NOT FOR PUBLICATION WITHOUT THE

APPROVAL OF THE APPELLATE DIVISION 

SUPERIOR COURT OF NEW JERSEY

APPELLATE DIVISION

DOCKET NO. A-5151-17

 A-1083-18

ELIZABETH HRYMOC and

TADEUSZ HRYMOC,

Plaintiffs-Respondents,

v.

ETHICON, INC., ETHICON

WOMEN'S HEALTH AND

UROLOGY, a Division of 

Ethicon, Inc., GYNECARE, 

and JOHNSON & JOHNSON,

Defendants-Appellants.

_________________________

MARY MCGINNIS and 

THOMAS WALSH MCGINNIS,

Plaintiffs-Respondents,

v.

C. R. BARD, INC.,

Defendant-Appellant,

and

BARD MEDICAL DIVISION, 

a Division of C. R. Bard, Inc., 

and BARD UROLOGICAL 
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A-5151-17

DIVISION, a Division of Bard 

Medical Division,

Defendants.

_________________________

Argued January 25, 2021 – Decided March 2, 2021

Before Judges Sabatino, Currier and Gooden Brown.

On appeal from the Superior Court of New Jersey, Law 

Division, Bergen County, Docket Nos. L-13696-14 and 

L-17543-14.

Maha M. Kabbash argued the cause for appellants 

Ethicon Inc., Ethicon Women's Health and Urology, a 

Division of Ethicon, Inc., Gynecare, and Johnson & 

Johnson (Riker, Danzig, Scherer, Hyland & Perretti, 

LLP, Stephen D. Brody (O'Melveny & Myers, LLP) of 

the District of Columbia bar, admitted pro hac vice and 

Jason Zarrow (O'Melveny & Myers, LLP) of the 

District of Columbia bar, admitted pro hac vice, 

attorneys; Stephen D. Brody, and Jason Zarrow, of 

counsel; Kelly S. Crawford, on the briefs). 

David R. Kott argued the cause for appellant C. R. 

Bard, Inc., (McCarter & English, LLP, Reed Smith 

LLP, Lori G. Cohen (Greenberg Traurig, LLP) of the 

Georgia bar, admitted pro hac vice, R. Clifton Merrell 

(Greenberg Traurig, LLP) of the Georgia bar, admitted 

pro hac vice, and Sean P. Jessee (Greenberg Traurig, 

LLP), of the Georgia bar, admitted pro hac vice, 

attorneys; David J. Cooner and David R. Kott, of 

counsel and on the brief; Natalie H. Mantell and Steven 

H. Del Mauro, on the brief).

Adam M. Slater argued the cause for respondents 

Elizabeth Hrymoc and Tadeusz Hrymoc 
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and Mary McGinnis and Thomas Walsh McGinnis 

(Mazie Slater Katz & Freeman, LLC, attorneys; Adam 

M. Slater, of counsel and on the brief; David M. Estes

and Christopher J. Geddis, on the briefs).

Daniel B. Rogers (Shook, Hardy & Bacon LLP) of the 

Florida bar, admitted pro hac vice, argued the cause for 

amici curiae Advanced Medical Technology 

Association, Chamber of Commerce of the United 

States of America, and the National Association of 

Manufacturers (Daniel B. Rogers (Shook, Hardy & 

Bacon LLP) of the Florida bar, admitted pro hac vice, 

and Katherine G. Mastrucci (Shook, Hardy & Bacon 

LLP) of the Florida bar, admitted pro hac vice, 

attorneys; Philip S. Goldberg, Daniel B. Rogers, and 

Katherine G. Mastrucci, on the brief).

Herrick, Feinstein LLP, Chilton Davis Varner (King & 

Spalding LLP) of the Georgia bar, admitted pro hac 

vice, and J. Franklin Sacha, Jr. (King & Spalding LLP) 

of the Georgia bar, admitted pro hac vice, attorneys for 

amicus curiae Product Liability Advisory Council, Inc. 

(Ronald J. Levine, on the brief).

Sills Cummis & Gross P.C., attorneys for amicus curiae 

Healthcare Institute of New Jersey (Beth S. Rose, of 

counsel and on the brief; Vincent Lodato, on the brief).

The opinion of the court was delivered by

SABATINO, P.J.A.D.

In these related appeals, which we consolidate solely for purposes of this 

opinion, we consider arguments seeking to overturn separate
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jury verdicts in favor of plaintiffs in two product liability actions involving 

pelvic mesh medical devices. The devices in question were designed and 

manufactured by the respective defendants. They were surgically implanted in 

the female plaintiffs in each case, and severe adverse complications ensued for 

them and their spouses.

In the Hrymoc case, Docket No. A-5151-17, a Bergen County jury found 

defendants liable under independent theories of defective design and inadequate 

warning under New Jersey products liability laws. The Hrymoc jury awarded 

the patient and her husband a total of $5 million in compensatory damages, and 

additionally awarded them punitive damages of $10 million.

In the McGinnis case, Docket No. A-1083-18, a different Bergen County 

jury found defendant liable for design and failure-to-warn defects under the 

products liability laws of North Carolina, the home state of those plaintiffs. The 

McGinnis jury awarded the patient and her husband a combined sum of $33 

million in compensatory damages, plus stipulated medical expenses. The jury 

further awarded them $35 million in punitive damages. 

Defendants now appeal, raising a host of evidentiary and substantive 

arguments. We reject those arguments, except for one important issue common 

to both cases that requires reversal.
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Specifically, we conclude the two respective judges who tried these 

difficult, complex cases erred by categorically excluding any proof that 

defendants had obtained what is known as "Section 510(k) clearance" from the 

Food and Drug Administration ("FDA"), see 21 U.S.C. § 360c, for the devices 

implanted by plaintiffs' surgeons. We conclude the total disallowance of such 

proof had the patent capacity to deprive defendants of a fair trial, most 

poignantly with respect to the state-of-mind and venal conduct issues that 

underlie the punitive damages awards.

Although several courts in other jurisdictions have chosen in their 

discretion to exclude such 510(k) evidence from jury trials involving the design 

and safety of mesh devices, we adopt the approach of other courts that have 

deemed such proof admissible with appropriate limiting instructions. We are 

persuaded there is sufficient probative value of such evidence under N.J.R.E. 

401 to justify informing the jurors, without extensive elaboration, that the 

products were reviewed by the FDA under the 510(k) clearance process before 

defendants' sales in these cases. The complete ban of such proof was unfairly 

and repeatedly capitalized upon by plaintiffs' counsel at both trials, in a manner 

that easily could have given the jurors a skewed impression of the totality of 

circumstances. 
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We are further persuaded that countervailing concerns under N.J.R.E. 403 

about potential juror confusion and consumption of time, while legitimate, can 

be capably addressed by the trial court through appropriate means discussed in 

this opinion. 

