Gurley, B. v. Janssen Pharmaceuticals, Inc. , 113 A.3d 283 ( 2015 )

J-A30036-14
2015 PA Super 49BRAYDEN & MICHAEL GURLEY AND IN THE SUPERIOR COURT OF
HALEY POWELL, PENNSYLVANIA
Appellees
v.
JANSSEN PHARMACEUTICALS, INC.,
Appellant No. 239 EDA 2014
Appeal from the Judgment Entered December 5, 2013
in the Court of Common Pleas of Philadelphia County
Civil Division at No.: May Term 2011 No. 02251
BEFORE: LAZARUS, J., MUNDY, J., and PLATT, J.*
OPINION BY PLATT, J.: FILED MARCH 16, 2015
Appellant, Janssen Pharmaceuticals, Inc.,1 appeals from the judgment
entered in favor of Appellees, Haley Powell, Brayden Gurley, and Michael
Gurley, following a jury trial. We affirm.
We take the relevant facts and procedural history of this case from the
trial court’s April 25, 2014 opinion and our independent review of the record.
In April 2005, at age eighteen, while living in Iva, South Carolina, Appellee
Haley Powell (Haley) experienced an epileptic episode that caused her to
____________________________________________
*
Retired Senior Judge assigned to the Superior Court.
1
Janssen is a Pennsylvania Corporation with a principal place of business in
New Jersey. (See Appellant’s Answer and New Matter, 3/15/13, at 2-3 ¶
10).
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lose consciousness.2 In May 2005, Powell’s neurologist, Dr. Bret Warner,
diagnosed her as having juvenile myoclonic seizures. Dr. Warner initially
prescribed Keppra and Lexapro, and Haley discontinued Lexapro within a few
weeks. On March 27, 2006, Dr. Warner prescribed Topamax3 for Haley to
control her headaches and seizures, and she continued using Keppra as the
main agent in treating her seizure disorder. Haley continued taking
Topamax through December 1, 2007.4 Neither Dr. Warner nor Haley were
aware that use of the drug during pregnancy could possibly cause birth
defects such as cleft lip, cleft palate, or oral palate. At the time Dr. Warner
prescribed Topamax to Haley, the Food and Drug Administration (FDA)
categorized it as a Pregnancy Category C drug.5
____________________________________________
2
Haley continued to reside in South Carolina at the time she filed the instant
lawsuit. (See Plaintiff Fact Sheet, 10/16/11, at 2).
3
Appellant manufactures Topamax, an antiepileptic medication used to treat
epilepsy and migraines. (See Appellant’s Brief at 12, n.5, 21).
4
Haley filled the last Topamax prescription for a thirty-day supply under her
own name on June 27, 2007. Haley then continued using Topamax through
her mother, Sandra Powell’s, prescription by another doctor. Sandra Powell
had been taking the drug to treat migraines. Sandra testified that her family
was having financial difficulties and she filled her prescription instead of
Haley’s to save money on the insurance co-pay.
5
(See Plaintiff’s Exhibits 1207-1208 (Topamax 2006 and 2007 Physicians’
Desk Reference excerpts)). On March 4, 2011, the FDA classified Topamax
as a Pregnancy Category D drug. (See Appellant’s Answer and New Matter,
3/15/13, at 6 ¶ 26).
The FDA has established 5 categories to indicate the
potential of a drug to cause birth defects if used during
(Footnote Continued Next Page)
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On November 19, 2007, Haley learned that she was pregnant with her
son, Brayden Gurley (Brayden). She and her husband, Michael Gurley, had
conceived Brayden in late October 2007. On November 21, 2007, Haley
informed Dr. Warner that she was pregnant and he advised her to taper off
Topamax. Haley reduced her intake and completely stopped taking the drug
by December 1, 2007. When Haley was twenty-seven weeks pregnant, she
learned through an ultrasound that her son had a cleft lip on the right side of
_______________________
(Footnote Continued)
pregnancy. Category A means that there are adequate, well-
controlled studies which have failed to demonstrate a risk to the
fetus. Few drugs are in category A because controlled studies of
medication use during pregnancy are ethically prohibited.
Category B means animal studies show no risk, but there are no
adequate and well-controlled studies of use by pregnant women.
Category C means that animal reproduction studies have shown
an adverse effect on the fetus, but there are no adequate and
well-controlled studies in humans, and so pregnant women
should weigh the potential benefits against the potential risks.
