Engleman, M. v. Ethicon, Inc.

J-A25038-18

2019 PA Super 287

MARGARET ENGLEMAN : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
:
v. :
:
:
ETHICON, INC., AND JOHNSON AND :
JOHNSON, :
: No. 3320 EDA 2017
Appellants. :

Appeal 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.

MARGARET ENGLEMAN, : IN THE SUPERIOR COURT OF
: PENNSYLVANIA
Appellant :
:
:
v. :
:
:
ETHICON, INC. AND JOHNSON & : No. 3400 EDA 2017
JOHNSON :

Appeal from the Judgment Entered, September 12, 2017,
in the Court of Common Pleas of Philadelphia County,
Civil Division at No(s): 05384.

BEFORE: PANELLA, J., DUBOW, J., and KUNSELMAN, J.

OPINION BY KUNSELMAN, J.: FILED SEPTEMBER 20, 2019

Ethicon, 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
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Engleman’s physicians implanted the product in her to treat stress urinary

incontinence (“SUI”). This surgery occurred in Philadelphia.

In 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.

The 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.

The 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.

Factual Background

Ms. 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.

The facts set forth in the trial court’s 1925(a) Opinion are as follows:

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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 “drastically.”

Trial Court Opinion, 1/23/18, at 2-3.

The case proceeded to a jury trial in April 2017. The jurors found the

manufacturers’ vaginal mesh defective under New Jersey’s Product-Liability

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Act1 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. 2

They 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 limitations?

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 implanted with?

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 surgery?

5. Did the trial court err when it refused to remit the
compensatory-damages award?

____________________________________________

1 N.J.S.A. 2A:58C-1 et seq.

2 Ms. Engleman also filed a timely cross-appeal, docketed at 3400 EDA 2017.
She claims the trial court erred by refusing to calculate delay-damages based
on both compensatory and punitive damages, instead of just compensatory
damages. While this appeal was pending, this Court rejected Ms. Engleman’s
reading of the Pennsylvania Rules of Civil Procedure in Hammons v. Ethicon,
Inc., 190 A.3d 1248, 1289-1290 (Pa. Super. 2018), allowance of appeal
granted in part, 206 A.3d 495 (Pa. 2019). At oral argument, Ms. Engleman’s
counsel agreed that Hammons controls her cross-appeal. We thus dismiss
her cross-appeal as meritless.

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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 constitutionally excessive?

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.

Manufacturers’ Request for Judgment N.O.V. under Pennsylvania’s

and New Jersey’s Statute of Limitations

As 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

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entitled to a judgment as a matter of law, regardless of which state’s statute

applies.

The 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.

When 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.

To 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

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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.

We 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.

The 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.

Gwaltney 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

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sustained.” Id. at 501 (emphasis in original). Because the wreck happened

in Tennessee, the Gwaltneys sustained their injuries in Tennessee.

Here, 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.

The 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.

Thus, 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

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court properly applied Pennsylvania’s statute of limitations to Ms. Engleman’s

lawsuit.

Under 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 Chestnut
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 suit.

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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.

Because 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”).

Admissibility of FDA’s Website Notifications on Vaginal Mesh

For their second claim of error, the manufactures assert the “trial court

erred by excluding evidence showing that [Ms. Engleman’s] claim was time-

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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.3 See id. In support

____________________________________________

3For example, the FDA published the following notice about a year after Ms.
Engleman began to experience complications from the mesh:

Medical Devices
FDA Public Health Notification: Serious
Complications Associated with Transvaginal
Placement of Surgical Mesh in Repair of Pelvic
Organ Prolapse and Stress Urinary
Incontinence
For updated information about Surgical Mesh for
Pelvic Organ Prolapse, see: UPDATE on Serious
Complications Associated with Transvaginal
Placement of Surgical Mesh for Pelvic Organ

Prolapse, released July 13, 2011.

Issued: October 20, 2008

Dear Healthcare Practitioner:

This is to alert you to complications associated with
transvaginal placement of surgical mesh to treat Pelvic
Organ Prolapse (POP) and Stress Urinary Incontinence
(SUI). Although rare, these complications can have serious
consequences. Following is information regarding the
adverse events that have been reported to the FDA and
recommendations to reduce the risks.

Nature of the Problem

Over the past three years, FDA has received over 1,000
reports from nine surgical mesh manufacturers of
complications that were associated with surgical mesh
devices used to repair POP and SUI. These mesh devices

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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).

