been selected, opening statements had been given, and the jury had
heard testimony from Dr. Kessler and Dr. Mathisen. See N.T., 1/20/2015
through 1/30/2015.

15In other words, the Pledgers sent notice to Janssen that they intended to
present Dr. Goldstein’s testimony by taking a deposition for use at trial, rather
than bringing him to testify as a live witness.

16This bench memorandum is not included in the certified record; however,
there is a copy of it in the Reproduced Record. See Reproduced Record,
Volume II, at 968a. “While the general rule is that this Court generally may
consider facts only if they are duly certified in the record, we [have]
acknowledged that where the accuracy of a pertinent document is undisputed,
the Court could consider that document if it was in the Reproduced Record,
even though it was not in the record that had been transmitted to the Court.”
In re Fiedler, 132 A.3d 1010, 1027 (Pa. Super. 2016) (internal citations and
quotation marks omitted). Because neither party has disputed the accuracy

                                     - 16 -
J-A18037-18

2/2/2015.   According to Janssen, Dr. Goldstein violated Alabama law by

practicing medicine in Alabama without being licensed to do so when he

conducted an examination of Austin and gave the aforementioned medical

advice to Mrs. Pledger.

      According to Janssen, Alabama law provides that a doctor who is not

licensed in Alabama may only practice medicine in Alabama in consultation

with a physician licensed to practice medicine in Alabama. Id. at 2-3; Ala.

Code § 34-24-74. Janssen argued that Dr. Goldstein’s failure to comply with

Alabama law renders his examination improper, and therefore “the admission

of his testimony would undermine the integrity of the proceeding.” Id. at 5.

Jannsen also claimed that they did not raise this issue earlier because it did

not come to light until the Pledgers requested the de bene esse deposition.

N.T., 2/2/2015, at 130.

      According to the Pledgers, they requested the de bene esse deposition

to accommodate Dr. Goldstein’s schedule. Id. at 135. The Pledgers also

informed the court that Dr. Goldstein was now unwilling to testify because of

concern about his potential for criminal legal exposure, and he was unavailable

to the Pledgers because he had left Pennsylvania.         Thus, the Pledgers

requested that the trial court permit them to re-open discovery, have Austin

fly to Philadelphia with his father, and then be examined by a new expert. The

of the bench memorandum included in the reproduced record, we will consider
it.

                                    - 17 -
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trial court agreed to permit the Pledgers to switch experts mid-trial, and

Janssen objected and moved for a mistrial, which the trial court denied. Id.

at 149; N.T., 2/3/2015, at 11.

      Austin was then examined by Dr. Mark Solomon, a doctor familiar to

Janssen because Dr. Solomon was also an expert in another Risperdal case

that had just settled. Trial Court Opinion, 8/11/2017, at 20 n.23.            That

examination occurred, Dr. Solomon was deposed, and Dr. Solomon testified

live for the jury on Monday, February 9, 2015. At trial, Dr. Solomon testified

as discussed supra.

      On appeal, Janssen first argues that it is entitled to a new trial because

the trial court erred or abused its discretion by permitting the Pledgers to

substitute their expert mid-trial in violation of the rules of discovery. Janssen’s

Brief at 27-30. According to Janssen, Janssen “had nothing to do with Dr.

Goldstein’s refusal to testify and sudden unavailability; rather it was [Dr.

Goldstein’s] own failure to comply with Alabama law that presumably caused

him to flee Pennsylvania.” Id. at 27. Thus, Janssen contends the trial court

violated Pa.R.C.P. 4003.5(b) because Dr. Solomon was not disclosed as a

witness prior to trial. Id. at 28.

      “Our standard of review in denying a motion for a new trial is to decide

whether the trial court committed an error of law which controlled the outcome

                                      - 18 -
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of the case or committed an abuse of discretion.”17 Corvin v. Tihansky, 184

A.3d 986, 992 (Pa. Super. 2018). “The admission of expert testimony is a

matter within the sound discretion of the trial court, whose rulings thereon

will not be disturbed absent a manifest abuse of discretion.” Walsh v. Kubiak,

661 A.2d 416, 419 (Pa. Super. 1995) (en banc).        The rules for discovery of

an expert witness provide that

      [a]n expert witness whose identity is not disclosed in compliance
      with subdivision (a)(1) of this rule shall not be permitted to testify
      on behalf of the defaulting party at the trial of the action.
      However, if the failure to disclose the identity of the
      witness is the result of extenuating circumstances beyond
      the control of the defaulting party, the court may grant a
      continuance or other appropriate relief.

Pa.R.C.P. 4003.5(b) (emphasis added).

      Here, there is no question that Dr. Solomon was not disclosed to Janssen

within the appropriate timeframe. Thus, the first hurdle the Pledgers had to

overcome was to convince the trial court that the failure to disclose Dr.