Category D is used when there is positive evidence of human
fetal risk based on adverse reaction data from investigational or
marketing experience or studies in humans, but potential
benefits may still warrant use of the drug. Category X is the
lowest category, used when use of the drug is not recommended
for any pregnant women, as the risks clearly outweigh any
benefits. . . .
In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation,
26 F.Supp.3d 449, 453 n.7 (E.D. Pa. 2014); (see also Plaintiff’s Exhibit
1221 (listing FDA Pregnancy Categories)).
We note that decisions of the federal district courts are not binding on
Pennsylvania courts, but we may look to them as persuasive authority. See
Dietz v. Chase Home Finance, LLC, 41 A.3d 882, 886 n.3 (Pa. Super.
2012).
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his mouth.6 On July 7, 2008, Brayden Gurley was born with a right side
unilateral cleft lip and gum line defects. Brayden had surgery to correct the
cleft lip on October 1, 2008. He still has a red scar running from under his
nose to his lip as a result of the surgery. Brayden’s tooth never grew in
correctly in the area where there is a notch in his gum, which makes it
appear as though he is missing a tooth. Brayden has difficulties with speech
and becomes extremely frustrated when people cannot understand him. He
treats with a speech therapist twice a week and regularly visits a plastic
surgeon as part of a cleft lip and palate team. Treatments that Brayden will
need in the future may include graft surgery to repair the notch in his gums,
evaluations to test his hearing, psychological evaluations, dental care related
to dental abnormalities, and rhinoplasty for his nasal deformity.
On May 19, 2011, Haley Powell, individually and as guardian of
Brayden Gurley, along with Michael Gurley, filed a negligence complaint
against Appellant based on a products liability theory. Appellees alleged,
inter alia, that Appellant failed to warn Haley and her physician about the
risk of birth defects associated with Topamax use during pregnancy,
including the risk of cleft lip, and that this failure to warn resulted in
____________________________________________
6
Neither Haley nor her husband has a family history of cleft lip or cleft
palate. (See N.T. Trial, 11/08/13, at 50-51).
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Brayden’s birth defect.7 On April 1, 2013, Appellant filed a motion for
summary judgment, which the trial court granted in part and denied in part.8
On June 10, 2013, Appellant filed a motion in limine, requesting that the trial
court preclude Appellees from offering evidence or argument that Appellant
could have unilaterally changed Topamax’s Pregnancy Category from C to D,
without FDA approval. On September 26, 2013, the court entered an order
granting Appellant’s motion in limine.9
Appellees’ failure to warn claim proceeded to a jury trial on October
29, 2013. On November 19, 2013, the jury returned a verdict in favor of
Appellees. It awarded Appellees a total sum of $10,955,000.00;
$10,620,000.00 for non-economic loss, and $335,000.00 for future health
care costs. On November 22, 2013, Appellees filed a post-trial motion
____________________________________________
7
Appellees assert that Appellant had actual knowledge that Topamax could
cause birth defects in humans from 2000, and certainly by 2006, and that it
negligently chose to hide that safety information from prescribing healthcare
providers. (See Appellees’ Brief, at 18-19).
8
The court granted summary judgment in favor of Appellant with respect to
Appellees’ strict liability design defect, negligent design, express warranty,
punitive damages, and gross negligence claims. It denied the remainder of
the motion. (See Order, 8/27/13, at 1).
9
On January 28, 2014, after the trial in this case concluded, the court issued
an order applicable to all Topamax cases. The order clarified that, while
plaintiffs could not offer argument or evidence that Janssen could have
unilaterally changed Topamax’s Pregnancy Category, they were permitted to
introduce argument or evidence that Janssen could have sought or
requested a change in the drug’s Pregnancy Category from the FDA. (See
Order, 1/28/14, at 2).
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seeking the addition of delay damages to the verdict. Appellant filed a post-
trial motion on November 29, 2013, requesting the trial court to grant
judgment notwithstanding the verdict (JNOV) or a new trial. On December
3, 2013, the court denied Appellant’s post-trial motion. On December 5,
2013, the court granted Appellees’ request for delay damages and ordered
$700,294.62 added to the verdict, resulting in a total judgment against
Appellant in the amount of $11,655,294.62. This timely appeal followed.10
Appellant raises three issues for our review:
1. Does federal law preempt a state-law negligent failure-to-
warn claim where (a) [Appellant] could not have changed the
pregnancy category without the Food and Drug Administration’s
prior permission and assistance; and/or (b) there was clear
evidence that the Food and Drug Administration would not have
approved the proposed additional warning that [Appellees]
advocate?