The manufacturers challenge both the trial court’s finding that the FDA

website notices were irrelevant and hearsay. They argue that, under the

____________________________________________

are usually placed transvaginally utilizing tools for minimally
invasive placement.

The most frequent complications included erosion through
vaginal epithelium, infection, pain, urinary problems, and
recurrence of prolapse and/or incontinence. There were
also reports of bowel, bladder, and blood vessel perforation
during insertion. In some cases, vaginal scarring and mesh
erosion led to a significant decrease in patient quality of life
due to discomfort and pain, including dyspareunia . . .

Sincerely,

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration

If you have questions about this Notification, please contact
FDA’s Division of Small Manufacturers, International and
Consumer Assistance (DSMICA) by e-mail at
dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or
301-796-7100

Page Last Updated: 03/21/2013

Manufacturers’ Exhibit 5 to CTX-C; U.S. Food and Drug Administration, FDA
Public Health Notification: “Serious Complications Associated with
Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse
and Stress Urinary Incontinence” (Oct. 20, 2008),
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNot
ifications/ucm061976.htm.

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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 “dispositive.” Id.

Our 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)).

An “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

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(Pa. 2000). If the record adequately supports the trial court’s reasons and

factual basis, the court did not abuse its discretion. Id.

Although it is not entirely clear from their brief, the manufactures appear

to claim the ruling was manifestly unreasonable and that exclusion of the FDA

notices was reversible error. See Manufacturers’ Brief at 31. They point out

that the “trial court’s primary rationale” for disallowing the notifications into

evidence “— that the notices ‘referred specifically to mesh used for pelvic

organ prolapse and not stress urinary incontinence,’ is incorrect.” Id. at 32

(quoting Trial Court Opinion, 1/23/18, at 42). They also attack the trial court’s

secondary grounds for exclusion – namely, that the notifications constituted

hearsay – as legally untenable. Thus, they also attack the ruling as legally

erroneous.4

The manufacturers’ argument attempts to reframe the issue of the

notices’ relevance on appeal in a manner that they did not present to the trial

court. While they may well be relevant under the Fourth Circuit’s application

of Utah law in Timothy, supra, they are obviously irrelevant under the case

law of this Commonwealth, because Ms. Engleman is not expected to self-

diagnose. She is “only charged with the knowledge communicated to . . . her

by the medical professionals who provided treatment and diagnosis.”

Nicolau, 195 A.3d at 893. As such, under Pennsylvania law, we only “impose

____________________________________________

4 Because we find the FDA notices irrelevant, we dismiss the issue of whether
they were also hearsay as moot.

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a relatively limited notice requirement upon the plaintiff [and] submit factual

questions regarding that notice to the jury as factfinder.” Id.

Given this limited notice requirement, Ms. Engleman did not need to

scour the Internet in the hopes of possibly uncovering the FDA notices and

then use them to determine whether the vaginal mesh was harming her, as a

matter of law. Thus, in Pennsylvania, these notices have no “tendency to

make a fact more or less probable than it would be without the evidence . . .

.” Pennsylvania Rule of Evidence 401. They are irrelevant to Ms. Engleman’s

discovery-rule theory under Nicolau; the FDA is not one of her “medical

professionals who provided treatment and diagnosis.” Id.

Additionally, according to defense counsel, the manufacturers were not

willing to say the FDA notices provided “notice of a defect in the product.”

N.T., 4/24/17, at 62. Thus, we do not see how the manufacturers can argue

the FDA notices to the public at large informed Ms. Engleman that their vaginal

mesh was defective and causing her injuries. This argument is duplicitous.

In other words, the manufacturers wished to introduce the FDA notices to

show Ms. Engleman should have known about the defect in their product, even

though they themselves did not think the FDA notices were accurate. The

manufacturers cannot have it both ways. Either the FDA notices were notice

of the defect in the product, or they were not.

As previously mentioned, the two relevant issues for the discovery rule

were when Ms. Engleman learned of 1) her injury, and 2) who caused that

injury. See Nicolau, supra. The exclusion of the notices that they believe

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were inaccurate did not harm or prejudice the manufactures. The notices

were clearly irrelevant to Ms. Engleman’s knowledge that she was suffering

an injury – she already knew that. And, as to whether the notices informed

her that the manufacturers were the cause of that injury, the manufacturers

themselves denied, at the time of proffer, that the notices did any such thing.

