from the Judgment Entered, September 12, 2017, in the Court
of Common Pleas of Philadelphia County, Civil Division at
No(s): March Term, 2014 - No. 05384.
BEFORE: PANELLA, J., DUBOW, J., and KUNSELMAN, J.
Inc. and Johnson & Johnson ("the
manufacturers") designed, produced, marketed, and sold
transvaginal-mesh, named "TVT-Secur, " from 2006
through 2012. Unaware of the mesh's health risks, in
2007, Margaret Engleman's physicians implanted the
product in her to treat stress urinary incontinence
("SUI"). This surgery occurred in Philadelphia.
2013, Ms. Engleman sued the manufacturers in the Court of
Common Pleas of Philadelphia. She claims their vaginal mesh
permanently damaged her internal organs, continues to cause
her pain and suffering, and will negatively impact her
standard of life indefinitely. Because Ms. Engleman and the
manufacturers are New Jersey residents, the parties agreed
New Jersey's substantive law governs this case.
manufacturers argued at trial that the statute of limitations
time-barred Ms. Engleman's lawsuit. The jury disagreed,
found them liable, and awarded her $20, 000, 000 in damages.
Both sides appealed.
manufacturers continue to argue Ms. Engleman's case is
time-barred. Additionally, they argue the punitive damages
must be reduced. We agree that, under New Jersey's
punitive-damages cap, this Court must reduce the punitive
damages to $12, 500, 000 – i.e., to five times
the compensatory damages of $2, 500, 000. This lowers the
jury's total verdict to $15, 000, 000. In all other
respect, we affirm the judgment below.
Engleman filed this lawsuit against the manufacturers on
October 8, 2014. Among many defenses raised at trial, the
manufacturers asserted the two-year statute of limitations
for personal-injury causes of action.
facts set forth in the trial court's 1925(a) Opinion are
Beginning in 2003, Dr. Gregory Bolton, a Philadelphia
gynecologist, began treating [Ms. Engleman] for mild stress
urinary incontinence ("SUI"). In June 2007, Dr.
Bolton recommended surgery.
On June 14, 2007, Dr. Bolton performed surgery to correct
[Ms. Engleman's] incontinence and implanted [the
manufacturers'] Tension Free Vaginal Tape Secur
("TVT-Secur"). A month after surgery, [Ms.
Engleman] experienced pain in her vagina and a return of
urinary incontinence. In September 2007, Dr. Bolton
surgically removed [part of the] TVT-Secur mesh which was
exposed in [Ms. Engleman's] vagina.
[Ms. Engleman's] vaginal pain continued and her
incontinence increased. Dr. Bolton referred [Ms. Engleman] to
Dr. Joseph Montella, a urogynecologist at Thomas Jefferson
University Hospital in Philadelphia. In February 2008, Dr.
Montella performed a third surgery and removed all but
approximately three centimeters of the TVT-Secur. In 2012 and
2013, [Ms. Engleman] pelvic pain returned. [Ms.
Engleman's] new gynecologist, Dr. Geoffrey Bowers,
identified additional TVT-Secur erosion in [Ms.
Engleman's] vaginal wall. In December 2013, Dr. Montella
performed yet another procedure to remove the remaining mesh.
[Ms. Engleman] continued to experience dyspareunia, vaginal
spasms, and sexual dysfunction following the surgery.
[Ms. Engleman] continued to treat with Dr. Bowers for chronic
vaginal pain, urgency, and frequent urination. Physical
therapy, oral medications, creams and vaginal suppositories
failed to alleviate [Ms. Engleman's] symptoms. [Ms.
Engleman] testified that her pain has changed her life
Trial Court Opinion, 1/23/18, at 2-3.
case proceeded to a jury trial in April 2017. The jurors
found the manufacturers' vaginal mesh defective under New
Jersey's Product-Liability Act and awarded Ms. Engleman
compensatory and punitive damages. The trial court denied all
post-trial motions, including the manufacturers' request
for a new trial. The manufacturers timely appealed.
bring eleven appellate issues before this Court, which we
have reordered for ease of disposition as follows:
1. Did the trial court err in not awarding defendants
judgment as a matter of law under the two-year statute of
2. Did the trial court err in excluding evidence of
public-health notices issued in 2008 and 2011 that linked Ms.