2. Did the trial court err in permitting the negligent failure-to-
warn claim to go to the jury when [Appellees] could not prove
causation (a) because the Topamax Haley ingested was
prescribed to a different patient in a higher dosage by a doctor
who had never treated Haley; and/or (b) because [Appellees]
failed to meet their burden of proving that their proposed
changes to Topamax’s warnings would have caused either doctor
not to prescribe Topamax?
____________________________________________
10
Pursuant to the trial court’s order, Appellant timely filed a concise
statement of errors complained of on appeal on January 27, 2014. See
Pa.R.A.P. 1925(b). The court entered a Rule 1925(a) opinion on April 25,
2014. See Pa.R.A.P. 1925(a).
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3. Did the trial court err in affirming the non-economic damage
award of $10,620,000?
(Appellant’s Brief, at 5).11
An appellate court will reverse a trial court’s grant or
denial of a JNOV only when the appellate court finds an abuse of
discretion or an error of law. Our scope of review with respect to
whether judgment n.o.v. is appropriate is plenary, as with any
review of questions of law.
In reviewing a motion for judgment n.o.v., the
evidence must be considered in the light most
favorable to the verdict winner, and he must be
given the benefit of every reasonable inference of
fact arising therefrom, and any conflict in the
evidence must be resolved in his favor. Moreover, a
judgment n.o.v. should only be entered in a clear
case and any doubts must be resolved in favor of the
verdict winner. Further, a judge’s appraisement of
evidence is not to be based on how he would have
voted had he been a member of the jury, but on the
facts as they come through the sieve of the jury’s
deliberations.
There are two bases upon which a judgment
n.o.v. can be entered: one, the movant is entitled to
judgment as a matter of law, . . . and/or two, the
evidence was such that no two reasonable minds
could disagree that the outcome should have been
____________________________________________
11
We note that Appellant’s eleven-page Rule 1925(b) statement of errors
contains issues that it did not address in its statement of questions involved
or in the body of its brief, including a statute of limitations claim. (See Rule
1925(b) Statement, 1/27/14, at 1-11). Because Appellant has abandoned
these issues on appeal, we will not address them. See Pa.R.A.P. 2116(a)
(“No question will be considered unless it is stated in the statement of
questions involved or is fairly suggested thereby”); see also Pa.R.A.P.
2119; In re Jacobs, 936 A.2d 1156, 1167 (Pa. Super. 2007) (issue is
waived for purposes of appellate review when an appellant does not develop
it in brief).
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rendered in favor of the movant[.] With the first a
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.
Questions of credibility and conflicts in the evidence are for
the [fact-finder] to resolve and the reviewing court should not
reweigh the evidence. If there is any basis upon which the jury
could have properly made its award, the denial of the motion for
judgment n.o.v. must be affirmed.
Braun v. Wal–Mart Stores, Inc., 24 A.3d 875, 890-91 (Pa. Super. 2011),
affirmed, 2014 WL 7182170 (Pa. filed Dec. 15, 2014) (citations and
quotation marks omitted).
In reviewing a trial court’s denial of a motion for a new trial, the
standard of review for an appellate court is as follows:
[I]t is well-established law that, absent a clear
abuse of discretion by the trial court, appellate
courts must not interfere with the trial court’s
authority to grant or deny a new trial.
* * *
Thus, when analyzing a decision by a trial
court to grant or deny a new trial, the proper
standard of review, ultimately, is whether the trial
court abused its discretion.
Moreover, our review must be tailored to a well-settled, two-
part analysis:
We must review the court’s alleged mistake
and determine whether the court erred and, if so,
whether the error resulted in prejudice necessitating
a new trial. If the alleged mistake concerned an
error of law, we will scrutinize for legal error. Once
we determine whether an error occurred, we must
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then determine whether the trial court abused its
discretion in ruling on the request for a new trial.
ACE Am. Ins. Co. v. Underwriters at Lloyds and Companies, 939 A.2d
935, 939 (Pa. Super. 2007), affirmed, 971 A.2d 1121 (Pa. 2009) (citations
omitted).