Thus, the manufacturers attempted to admit the notices solely to ask Ms.

Engleman whether she saw them, not for proving the FDA’s conclusion therein

– i.e., the mesh was harmful.

Now, on appeal, they switch positions. The manufacturers advance the

accuracy of the FDA notices as dispositive of Ms. Engleman’s case, because

they now contend that any reasonable person reading the FDA notices should

have known their product was defective. Both theories cannot be true, and

the manufactures did not advance the latter in the trial court.

Finally, we note the manufacturers disregarded the FDA notices. They

kept marketing their product for years after the 2008 notice, and for some

time after the 2011 one. They did not alter their behavior when the FDA

published these notices; yet, they hypocritically contend that Ms. Engleman

and any reasonable person in her position should have altered theirs. We

disagree. Under these circumstances, the manufacturers fall woefully short

of meeting their burden to show harm or prejudice due to the exclusion of the

FDA notices from evidence.

We dismiss their second appellate issue as meritless.

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Admissibility of the FDA 510(k) Clearances

For their next issue, the manufacturers claim that the trial judge’s

exclusion of FDA-created evidence, in the form of 510(k) clearances,5 was

“wrong.” Manufacturers’ Brief at 46. They disagree with the trial judge’s

conclusions on this issue. To underscore that disagreement, they reargue this

point to us de novo, and rely on an opinion from the United States District

Court for the District of Arizona, reaching the opposite conclusion. See In re

Bard IVC Filters Prods. Liab. Litig., 289 F. Supp. 3d 1045 (D. Ariz. 2018).

____________________________________________

5 According to the FDA:

Section 510(k) of the Food, Drug and Cosmetic Act requires
device manufacturers who must register, to notify FDA of
their intent to market a medical device at least 90 days in
advance. This is known as Premarket Notification – also
called PMN or 510(k). This allows FDA to determine whether
the device is equivalent to a device already placed into one
of the three classification categories. Thus, “new” devices
(not in commercial distribution prior to May 28, 1976) that
have not been classified can be properly identified.
Specifically, medical device manufacturers are required to
submit a premarket notification if they intend to introduce a
device into commercial distribution for the first time or
reintroduce a device that will be significantly changed or
modified to the extent that its safety or effectiveness could
be affected. Such change or modification could relate to the
design, material, chemical composition, energy source,
manufacturing process, or intended use.

United States Food & Drug Administration, “510(k) Clearances,” available at
https://www.fda.gov/medicaldevices/productsandmedicalprocedures/devicea
pprovalsandclearances/510kclearances/ (last visited 11/29/18).

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However, as mentioned above and as the manufacturers acknowledge

in the opening of their brief, when an evidentiary ruling is on appeal, this

“Court determines whether the trial court abused its discretion or misapplied

the law.” Manufacturers’ Brief at 2 (citing Hutchinson v. Penske Truck

Leasing Co., 876 A.2d 978 (Pa. Super. 2005)). The manufactures overlook

what constitutes an abuse of discretion. “Abuse of discretion occurs if the trial

court renders a judgment that is manifestly unreasonable, arbitrary or

capricious; that fails to apply the law; or that is motivated by partiality,

prejudice, bias or ill-will.” Hutchinson, 876 A.2d at 984. In other words, a

judgment call by the trial court – even a judgment call this Court thinks is

“wrong” – does not create an abuse of discretion, without something more.

Here, by re-litigating their argument on the FDA clearances from the

beginning, without something more, the manufacturers have not shown an

abuse of discretion. They do not contend that the trial court’s decision was

arbitrary or capricious; based on partiality, prejudice, bias, or ill-will; or

manifestly unreasonable. Nor do they reference any Pennsylvania Rule of

Evidence that they believe the trial judge misapplied. And their citation to the

Arizona trial court’s Bard IVC case, at most, indicates that reasonable minds

can differ regarding this FDA evidence. The Arizona judge reached one

reasoned conclusion by admitting the evidence; the Pennsylvania judge

reached the other by excluding it.