Accordingly, the verdicts in both cases are vacated. The matters are 

remanded for new trials to be preceded by N.J.R.E. 104 hearings, at which the 

trial court may consider adopting measures such as explanatory jury 

instructions, reasonable time and witness limits, and prohibitions on misleading 

demonstrative aids about the 510(k) clearance process. The Rule 104 hearings 

should address the potential use of the 510(k) evidence in the 

liability/compensatory damages phase of the retrials, and, if reached again by 

the jurors, the punitive damages phase.

Aside from this one point of reversal, we affirm the trial court in all other 

respects in both cases. Among other things, we uphold the Hrymoc court's 

rulings that: (1) plaintiffs at this trial met their burden of establishing defective 

design of the pelvic mesh devices under N.J.S.A. 2A:58C-2, and presented to 

the jury sufficient evidence of reasonably safer alternatives; (2) defendants 

failed to establish a viable "state-of-the-art" defense under N.J.S.A. 2A:58C3(a), and thus no jury charge on that defense was warranted; and (3) plaintiffs 
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adduced sufficient evidence of proximate causation arising from a defective 

warning, as there was not "unequivocal" evidence that Mrs. Hrymoc's surgeon 

would have implanted a pelvic mesh device in her anyway if defendants had 

provided more complete material information about the product's dangers. 

We address other issues raised on appeal in Hrymoc and McGinnis in an 

unpublished, latter portion of this opinion.

I.

A. Overview

These two products liability cases involve medical "pelvic mesh" devices 

manufactured and marketed by defendants. The cases are part of a multicounty 

grouping of lawsuits ("MCL") specially venued before the Law Division in 

Bergen County. The Hrymoc case, which was tried before a jury in late 2017,

was the second pelvic mesh case that went to verdict in New Jersey. The 

McGinnis case, which was tried in 2018 before a different judge,

1 was the third. 

No other products liability cases involving pelvic mesh have been tried since in 

this state.2 

1

 Apparently, the judge who had presided over the Hrymoc trial was unable to 

preside over the McGinnis trial during that particular time frame.

2

 Although it does not bear on the issues now before us, we note our 2012 

published decision regarding defendants' access to physicians who implanted 
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We are advised by counsel that most of the pelvic mesh cases in New 

Jersey have been settled or dismissed, but at least several hundred remain 

pending. In addition, there have been over 100,000 pelvic mesh cases against 

various manufacturers filed and litigated in other federal and state courts. Some 

of those cases have generated published and unpublished opinions. Several have 

gone to trial, with varying results on liability and damages.

To frame the issues for legal analysis, we discuss aspects of the factual 

and procedural backgrounds, with the caveat that these two cases are remanded 

for a new trial and thus additional testimony and proofs may still emerge. We 

caution that the omission of details from our opinion does not signify we have 

overlooked them or deem them unimportant.

B. Pelvic Organ Prolapse and Stress Urinary Incontinence

Defendants' mesh devices are intended to address the medical conditions

pelvic mesh products as potential expert witnesses. In re Pelvic Mesh/Gynecare 

Litig., 426 N.J. Super. 167 (App. Div. 2012) (reversing pretrial order barring the 

defendants from retaining as experts in pelvic mesh litigation any physicians 

who treated the plaintiffs). 

In addition, our court issued an unpublished opinion in 2016 affirming a jury 

verdict for compensatory and punitive damages in a pelvic mesh products 

liability case against one of Ethicon's related entities. Gross v. Gynecare, No. 

A-0011-14 (App. Div. Mar. 29, 2016). Because that earlier opinion is nonprecedential, we do not discuss or quote from it here. R. 1:36-3.
9

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of pelvic organ prolapse (often referred to as "POP") and stress urinary 

incontinence ("SUI"). 

Pelvic organ prolapse occurs when the muscles that support the pelvic 

organs become weak, causing connective tissue attachments to stretch or break 

and the organs to become displaced. A POP may occur in the anterior or 

posterior vaginal wall, or in the vaginal apex. An anterior prolapse occurs when 

the bladder drops into the vagina (cystocele), a posterior prolapse occurs when 

the rectum protrudes upward (rectocele) or the intestine pushes the top part of 

the vagina, creating a bulge (enterocele), and an apical or medial prolapse occurs

when the uterus pushes into the vagina (uterine prolapse), or, for women with 

hysterectomies, the top of the vagina pushes into the lower vagina (vaginal vault 

prolapse). 

Multiple factors can cause POP, such as childbirth, increasing age, 

obesity, a chronic cough, and a hysterectomy. Depending on its severity, a 

prolapse may cause pelvic pressure and discomfort, pain, dyspareunia (i.e., pain 

during sexual intercourse), and urinary and bowel problems. 

According to Daniel S. Elliott, a urologic reconstructive surgeon who 

testified on behalf of plaintiffs in Hrymoc, a pelvic organ prolapse can be 

"embarrass[ing]," affecting a woman's feelings about herself and her desire to 
10 A-5151-17

engage in intercourse. Anne M. Weber, the plaintiffs' expert in urogynecology

in both cases, described "[r]ecurrent pelvic organ prolapse" as "one of the most 

vexing problems in reconstructive pelvic surgery," and recurrent anterior 

vaginal prolapse as its "Achilles heel." 

Non-surgical treatments to manage prolapse include Kegel exercises to 

contract and relax the pelvic floor muscles, and the use of a pessary inside the 

vaginal area to hold back the prolapse. There also are several surgical options 

that do not involve the devices in these cases. 

One surgical option is native tissue repair or colporrhaphy, which uses 

absorbable sutures to repair a patient's weakened connective tissues to support 

the descending organ. This procedure can have the disadvantage of a significant 

rate of recurrence of the prolapse. 

Another surgical procedure is sacrospinous or uterosacral ligament 

fixation, which is used for vault prolapses. This procedure is performed through 

the vagina to suture it to various different structures to provide support. 

Abdominal sacrocolpopexy, which is done with an incision, a 

laparoscope, or a robot, can be more durable. However, it is more invasive and 

marked by increased morbidity as compared with vaginal repairs. 

Colporrhaphy and abdominal sacrocolpopexy, like all pelvic floor 
11 A-5151-17

surgeries, present risks of pain and dyspareunia. Other prolapse treatments have 

included biological grafts using tissue from a cadaver or tissue bank, and 

xenografts using tissue from a nonhuman source such as a pig or cow. 