In its first issue, Appellant argues that it is entitled to JNOV because
Appellees’ only claim at trial, their state-law negligent failure to warn claim,
was preempted by federal law. (See Appellant’s Brief, at 23-40).
Specifically, Appellant contends that Appellees’ claim is preempted because
the federal regulatory scheme prevented it from unilaterally changing the
Pregnancy Category in Topamax’s labeling without prior FDA approval. (See
id. at 21, 28). The trial court determined, however, that federal law did not
preempt Appellees’ claim, and that the issue of preemption is controlled by
the United States Supreme Court’s decision in Wyeth v. Levine, 555 U.S.
555 (2009). (See Trial Court Opinion, 4/25/14, at 12-13). Upon review of
the record and relevant case law, we agree with the trial court.12
In Wyeth, the plaintiff contended that Wyeth, the brand-name drug
manufacturer of Phenergan, an antihistamine used to treat nausea,13 had
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12
“Issues of preemption comprise pure questions of law, of which the
standard of review is de novo and the scope of review plenary.” Ruspi v.
Glatz, 69 A.3d 680, 684 (Pa. Super. 2013), appeal denied, 81 A.3d 78 (Pa.
2013) (citation omitted).
13
Phenergan causes irreversible gangrene if it enters a patient’s artery. The
plaintiff in Wyeth developed gangrene after receiving an injection of
(Footnote Continued Next Page)
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breached a state tort-law duty to provide an adequate warning label.14 See
Wyeth, supra at 558-59. The United States Supreme Court held that
federal law did not preempt the lawsuit because it was possible for Wyeth to
comply with both state and federal law. See id. at 573. Specifically, the
FDA’s Changes Being Effected (CBE) regulation15 permitted a brand-name
drug manufacturer like Wyeth “to unilaterally strengthen its warning”
without prior FDA approval. Id. Therefore, federal regulations allowed
Wyeth to strengthen its label to comply with its state law duty to provide an
adequate warning. The Court stated:
it has remained a central premise of federal drug regulation that
the manufacturer bears responsibility for the content of
its label at all times. It 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.
See, e.g., 21 CFR § 201.80(e) (requiring a manufacturer to
_______________________
(Footnote Continued)
Phenergan in April 2000, and as a result, doctors amputated her right hand
and forearm. See Wyeth, supra at 558-59.
14
A drug’s “FDA approved label is the official description of a drug product
which includes indication (what the drug is used for); who should take it;
adverse events (side effects); instructions for uses in pregnancy, children,
and other populations; and safety information for the patient.” U.S.
Department of Health and Human Services, U.S. Food and Drug
Administration Glossary of Terms (2015). Drug labeling is “[t]he centerpiece
of risk management for prescription drugs” because it “communicates to
health care practitioners the [FDA’s] formal, authoritative conclusions
regarding the conditions under which the product can be used safely and
effectively.” 71 Fed.Reg. 3934 (2006). A drug’s label is a pharmaceutical
company’s primary mechanism to communicate with physicians. (See N.T.
Trial, 10/30/13, at 19-20; N.T. Trial, 11/13/13, at 12).
15
See 21 CFR §§ 314.70(c)(6)(iii)(A),(C).
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revise its label “to include a warning as soon as there is
reasonable evidence of an association of a serious hazard with a
drug”); § 314.80(b) (placing responsibility for postmarketing
surveillance on the manufacturer); 73 Fed.Reg. 49605
(“Manufacturers continue to have a responsibility under Federal
law ... to maintain their labeling and update the labeling with
new safety information”).
* * *
Of course, the FDA retains authority to reject labeling
changes made pursuant to the CBE regulation in its review of the
manufacturer’s supplemental application, just as it retains such
authority in reviewing all supplemental applications. But
absent clear evidence that the FDA would not have
approved a change to [a drug’s] label, we will not
conclude that it was impossible for Wyeth to comply with
both federal and state requirements.
* * *
In short, Wyeth has not persuaded us that failure-to-warn
claims . . . obstruct the federal regulation of drug labeling.
Id. at 570-71, 581 (emphases added); see also Maya v. Johnson and
Johnson, 97 A.3d 1203, 1213 (Pa. Super. 2014) (rejecting federal
preemption argument made by brand name drug manufacturer claiming that
it could not be found negligent for failing to add “skin reddening,” “rash,”
and “blisters” to the list of symptoms in drug’s Allergy Alert when they were
not required by the FDA) (citing Wyeth).