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Thus, we are unpersuaded that the Pennsylvania trial court abused its

discretion, when it reached the opposite, equally reasonable conclusion. As

the trial court explained in its 1925(a) Opinion:

Prior to trial, [Ms. Engleman] submitted a motion in
limine to preclude all evidence of the FDA 510(k) clearance
of any Ethicon products . . . During trial, [Ms. Engleman]
moved to preclude evidence regarding the regulatory
history of the [defective product], arguing that the evidence
was irrelevant and thus precluded under Pa.R.E. 403. The
court, in its discretion, granted these motions. The court
excluded FDA-related evidence under Pa.R.E. 403 as
irrelevant to the trial at hand. Under Rule 403, the court
may exclude relevant evidence if its probative value is
outweighed by a danger of one or more of the following:
unfair prejudice, confusing the issues, misleading the jury,
undue delay, wasting time, or needlessly presenting
cumulative evidence. Pa.R.E. 403.

In its discretion, the trial court chose not to hold a “trial
within a trial” over the FDA approval process. FDA 510(k)
approval . . . is not a review for the safety and efficacy of a
product and is instead only a review of substantial similarity
between two devices. Including FDA evidence on the
approval process for other TVT devices would involve a
history of the TVT line of products and devices, which would
not be relevant to TVT-Secur safety, design, or warnings.
Such evidence would serve only to confuse the issues and
mislead the jury regarding the role of the 510(k) approval
process.

Trial Court Opinion, 1/23/18, at 41-42.

This opinion is well-reasoned and based upon a proper construction of

Rule of Evidence 403. Simply because the trial court reached conclusions that

the manufacturers consider “wrong” does not mean that the court abused its

discretion. We may not second guess its logical determination that the FDA

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clearances risked confusing the jurors and creating undue delay by leading to

a trial within the trial. Nor may we second guess its conclusion that such a

risk outweighed the probative value of the FDA clearances.

Hence, this issue warrants no relief.

Admissibility of the Australian Physicians’ Complaints

The manufacturers also allege that the trial court should not have

admitted complaints from Australian physicians about the safety of the vaginal

mesh. They argue that these complaints were irrelevant and inadmissible

hearsay. The trial judge decided otherwise.

Addressing this issue, the trial court explained in great detail why this

evidence was relevant:

In September 2007, [the manufacturers] began
receiving complaints from Australian doctors who were
having difficulty implanting the [defective mesh]. In
response, [the manufacturers] performed a quality
investigation and root cause analysis with Australia’s
Therapeutic Goods Administration. Dr. Aran Maree placed a
“quality block” on [vaginal mesh] devices, meaning they
could not be used until the investigation was completed.

The trial court properly admitted evidence of the
Australian doctors’ concerns and the “quality block.”
Evidence of complaints is relevant to [Ms. Engleman’s]
failure-to-warn and design-defect claims under the NJPLA.
See N.J.S.A. § 2A:58C-1. Under New Jersey law, a product
is unreasonably dangerous if not accompanied by adequate
warnings. See N.J.S.A. § 2A:58C-2. To succeed in an
action under the NJPLA, a Plaintiff must prove that the
product was not reasonably fit, suitable, or safe for its
intended purpose, because it either contained a
manufacturing defect, failed to contain adequate warnings

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J-A25038-18

or instructions, or was designed in a defective manner. Id.
A manufacturer is required to warn of risks known during
the time in which the plaintiff was using the product.
Evidence of either “deliberate concealment or nondisclosure
of after-acquired knowledge of harmful effects” or
economically driven manipulation of the post-market
regulatory process will rebut a presumption of adequate
warning. Perez v. Wyeth Laboratories Inc., 734 A.2d
1245, 1261 (N.J. 1999).

The evidence is also relevant to [Ms. Engleman’s] design-
defect claim. To prevail on a design-defect claim, a plaintiff
“must prove either that the product’s risk outweighed its
utility or that the product could have been designed in an
alternative manner so as to minimize or eliminate the risk
of harm.” Lewis v. Am. Cyanamid Co., 715 A.2d 967 (N.J.
1998). A plaintiff must provide sufficient evidence, so a
reasonable juror could find “either that the product’s risks
outweighed its utility or that the product could have been
designed in an alternate manner so as to minimize or
eliminate the risk of harm.” Id. at 571.

Here, evidence of the complaints in Australia is relevant
to show that [the manufacturers] were aware of the risks
associated with the [defective vaginal mesh] but failed to
take action and adequately warn [Ms. Engleman’s]
physicians of these issues. Alternatively, [the
manufacturers] assert that the complaints were
inadmissible hearsay. However, this evidence was not
offered to prove the truth of the matter asserted. Rather,
the evidence of complaints from Australian doctors and
subsequent quality block was offered to establish notice,
which is not hearsay. See Castellani v. Scranton Times,
L.P., 124 A.3d 1229 (Pa. 2015) (holding that out-of-court
statements offered to put a defendant on notice is not
hearsay).