17 To the extent Janssen suggests that any error in the trial court’s permitting
the substitution of experts would permit the entry of JNOV, it is incorrect. See
Janssen’s Brief at 25 (“The law required a verdict for [Janssen] …”.). An error
regarding the trial court’s decision to admit testimony based upon a discovery
violation, as Janssen suggests occurred here, would result in the granting of
a new trial. See Woodard v. Chatterjee, 827 A.2d 433, 440 (Pa. Super.
2003) (“If the trial court made an erroneous evidentiary ruling that caused
harm to the complaining party, the only remedy is to grant a new trial.”); see
also Brandon v. Peoples Natural Gas Co., 207 A.2d 843 (Pa. 1965)
(reversing trial court’s grant of JNOV where trial court determined evidence
had been erroneously admitted; relief was new trial, not JNOV, because court
cannot enter judgment on diminished record). Thus, we consider this
argument in that context.

                                     - 19 -
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Solomon was the “result of extenuating circumstances” beyond the Pledgers’

control. Id. The trial court offered the following.

      The timing of Janssen’s motion and nature of their accusation
      were extraordinary and seemed calculated for maximum surprise.
      If Janssen’s late motion were granted, [the Pledgers] would have
      no choice but move for a voluntary nonsuit. If the motion were
      denied, then Dr. Goldstein would likely choose to take the Fifth
      Amendment or testify with predictable damage to his credibility.
      Either way, if the motion had been filed before trial, there would
      not have been extraordinary prejudice to [the Pledgers] who
      would likely have moved for a continuance before undergoing the
      expense of trial.

Trial Court Opinion, 8/11/2017, at 34.

      The trial court’s conclusion that Janssen purposely waited until the

middle of trial to raise this issue is supported by the record. Despite Janssen’s

protestations to the contrary, it admitted it was aware of this Alabama law at

the time it hired its own expert. See Bench Memorandum, 2/2/2015, at 5 n.1

(“Indeed, mindful of the limitations of Alabama law, [Janssen] retained a local

Alabama endocrinologist to perform a physical examination of [Austin], rather

than use a previously retained out[-]of[-]state endocrinologist with whom

[Janssen] already had a relationship.”). Thus, we agree with the trial court

that it appears that the “timing of Janssen’s motion and nature of [its]

accusation were extraordinary and seemed calculated for maximum surprise.”

Trial Court Opinion, 8/11/2017, at 34.

      Accordingly, the trial court did not err or abuse its discretion in

permitting the Pledgers to change experts mid-trial due to “extenuating

circumstances beyond the control of” the Pledgers. Pa.R.C.P. 4003.5(b).

                                     - 20 -
J-A18037-18

Moreover, we conclude the relief granted by the trial court was appropriate

under the circumstances. See id; see also Rutyna v. Schweers, 177 A.3d

927, 936 (Pa. Super. 2018) (en banc) (holding trial court abused its discretion

by failing to grant continuance to plaintiffs in a medical malpractice case

“where, through no fault of their own, their expert was precluded from

testifying”). Here, the new expert, Dr. Solomon, was familiar to Janssen. The

Pledgers were willing to have Austin examined, a report prepared, and a

deposition taken in an expeditious manner at no cost to Janssen. Based on

the foregoing, we conclude there was no abuse of discretion or error of law

that would entitle Janssen to a new trial on this basis.18

      We now turn to Janssen’s next two contentions regarding Dr. Solomon.

First, Janssen argues that Dr. Solomon, a plastic surgeon, was not qualified

to opine on the causes of gynecomastia, and therefore the trial court erred on

this basis.19 Janssen’s Brief at 30.    In addition, Janssen contends that Dr.

Solomon’s methodology for diagnosing Austin with gynecomastia was not

“generally accepted by scientists in the relevant scientific community.”

Janssen’s Brief at 33 (citing Grady v. Frito Lay, 839 A.2d 1038 (Pa. 2003)).

18 Additionally, if there were a new trial on this basis, the Pledgers would have
more than enough time to obtain either Dr. Solomon or a new expert
altogether to testify on the Pledgers’ behalf.

19Again, it appears that Janssen contends the trial court erred in denying
JNOV. However, the remedy for trial court error based upon the admission of
improper expert testimony is a new trial. See Cummins v. Rosa, 846 A.2d
148, 150 (Pa. Super. 2004).

                                       - 21 -
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      This Court recently considered similar arguments by Janssen in Stange,

179 A.3d at 53, and concluded the following.20

            According to Janssen, Dr. Solomon failed to meet the
      standard set forth in Frye v. United States, 293 F. 1013
      (D.C.Cir. 1923), for admission of expert testimony. We disagree.