Here, Appellant attempts to circumvent the clear holding in Wyeth by
asserting “[a]t trial, [Appellees] contended that [it] should have unilaterally
changed the pregnancy category for Topamax from C to D.” (Appellant’s
Brief, at 28) (record citation omitted). It argues “[b]ecause [Appellees’] first
theory—that [Appellant] should have changed the pregnancy category from
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C to D—was a change that was within [the] FDA’s sole control, it was
preempted.” (Id. at 27).
After review, we conclude that this argument lacks record support, and
we agree with Appellees that it is an “irrelevant red herring.” (Appellees’
Brief, at 22). As noted above, prior to trial, the court entered an order
specifically prohibiting Appellees from presenting any argument or evidence
that Appellant could have unilaterally changed the Topamax pregnancy
category without FDA-approval. (See Order, 9/26/13). Appellees maintain
that they fully adhered to the court’s order during trial. (See Appellees’
Brief, at 23). Appellant has not directed this Court to any place in the
voluminous record where Appellees failed to comply with this order by
contending that Appellant should have unilaterally changed its pregnancy
category. (See Appellant’s Brief, at 28). Moreover, as the Wyeth Court
explained, the FDA’s CBE regulation allows drug manufacturers to make
certain changes to update and strengthen safety information in its label
before receiving the FDA’s approval. See Wyeth, supra at 568; (see also
N.T. Trial, 10/30/13, at 19-20). Accordingly, we find this portion of
Appellant’s argument specious.
Appellant also attempts to evade the Wyeth decision by relying on the
United States Supreme Court’s holding in PLIVA, Inc v. Mensing, 131
S.Ct. 2567 (2011), to argue that it “cannot be held accountable under state
law for failing to do something that it could not do without the FDA’s prior
authorization.” (Appellant’s Brief, at 29) (citing PLIVA, supra at 2577-78).
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However, we agree with the trial court that Appellant’s reliance on PLIVA is
misguided. (See Trial Ct. Op., at 14). PLIVA involved federal preemption
of state-law failure to warn claims brought against generic drug
manufacturers, and is not applicable to the instant case involving a brand-
name drug manufacturer. See PLIVA, supra at 2574. The PLIVA Court
explained that, while a brand-name manufacturer is responsible for the
accuracy and adequacy of its label, a generic manufacturer is responsible for
ensuring that its warning label is the same as the brand name’s label. See
id. The Court stated: “It is beyond dispute that the federal statutes and
regulations that apply to brand-name drug manufacturers are meaningfully
different than those that apply to generic drug manufacturers. . . .
[D]ifferent federal statutes and regulations may . . . lead to different pre-
emption results.” Id. at 2582. Thus, we conclude that Appellant’s argument
based on PLIVA is not legally persuasive.
Appellant next attempts to fit within Wyeth’s holding to establish
preemption by arguing there is clear evidence that the FDA would not have
approved Appellees’ proposed change to the Topamax label to warn that the
drug could cause oral clefts in newborns prior to Brayden’s conception. (See
Appellant’s Brief, at 33, 36-37 (citing Wyeth, supra at 571 (“absent clear
evidence that the FDA would not have approved a change to [a drug’s] label,
we will not conclude that it was impossible for Wyeth to comply with both
federal and state requirements.”)). Appellant maintains that, because the
“FDA rejected [its] attempts to link human birth defects to Topamax use[,]”
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in its Patient Package Insert (PPI)16 in 2006, “[i]t follows that [Appellees’]
contention that Topamax’s label should have stated that Topamax caused
oral clefts in humans would not have been approved at that time.” (Id. at
36) (record citation omitted). In support of this argument, Appellant points
to evidence showing that in September 2005, it submitted a revised version
of Topamax’s PPI to the FDA, proposing to include the following language:
“Birth defects have been reported, including a minor malformation of the
penis called hypospadias, in newborns of women who used TOPAMAX during
pregnancy.” (Appellant’s Brief, at 34 (emphasis omitted); Exhibit D-1196,
9/29/05, at 3). Appellant argues that because the FDA did not accept this
proposed change to the Topamax PPI,17 the agency would have also rejected
a proposed change to the Topamax label to warn that the drug caused oral
clefts in humans. (See Appellant’s Brief, at 34-36).