Engleman's symptoms with the type of mesh device she was
3. Did the trial court commit reversible error by barring all
evidence from the federal Food and Drug Administration (FDA)
regarding TVT-Secur, an FDA-regulated medical device?
4. Did the trial court commit reversible error by admitting
evidence regarding Australian complaints about TVT-Secur that
Ethicon received months after Ms. Engleman's implantation
5. Did the trial court err when it refused to remit the
6. Should the punitive-damages award be eliminated, because
New Jersey law prohibits any award?
7. Should the punitive-damages award be eliminated or
reduced, because the award violates New Jersey law and is
8. Did the trial court err in instructing the jury to
consider whether fraudulent concealment tolled the statute?
9. Did the trial court commit legal error in not awarding
defendants judgment as a matter of law on the design-defect
claim, when Ms. Engleman failed to present legally sufficient
evidence of a safer, effective, feasible, and available
alternative design to TVT-Secur?
10. Did the trial court commit legal error in excluding
evidence demonstrating that Ms. Engleman's theoretical
"alternative" was neither available in 2007 nor
safer than TVT-Secur?
11. Did the trial court commit legal error in refusing to
instruct the jury that Ms. Engleman was required to prove a
safer, effective, feasible, and available alternative design?
See Manufacturers' Brief at 3-4.
Request for Judgment N.O.V. under Pennsylvania's and New
Jersey's Statute of Limitations
their first appellate issue, the manufacturers assert that
the trial court erred by not granting them judgment
notwithstanding the verdict ("n.o.v.") on their
statute-of-limitations defense. They argue Ms. Engleman
brought this case well after the two-year statute of
limitations had expired, under both New Jersey and
Pennsylvania law. Thus, they believe they are entitled to a
judgment as a matter of law, regardless of which state's
trial court ruled that Pennsylvania's statute of
limitations applied and instructed the jury accordingly. The
jury found that Ms. Engleman had timely filed her lawsuit,
and the trial court denied the manufacturers' post-trial
motion for judgment n.o.v. on this issue. As we will explain
below, Pennsylvania's statute of limitations and
corresponding discovery rule apply.
reviewing a trial court's ruling on a post-trial motion
for judgment n.o.v., our scope of review:
is plenary, as with any review of questions of law. Our
standard of review when examining the lower court's
refusal to grant a judgment n.o.v. is whether, when reading
the record in the light most favorable to the verdict winner
and granting that party every favorable inference therefrom,
there was sufficient, competent evidence to sustain the
verdict. Although we accord deference to a trial court with
regard to its factual findings, our review of its legal
conclusions is de novo.
Bailets v. Pennsylvania Tpk. Comm'n, 181 A.3d
324, 332 (Pa. 2018). To the extent that the manufacturers
challenge the trial court's interpretations of various
statutes, they "present this Court with questions of law
for which our standard of review is de novo, and our
scope of review is plenary." Id.
support their assertion for judgment n.o.v., the
manufacturers begin by claiming that we should apply New
Jersey's statute of limitations, because they think that
Ms. Engleman's claim accrued there. See
Manufacturers' Brief at 21 n. 2. Under New Jersey law,
the trial court, and not the jury, decides whether the
discovery rule tolls a plaintiffs' claims. Compare
Burd v. New Jersey Telephone Co., 386 A.2d 1310, 1312
(N.J. 1978) (accepting, for New Jersey statute-of-limitations
purposes, "findings of fact made by the trial
judge") with Nicolaou v. Martin, 195 A.3d 880,
894-895 (Pa. 2018) (reinforcing Pennsylvania's long
history of submitting all statute-of-limitations factual
disputes to a jury).
The manufacturers contend that:
Plaintiff's claims accrued in New Jersey, where she
resides and experienced complications. Thus,
Pennsylvania's borrowing statute compels the Court to
apply New Jersey limitations law if it first bars
Plaintiff's claims. 42 Pa.C.S.A. § 5521(b).
