J

- A25038

- 18 2019 PA Super 287

MARGARET ENGLEMAN

v.
ETHICON, INC., AND JOHNSON AND JOHNSON, Appellants. : : : : : : : : : : IN THE SUPERIOR COURT OF

PENNSYLVANIA

No. 3320 EDA 2017

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,

Appellant

v.

ETHICON, INC. AND JOHNSON & JOHNSON : : : : : : : : : : IN THE SUPERIOR COURT OF

PENNSYLVANIA

No. 3400 EDA 2017

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 (“t he manufacturers”) designed, produced, marketed, and sold trans vaginal

- mesh, named “ TVT

- Secur, ” from 2006 through 2012

. Unaware of the mesh’s healt h risks , in 2007 , MargaretJ

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Engleman ’s physicians implanted the product in her to treat stress urinary
incontinence (“SUI”)

. This surgery occurred in Philadelphia.
I n 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 resident s , the part ies agree d New Jersey’s substantive law governs this case

. The manufacturers argued at trial t hat the statute of limitations time

barred Ms. Engleman’s lawsuit. The jury disagree d , 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, u nder New Jersey’s punitive

- damages cap , this Court mus t 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 th e judgment below.

Factual Background Ms. Engleman filed th is 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.
T he facts set forth in the trial court’s 1925(a) Opinion are as follows :J

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- Beginning in 2003, Dr. Gregory Bolton, a Philadelphia gynecologist, began treating [Ms. Engleman] for mild st ress 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’] Te nsion 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 wa s exposed in [Ms. Engleman’s] vagina. [Ms. Engleman’s] vaginal pain continued and her incontinence increased. Dr. Bolton referred [Ms. Engleman] t o 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. Englem an] pelvic pain returned. [Ms. Engleman’s] new gyn ecologist, Dr. Geoffrey Bowers, identified additional TVT

- Secur erosion in [Ms. Engleman’s] vaginal wall. In December 2013, Dr. Montella performed yet another procedur e 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, c reams 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.
T he case proceeded to a jury trial in April 2017

. The jurors found the manufacturers’ vaginal mesh defective under New Jersey’s Product

- LiabilityJ

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Act 1 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 eas e of disposition as follows :

1. D id the trial court err in not awarding d efenda nts 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 devic e she was implanted with? 3

. Did the trial court commit reversibl e 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 reversi ble error by admitting evidence regarding Australian complaints a bout TVT

- Sec ur that Ethicon received months after Ms. Englema n ’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 t o calculate delay

- damages based on both compensatory and punitive damage s, instead of just compensatory damages

. While this appeal wa s pending, thi s Court rejected Ms. Engleman’s reading of the Pennsylvania Rules of Civil Procedure in Hammons v. Ethicon, Inc ., 190 A.3d 124 8, 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 con trols her cross

- appeal. W e thus dismiss her cross - appeal as meritless.J

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. 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 alternati ve 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 r efusing 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 S tatute of Limitations
As their first appellate issue , the manufacturers assert that the trial court erred by not grant ing 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 s tatute of limitations had expired , under both New Jersey and Pennsylvania law . Thus, they believe they areJ

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entitl ed to a judgment as a matter of law , regardless of which state’ s statute applies

. The trial court ruled that Pennsylvan ia’s statute of limitation s applie d 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 th is 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 e vidence 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. U nder New Jersey law , the trial court , and not the jury , decidesJ

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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

- limitat ions 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 isJ

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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 Pen nsylvania. When Ms. Engleman’s surgeon s 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 t he wrongful conduct occurred

– i.e. , in Pennsylvania

. The manufacturers ’ suggest ion 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 no t 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 occ urred in Pennsylvania, even though the resultant pain manifest ed after she returned to New Jersey.
T h us, th e 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, t he trialJ

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

. Under Pennsylvania’s two

- year statu t e of limitations for personal injuries and corresponding discovery rule , whether a plaintiff exercised reasonable dilige nce 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 c reated 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 ano ther’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. Eng leman] 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 sympt oms 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 learn ing of the potentia l defect, [Ms. Engleman] filed suit.J

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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 pro per as a matter of law for the trial c ourt 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 lig ht 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.

Tr ial Court Opinion, 9/5/1 7, at 12

- 13 (emphasis added; citations to the record omitted)

. T he trial court properly submitted the question of whether the discovery rule tolled the Pennsylvania statu t e 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 Nicola ou , 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 Notification s on Vaginal Mesh For their second claim of error, the manufactures assert the “trial court erred by excluding evidence showing th at [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 i d. In support

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

### Medic al 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 associate d 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 b een 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 devicesJ

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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 (4 th Cir. 2016). The manufacturers challenge both the t rial court’s finding that the FD A 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 vagin al 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 signific ant 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 N otification, 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 Admin istration , 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

.J

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discovery rule, Ms. Engleman should have “the knowledge that a reasonable investigation would have uncovered . . . .” Manufacturers’ Brief at 32. Not

on ly 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 st andard, 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 cour t and we review the t rial 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, 1123J