                   As we held [ ] in Trach v. Fellin, 817 A.2d 1102
            (Pa. Super. 2003) [(en banc)], the Frye test sets forth
            an exclusionary rule of evidence that applies only
            when a party wishes to introduce novel scientific
            evidence obtained from the conclusions of an expert
            scientific witness. Trach, 817 A.2d at 1108–1109.
            Under Frye, a party wishing to introduce such
            evidence must demonstrate to the trial court that the
            relevant scientific community has reached general
            acceptance of the principles and methodology
            employed by the expert witness before the trial court
            will allow the expert witness to testify regarding his
            conclusions. [Trach,] 817 A.2d at 1108–1109, 1112.
            However, the conclusions reached by the expert
            witness from generally accepted principles and
            methodologies need not also be generally accepted.
            Id. [at] 817 A.2d at 1112. Thus, a court’s inquiry into
            whether a particular scientific process is “generally
            accepted” is an effort to ensure that the result of the
            scientific process, i.e., the proffered evidence, stems
            from “scientific research which has been conducted in
            a fashion that is generally recognized as being sound,
            and is not the fanciful creations [sic] of a renegade
            researcher.” See id., 817 A.2d at 1111 (quoting Blum
            v. Merrell Dow Pharms., Inc., 764 A.2d 1, 5 ([Pa.]
            2000) (Cappy, C.J., dissenting)).

20 Stange is also a member case in the In Re: Risperdal Litigation, March
Term 2010 No. 296. The plaintiff was prescribed Risperdal for his Tourette
Syndrome from January 2006 to 2009 and developed gynecomastia. After a
jury trial, damages were awarded to Stange. Janssen appealed to this Court,
and on appeal, complained inter alia, that “the trial court erred in admitting
expert testimony of Dr. Mark Solomon” because his “methodology, as applied,
was not generally accepted in the relevant field, and that his conclusions were
speculative.” Stange, 179 A.3d at 52.

                                    - 22 -
J-A18037-18

     Reading Radio, Inc. v. Fink, 833 A.2d 199, 208 (Pa. Super.
     2003) [] (emphasis deleted).

                 [A]s to the standard of appellate review that
           applies to the Frye issue, we have stated that the
           admission of expert scientific testimony is an
           evidentiary matter for the trial court’s discretion and
           should not be disturbed on appeal unless the trial
           court abuses its discretion. An abuse of discretion may
           not be found merely because an appellate court might
           have reached a different conclusion, but requires a
           result of manifest unreasonableness, or partiality,
           prejudice, bias, or ill-will, or such lack of support so
           as to be clearly erroneous.

     Grady[, 839 A.2d at 1046]. “[W]e emphasize that the proponent
     of expert scientific evidence bears the burden of establishing all of
     the elements for its admission under Pa.R.E. 702, which includes
     showing that the Frye rule is satisfied.” Id. at 1045. “[I]n applying
     the Frye rule, we have required and continue to require that the
     proponent of the evidence prove that the methodology an expert
     used is generally accepted by scientists in the relevant field as a
     method for arriving at the conclusion the expert will testify to at
     trial.” Id.

          Dr. Solomon is a plastic and reconstructive surgeon with
     extensive experience operating on the breast. He is familiar with
     gynecomastia and has diagnosed and operated on young men with
     that condition. Dr. Solomon used differential diagnosis, a
     generally accepted scientific process, to conclude that Risperdal
     caused Stange’s gynecomastia. Dr. Solomon explained,

                 Let’s break it down. First, I think you asked me
           the relationship between Risperdal as an agent
           creating a rise in prolactin, and that’s very well-
           documented.

                  Prolactin is a hormone secreted by the pituitary
           gland. I’m not sure if the jury heard about all of this.
           Pituitary gland is a gland that sits in your brain, and
           we know [Stange’s] pituitary was normal because he
           had an MRI before he started on the medication.

                                    - 23 -
J-A18037-18

                I think that’s important, as we talk about this
           process.

                So Risperdal is well-known to stimulate the
           production of this hormone, prolactin. Prolactin has
           several ways it acts on the breast.

                 It will cause the breast to grow. Then, in
           women—and in men, it can do this too—it will cause
           the breasts to secret[e] milk. That’s the direct effect.

                 There’s also an indirect effect that’s discussed,
           where it suppresses the testosterone, which boosts
           estrogen, which also acts upon the breast almost
           synergistically, meaning, the two together are a
           bigger punch than either one alone.

                 So if you look at the data, what I see, the
           internal documents are also published, but the
           internal documents break down in a graphic way,
           patient takes the drug. Prolactin goes up and typically,
           at a period after some weeks of exposure to the drug,
           patient starts developing breasts.

                 There are table after table of these [sic] history
           of Tim, where he was given the drug in ’06. [Stange’s]
           Mom talks about change … in ’06. We have photos in
           ’07 that are certainly consistent with gynecomastia,
           even though no one had made a diagnosis. It’s plain
           as day.