Mesh devices also have been used to treat patients with SUI, which is 

"leakage of urine as a result of coughing, straining, or some sudden voluntary 

movement, due to incompetence of the sphincteric mechanisms." Stedman's 

Medical Dictionary 962 (28th ed. 2006). Here, both Mrs. Hrymoc and Mrs. 

McGinnis were diagnosed with SUI in addition to POP. Each plaintiff had mesh 

implantation surgery to correct the condition: Mrs. Hrymoc's surgeon, Dr. Mark 

Mokzrycki, implanting Ethicon, Inc.'s ("Ethicon") TVT-Obturator ("TVT-O") 

device and Mrs. McGinnis's surgeon, Dr. Elizabeth Barbee, implanting C. R. 

Bard, Inc.'s ("Bard") Align Transobturator Urethral Support System ("Align 

TO") device.3

3

 The details of the plaintiffs' respective SUI diagnoses do not affect the legal 

issues before us because (1) the Hrymoc jury found no proximate cause between 

plaintiff's injuries and the TVT-O's inadequate warnings, and (2) Bard has not 

challenged on appeal the McGinnis jury's finding that plaintiff's injuries were 

proximately caused by the defective design and inadequate warnings of the 

Align TO.
12 A-5151-17

C. Defendants' Pelvic Mesh Medical Devices

The Hrymoc case involves Ethicon's "Prolift" mesh device and associated

TVT-O sling,

4 whereas the McGinnis case involves two mesh products

developed and sold by Bard: the Avaulta Solo Anterior Synthetic Support 

System ("Avaulta Solo") and the Align TO.

5 The devices were marketed as 

"Class II" medical devices, upon the FDA finding them "substantially 

equivalent" to other mesh devices the FDA had either previously approved or 

cleared for sale, or which otherwise were already lawfully on the market.

6

Eventually, defendants withdrew these pelvic mesh devices from the market

after pervasive complications arose, although the trial court disallowed plaintiffs 

4

 Because the Hrymoc jury rejected plaintiffs' failure-to-warn claims concerning 

TVT-O, and plaintiffs have not cross-appealed that decision, we focus our 

factual discussion on the marketing and development of Prolift.

5

 The Prolift and TVT-O devices were produced and sold by defendant Ethicon, 

a medical device company owned by defendant Johnson & Johnson ("J&J"). 

Defendant Gynecare is a business unit within Ethicon, which later became 

known as Ethicon Women's Health and Urology ("EWHU"). The Avaulta Solo 

and Align TO devices were produced and sold by defendant Bard with the 

involvement of its medical and urological divisions. For the sake of simplicity, 

at times we use the term "defendants" to refer to one or more of these entities. 

6

 We describe the FDA 510(k) clearance process more extensively in Part II of 

this opinion. 
13 A-5151-17

from informing the juries of that subsequent remedial measure. See N.J.R.E. 

407. Plaintiffs have not cross-appealed that ruling.

1. Prolift's Development

In the late 1960s, Ethicon introduced Prolene sutures and a decade later it 

introduced Prolene Soft mesh for use in abdominal hernia repairs. At some 

point, Ethicon began working to develop a procedure for treating pelvic organ 

prolapse with a synthetic mesh. Before then, physicians had developed their 

own approaches using different mesh shapes. Ethicon wanted to develop a 

standardized approach to perform POP repairs with lighter-weight 

polypropylene meshes and lower recurrence rates. 

In 2002 or 2003, Ethicon began to market a pelvic floor mesh called 

Gynemesh Prolene Soft ("Gynemesh PS"), which consisted of the same 

polypropylene fibers used in Prolene Soft. Gynemesh PS was initially 

developed for use in hernia repairs. Its purpose as a transvaginal mesh ("TVM") 

was to allow fibrous connective tissue to grow between the pores to stabilize the 

mesh and vaginal wall. Gynemesh PS was a sheet of mesh that the surgeon 

would trim and tailor to his or her patient and then place through the vagina. 

Gynemesh PS was the type of mesh eventually incorporated into the Prolift 

product.
14 A-5151-17

The French TVM Group's R&D

In the early 2000s, nine gynecologists and urogynecologists in France

began to develop a standardized procedure using TVM, aimed at treating pelvic 

organ prolapse with a low level of risk and an improved rate of recurrence (the 

"TVM group"). Their goal was to identify a procedure and mesh product to 

increase the success rate, while keeping complications as low as possible. The 

TVM group selected the same nonabsorbable mesh material as Gynemesh PS,

based on their experiences with synthetic grafts and other types of repairs. 

The TVM group designed the shape of the mesh. The prototype consisted 

of pre-cut mesh that could be surgically implanted through the vagina to repair 

an anterior (bladder), posterior (rectal), or total prolapse. The mesh involved 

the use of "arms" to fix the implant in place, instead of sutures. Axel Arnaud, a 

physician and Scientific Director of Ethicon Europe from 2001 to 2008, worked 

with the French TVM group to coordinate the project, which was called Project 

D'Art. 

Meanwhile, Ethicon formed a team "to create a standardized procedure 

for pelvic organ prolapse repair that would present low levels of risks to the 

patient." The team consisted of Scott Ciarrocca, the research and development 

("R&D") project leader, Sean O'Bryan, a senior project manager at Gynecare, 
15 A-5151-17

Gene Kammerer, a research and development engineer, Arnaud, and others. As 

verified at trial by Ciarrocca, the design intent was to develop a product that 

would "support organs and restore anatomical form" and place the implants in 

the body tension-free. The Ethicon team adapted the mesh shape developed by 

the TVM group.

Over time, Ethicon developed prototypes for the pelvic mesh device. To 

assess their safety and efficacy, the Ethicon team worked with the French TVM 

group and other physicians in the United States who performed surgeries on 

cadavers and provided feedback. 

Ultimately, Ethicon designed single-use instruments for the pelvic 

implant, including a guide, cannula, and retrieval device. The guide created 

paths in the tissue to direct the placement of the cannula. The cannula was used 

in conjunction with the guide to facilitate passage of the arms through the 

"tunnels" while protecting the surrounding tissue. 

As explained by Ciarrocca, "[t]he primary intent of the cannula is to keep

the tissue in the tissue passage from being torn as the mesh arm is pulled into 

place." The cannula remained in place in the patient after the guide was 

withdrawn. The retrieval device facilitated placement of the arms as they passed 

through the cannula, until a loop on its distal end captured the arms as they were 
16 A-5151-17

drawn out. At the end of the procedure, the only thing that was supposed to 

remain in the patient was the mesh.

Ciarrocca's team conducted a device design safety assessment to assess 

the risks, a design failure modes and effects analysis to review the risks 

associated with product design, an application failure modes and effects analysis 

to anticipate ways the instruments could be misused, and a process failures 

modes and effect analysis to anticipate breakdowns in the manufacturing 

process.