For the reasons set forth, [Ms. Engleman’s] evidence of
Australian doctors’ complaints was admissible and relevant
to her case. The trial court did not abuse its discretion in
permitting this evidence, and, thus, the ruling of the trial
court should be affirmed.

Trial Court Opinion, 1/23/18, at 44-47 (citations to record omitted).

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J-A25038-18

Much like their attack against the trial court’s refusal to admit the FDA

clearances above, the manufacturers again failed to explain how the trial

court’s judgment was manifestly unreasonable, biased, prejudiced, based on

ill-will, clearly erroneous, or misapplied the Pennsylvania Rules of Evidence.

In fact, the manufacturers only mention Pennsylvania Rule of Evidence 403 as

an afterthought in the last paragraph of their argument on this issue. See

Manufacturers’ Brief at 53.

They baldly claim that the evidence of complaints from the Australian

physicians violated that Rule 403, “because the jury likely viewed the evidence

as proof of Ethicon’s knowledge, which it logically could not be.” Id.

Additionally, the manufacturers speculate that the “jury very well may have

based its $17,500,000 verdict on this evidence, even though post-implant

knowledge cannot support a punitive award.” Id.

Whatever the jury may have based its verdict and damages award is an

unproductive guessing game, played in hindsight, well after the trial court

ruled this evidence admissible. And, more to the point, it does not speak to

the test established in Rule 403. Under that Rule:

The court may exclude relevant evidence if its probative
value is outweighed by a danger of one or more of the
following: unfair prejudice, confusing the issues, misleading
the jury, undue delay, wasting time, or needlessly
presenting cumulative evidence.

Pa.R.E. 403 (emphasis added).

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J-A25038-18

The test focuses on “outweighed.” This requires trial judges to balance

the relevant evidence’s truth-proving value against the Rule’s six competing

factors. For the manufacturers to show that the trial court has misapplied this

Rule, they need to prove that the danger of prejudice, confusion, delay, etc.

exceeded the evidence’s probative value. But the manufacturers attempt no

such weighing analysis in their brief, much less craft a persuasive argument

showing how the trial judge exceeded the scope of her discretion in applying

Rule 403.

As this Court previously told these same manufacturers in another

vaginal-mesh case:

all relevant evidence is meant to prejudice a defendant, so
exclusion is limited to evidence so prejudicial that it would
inflame the jury to make a decision based upon something
other than the legal propositions relevant to the case. A
trial court is not required to sanitize the trial to eliminate all
unpleasant facts from the jury’s consideration, where those
facts form part of the history and natural development of
the events.

In other words . . . a party may strike hard blows, so long
as it does not strike foul blows. The evidence . . . in this
case was highly relevant . . . its probative value outweighed
any prejudice to Ethicon. Indeed, we do not consider
Ethicon to have suffered “unfair prejudice [or delay],” Rule
403’s operative term[s].

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J-A25038-18

Hammons v. Ethicon, Inc., 190 A.3d 1248, 1283 (Pa. Super. 2018),

allowance of appeal granted in part, 206 A.3d 495 (Pa. 2019) (citations and

some punctuation omitted).6

Thus, we find the trial court acted within its discretion when it made the

reasonable decision to admit evidence of the Australian doctors’ complaints,

and we dismiss this issue as it affords the manufacturers no relief.

Remittitur of Compensatory Damages

Next, the manufacturers challenge the trial judges’ refusal to remit the

jury’s award of $2,500,000 in compensatory damages. However, their

argument not only repeats, but magnifies, the error they committed when

arguing the evidentiary rulings above. The manufacturers totally ignore our

deferential standard of review. They incorrectly state, as our standard of

review, that remittitur “is proper if the verdict is ‘excessive, exorbitant, and

beyond what the evidence warrants, or where the verdict resulted from

partiality, prejudice, mistake, or corruption.’” Manufacturers’ Brief at 2

(quoting Smalls v. Pittsburgh-Corning Corp., 843 A.2d 410, 414 (Pa.

Super. 2004)).