                 This is all consistent with that, plus the history,
           plus the subsequent finding of breast tissue, is all
           consistent with the fact that Risperdal was the
           insinuating agent to elevate prolactin, which has a
           direct effect on breast tissue which gave [Stange]
           gynecomastia[].

            There is nothing scientifically novel about using differential
     diagnosis to conclude that Stange’s gynecomastia was caused by
     Risperdal. Certainly differential diagnosis is a generally accepted
     methodology; indeed, Janssen does not dispute the validity of
     differential diagnosis generally. See Cummins, [] 846 A.2d [at]
     151 [] ([holding] Frye did not apply where the methodology

                                    - 24 -
J-A18037-18

     employed by the plaintiffs’ medical experts was generally
     accepted among the medical community for diagnosis and
     treatment; plaintiffs’ experts analyzed plaintiff-wife’s medical
     records and relied upon their personal expertise to reach a
     conclusion regarding the source of her injuries).

           Janssen complains that Stange’s prolactin levels were never
     tested while he was taking Risperdal and that Dr. Solomon could
     not rule out puberty as the cause of Stange’s gynecomastia.
     However, Dr. Solomon testified that prolactin testing was not
     necessary in order to render an opinion within a reasonable degree
     of medical certainty that Risperdal was responsible for Stange’s
     gynecomastia:

                Because in anywhere from 25 times the control
          to up to 80 some percent of patients, depending upon
          the doses of Risperdal, prolactin goes up. In all the
          agents of this class of drugs, Risperdal is the greatest
          offender at increasing prolactin.

                 So as part of my job as a physician is to take a
          set of the facts and come to a conclusion. If I can get
          an ancillary test—and it’s easy to get, you can
          certainly get it—part of the thing that most of us are
          taught is it’s not going to change our opinion. It’s not
          even essential to do it.

               Here, we have a young man on a drug known to
          cause prolactin elevations who has gynecomastia.

                On top of that, there’s no—nothing in the
          package insert that says you should follow it along.
          Whereas certain drugs, they say you should check a
          blood sugar, a potassium, those are in that big red
          book there, the Physicians Desk Reference, package
          incident [sic].

                 We can make a diagnosis using our fundamental
          knowledge as physicians and be absolutely certain
          that it’s a clear correlation between taking the drug,
          prolactin, breast growth.

     See [] [T]rial [C]ourt [O]pinion, 5/23/[20]16 at 22–23
     (“However, [Janssen] knew that Risperdal elevated prolactin and

                                   - 25 -
J-A18037-18

     chose not to recommend that prescribing doctors monitor
     prolactin levels of patients taking their medication. […] Now
     [Janssen] wish[es] to benefit from their own concealment by
     alleging that [Stange’s] doctors’ differential diagnosis is
     insufficient because of a failure to perform prolactin monitoring.”).

           Regarding pubertal changes, Dr. Solomon was able to rule
     that out in this case because Stange’s breast tissue was extensive,
     remained after puberty, and was not affected by weight gain or
     loss:

                 So yes, there’s something called pubertal
           gynecomastia. The time cause is self-limited. That’s
           the majority of patients that I see as a plastic
           [surgeon] who are adolescents, boys with breasts.

                 We encourage the family to be patient, because
           we know that pubertal gynecomastia will resolve with
           time and age. The breast tissue as the hormonal
           environment changes in puberty. That stimulus goes
           away, the breast tissue goes away.

                 That’s    the    vast   majority  of    puberty
           gynecomastia. A small percentage may exist. But in a
           circumstance where you have a patient who took a
           drug that’s known to be an offending agent, developed
           breast tissue in a reasonable time course in relation
           to that agent, lost his pubescent changes, his weight
           sort of went up and went down, but the breast tissue
           remained.

                 And the breast tissue, as I have said before, was
           dysmorphic, in excess of his body shape. The cause of
           his gynecomastia was the drug, without a doubt in my
           mind.

           Janssen’s arguments really go to weight and not
     admissibility. As stated above, differential diagnosis is a standard
     well-established methodology and is routinely used by doctors.
     The weight to be afforded Dr. Solomon’s testimony and whether
     to accept his conclusions was for the jury. The trial court did not
     abuse its discretion in permitting Dr. Solomon to testify regarding
     causation.

                                    - 26 -
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Stange, 179 A.3d at 53–56 (some citations omitted).

      With this background in mind, we turn to Janssen’s arguments in this

case. We begin with Janssen’s contention that even though

      Dr. Solomon is a board-certified plastic surgeon[,] … [that] may
      permit him to diagnose gynecomastia in an appropriate clinical
      setting, or to testify about treatment options, he is not qualified
      to offer an expert opinion about the causes of gynecomastia
      generally or in an individual.        That would be within an
      endocrinologist’s expertise, as Dr. Solomon conceded.

Id. (emphasis in original).