Ciarrocca acknowledged the design process did not evaluate what would 

happen if a woman had complications and the mesh needed to be removed

surgically. He asserted the only possible way to assess the consequences of 

mesh removal was through published data from other studies. 

At an internal company meeting in June 2003, Ciarrocca sought funding 

to move the project from the concept stage to the feasibility stage. Ciarrocca 

and his team identified critical assumptions to help assure the project's success, 

including that the product would be a permanent implant, that it would enter the 

market before any "major competitive offerings with similar features or 

advantages," and that its features would justify a premium price. The team 

assumed that a clinical trial of Prolift implants with a six-month follow-up 
17 A-5151-17

would be sufficient to support the launch and that multiple kits would be 

required, as Ciarrocca put it, to "fully exploit the market." The June 2003 

presentation also included a patient risk assessment. 

In July 2003, Michel Cosson, a physician and member of the TVM group, 

advised Ciarrocca by email that the group was seeing problems with erosion and 

retraction of the Project D'Art TVM implant that could cause a recurrence. 

Erosion, "a potential complication of any mesh-based repair," occurred 

when the mesh became exposed or went through the tissue. As explained by 

plaintiffs' expert Elliott, although the terms were often used interchangeably, 

mesh "exposure" referred to mesh that went through the vagina, whereas mesh 

"erosion" occurred when the mesh went through another organ such as the 

bladder or rectum. Retraction, also called contraction, occurred when scar 

formation caused tension on the mesh as the scar tissue contracted and pulled 

the mesh along with it. That could cause shrinkage of the pore size and increase

the risk of foreign body reaction and inflammation. When mesh retraction 

occurred, the risk of recurrence increased. Despite these concerns about 

complications, Ciarrocca's team continued forward with the project. 

In May 2004, Ophélie Berthier, Ethicon's marketing director in France and 

its commercial launch leader for Prolift, sent an email, noting, among other 
18 A-5151-17

things, that the researchers' "main concern is now the shrinkage of the mesh 

which may lead to pain [and] dyspareunia . . . now that they have tremendously 

improved the technique and lowered the erosion rate what needs to be improved 

is the shrinkage of the mesh." She added that "[w]e will need to address this 

when thinking about a next generation mesh." 

The same day, Kammerer of the project team responded to Berthier's email 

by presenting input from the Gynecare European Unit regarding mesh used for 

pelvic floor repair. He noted that Ethicon was working closely with Professor 

Bernard Jacquetin, the inventor of the pelvic floor repair technique and leader 

of the TVM group, and Cosson, but that the "competition" was ahead of Ethicon 

in this area. Kammerer wrote: "We need to think about how we can fast forward 

this project, get more support from both Gynecare and Ethicon as well as quickly 

optimize the construction." 

In November 2004, Cosson and others in the TVM group published an 

article discussing advances in the surgical management of genital prolapse. 

They reviewed the relevant literature and identified various problems with 

mesh-based treatments such as chronic infection, erosion, retraction, and 

recurrence. They noted that retraction was highly variable and impossible to 

forecast, and that it implied the need to place mesh with "as low a tension as 
19 A-5151-17

possible." They further noted that no reported studies mentioned "the more 

worrying retraction phenomenon and its after-effects, the symptomatic 

manifestation of which is dyspareunia." The article concluded that the TVM 

technique should be reserved for Stage III and IV prolapse, "possibly as firstline treatment." 

The Prolift Device's Instructions for Use (IFU)

Meanwhile, the medical affairs unit at Ethicon prepared the Instructions 

for Use ("IFU") for the Gynecare Prolift. The IFU was the booklet or "primary 

label" that came with every Prolift kit. It provided information about the 

product, including illustrations. The IFU was given to doctors so they would 

know what to tell their patients about specific risks. 

David B. Robinson, a medical director at Ethicon from November 2005

until the end of 2010, testified that surgeons relied on the IFU to accurately 

disclose the risks associated with the use of the Prolift system. Debra Fromer, 

a urologist and the defense's expert in the field of female pelvic medicine and 

reconstructive surgery, testified that it was a "good idea" for surgeons to read 

the IFU in advance of operating on patients. 

The IFU advised physicians that the "[f]ailure to properly follow 

instructions may result in improper functioning of the devices and lead to 
20 A-5151-17

injury," and that training on the use of the Prolift pelvic floor repair system was 

"recommended and available." The IFU stated that total, anterior, and posterior 

repairs were "indicated for tissue reinforcement and long-lasting stabilization of 

fascial structures of the pelvic floor in vaginal wall prolapse." Fascia are tissue 

that hold things within the body together such as tendons and ligaments.

In describing the device's performance, the IFU stated that animal studies 

showed that implantation of Gynemesh PS elicited "a minimum to slight 

inflammatory reaction, which is transient and is followed by the deposition of a 

thin fibrous layer of tissue which can grow through the interstices of the mesh, 

thus incorporating the mesh into adjacent tissue." It noted that the mesh 

remained soft and pliable. 

The IFU's section on warnings and precautions listed the following:

• Users should be familiar with surgical procedures 

and techniques involving pelvic floor repair and 

nonabsorbable meshes before employing the 

GYNECARE PROLIFT Pelvic Floor Repair 

Systems.

• Acceptable surgical practices should be followed 

in the presence of infected or contaminated 

wounds.

• Post-operatively the patient should be advised to 

refrain from intercourse, heavy lifting and/or 

exercise (e.g. cycling, jogging) until the 

physician determines when it is suitable for the 
21 A-5151-17

patient to return to her normal activities.

• Avoid placing excessive tension on the mesh 

implant during handling.

• Refer to the recommended surgical technique for 

the GYNECARE PROLIFT Pelvic Floor Repair 

System for further information on the 

GYNECARE PROLIFT procedures.

• The GYNECARE PROLIFT Pelvic Floor Repair 

System should be used with care to avoid damage 

to vessels, nerves, bladder and bowel. Attention 

to patient anatomy and correct use of the device 

will minimize risks.

• Transient leg pain may occur and can usually be 

managed with mild analgesics.

• Do not manipulate the GYNECARE PROLIFT 

Retrieval Device with sharp instruments or cut it 

to alter its length.

The IFU warned that potential adverse reactions were "those typically 

associated with surgically implantable materials, including infection 

potentiation, inflammation, adhesion formation, fistula formation, erosion, 

extrusion and scarring that results in implant contraction." Other identified 

potential adverse reactions included "[p]unctures or lacerations of vessels, 

nerves, bladder, urethra or bowel" that might occur during guide passage and 

require surgical repair.
22 A-5151-17

Charlotte Owens, the Worldwide Medical Director for Gynecare from 

2003 until late August 2005, was involved in the preparation of the IFU. Owens 

contended the IFU communicated to physicians all necessary warnings, 

precautions and adverse reactions that were known to Ethicon at the time. She 

noted many of the adverse reactions of Prolift were common to all pelvic floor 

procedures, such as inflammation, infection, adhesion, fistula formation, 

scarring, lacerations and punctures, pain with sexual intercourse, and chronic 

pain. 