To be clear, that is NOT our standard of review; it is the legal test for

the trial court. As the trial court clearly and correctly informed them in the

____________________________________________

6 The parties had already filed their briefs when this Court issued its Opinion
in Hammons, supra. They therefore did not have the benefit of that decision
in preparing their written arguments.

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J-A25038-18

1925(a) Opinion, a “grant of remittitur is a matter within the sound discretion

of the trial court and will not be disturbed absent a gross abuse of discretion.”

Trial Court Opinion, 1/23/18, at 40 (citing Botek v. Mine Safety Appliance

Corp., 611 A.2d 1174, 1177 (Pa. 1992) (emphasis added).

Despite the trial court’s admonition, the manufacturers look the other

way. Citing two cases from New Jersey and one from Pennsylvania, they

reargue their cause for remittitur de novo. Because the manufacturers do not

explain how the trial court abused its discretion, we dismiss this issue as

affording them no relief.

Availability of Punitive Damages

Next, the manufacturers claim that, under New Jersey law, punitive

damages are unviable, because they are barred when a medical device “is

generally recognized as safe and effective pursuant to conditions established

by the federal [FDA] and applicable regulations, including packaging and

labelling regulations.” Manufacturers’ Brief at 56-57 (quoting N.J.S.A. §

2A:58C-5). They argue that the “FDA cleared TVT-Secur for marketing

through its 510(k) process,” and the FDA’s 510(k) process “is a safety and

efficacy review . . . .” Id. at 57 (emphasis in original).

This issue involves the interpretation of the New Jersey statute and the

Pennsylvania Rules of Appellate Procedure, which are both questions of law.

As such, our scope of review is plenary, and our standard of review is de novo.

See Snead, supra.

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J-A25038-18

The manufacturers’ statement that the FDA’s 510(k)-clearance process

“is a safety and efficacy review” is untenable. The Supreme Court of the

United States has said “the 510(k) process is focused on equivalence, not

safety.” Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008). Indeed, the

trial court included that very quote in its 1925(a) Opinion. See Trial Court

Opinion, 1/23/18, at 32-33. As if that quote alone did not render this issue

meritless, the trial court also provided another decisive quote from the United

States Court of Appeals for the Third Circuit:

A device found to be ‘substantially equivalent’ to a predicate
device is said to be ‘cleared’ by FDA (as opposed to
‘approved’ by the agency under a [premarket approval
(“PMA”)]. A premarket notification submitted under
Section 510(k) is thus entirely different from a PMA,
which must include data sufficient to demonstrate to
FDA that the device is safe and effective. See
[Medtronic, Inc. v.] Lohr, 518 U.S. at 478–79 (1996)
(“The § 510(k) notification process is by no means
comparable to the PMA process.”).

Horn v. Thoratec Corp., 376 F.3d 163, 167 (3rd. Cir. 2004) (quoting an FDA

amicus brief) (emphasis in original). Based on this language, neither the FDA

nor the Supreme Court of the United States views the 510(k) process as a

safety or efficacy review on the level of PMA review.

Finally, the trial court recognized this Court’s holding that 510(k) review

does not equate to a safety or efficacy declaration from the FDA. “See also

Burgstahler v. AcroMed Corp., 670 A.2d 658 (Pa. Super. 1995) (‘At least

two federal courts have expressly found that the 510(k) approval under the

[Medical Device Amendments of 1979, 21 U.S.C. §§ 360c-360k (Supp. 1995)],

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J-A25038-18

standing alone, is not a finding of safety and effectiveness . . .’).” Trial Court

Opinion, 1/23/18, at 33. Furthermore, this Court has said, “The FDA’s own

regulations provide that its acceptance of a claim that a device is ‘substantially

equivalent to a device in commercial distribution before May 28, 1976, . . .

does not in any way denote official approval of the device . . . .’ 21

C.F.R. 807.97 (emphasis supplied).” Burgstahler, 670 A.2d at 663.

Accordingly, we dismiss this appellate issue as affording no relief to the

manufactures.

New Jersey’s Punitive Damages Limit

The manufacturers also assert that the jury improperly imposed

$17,500,000 punitive-damages award against them, because “the award

violates New Jersey law and is constitutionally excessive.” Manufacturers’

Brief at 4. The manufacturers advance two appellate theories here.