      During voir dire, Dr. Solomon was questioned about his experience in

diagnosing gynecomastia. He testified that he had “diagnosed patients with

drug-induced gynecomastia.” N.T., 2/9/2015 (a.m.), at 28. When asked “why

it is necessary to understand the … endocrine system” when considering

performing breast-related surgery, Dr. Solomon stated that “in order to

operate on someone … you need to know if the problem is something you can

treat surgically or nonsurgically.” Id. at 33-34. Dr. Solomon testified that he

is an expert in the “physiology and pathology of the breast.” Id. at 38. After

questioning Dr. Solomon about the fact he was not an endocrinologist qualified

to diagnose gynecomastia, Janssen objected to Dr. Solomon being qualified

as an expert in this case because he is not an endocrinologist. N.T., 2/9/2015

(a.m.), at 69. The trial court concluded that Dr. Solomon is an expert in the

disease of gynecomastia, and it is up to the jury “to determine the weight …

to give his opinion.” Id. at 70.

                                    - 27 -
J-A18037-18

            Experts in one area of medicine have been ruled [to be]
     qualified to address other areas of specialization where the
     specialties overlap in practice, or where the specialist has
     experience in another related medical field. See, e.g. Kearns v.
     Clark, [] 493 A.2d 1358 ([Pa. Super.] 1985) (urologist qualified
     to testify against surgeon to evaluate surgeon’s performance in
     hysterectomy where urologist was familiar and had assisted in
     performance of other hysterectomies); Pratt v. Stein, 444 A.2d
     674 ([Pa. Super.] 1982) (professor of pharmacology qualified to
     testify to post-operative care given by orthopedic surgeon with
     respect to drug administered to patient); Ragan v. Steen, 331
     A.2d 724 ([Pa. Super.] 1974) (surgeon permitted to testify in
     medical malpractice action as to causation against radiologist
     where surgeon was knowledgeable through experience as to x-ray
     treatments); Christy v. Darr, 467 A.2d 1362 ([Pa. Cmwlth.]
     1983) (neurosurgeon qualified to testify on causation in personal
     injury cases where plaintiff suffered double vision and hearing loss
     despite objection that such testimony concerned problems outside
     neurosurgical specialty); Workmen's Compensation Appeal
     Board v. Jones E. Laughlin Steel Corp., 349 A.2d 793 ([Pa.
     Cmwlth.] 1975) (orthopedist permitted to testify to causation, and
     urological and psychological effects of fractured pelvis). The
     rationale behind the standards enunciated in these cases is that
     the qualified witness need only have a reasonable pretension to
     specialized knowledge; the standard is not set so high as to
     exclude the kind of testimony ordinarily available.

McDaniel v. Merck, Sharp & Dohme, 533 A.2d 436, 442 (Pa. Super. 1987).

     Based on the foregoing, we conclude the trial court did not err in

permitting Dr. Solomon to testify about the potential causes of gynecomastia.

We agree with the trial court that it was within the province of the jury to

weigh Dr. Solomon’s testimony as a board certified plastic surgeon, against

the testimony of Janssen’s expert, an endocrinologist.21 Thus, we conclude

21As discussed supra, both Dr. Solomon and Janssen’s expert, Dr. Vaughn,
agreed that Austin had gynecomastia. Their disagreement focused on
whether the gynecomastia occurred prior to or after puberty.

                                    - 28 -
J-A18037-18

that Janssen is not entitled to relief on the basis that the trial court erred in

qualifying Dr. Solomon as an expert in this case.

      We next consider Janssen’s contention that Dr. Solomon’s diagnosis of

Austin having gynecomastia by looking at a 2005 photograph of him is not a

generally accepted method of diagnosis pursuant to Grady and Frye. See

Janssen’s Brief at 33-34.      Here, Janssen contends that Dr. Solomon’s

causation opinion should have been excluded pursuant to Pa.R.E. 702, which

provides the following.

            A witness who is qualified as an expert by knowledge, skill,
      experience, training, or education may testify in the form of an
      opinion or otherwise if:

            (a)   the expert’s scientific, technical, or other specialized
                  knowledge is beyond that possessed by the average
                  layperson;

            (b)   the expert’s scientific, technical, or other specialized
                  knowledge will help the trier of fact to understand the
                  evidence or to determine a fact in issue; and

            (c)   the expert’s methodology is generally accepted in the
                  relevant field.

Pa.R.E. 702.