Owens felt there was adequate and sufficient information to support the 

safety and effectiveness of Prolift. In this regard, she pointed to historical and 

retrospective data, and the results of a prospective study of over 600 women that 

was then underway. She did acknowledge, however, that certain representations 

in the IFU were based on what Ethicon had learned from animal studies.

Owens stressed that the company sold Prolift to physicians with expertise 

in pelvic floor repair, who could determine patients suitable for the product. She 

testified, "I can't emphasize enough how important it is for the surgeon and the 

patient to have that deeper conversation to ultimately make that final decision." 
23 A-5151-17

A Stronger Warning Is Proposed But Not Adopted

In January 2005, Arnaud, who was then the scientific director of Gynecare 

Europe, sent an email to Berthier suggesting they add a warning to the new 

version of the IFU. Arnaud proposed the following wording: 

WARNING: Early clinical experience has shown that 

the use of mesh through a vaginal approach can 

occasionally/uncommonly lead to complications such 

as vaginal erosion and retraction which can result in an 

anatomical distortion of the vaginal cavity that can 

interfere with sexual intercourse. Clinical data suggest 

the risk of such a complication is increased in case of 

associated hysterectomy. This must be taken in[to]

consideration when the procedure is planned in a 

sexually active woman.

Berthier passed along the proposed warning to Ciarrocca, saying that she would 

like to incorporate the changes. Ciarrocca, in turn, forwarded the email to 

O'Bryan and Owens. O'Bryan responded: "We can change the adverse event to 

whatever is most appropriate without FDA implications. I will leave it to 

Charlotte [Owens] and Axel [Arnaud] to decide." He noted that the Prolift IFU 

"most likely has gone out for translations and final proof so unless it is 

absolutely necessary we should probably leave it as is." Ciarrocca replied: "We 

have already printed launch stock. This would be a 'next-rev' addition but they 

want it in there ASAP." 
24 A-5151-17

Owens approved the IFU without the suggested change. Although she 

knew a small number of patients had long-term impacts from Prolift, Owens 

explained she approved the IFU because the overall risk/benefit analysis showed 

that the Prolift was a safe and effective product. Neither the 2004 nor the revised 

IFU brochure issued in 2007 included Arnaud's proposed warning. 

Although the Prolift IFU did not include the word "dyspareunia," Owens 

asserted "the words in there are synonymous to a surgeon with the possibility of 

dyspareunia." Even though the IFU did not mention that tissue contraction was 

a known risk, she explained that contraction was discussed under the definition 

of "clinical need," which stated that "[v]aginal repairs and retention may cause 

anatomical distortion of the vagina, affecting bowel and/or sexual functioning." 

She further asserted that surgeons were trained to know about complications as 

well as the risks of surgery in the area in which they operated. 

Nonetheless, according to O'Bryan's deposition testimony, used in 

plaintiffs' case-in-chief, the Prolift IFU should not have omitted any important 

facts, such as potential significant injuries to patients. O'Bryan testified the need 

to reprint the IFU should not have played any role in the decision whether to add 

Arnaud's suggested warnings. Additionally, in other deposition testimony 

presented in plaintiffs' case-in-chief, Bryan Lisa, an associate design quality 
25 A-5151-17

engineer at Ethicon, contended Ethicon was obligated to change the language of 

the IFU and update it. 

The Prolift Patient Brochure

Ethicon also prepared a patient brochure, which it used to market Prolift. 

The brochure described Gynecare Prolift as "a revolutionary surgical technique 

that offers promising results for women with pelvic organ prolapse." It 

explained that Prolift "employs a specially designed supportive soft mesh placed 

in the pelvis to restore pelvic support." "After insertion, the soft mesh is initially 

held in place by the friction created by long extension strap-like arms of mesh 

material weaved through the pelvis. The body tissues then quickly grow into 

the pores of the mesh, creating the final support." 

The brochure noted that "[a]ll surgical procedures present some risks." It 

then stated:

Although rare, complications associated with the 

procedure include injury to blood vessels of the pelvis, 

nerve damage, difficulty urinating, bladder and bowel 

injury. There is also a small risk of the mesh material

becoming exposed into the vaginal canal.

The brochure essentially included the same warnings and precautions, and 

adverse reactions as the IFU. It instructed patients to "[t]alk with your doctor 

or healthcare professional about pelvic organ prolapse and what you can do 
26 A-5151-17

about it." 

Robinson acknowledged that patients relied on the brochure to learn about 

the risks and benefits of Prolift. He believed they would discuss the information 

with their doctors as part of their decision-making process. According to 

Robinson, the 2005 brochure conveyed that complications were "rare," meaning 

the "benefits far outweigh the risk." 

The Prolift Clinical Expert Report

Late in Prolift's development process, Ethicon performed a design 

validation to test the completed product. To meet this requirement, Ethicon 

prepared a clinical expert report that compiled data supporting Prolift's safety 

and effectiveness, and which evaluated its benefits and risks. 

It was Owens's responsibility to prepare, review, and sign the clinical 

expert report. In November 2004, Owens wrote an email regarding the report,

in which she called for the release of thirty Prolift kits to experienced clinical 

investigators to obtain an in-vivo assessment of its performance. At that point, 

there had been no study of the Prolift system in women. 

Ciarrocca prepared the draft clinical expert report. He relied on the 

Gynemesh PS clinical expert report from September 2002, regarding it as 

essentially the same mesh. Because there was never a clinical investigation of 
27 A-5151-17

Prolift in women, the draft Prolift report was instead "literature based." 

Following the draft report's section on clinical evidence, Ciarrocca wrote: 

"Charlotte [Owens], Need to add TVM/Cosson Data." The draft report 

concluded that the Prolift kits were "safe and efficacious on the basis of large 

scale use of predicate devices over the last decade and a review of the clinical 

literature as described." Ciarrocca forwarded the draft report to Owens.

In December 2004, O'Bryan advised Owens, Ciarrocca, and others within 

the company that he had reviewed the draft clinical expert report and had 

"significant concerns about it." Since the report was taking a literature-based 

path, O'Bryan recommended that the company generate a new report that 

included sections on clinical evidence (based on reviews of published clinical 

literature), potential complications and side effects, and a clinical opinion as to 

the device's safety and efficacy for human use. 