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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 ma nufacturers’ 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 ar e 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.J

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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 requireme nt, 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 t reatment 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, t he manufacturers wish ed 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 we re notice of the defect in the product, or they we re not

. As pre viously mentioned, t he two relevant issues for the discovery rule were when Ms. Engleman learned of 1) her injury, and 2) who cause d that injury. See Nicolau , supra
. T he exclusion of the notices that they believeJ

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were inaccurate did not harm or prejudic e the manufactures. The notices

were clearly ir relevant 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 position s . 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 know n 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; y et, they hypocritically contend that Ms. Engleman and any reasonable person in her position should have altered theirs. We disagree. Under th ese 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.J

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- Admissibility of the FDA 510(k) Clearances For their next issue, the manufacture rs claim that the trial judge’s exclusion of FDA

- created evidence, in the form of 510(k) clearances, 5 wa s “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. Su pp. 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 9 0 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 distr ibution 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, ene rgy source, manufacturing process, or intended use. United States Food & Drug Administration, “510(k) Clearances,” available at htt ps://www.fda.gov/medicaldevices/productsandmedicalprocedures/devicea pprovalsandclearances/510kclearances/ (last visited 11/29/18).J

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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 l aw.” 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 C ourt thinks is “wrong ”

– does not create an abuse of discretion, without something more. Here, by re

- litigating their argument o n 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 misapplie d

. 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 e vidence; the Pennsylvania judge reached the other by excluding it.J

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Thus, we are unpersuaded that the Penn sylvania 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 w as irrelevant and thus precluded under Pa.R.E. 403. The c ourt, in its discretion, granted these motions. The c ourt excluded FDA

- related evidence under Pa.R.E. 403 as irrelevant to the trial at hand. Under Rule 403, the c ourt may exclude relevant evidence if its probative value is outweighed by a danger o f one or more of the following: unfair prejudice, confusing t he issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence. Pa.R.E. 403. In its discretio n, the t rial c ourt chose not to hold a “trial within a trial” over the FDA approval process. FDA 510(k) approval . . . is not a review f or the safety and efficacy of a product and is instead only a r eview of substantial similarity between two devices. In cluding FDA evidence on the approval process for ot her TVT devices would involve a history of the TVT line of pr oducts and devices, which would not be relevant to TVT

- Sec ur 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 Co urt 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 cou rt reached conclusions that the manufacturers consider “wrong” does not mean that the court abused its discretion. We may not second guess its logical deter mination that the FDAJ

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clearances risked confusing the jurors and creating undue delay by leading to a trial within the tri al

. 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
T h e 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 cour t 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 pr op erly admitted evidence of the Australian doctors’ co ncerns 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 e ither contained a manufacturing defect, fail ed to contain adequate warningsJ

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- or instructions, or was designed in a defective manner. Id. A manufacturer is require d to warn of risks known during the time in which the p laintiff was using the product. Evidence of either “delibera te concealment or nondisclosure of after

- acquired k nowledge of harmful effects” or economically driven manipulat ion 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 c laim, a plaintiff “must prove either that th e product’s risk outweighed its utility or that the product could hav e 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 pr ovide sufficient evidence, so a reasonable juror could find “ either that the product’s risk s outweighed its utility or t hat the product could have been designed in an alter nate manner so as to minimize or eliminate the risk of harm.” Id. at 571. Here, evidence of the comp laints in Australia is relevant to show that [the manufac turers] were awar e of the risks associated with the [defect ive vaginal mesh] but failed to take action and a dequately 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 complai nts from Australian doctors and subsequent quality block w as offered to establish notice, which is not hearsay. See Castellani v. Scranton Times, L.P. , 124 A.3d 1229 (Pa. 2 015) (holding that out

- of

- court statements offered to p ut a defendant on notice is not hearsay). For the reasons set forth , [Ms. Engleman’s] evidence of Australian doctors’ complai nts was admissible and relevant to her case. The trial cou rt 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).J

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-

Much like their attack against the trial c ourt’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 Eviden ce. 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 Australia n physicians v iolat ed 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 verdi ct on this evidence, even though post

- implant knowledge cannot support a punitive award.” Id. Whatever the jury may have based its verdict and damages awa rd is an unproductive guessing game, played in hindsight, well after the trial court ruled this evide nce admissible. And, more to the point, it does not speak to th e 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).J

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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 manufac turers 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 eviden ce 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 c ourt is not required to sanitize the trial to eliminate all unpleasant facts from the jury’s consideration, where those facts form part of the his tory 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 “unf air prejudice [or delay],” Rule 403’s operative term[s]

.J

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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 reasonabl e decision to admit evidence of the Australian doctors’ complaints, and we dismiss this issue as it affords the m anufacturers no relief.