First, they argue “New Jersey law caps punitive damages at five times

the compensatory award.” Id. at 56 (citing N.J.S.A. § 2A:15-5.14(b)). The

jury awarded compensatory damages of $2,500,000. The manufacturers

therefore claim the jury could not lawfully award any more than $12,500,000

in punitive damages – $5,000,000 less than its original award.

Second, after the award is reduced under the cap, the manufacturers

believe that this Court should either (a) totally eliminate or (b) reduce the

remaining $12,500,000 punitive award to $2,500,000 or less. They claim that

a $12,500,000 punitive-damages award violates the New Jersey statute

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J-A25038-18

and/or the Constitution of the United States. By way of support, the

manufacturers cite N.J.S.A § 2A:15-5.14(a) and the Due Process Clause of

the Fourteenth Amendment via a quote from State Farm Mutual Auto.

Insurance Co. v. Campbell, 538 U.S. 408 (2003).

Ms. Engleman agrees that N.J.S.A. § 2A:15-5.14(b) limits punitive

damages to five times the compensatory damages.7 However, she disagrees

that we should reduce punitive damages below $12,500,000. Instead, she

says New Jersey substantive law does not control, because, under

Pennsylvania law, “remittitur is a ‘procedural mechanism by which an

excessive verdict of the jury is reduced.’” Engleman’s Brief at 62 (quoting

Refuse Management Sys. v. Consol. Recycling & Transfer Sys., 671 A.2d

1140 (Pa. Super. 1996)). And, she asserts, even if reduction is substantive,

there is no conflict between New Jersey and Pennsylvania law, because, under

both laws, the standard of review is an abuse of discretion. She claims no

such abuse occurred, as the record supports punitive-damages award.

In resolving these issues, the trial court applied New Jersey law and the

____________________________________________

7 In the trial court and her appellee brief, Ms. Engleman originally asked the
courts of Pennsylvania to strike-down N.J.S.A. § 2A:15-5.14(b), because it
violated her right to a jury trial under Article I, § 9 of the Constitution of New
Jersey. When we questioned her counsel on this Court’s power to declare a
Sister State’s law unconstitutional under its constitution, counsel was unaware
of any case where that had occurred. He also said that we may not certify this
issue to the Supreme Court of New Jersey, as the United States Court of
Appeals for the Third Circuit might do under New Jersey Rule of Appellate
Procedure 2:12A. Essentially, counsel withdrew this constitutional attack on
the New Jersey statute at oral argument, and, therefore, we do not reach its
merits.

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J-A25038-18

federal constitution. The court recognized the jury award must be reduced; it

opined:

States have discretion over the imposition of punitive
damages. However, there are “procedural and substantive
constitutional limitations on these awards.” State Farm
Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408, 416
(2003). The Supreme Court gives three guideposts for
reviewing a punitive damages award for reasonableness:
(1) the degree of reprehensibility of the defendant’s
misconduct; (2) the disparity between the actual or
potential harm suffered by the plaintiff and the punitive
damages-award; and (3) the difference between the
punitive damages awarded by the jury and the civil penalties
authorized or imposed in comparable cases. Id. at 418.

“Perhaps the most important indicium of the
reasonableness of a punitive damages award is the degree
of reprehensibility of the defendant’s conduct.” BMW of N.
Am., Inc. v. Gore, 517 U.S. 559, 576 (1996).
Considerations are the nature of the victim’s harm, the
degree of defendant’s culpability, the victim’s vulnerability
to the harm, and whether the conduct involved repeated
actions. Id. at 576-77.

Trial evidence supported the jury’s determination that
[the manufacturers] acted reprehensibly. [Ms. Engleman]
established that [they] misrepresented the safety concerns
of [their vaginal mesh] to patients and physicians in an
effort to gain a foothold in a quickly growing market and
subsequently marketed the device for six years, despite
knowledge of the risks.

Regarding proportionality, the Supreme Court has stated
“we have been reluctant to identify concrete constitutional
limits on the ratio between harm or potential harm to the
plaintiff and the punitive damages award.” State Farm
Mutual Automobile Insurance Co. v. Campbell, 538
U.S. 408, 425 (2003). The Supreme Court has “consistently
rejected the notion that the constitutional line is marked by
a single mathematical formula, even one that compares
actual and potential damages to the punitive award” though
“single-digit multipliers are more likely to comport with due

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J-A25038-18

process.” Id. Here, the jury’s punitive damage award used
a multiplier of seven.[8] Although there is no bright-line test
to determine when a ratio is excessive, the damage award
is within the Supreme Court’s suggested proportionality
test.