Manufacturers' Brief at 21 n. 2.
disagree. Pennsylvania's Uniform Statute of Limitations
on Foreign Claims Act only applies to claims "accruing
outside this Commonwealth . . . ." 42 Pa.C.S.A. §
5521. Thus, we must establish when and where Ms. Engleman
first suffered harm from the manufacturers' product.
manufacturers suggest that their mesh only harmed Ms.
Engleman after she returned home from Pennsylvania
to New Jersey. In support of their contention, the
manufacturers cite to Gwaltney v. Stone, 564 A.2d
498 (Pa. Super. 1989). That case cuts against them.
involved a car accident in Tennessee, but the plaintiffs
filed suit in Pennsylvania. This Court held that
Tennessee's one-year statute of limitations applied,
because "a claim accrues when and where the
injury is sustained." Id. at 501 (emphasis in
original). Because the wreck happened in Tennessee, the
Gwaltneys sustained their injuries in Tennessee.
Ms. Engleman's doctors implanted the manufacturers'
defective vaginal mesh in Philadelphia. See
Complaint at 6. Additionally, the manufacturers failed to
warn Ms. Engleman and her doctors that their product could
harm her in the manufacturer's product literature in
Pennsylvania. When Ms. Engleman's surgeons implanted the
vaginal mesh inside her body, the manufacturers' tort of
product liability was completed and accrued. Thus, as in
Gwaltney, we conclude that Ms. Engleman's cause
of action accrued in the state where the wrongful conduct
occurred – i.e., in Pennsylvania.
manufacturers' suggestion that Ms. Engleman's tort
accrued in New Jersey, because that is where she first felt
pain from their vaginal mesh, has no basis in the law. Were
we to accept their theory that the situs of pain
dictates where and when a cause of action accrues, then a
person in a Tennessee car accident, who did not feel its
effects until returning to Pennsylvania, would be able to
circumvent Gwaltney simply because his injury did
not manifest itself immediately. But the event that caused
the underlying harm – i.e., the tort
– would have still occurred in Tennessee. The same is
true of Ms. Engleman. The harmful event occurred in
Pennsylvania, even though the resultant pain manifested after
she returned to New Jersey.
the Uniform Statute of Limitations on Foreign Claims Act does
not apply in the instant case, because Ms. Engleman's
cause of action did not accrue in a foreign jurisdiction. It
accrued here. As a matter of law, the trial court properly
applied Pennsylvania's statute of limitations to Ms.
Pennsylvania's two-year statute of limitations for
personal injuries and corresponding discovery rule, whether a
plaintiff exercised reasonable diligence in investigating the
cause of her injuries generally raises a question of fact for
the jury. See 42 Pa.C.S.A. § 5524; see also
Nicolaou, supra. As the trial court explained:
In Pennsylvania, the discovery rule is a judicially created
exception that tolls the applicable statute of limitations
when an injury or its cause was not known or reasonably
knowable. Fine v. Checcio, D.D.S., 870 A.2d 850 (Pa.
2005). The discovery rule is invoked in cases "involving
latent injury, and/or instances in which the causal
connection between an injury and another's conduct is not
apparent." Wilson v. El-Daief, 964 A.2d 354,
361-62 (Pa. 2009). "Application of the discovery rule
involves a factual determination as to whether a party was
able, in the exercise of reasonable diligence, to know of his
injury and its cause. Therefore, application of the rule
ordinarily must be decided by a jury." Mariner
Partners v. Lenfest, 152 A.2d 265, 279 (Pa. Super.
2016) . . .
During trial, [Ms. Engleman] introduced sufficient evidence
to permit the jury to decide whether her claims were timely
filed. [Ms. Engleman] testified that she believed that her
body was rejecting the pelvic mesh for an unknown reason and
that this was the cause of her symptoms. She further
testified that, in December 2013, she saw advertisements on
television describing the symptoms she was experiencing, and
that the advertisements connected the symptoms to TVT-Secur.