In January 2005, Owens approved and signed the clinical expert report. 

The report stated the Prolift system had been "extensively studied, refined, and 

proven in [c]adaveric evaluations." It included a section on clinical evidence 

and stated that "[b]ased on this and other literature it can be concluded that the 

use of polypropylene mesh for vaginal prolapse surgery is safe and efficacious." 

For potential complications, it listed "infection, mesh exposure, fistula, 
28 A-5151-17

hematoma and contraction." Despite such potential complications, the report

described Prolift as safe and efficacious, based on "large-scale use of 

polypropylene over the last decade and a review of clinical literature and clinical 

trials as described." 

Owens acknowledged she was familiar with the 2004 article by the TVM 

group, but did not refer to it in the clinical expert report or mention its finding 

that retraction was a potential complication that could cause severe pain, 

including dyspareunia. She also was aware at the time that some patients would 

develop severe complications that would result in lifelong pain and disability. 

James Hart, who was Ethicon's Vice President of Medical Operations at 

the time of Prolift's launch, testified that he likewise was aware that Prolift could 

result in "life-changing complications, incapacitating pelvic pain, dyspareunia, 

[and] large-scale erosions exceedingly complex and not easily resolved." He 

further noted potential risks of chronic foreign body response, contraction, and 

the difficulty of mesh removal.

Hart agreed that, to the extent such complications were known, Ethicon 

needed to evaluate them in the clinical expert report and within the prelaunch 

design control risk analysis. He also agreed that if they were not considered, 

the prelaunch risk-and-benefit analysis was not valid. Hart conceded on cross-
29 A-5151-17

examination that "a reasonable argument could be made that as a result of the 

very, very serious complications, the risk outweighed the benefit and it shouldn't 

have been sold."

Further Pre-Launch Events

In January 2005, the same month Owens approved and signed the clinical 

expert report, and about two months before the Prolift launch, Kammerer wrote 

an email saying a different material, UltraPro mesh, fit the requirements "as an 

interim step to reduce erosion and contraction," and "suggesting we market this 

mesh for pelvic floor repair." Unlike Prolene Soft, otherwise known as 

Gynemesh PS, UltraPro mesh was partially absorbable and lighter in weight with 

larger pores.

The following month, in February 2005, the TVM group released the 

results of its six-month follow-up study of forty women who underwent total 

repairs. The group considered success for a subject at six months as a Stage 0 

or 1 prolapse at the treated site, and set the failure rate as 20% with a 95% 

confidence interval. The results in February 2005 showed the rate of failure 

over the 20% desired limit.
30 A-5151-17

Prolift's Launch in March 2005

The market launch of Prolift took place in March 2005. The device was 

marketed in kits for total, anterior, and posterior pelvic floor repairs. The kits 

included pre-cut Gynemesh PS implants with a set of instruments to facilitate 

placement. The mesh for a total repair was shaped with six straps or arms to 

secure anterior and posterior portions of the implant. The anterior mesh implant 

had four arms to support the bladder, whereas the posterior mesh implant had 

two arms. The kits were accompanied by the 2004 IFU and the patient brochure.

Owens did not recall anyone at Ethicon suggesting more data was needed 

before the launch. Owens felt there was "adequate and sufficient information to 

support the safety and effectiveness" of Prolift as a "good option" for women. 

Owens understood at the time of launch that Prolift could cause scarring 

that resulted in implant contraction, which could lead to chronic pelvic pain, 

dyspareunia, and recurrence of prolapse. She knew that vaginal erosions and 

contractions could interfere with or make it impossible for women to enjoy 

comfortable sexual relations. Nonetheless, she explained: "That is one of the 

risks that we expected [the patient's] surgeon to inform her of because it's not 

just with Prolift, it is also with any pelvic floor repair surgery." 
31 A-5151-17

Ciarrocca similarly asserted that Ethicon did not violate its own rules for 

bringing Prolift to market, and that the company followed the governing 

procedures for design and control. However, he did acknowledge that, up until 

the launch, "there never was a study of the Prolift as it comes out of the box with 

the actual instruments that it's sold with in human bodies." 

In his own testimony, Arnaud stated that at the time of launch he did not 

understand the mechanism of erosion, know how to reduce mesh shrinkage, or 

understand the long-term consequences of potential complications. 

Piet Hinoul, a urogynecologist who joined EWHU in October 2008 as 

director of medical affairs, testified that, by the time of launch, Ethicon had 

studied "the Prolift mesh in a prototype called PVM in two multi-center trials in 

the US and in France" and "could also leverage Prolene PS data in several 

hundred patients that had been used for over five years . . . in the pelvic floor." 

He asserted Ethicon weighed risks and benefits before putting the product on 

the market, although he acknowledged there was no long-term data on the Prolift 

system. He recognized that some complications could be "very, very serious" 

and "life-changing." He was aware of what he termed "a couple of case reports" 

of women who suffered "mutilated or destroyed vaginas due to the Prolift." 
32 A-5151-17

Post-Launch Events

In March 2005, Cosson and others published a retrospective study of 

Prolift that followed 277 patients, identified thirty-four cases of mesh exposure, 

and recommended experimental and clinical trials to reduce the exposure rate to 

less than five percent of cases. The study later expanded to include 687 patients. 

In April 2005, Kammerer sent an email to co-workers at Ethicon, saying 

that scar contracture around the mesh had caused procedural complications and 

that surgeons who were Ethicon consultants wanted a mesh that was better than 

Prolene Soft. Kammerer identified those complications as prolapse recurrence, 

pain, stiffness, erosion, and discomfort during sex. 

On November 8, 2005, Dieter Engel, a doctor and colleague in Ethicon 

Germany, wrote to Kammerer and others that he did not believe UltraPro could 

be used as an alternative mesh due to commercial limitations. He explained that 

"[r]eplacing Gynemesh by UltraPro would either reduce the market price, which 

is no[t] good business, or the UltraPro price would have to be increased, which 

is not possible." The next day, Kammerer wrote to Engel and others, saying 

Gynecare marketing and R&D looked into the mesh portion of Prolift and 

learned that surgeons wanted a mesh that addressed the issues of mesh erosion, 

scar contracture, and residual material. He indicated that the company's plan 
33 A-5151-17

was "not to simply substitute the UltraPro for the Gynemesh," but to find a more 

comprehensive and long-term answer. 

In January 2006, Ciarrocca wrote to Jacquetin and Cosson, proposing to 

add a warning under the section on adverse reactions that the Prolift procedure 

had the potential to impair voiding. Cosson responded that impaired voiding 

was probably "a rare event," but that "we should add something about the 

potential pain or dyspareunia in the postoperative course." 