Alternatively, [the manufacturers] claim that the punitive
damages should be reduced to $12,500,000 (the maximum
amount permitted under the New Jersey Punitive Damages
Act). N.J.S.A. § 2A:15-5.14(b). . . . The Trial Court
acknowledges that this section of the New Jersey Punitive
Damages Act applies and, under New Jersey law, [Ms.
Engleman’s] punitive damage award should be reduced
from $17,500,000 to $12,500,000.

Trial Court Opinion, 1/23/18, at 38-39.

We agree with the trial judge’s well-reasoned opinion above and adopt

it as our own on the issue of punitive damages. Accordingly, we modify Ms.

Engleman’s punitive-damages award, under N.J.S.A. § 2A:15-5.14(b), to

$12,500,000.

Wavier of Jury-Instructions Issue

Next, the manufacturers assert that the trial court erroneously charged

the jury on fraudulent-concealment. See Manufacturers’ Brief at 33. Without

reference to or quoting from any authority whatsoever, the manufacturers

offer only one paragraph of conclusory statements in their appellants’ brief to

allege that the trial court was “triply wrong.” Id.

____________________________________________

8 Moreover, after New Jersey’s punitive-damages cap is applied, the multiplier
is reduced to five times the compensatory damages.

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It is incumbent upon the party claiming error in this Court to develop all

issues raised in its brief fully. See Pennsylvania Rules of Appellate Procedure

2111 and 2119. Those Rules require that arguments include, among other

things, “citation of authorities . . . .” Pa.R.A.P. 2119. As the manufacturers

have failed to cite or quote any rule, case law, or statutory basis for their claim

that the trial court’s charge was erroneous, we dismiss this claim of error as

waived.

Mootness of Design-Defect Issues

Finally, the manufacturers argue that they were entitled to judgment

n.o.v. on Ms. Engleman’s design-defect claim, because she “failed to prove

that a safer, alternative design to TVT-Secur was feasible and available.”

Manufacturers’ Brief at 35.

Ms. Engleman argues that we “should not even reach this argument.”

Engleman’s Brief at 20. She points out that she:

[b]rought one product-liability action under the New Jersey
Product Liability Act and submitted that claim to the jury on
two factual theories: design-defect and failure-to-warn. The
jury found in [her] favor on both theories, as it was entitled
to do. On appeal, [the manufacturers] made no argument
concerning the failure-to-warn theory. This amounts to a
concession that there was sufficient evidence to sustain the
jury’s verdict on failure-to-warn grounds.

Id. at 20-21 (citations omitted) (emphasis in original). We agree.

In fact, the manufacturers’ failure to appeal both theories renders the

jury’s verdict against it, on the failure-to-warn theory, conclusive. Thus, as a

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matter of law, this vaginal mesh is defective due to the manufacturers’ failure

to warn, regardless of whether a design defect was present. Hence, no ruling

from this Court regarding Ms. Engleman’s design-defect theory will change

that. We therefore dismiss this claim of error as moot.

Additionally, the manufacturers argue that a new trial is warranted,

because the trial court should have (1) admitted FDA evidence regarding the

unavailability of a safer, alternative design and (2) instructed the jury

regarding Ms. Engleman’s obligation to prove the existence of “a safer,

practical, and feasible alternative design.” Manufacturers’ Brief at 40.

We have concluded that, as a matter of law, the jury verdict may be

upheld solely on Ms. Engleman’s failure-to-warn theory. Thus, no new trial

on the design-defect issue is warranted as to either of these alleged errors.

Hence, we also dismiss these two issues as moot.

Conclusion

In sum, the manufacturers raised many appellate issues. Some they

forfeited on procedural grounds, and on others, they ignored the correct

standard of review. Their only surviving issue of merit is the trial court’s

failure to apply New Jersey’s punitive-damages cap. Accordingly, we modify

the judgment in favor of Ms. Engleman to $12,500,000 for punitive damages.

We find no basis to alter the jury’s award of $2,500,000 for compensatory

damages or the trial court’s award for delay damages, based solely upon those

compensatory damages.

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J-A25038-18

Judgment, as modified, affirmed.

Judge Panella joins this Opinion.

Judge Dubow files a Dissenting Statement.

Judgment Entered.

Joseph D. Seletyn, Esq.
Prothonotary

Date: 9/20/19

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