For the first time, [Ms. Engleman] testified, she was made
aware of the connection. On April 2, 2014, within two years
of learning of the potential defect, [Ms. Engleman] filed
It is undisputed that none of Plaintiff's physicians
advised [Ms. Engleman] of a possible defect in the TVT-Secur.
Dr. Bolton testified that he was unaware of any possible
defects. Dr. Montella testified that he did not suspect the
TVT-Secur caused [Ms. Engleman's] symptoms.
It was proper as a matter of law for the trial court to apply
Pennsylvania law with regard to the statute of limitations
and the discovery rule. Under Pennsylvania law, the trier of
fact determines whether the statute of limitations is tolled
by the discovery rule. Viewed in the light most favorable to
the [Ms. Engleman], as the verdict winner, the evidence
presented at trial was sufficient to permit the jury to
determine that [Ms. Engleman] filed suit within two years of
learning the cause of her injuries.
Trial Court Opinion, 9/5/17, at 12-13 (emphasis added;
citations to the record omitted). The trial court properly
submitted the question of whether the discovery rule tolled
the Pennsylvania statute of limitations to the jury.
the jury believed Ms. Engleman's version of events, we
must defer to its finding of fact that the discovery rule
tolled the statute of limitations on her claims. As such, the
manufacturer's claim for judgment n.o.v. warrants no
relief. See Nicolaou, 195 A.3d at 894-895 (Pa. 2018)
(holding "courts may not view facts in a vacuum when
determining whether a plaintiff has exercised the requisite
diligence as a matter of law, but must consider what a
reasonable person would have known had he or she been
confronted with the same circumstances that [plaintiff] faced
at the time").
of FDA's Website Notifications on Vaginal Mesh
their second claim of error, the manufactures assert the
"trial court erred by excluding evidence showing that
[Ms. Engleman's] claim was time- barred."
Manufacture's Brief at 31. Specifically, the manufactures
disagree with the trial court's decision to exclude from
evidence public-health notices from the Food and Drug
Administration (FDA) website. See id. In support of
their theory that the trial court erred, the manufacturers
offer a case from the United States Court of Appeals for the
Fourth Circuit, Timothy v. Bos. Sci. Corp., 665
F.App'x 295 (4th Cir. 2016).
manufacturers challenge both the trial court's finding
that the FDA website notices were irrelevant and hearsay.
They argue that, under the discovery rule, Ms. Engleman
should have "the knowledge that a reasonable
investigation would have uncovered . . . ."
Manufacturers' Brief at 32. Not only do they view the
notices as relevant as to when the statute of limitations
began to run, the manufactures say the notices are
standard of review for a challenge to an evidentiary ruling
is the deferential abuse-of-discretion standard, and, even if
an abuse of discretion occurred, we will not disturb the
result below without some harm or prejudice befalling the
appellant. As we have said:
Admission of evidence is within the sound discretion of the
trial court and we review the trial court's
determinations regarding the admissibility of evidence for an
abuse of discretion. To constitute reversible error, an
evidentiary ruling must not only be erroneous, but also
harmful or prejudicial to the complaining party. For evidence
to be admissible, it must be competent and relevant. Evidence
is competent if it is material to the issue to be determined
at trial. Evidence is relevant if it tends to prove or
disprove a material fact. Relevant evidence is admissible if
its probative value outweighs its prejudicial impact. The
trial court's rulings regarding the relevancy of evidence
will not be overturned absent an abuse of discretion.
Czimmer v. Janssen Pharm., Inc., 122 A.3d 1043, 1058
(Pa. Super. 2015) (quoting Conroy v. Rosenwald, 940
A.2d 409, 417 (Pa. Super. 2007)).
"abuse of discretion" is not merely an error of
judgment. Paden v. Baker Concrete Construction,
Inc., 658 A.2d 341, 343 (Pa. 1995). It only occurs when
a trial court renders a judgment that is manifestly
unreasonable, arbitrary, or capricious, or if it fails to
apply the law or was motivated by partiality, prejudice,
bias, or ill will. Harman v. Borah, 756 A.2d 1116,
1123 (Pa. 2000). If the record ...