In February 2006, Kammerer sent an email to Arnaud and others, saying 

he had met with Cosson and Jacquetin back in 2004 and they had expressed an 

"interest in a new mesh to control and reduce scar contraction." He wrote that 

the previous year the mesh team suggested the substitution of UltraPro for 

Gynemesh PS as a short-term solution. He noted an investigation showed that 

it could be done and that "[t]he team wanted to move forward, but then everyone 

got re-assigned, and so the project kind of went into limbo." 

The June 2006 TVM Clinical Study Report 

In June 2006, Cosson and the TVM group published a "Clinical Study 

Report" based on twelve months of data. The study looked at the results, 

complications, and efficacy of the TVM technique, which ultimately became 

Prolift. However, Ciarrocca acknowledged the TVM group study did not meet 
34 A-5151-17

the pre-defined criteria of a failure rate of less than 20%. 

Efforts to Improve the Prolift

Cliff Volpe, who worked in Ethicon's R&D unit, testified that in early 

2006, Ethicon formed a team to look into the improvement of Prolift, including 

other mesh materials that might be lighter and softer for use in the pelvis. In a 

November 2006 email, Robinson wrote to Volpe, saying he had several 

conversations with Cosson and Jacquetin, who were pressing for more changes 

in Prolift other than just the mesh. Volpe testified that his team looked at ways 

to improve the mesh material and determined that the increased size of the pores 

in UltraPro mesh would reduce fibrotic bridging. Hinoul similarly testified that 

the new team sought to upgrade Prolift with a mesh that had larger pores to 

prevent bridging, scarring, and subsequent erosion. 

In August 2008, two months after Prolift was implanted into Mrs. Hrymoc,

and three-and-a-half years after Prolift went on the market, an "executive 

summary" presentation given to high-level executives at Ethicon identified the 

need to "[r]educe vaginal stiffness, mesh exposure, [and] pain," to "[r]educe the 

rate of tissue contraction [and] folding," to "[l]ower [the] amount of foreignbody mass," to be "[e]asy to learn and use," and to result in a "[l]ow recurrence 

rate." 
35 A-5151-17

In February 2009, Scott Jones, a product director in Ethicon's Pelvic Floor 

Repair unit, wrote an email to a team of urogynecologists in St. Louis, saying 

he was "in the middle of launching a new product called PROLIFT+M." He 

described the product as "basically the same procedure as PROLIFT but utilizing 

a partially absorbable mesh material." The new mesh material was UltraPro.

Defense expert Fromer testified that she was happy with the switch to Prolift+M, 

with its partially absorbable material, saying: "It seemed intuitively the right 

thing to do."

Withdrawal from the Market 

As we have already mentioned, Ethicon ultimately withdrew Prolift from 

the market. 

2. Bard's Development and Sale of Avaulta Solo and Align TO

Bard's development and marketing of the Avaulta Solo and Align TO 

pelvic mesh devices traced a different path, albeit one that prompted similar 

litigation themes in the McGinnis case.

Because defendant in McGinnis, unlike in Hrymoc, has not appealed the 

substance of the jury's design defect and failure-to-warn findings in that case 

and instead focuses on the 510(k) evidential admissibility issue and certain other 

matters, we need not detail here the chronology of Bard's Avaulta Solo and Align 
36 A-5151-17

TO as we did above with Prolift. For purposes of this portion of the opinion, it 

will suffice to note the following. 

Decades before it developed pelvic mesh products, Bard produced mesh 

products designed to repair hernias. The mesh material was knitted from

polypropylene monofilament by a division of Bard at a facility in Delran, New 

Jersey, which also finished and packaged the final medical device kit that 

included the mesh. 

The Delran plant received "big spools" of polypropylene monofilament 

that had been extruded from pellets of polypropylene resin manufactured by 

Phillips Petroleum ("Phillips") and marketed under its Marlex brand ("Marlex 

resin").

Bard purchased the monofilament used in its surgical mesh products from 

Red Oak Sales ("Red Oak"). Red Oak did not purchase the Marlex resin it used 

to extrude the monofilament directly from Phillips, but instead obtained it from 

a distributor called Channel. Red Oak produced monofilament in different 

diameters according to Bard's specifications, using equipment purchased by

Bard. 

From about 1962 until 1997, Bard used the "Marlex" brand name in 

connection with its hernia-mesh products, pursuant to a licensing agreement 
37 A-5151-17

with Phillips. However, in 1997, Phillips requested that Bard cease using the 

name for any implantable mesh device because it was "concerned about 

litigation and the association [of] the Marlex name with a permanent medical 

implant." Phillips did not specifically advise Bard that it should discontinue 

using Marlex resin at that time.

Roger Darois, a former vice president of Bard's mesh-manufacturing 

division, acknowledged that from 1997 onward, Bard took steps to ensure that 

Phillips would not discover the use to which Bard put the Marlex resin. He 

contended that because Phillips had known decades earlier that Bard used the 

Marlex resin for surgical mesh products, Bard was not "hiding" anything from 

Phillips, but it "chose not to remind them." Darois explained in this regard:

We just didn't know beyond 1997 if they still were 

aware of mesh use. So we had no reason to contact 

them. We had all biocompatibility testing, all the 

literature I've already testified on, we had no reason to 

contact Phil[l]ips and remind them that we were still 

using their resin. We were buying on it [sic] the 

commercial sale in free commerce from a distributor. 

There really is no way they can prevent us from buying 

this product legally.

In March 2004, Darois emailed an employee of a German affiliate of Bard 

who was looking for a vendor for polypropylene. Darois noted that "[t]hese 

suppliers will likely not be interested in a medical application due to product 
38 A-5151-17

liability concerns" and that "it is likely that they do not know of our implant 

application." He went on to state:

Do NOT mention [Bard's division's] name in any 

discussions with these manufacturers. In fact, I would 

advise purchasing the resin through a third party, NOT 

the resin supplier, to avoid a supply issue once the 

medical application is discovered.

According to Darois, he was "trying to make sure that we didn't have an 

interruption of supply for the resin we relied on for all of these products," 

knowing that "one of the outcomes" of this information being discovered could 

be a prohibition by the resin manufacturer on Bard's use of the material.

In late 2007, a few months after Bard began selling its Align pelvic mesh, 

Darois learned that Phillips had what is known as a "material safety data sheet"

concerning Marlex polypropylene (the "Marlex MSDS"). The Marlex MSDS 

stated, in part:

MEDICAL APPLICATION CAUTION: Do not use 

this Phillips Sumika Polypropylene Company material 

in medical applications involving permanent 

implantation in the human body or permanent contact 

with internal body fluids or tissues.