      Our review of the record reveals that despite Janssen’s attempt to

characterize Dr. Solomon’s testimony otherwise, Dr. Solomon indeed relied on

several factors, including a differential diagnosis, in concluding Austin had

gynecomastia in 2002. Specifically, Dr. Solomon testified that Mrs. Pledger

provided history about when “she first saw breast development,” see N.T.,

2/9/2015 (a.m.), at 86; he viewed the 2005 photograph, id.; and he ruled

                                     - 29 -
J-A18037-18

out other conditions which cause gynecomastia, such as Klinefelter’s

syndrome, id. at 93. Dr. Solomon testified that he performed a “differential

diagnosis” to “narrow down” other causes. Id. at 101.               Dr. Solomon

expounded:

            So in putting together a picture of Austin [], I took a history.
      Part of that history was what things was he exposed to that might
      cause this condition. So in his history, to be brief, the only thing
      he was exposed to that would cause the condition in the time
      frame that it was described to me and in the time frame as
      evidenced by the photographs is Risperdal. That’s number one.

             Number two, he has no evidence of any of the other
      causative factors of gynecomastia, such as – we briefly mentioned
      – Klinefelter’s syndrome, which is a chromosomal abnormality,
      that he does not have. He does not have thyroid disease. He
      does not have – he’s not an alcoholic and doesn’t have alcoholic
      liver disease. He doesn’t have a pituitary tumor, from which I can
      establish. He doesn’t have any of the other – he doesn’t have any
      testicular tumors because I examined his testicles. So he doesn’t
      have any of the other major groups of conditions that can cause
      gynecomastia.

Id. at 103.

      As we did in Stange, we conclude that Dr. Solomon’s methodology was

not novel, and indeed is a generally accepted methodology in the medical

community.     Further, “Janssen’s arguments really go to weight and not

admissibility.” Stange, 179 A.3d at 56.            Accordingly, we conclude that

Janssen is not entitled to relief on this basis.

      Finally, with respect to Dr. Solomon, Janssen contends that it is entitled

to a new trial “because the [trial] court wrongly denied defense counsel the

                                      - 30 -
J-A18037-18

opportunity to use learned treatises to cross-examine Dr. Solomon.” Janssen’s

Brief at 37.

            The law in this Commonwealth is well-settled that an expert
      witness may be cross-examined on the contents of a publication
      upon which he or she has relied in forming an opinion, and also
      with respect to any other publication which the expert
      acknowledges to be a standard work in the field. In such
      cases, the publication or literature is not admitted for the truth of
      the matter asserted, but only to challenge the credibility of the
      witness’ opinion and the weight to be accorded thereto. Learned
      writings which are offered to prove the truth of the matters therein
      are hearsay and may not properly be admitted into evidence for
      consideration by the jury.

Majdic v. Cincinnati Mach. Co., 537 A.2d 334, 349 (Pa Super. 1988) (en

banc) (emphasis added; citations omitted).

      With this standard in mind, we analyze Janssen’s cross-examination of

Dr. Solomon. Dr. Solomon testified that he did not cite any medical literature

in his expert report. See N.T., 2/9/2015 (p.m.), at 59. He further stated that

“the incidence of prepubertal gynecomastia is zero. It should never occur.”

Id. at 59-60. Then, counsel for Janssen sought to show Dr. Solomon “an

article … by Dr. Bachar, Dr. Phillip, and Dr. Klippert and Dr. Lazar from Clinical

Endocrinology, dated 2004, talking about prepubertal gynecomastia.” Id. at

60. Counsel for Janssen told the trial court that it “is a learned treatise from

a respected journal.” Id. Thus, it wished to “cross-examine [Dr. Solomon] on

it.” Id. Counsel for the Pledgers objected and stated that “[Dr. Solomon]

needs to agree it’s authoritative.” Id. at 61. Counsel for Janssen argued that

                                     - 31 -
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she could “authoritate [sic] it with [her] experts.”22 Id. Further, when asked

when he was aware of the article, Dr. Solomon responded that he had not

read it. Id. at 62.

      Putting this exchange into the context of the law set forth supra, it is

clear the trial court did not err by not permitting counsel for Janssen to cross-

examine Dr. Solomon about this article. Dr. Solomon specifically stated he

had not read the article. Moreover, counsel for Janssen never even asked Dr.

Solomon whether the treatise or the article was a standard work in his field;

rather, she continued to ask Dr. Solomon questions about the contents of the

article to which counsel for the Pledgers objected.      Janssen complains on

appeal that this was error because “[e]xploring Dr. Solomon’s total lack of

knowledge of the relevant medical literature would have shown that he was

unqualified to offer his causation opinion, and that the opinion failed to take

into account studies contrary to his view.” Janssen’s Brief at 40.

      Janssen is correct that this would have been fertile ground for cross-

examination of Dr. Solomon; however, counsel did not ask any of these

questions at trial. Per Majdic, counsel could have asked Dr. Solomon about

any treatise it wanted, so long as it also asked whether the treatise was a

standard work in the field. However, counsel did not do that.23 Accordingly,

22 Although it does not affect our conclusions infra, during trial, Janssen’s
experts did not testify about the authority of this article.
23 Janssen also cites to its re-cross examination of Dr. Solomon where counsel

asked Dr. Solomon if he was “familiar with the [g]overnment study that
showed no relationship in autistic kids between prolactin levels on Risperdal

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we conclude that the trial court did not err in any respect by not permitting

Janssen to question Dr. Solomon on this learned treatise.