Remittitur of Compensatory Damages Next, the manufacturers challeng e the trial judges’ refusal to remit the jury’s award of $2,500,000 in compensatory damages. However, their argument not only repeats , but magnif ies , the error they committed when arguing t he evidentiary rulings above. The manufacturers totally ignore our deferential standard of revie w. The y incorrectly state, as our standard of review, that remittitur “is proper if the verdict is ‘excessive, exorbitan t, and beyond what the evidence warrants, or where the verdict resulted from partiality, prejudice, mistake, or corruption.’” Manufact urers’ Brief at 2 (quoting Smalls v. Pittsburgh - Corning Corp. , 843 A.2d 410, 414 (Pa. Supe r. 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 correct ly informed them in the

_________________ __________ ______ ____ _______ 6 The parties had already filed their briefs whe n this Court issued its Opinion in Hammons , supra
. They therefore d id not h ave the benefit of that decision in preparing their written arguments.J

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1925(a) Opinion, a “grant of remittitur is a matter wit hin 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 1 174, 1177 (Pa. 1992) (emphasis added). Despite the trial court’s admonition, t he manufacturers look the other
way. Citing two case s 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 abuse d its discretion, we dismiss this issue as affording them no relief

.

Availability of Punitive Damages Next, t he m anufacturers claim that, under N ew 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, in cluding packaging and labelling regulations. ” Manufacturers’ Brief at 56

- 57 (quoting N.J.S.A. §
2A:5 8C

- 5). They argue that the “FDA cleared TVT

- Secur f or marketing through its 510(k) process,” and the FDA’s 510(k) process “ is a safe ty 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, w hich are both questions of law. As such, our scope of review is plenary, and our standard of review is de novo

. See Snead , supra.J

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The manufacturers’ statement that the FD A’s 510(k)

- clearance pr ocess “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 ‘substanti ally equivalent’ to a predicate device is said to be ‘cleared’ by FDA (as opposed to ‘approved’ by the a gency under a [premarket approval (“PMA” ) ]

. A premarket notification submitted under Section 510(k) is thus entirely different f rom 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 t he 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 view s 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)] ,J

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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 distribu tion before May 28, 1976, . . . does not in any way denote offi cial 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
T he man ufacturers also assert that the jury improperly imposed $17,500,000 punit ive

- 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 da mages of $2,500,000. The manufacturers therefore claim the jury could not lawfu lly award any more than $12,500,000 in punitive damages

– $5,000,000 less than it s original award. Second, after the award is reduced u nder the cap, the manufacturers believe that this Court should either (a) tota lly 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 statuteJ

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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 dama ges . 7 However, she disagrees that we should reduce punitive damages below $12,500,000. Instead, she says New Jersey substantive law d oes not control, because, under Pennsylvania law, “remittitur is a ‘p rocedural 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 P ennsyl vania law, because, under both laws , the standard of review is an abu se of discretion. She claims no such abuse occurred, as the record support s punitive

- dama ges 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 tr ial under Articl e 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 sai d 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 und er New Jersey Rule of Appellate Procedure 2:12A. Essentially , counsel withdrew this constitutional attack on t he New Jersey statute at oral argument, and, therefore, we do not reach its merits.J

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federal con stitution. 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 C ourt gives three guideposts for reviewing a punitive da mages award for reasonableness: (1) the degree of reprehensibi lity 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 t he jury and the civil penalties authorized or imposed in comparable cases. Id. at 418. “Perhaps the most important i ndicium of the reasonableness of a punit ive 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 n ature of the victim’s harm, the degree of defendant’s culpabil ity, the victim’s vulnerability to the harm, and whethe r 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] mis represented the safety concerns of [their vaginal mesh] t o 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 i dentify concrete constitutional limits on the ratio betwee n 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 c onstitutional line is marked by a single mathematical formula, even one that compares actual and potential damage s to the punitive award” though “single

- digit multipliers are more likely to comport with dueJ

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- process.” Id. Here, the ju ry’s punitive damage award used a multiplier of seven. [ 8 ] Althou gh there is no bright

- line test to determine when a ratio is excessive, the damage award is within th e Supreme Co urt’s suggested proportionality test. Alternatively, [the manufac turers] claim that the punitive damages should be redu ced 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 sec tion 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.
W e a gree 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 o f 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.J

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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

- liabil ity act ion under the New Jersey Product Liability Act and subm itted that claim to the jury on two factual theories: des ign

- defect and failure

- to

- warn. The jury found in [her] favor on both theories, as it was entitled to do. On appe al, [the manufacturers] made no argument concerning the failure

- to

- warn theory. This amounts to a concession tha t 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 aJ

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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 tr ial is warranted, because the trial court should have (1) admitted FDA evidence regarding the unavailabilit y of a safer, alternative design and (2) instructed th e jury regarding Ms. Engleman’s obliga tion to prove the existence of “ a safer,
prac tical, 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 error s . He nce , 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 ignore d the correct standard of review

. The ir 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 t he 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

.J

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J udgment, 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