____________________________________________
16
“A patient package insert contains information for patients’ understanding
of how to safely use a drug product.” U.S. Department of Health and Human
Services, U.S. Food and Drug Administration Glossary of Terms (2015).
17
Specifically, in May 2006, the FDA sent Appellant a draft PPI that did not
include Appellant’s proposed change and instead included the following
language: “Various abnormalities have been described in the offspring of
animals exposed to TOPAMAX during pregnancy.” (Appellant’s Brief, at 35
(emphasis omitted); Exhibit D-1206, 5/02/06, at unnumbered page 5).
Although the FDA provided no commentary in this specific section of the
draft PPI, it did advise “[t]he PPI is not expected to contain all
known/possible side effects. . . . If . . . information is important for
prescribers and patients, its prominence in the label should be elevated[.]”
(Exhibit D-1206, 5/02/06, at unnumbered page 5) (emphases added).
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Upon review, we cannot credit Appellant’s contention that it presented
“clear evidence that the FDA would not have approved a change to
[Topamax’s] label,” to warn of increased risk of cleft lip/palate. Wyeth,
supra at 571 (emphases added). Appellant’s proposed change to the PPI in
2005 involved a warning regarding a minor malformation in the genitalia of
some newborns born to mothers taking Topamax; it did not address
increased risk of cleft lip/palate. Further, Appellant’s proposed change in
2005 was to the PPI, directed at patients, and not to the Topamax label,
directed at prescribers. Therefore, we conclude that Appellant has failed to
establish federal preemption of Appellees’ state failure to warn claim under
Wyeth. Accordingly, Appellant’s first issue does not merit relief.
In Appellant’s second issue, it claims that the trial court erred in
permitting Appellees’ negligent failure-to-warn claim to go to the jury where
they could not prove that Topamax proximately caused Brayden’s cleft lip.
(See Appellant’s Brief, at 5, 40-53).18 Specifically, it argues that because
Haley ingested Topamax using her mother’s prescription instead of her own
____________________________________________
18
The trial court, after conferring with the parties, gave a modified charge to
the jury incorporating South Carolina terminology regarding causation. (See
N.T. Trial, 11/14/13, at 108-09, 111-12). The court acknowledged that
causation is essentially the same concept in South Carolina and
Pennsylvania. (See id. at 112; see also Trial Ct. Op. at 18 (citing
Pennsylvania law with respect to causation)). Specifically, the court
instructed the jury that it was to decide the issue: “[W]as [Appellant’s]
negligent conduct a proximate cause in bringing about Brayden Gurley’s
harm?” (N.T. Trial, 11/15/13, at 22). The court’s standard charge used the
term “factual cause.” (See N.T. Trial, 11/14/13, at 112).
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in the months before her pregnancy, she severed the link between the
learned intermediary (the prescribing physician, Dr. Warner) and herself as
the patient. (See id. at 42-47). Appellant also claims that Appellees failed
to prove that Dr. Warner’s prescribing decision would have been different if
the Topamax label had warned of an increased risk of cleft lip or cleft palate.
(See id. at 47-53). This issue lacks merit.
Proximate cause is an essential element in a failure to
warn case. A proximate, or legal cause, is defined as a
substantial contributing factor in bringing about the harm in
question. Assuming that a plaintiff has established both duty
and a failure to warn, a plaintiff must further establish proximate
causation by showing that had defendant issued a proper
warning [ ], he would have altered his behavior and the injury
would have been avoided. To create a jury question, the
evidence introduced must be of sufficient weight to establish . . .
some reasonable likelihood that an adequate warning would
have prevented the plaintiff from receiving the drug.
Maya, supra at 1213-14 (citation omitted).
In cases involving the failure to warn of risks associated with
prescription drugs, both Pennsylvania and South Carolina apply the learned
intermediary doctrine.
Under the learned intermediary doctrine, a manufacturer will be
held liable only where it fails to exercise reasonable care to
inform a physician of the facts which make the drug likely to be
dangerous. The manufacturer has the duty to disclose risks to
the physician, as opposed to the patient, because it is the duty
of the prescribing physician to be fully aware of (1) the
characteristics of the drug he is prescribing, (2) the amount of
the drug which can be safely administered, and (3) the different
medications the patient is taking. It is also the duty of the
prescribing physician to advise the patient of any dangers or side
effects associated with the use of the drug as well as how and
when to take the drug.