      We now turn to Janssen’s final issue on appeal, which is a challenge to

the trial court’s causation jury instruction. See Janssen’s Brief at 44-49.

Specifically, Janssen complains the trial “court failed to give a complete

instruction on proximate causation under Alabama law.” Id. at 44. Janssen

also contends that the trial court erred by giving a “concurrent causation”

instruction. Id. at 47.

      We address these claims mindful of the following.

             Our standard of review regarding jury instructions is limited
      to determining whether the trial court committed a clear abuse of
      discretion or error of law which controlled the outcome of the case.
      Error in a charge occurs when the charge as a whole is inadequate
      or not clear or has a tendency to mislead or confuse rather than
      clarify a material issue. Conversely, a jury instruction will be
      upheld if it accurately reflects the law and is sufficient to guide the
      jury in its deliberations.

           The proper test is not whether certain portions or isolated
      excerpts taken out of context appear erroneous. We look to the
      charge in its entirety, against the background of the evidence in
      the particular case, to determine whether or not error was
      committed and whether that error was prejudicial to the
      complaining party.

and gynecomastia.” Janssen’s Brief at 38; N.T., 2/9/2015 (p.m.), at 93.
Counsel for the Pledgers objected, and counsel for Janssen again brought up
the “learned treatise rule.” Id. However, after some discussion about whether
the question was outside the scope of the Pledgers’ re-direct examination, Dr.
Solomon testified that he was indeed familiar with that study and answered
questions about the study. See N.T., 2/9/2015 (p.m.), at 95-96. Thus, we
conclude there was no error here.

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J-A18037-18

               In other words, there is no right to have any particular form
         of instruction given; it is enough that the charge clearly and
         accurately explains the relevant law.

James v. Albert Einstein Med. Ctr., 170 A.3d 1156, 1163–64 (Pa. Super.

2017) (quoting Krepps v. Snyder, 112 A.3d 1246, 1256 (Pa. Super. 2015)

(citations and internal punctuation omitted)).

         Here, Janssen contends the following instruction, given by the trial court

in response to Janssen’s closing argument,24 was in error: “Now, this case is

also not about something that was argued to you specifically by [Janssen],

and that is whether a different warning would have caused a doctor not to

prescribe. I will give you the law on this. But I want to say up front, that is

not the law that we are examining in this case, okay?” N.T., 2/20/2015 (p.m.),

at 18.

         Janssen then takes issue with the trial court’s explanation of the

Alabama law applicable in this case.         The trial court offered the following

causation instruction:

24   In her closing argument, counsel for Janssen stated the following.

         So, the second question you are going to be asked to answer is:
         Do you find that Janssen’s negligent failure to provide an adequate
         warning was the cause of Austin Pledger’s gynecomastia?

               And there is [sic] a couple of parts to that the Judge is going
         to charge you. One part is would a different Warning have made
         a difference to Dr. Mathisen. And I am going to show you it
         wouldn’t. Would a different Warning have changed his decision to
         prescribe.

N.T., 2/20/2015 (a.m.), at 99.

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            You must decide whether Janssen’s conduct caused Austin
      Pledger’s harm. Janssen’s conduct caused the harm if the conduct
      naturally and probably brought about the harm; and, two, the
      harm would not have happened without the conduct.

             The failure of a manufacturer to … provide the prescribing
      physician with an adequate warning of the risks associated with a
      prescription product is not the cause of the patient’s injury if the
      prescribing physician has his own independent knowledge of the
      risks that should have been included in an adequate warning.

           In other words, if you find that the doctor was not given
      adequate warning, yet at the same time had independent
      knowledge on his own of the risk, then cause has not been shown.

            Now, the conduct of two or more persons, however, may
      cause harm. Two or more persons may cause harm in the sense
      of causation.

             Now, in this case you may find that Dr. Mathisen, though
      not named as a defendant here, engaged in wrongful conduct. If
      this is so, and you find that Janssen’s negligence also caused
      injury to Austin Pledger, each is a cause of his harm, if it naturally
      and probably brings about the harm.

            The fact that Dr. Mathisen is not a defendant here does not
      relieve Janssen of responsibility for the harm if you find that
      Janssen’s negligence caused [Austin] harm, all right? So that’s
      causation.

N.T., 2/20/2015 (p.m.), at 38-39.

      According to Janssen “[t]his statement is accurate but incomplete. The

instruction did not describe [the Pledgers’] burden under Alabama law to prove

that a different warning would have caused him to avoid injury.” Janssen’s

Brief at 46. According to Janssen, “[t]his was particularly crucial here, where

Dr. Mathisen never read the October 2006 labeling, and so could not have

changed his prescribing decisions in response to additional risk information.”