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Cochran v. Wyeth, Inc., 3 A.3d 673, 676 (Pa. Super. 2010), appeal
denied, 20 A.3d 1209 (Pa. 2011) (citations and quotation marks omitted);
see also Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992)
(applying South Carolina law and stating that sole issue in case controlled by
learned intermediary doctrine is whether an adequate warning to patient’s
doctor about injury would have deterred doctor from prescribing product).
Here, in order to establish causation, Appellees presented to the jury
the following deposition testimony of Dr. Warner:
Q. Do you expect that the information that is provided to you
through the PDR [Physicians’ Desk Reference, containing the
drug’s label] to be accurate and complete?
A. Yes.
Q. Do you expect manufacturers of medications to fully inform
you as to the risks of the medication through the PDR?
A: As thoroughly as possible.
* * *
Q: Did you avoid using Depakote because of the high risk of
birth defect?
A: Yes.
* * *
Q: Doctor, when you prescribed Topamax for Haley on March the
27th, 2006, did you do a risk/benefit analysis at that time?
A: Yes
Q: Did you have any knowledge in March of 2006 of Topamax
putting a patient at an increased risk for cleft lip or cleft palate,
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more specifically, the unborn child at risk for cleft lip or cleft
palate?
A: No.
* * *
Q: If you had been aware of a risk with Topamax and a risk of a
cleft lip or cleft palate to an unborn fetus, is that a risk that you
would have taken into consideration when prescribing it to Haley
in March of 2006?
A: Yes.
Q. If you had been aware of cleft lip or cleft palate as a risk with
Topamax when you prescribed it to Haley in March of 2006,
would it have altered your prescribing habits?
A: It would have had a major impact, I think.
(Deposition of Dr. Bret Warner, 7/30/12, at 3, 7, 14, 20).
Dr. Warner further testified that on November 28, 2007, after learning
that Haley was pregnant, he immediately advised her to taper off Topamax.
(See id. at 18). He testified that he had no reason to believe that she had
stopped taking Topamax before he instructed her not to, and that he
believed that she had been continuously using the drug since he first
prescribed it to her in March 2006. (See id. at 19). Haley testified that she
ingested Topamax on a daily basis from the time Dr. Warner prescribed it to
her until he instructed her to discontinue the drug. (See N.T. Trial,
11/08/13, at 32-34, 36, 38, 41-42).
Based on the foregoing, we conclude that the trial court properly
determined that “the evidence introduced [was] of sufficient weight to
establish . . . some reasonable likelihood that an adequate warning would
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have prevented [Haley] from receiving the drug.” Maya, supra at 1214
(citation omitted). The testimony showed that Dr. Warner was unaware of
Topamax’s increased risk of cleft lip and/or palate in newborns when he
prescribed the drug to Haley, and that knowledge of this risk would have
deterred him from prescribing the medication for her. Haley ingested
Topamax on a daily basis from the time Dr. Warner prescribed it to her until
he instructed her to discontinue it. The fact that Haley obtained the
Topamax for a few months using her mother’s prescription instead of her
own because of the family’s financial difficulties does not permit Appellant to
evade liability for Brayden’s injuries. Accordingly, the trial court did not err
in allowing the issue of causation to go to the jury, or in subsequently
denying Appellant’s motion for JNOV on this issue. See Braun, supra at
891. The jury clearly credited Dr. Warner and Haley’s testimony and this
Court will not reweigh the evidence. See id. Appellant’s second issue does
not merit relief.
In its third issue, Appellant claims that the evidence does not support
the jury’s award of $10,620,000.00 in noneconomic damages19 and that it is
therefore entitled to remittitur. (See Appellant’s Brief, at 5, 53-58).
Appellant argues that the award is excessive in light of Brayden’s injuries,
____________________________________________
19
“Noneconomic loss is composed of (1) pain and suffering, (2)
embarrassment and humiliation, (3) loss of ability to enjoy the pleasures of
life, and (4) disfigurement.” Renna, infra at 672 n.4 (citation omitted).
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under circumstances where his cleft lip has been repaired, he has only a
faint scar, and his injury does not prevent him from attending school and
developing normal relationships with his peers. (See id. at 54-56). This
issue does not merit relief.
Our standard of review from the denial of a remittitur is
circumspect and judicial reduction of a jury award is appropriate
only when the award is plainly excessive and exorbitant. The
question is whether the award of damages falls within the
uncertain limits of fair and reasonable compensation or whether
the verdict so shocks the sense of justice as to suggest that the
jury was influenced by partiality, prejudice, mistake, or
corruption. Furthermore, [t]he decision to grant or deny
remittitur is within the sole discretion of the trial court, and
proper appellate review dictates this Court reverse such an
Order only if the trial court abused its discretion or committed an
error of law in evaluating a party’s request for remittitur.
Renna v. Schadt, 64 A.3d 658, 671 (Pa. Super. 2013) (citations and
quotation marks omitted).
We begin with the premise that large verdicts are not necessarily
excessive verdicts. Each case is unique and dependent on its
own special circumstances and a court should apply only those
factors which it finds to be relevant in determining whether or
not the verdict is excessive. A court may consider the following
factors, inter alia:
(1) the severity of the injury; (2) whether the
plaintiff’s injury is manifested by objective physical
evidence or whether it is only revealed by the
subjective testimony of the plaintiff (. . . where the
injury is manifested by broken bones, disfigurement,
loss of consciousness, or other objective evidence,
the courts have counted this in favor of sustaining a
verdict); (3) whether the injury will affect the
plaintiff permanently; (4) whether the plaintiff can
continue with his or her employment; (5) the size of
the plaintiff’s out-of-pocket expenses; and (6) the
amount plaintiff demanded in the original complaint.
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Gbur v. Golio, 932 A.2d 203, 212 (Pa. Super. 2007), affirmed, 963 A.2d
443 (Pa. 2009) (citation omitted).
“In reviewing the award of damages, the appellate courts should give
deference to the decisions of the trier of fact who is usually in a superior
position to appraise and weigh the evidence.” Ferrer v. Trustees of Univ.
of Pennsylvania, 825 A.2d 591, 611 (Pa. 2002) (citation omitted).
Here, the trial court stated that:
[it] did not find that the verdict was excessive or shocking
to the conscience given the evidence and issues in this case. In
addition, it should be noted that the jury based their verdict on
evidence presented by both Appellant and [Appellees]
throughout the trial. The jury heard testimony from various
physicians that testified to Brayden Gurley’s injuries and
accompanying treatments that would be needed to correct those
injuries. [(See Deposition Testimony of Dr. Russell Reid,
10/08/13, at 14-16; see also N.T. Trial, 11/07/13 at 127-28,
164-65)]. The jury also heard testimony from Braydon Gurley’s
stay-at-home mother who is responsible for his care. [She]
testified how the surgery for his severe cleft lip has negatively
affected his self-esteem, confidence and his ability to have a
simple conversation with others. [(See N.T. Trial, 11/08/13, at
58, 60, 63, 66)]. [She] also stated that her son becomes
extremely frustrated when people do not understand him and
suffers from embarrassment due to the residual scar from his
cleft lip surgery. [(See id. at 65-66)]. Additionally, physicians’
testimony as to Braydon Gurley’s injuries included[:] ongoing
visits with a plastic surgeon, dental surgery, speech therapy,
auditory evaluations, oral surgery, possible rhinoplasty and
treatment for possible psychological issues related to these
various corrective surgeries. [(See Deposition Testimony of Dr.
Russell Reid, 10/08/13, at 14-16; N.T. Trial, 11/07/13, at 128-
29, 164)]. Given the injuries that will plague Brayden Gurley
into adulthood, the award determined by the jury can hardly be
said to be excessive.
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This verdict does not shock this court’s sense of justice nor
does it demonstrate the jury was influenced by partiality,
prejudice, mistake or corruption. Rather, this verdict shows the
jury made an informed and educated finding based on the facts
and evidence presented at trial. Brayden Gurley’s pain, suffering
and loss were significant and demonstrated on the record
throughout the trial. Hence, the jury decided on a just and fair
award to compensate Brayden Gurley for his injuries.
(Trial Ct. Op., at 35-36).
Upon review of the record, we conclude that it supports the trial
court’s ruling regarding the jury’s damage award. We find no abuse of
discretion, and no basis to disturb the jury’s verdict. See Renna, supra at
671. Appellant’s final issue on appeal does not merit relief.
Judgment affirmed.
Judgment Entered.
Joseph D. Seletyn, Esq.
Prothonotary
Date: 3/16/2015
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