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Id. Furthermore, Janssen suggests that the trial court should not have given

the “concurrent causation” instruction at all because it is appropriate only

“when ‘an injury may have several concurrent proximate causes … including

the actions of two or more tortfeasors, neither of whose action was sufficient

in and of itself to produce the injury, who act, either together or

independently, to produce it.’” Id. at 47-48. Janssen suggests that since it

did not contend that Dr. Mathisen was negligent and he did not appear on the

verdict form, this instruction “left jurors with the misimpression that Dr.

Mathisen’s failure to read the labeling was irrelevant to [the Pledgers’] warning

claim.” Id. at 48-49.

      First, with respect to the combined or concurrent cause instruction,

Janssen did not object to the trial court’s including it at trial. See N.T.,

2/19/2015 (p.m.), at 136-38. Thus, even though Janssen raised this issue in

its post-trial motion, it failed to preserve this issue at trial, and it cannot raise

it on appeal. See Pa.R.C.P. 227.1(b) Note (“If no objection is made, error

which could have been corrected in pre-trial proceedings or during trial by

timely objection may not constitute a ground for post-trial relief.”).

      Furthermore, upon our review of the jury instruction given by the trial

court as a whole, we conclude there was no error. Janssen acknowledges that

the instruction accurately reflected Alabama law. Moreover, we have already

held that Janssen’s arguments about Dr. Mathisen’s failing to read the 2006

label prior to refilling Austin’s prescription are without merit. The issue, as

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reflected accurately in the jury instructions, was whether the information

provided by Janssen to Dr. Mathisen in 2002 was adequate, and whether a

different warning would have changed his prescribing behavior then. Based

on the foregoing, we conclude that Janssen is not entitled to relief on the basis

of its jury instruction issues.

      Having concluded that Janssen has presented no issue on appeal

entitling it to relief, we affirm the judgment as to Janssen.

Appeal of The Pledgers

      The Pledgers have appealed from the July 11, 2014 order of the trial

court, which granted summary judgment in favor of Janssen and against the

Pledgers on the Pledgers’ claim for punitive damages.25 In granting Janssen’s

motion as to all plaintiffs involved in the Risperdal litigation, the trial court

held the following: 1) “New Jersey had a greater interest than Pennsylvania

in the application of its law on the issue of punitive damages,” and 2) “the

New Jersey Products Liability Act does not permit Plaintiffs to recover punitive

damages.” Trial Court Opinion, 10/22/2015, at 10.

      This Court recently considered these issues in both Stange and Murray.

First, despite Janssen’s arguments to the contrary in those cases, this Court

concluded that the plaintiffs did not waive the issues and thus they are

preserved on appeal. See Stange, 179 A.3d at 64; Murray, 180 A.3d at

25This was part of a global motion for summary judgment filed by Janssen
against all plaintiffs in the Risperdal litigation. It was heard by the Honorable
Arnold L. New. Judge New filed an opinion on October 22, 2015.

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1248-49. Next, this Court concluded that there was a true conflict between

New Jersey law and Wisconsin law (Stange’s home state), see Stange, 179

A.3d at 65, and between New Jersey law and Maryland law (Murray’s home

state), see Murray, 180 A.3d at 1250.            Then, this Court concluded that

because “the trial court considered only whether New Jersey law or

Pennsylvania law should apply, not the law of the individual plaintiff’s home

state,” we were required to “remand for the trial court to consider conflict-of-

law principles” with respect to New Jersey and the plaintiff’s home state. See

Stange, 179 A.3d at 66-67; see also, Murray, 180 A.3d at 1251 (remanding

“so that Mr. Murray may create an individual record pertaining to the distinct

conflict-of-law principles at play in his particular case”).

        In this appeal, the Pledgers set forth the same arguments. See The

Pledgers’ Brief at 52-62 (arguing that there is a true conflict between New

Jersey law and Alabama law regarding punitive damages and the trial court

erred    by   concluding   that   New   Jersey   had   a   greater   interest   than

Pennsylvania).     Janssen sets forth the same counter-arguments. See

Janssen’s Reply Brief at 21-25 (arguing that the Pledgers waived this issue

and development of an individualized record is unnecessary).

        “[W]e have long held that as long as the decision has not been

overturned by our Supreme Court, a decision by our Court remains binding

precedent.” Marks v. Nationwide Ins. Co., 762 A.2d 1098, 1101 (Pa. Super.

2000). Thus, as we did in Stange and Murray, we reverse the order of the

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

for proceedings consistent with those in Stange and Murray.26

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

proceedings consistent with this opinion.      Motion for leave to file post-

submission communication denied as moot. Jurisdiction relinquished.

Judgment Entered.

Joseph D. Seletyn, Esq.
Prothonotary

Date: 10/31/18

26   At oral argument, counsel for Janssen agreed that remand was appropriate.

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