Do not use this Phillips Sumika Polypropylene 

Company material in medical applications involving 

brief or temporary implantation in the human body or 

contact with internal body fluids or tissues unless the 

material has been provided directly from Phillips 
39 A-5151-17

Sumika Polypropylene Company under an agreement 

which expressly acknowledges the contemplated use.

Phillips Sumika Polypropylene Company makes no 

representation, promise, express warranty or implied 

warranty concerning the suitability of this material for 

use in implantation in the human body or in contact 

with internal body fluids or tissues.

Darois eventually learned that Phillips began including this medical 

application caution on the Marlex MSDS in 2004. He was not concerned about 

the warning because he "viewed it as a legal statement" and because Bard had 

done testing and studies and had "five decades of successful use" of Marlex resin 

in its products. 

The Avaulta and Align Solo devices that were implanted in plaintiff Mary 

McGinnis in March 2009 contained monofilament made from Marlex resin.

As we have noted, Bard eventually removed Avaulta Solo and Align TO 

from the market.

D. Plaintiffs' Backgrounds, Product Usage, and Medical Complications

1. Hrymoc

Plaintiff Elizabeth Hrymoc was born in 1946. She and her husband, coplaintiff Tadeusz Hrymoc, met in 1961 and married in October 1967. They 

currently reside in New Jersey. Mrs. Hrymoc worked for seventeen years as a 

research laboratory technician before retiring. She then opened a deli with her 
40 A-5151-17

sister and later worked part-time as a medical receptionist before moving and 

helping to raise her grandchildren.

In November 2005, Mrs. Hrymoc, then fifty-nine years old, saw Dr. 

Mokrzycki, a urogynecologist who specialized in pelvic reconstructive surgery 

and the management of bladder, prolapse, and rectal problems in women. Dr. 

Mokrzycki was a consultant for Ethicon from October 2001 to February 2011. 

He worked with their engineers to develop techniques to treat prolapse and 

incontinence, trained their sales force on anatomy, and trained other physicians 

on Prolift surgery. He implanted about 100 to 200 Prolifts per year from 2005 

until 2012, when the product was taken off the market. 

Mrs. Hrymoc reported to Dr. Mokrzycki she was experiencing cramps and 

pressure, stress incontinence, and discomfort or pain during sexual relations. 

His examination revealed that Mrs. Hrymoc was suffering from a significant 

anterior vaginal wall prolapse (cystocele), which he estimated at trial as Stage 

II, a uterine prolapse, and a mild-to-moderate posterior prolapse (rectocele). 

Dr. Mokrzycki discussed with Mrs. Hrymoc various options, explaining 

that "doing nothing" could lead to worse consequences, that "muscle exercises" 

were not appropriate for the majority of people at this stage, and that a pessary 

had "annoying side effects" and did not work for everyone. He recommended a 
41 A-5151-17

vaginal hysterectomy, an anterior repair with mesh, and a pubovaginal sling for 

SUI. Mrs. Hrymoc initially decided against surgery because she was not in pain 

and the prolapse was not uncomfortable enough. 

In August 2007, Mrs. Hrymoc saw Karen Katz, a gynecological nurse 

practitioner for her annual pelvic examination. She reported having pain with 

intercourse. Katz's exam found that pelvic support was normal, meaning there 

was "no significant prolapse of the uterus [and] no significant abnormality of 

the vagina." 

Mrs. Hrymoc returned to see Dr. Mokrzycki in March 2008 because her 

incontinence had become a "little bit worse." She also complained of discomfort 

during sexual relations, saying she was intimate with her husband "with a little 

bit of discomfort, but there was no pain." Dr. Mokrzycki found that the prolapse 

of the posterior vaginal wall had gotten worse and described it in her chart as 

"severe." 

Dr. Mokrzycki discussed the benefits and potential risks of various 

procedures, "including bleeding, infection, damage to adjacent organs, possible 

mesh erosion and possible post-void dysfunction." He suggested a mesh 

implant, saying it was "a very simple procedure" and general anesthesia was not 

required. 
42 A-5151-17

He recommended Prolift, explaining that "it gave her the best chance to 

have a satisfactory long-term result," and that it was "the best product available." 

He explained at trial that the failure rates of traditional suture repairs were "too 

high considering her age." He typically did not discuss abdominal 

sacrocolpopexy with a patient because it came with "significant potential 

complications" that were not present with vaginal surgery. 

Dr. Mokrzycki gave Mrs. Hrymoc a copy of the Prolift patient brochure, 

which she read to learn about the procedure and its risks. Mrs. Hrymoc

understood that complications were rare, but she told Dr. Mokrzycki that she 

was "a little bit reluctant." He assured Mrs. Hrymoc that "all these risks [we]re 

very easily fixable," which was very important to her. Mrs. Hrymoc agreed to 

undergo a vaginal hysterectomy, a total Prolift, and a pubovaginal sling, "which 

was the TVT obturator [TVT-O] at that time." She understood the risks and 

signed the informed consent. 

On June 10, 2008, Dr. Mokrzycki performed Mrs. Hrymoc's total Prolift 

repair. Dr. Mokrzycki used Prolift's specially designed trocars to place the 

anterior portion of the mesh under the bladder and between the bladder and 

vagina (cystocele repair), and the posterior portion between the vagina and 

rectum (rectocele repair). He took precautions to avoid placing tension on the 
43 A-5151-17

Prolift arms. He did not recall any problems during surgery. His postoperative 

diagnosis was severe prolapse of the uterus, cystocele, and rectocele with "weak 

connective tissues under the bladder and over the rectum."

Dr. Mokrzycki next saw Mrs. Hrymoc at her three-week postoperative 

visit in early July 2008, and he found the placement of the mesh was where he 

wanted it. She returned later that month, complaining of "something coming out 

again" and "persistent urge incontinence." He confirmed that there was no 

prolapse, but he thought she might have some inflammation around the sutures. 

She returned again in September 2008 for her three-month postoperative visit,

with complaints of increasing discomfort on the left side. He felt "some

tightness" in the area of the implant's left arm. 

Also in September 2008, Mrs. Hrymoc returned to Katz for an annual 

pelvic exam. She complained of significant pain during intercourse and in an 

area on the left lateral wall of her vagina. Katz recalled that Mrs. Hrymoc

expressed sadness about the loss of her intimate relationship with her husband 

and cried during the visit. 

On September 17, 2008, Dr. Mokrzycki performed the first mesh removal 

operation and released a "tight band" on Mrs. Hrymoc's "left side towards the 

proximal end of the vagina" that had "some evidence of mesh exposure." His 
44 A-5151-17

operative report stated that "[t]his band was encased in scar tissue consistent 

with a strap of the mesh which was too tight and causing probable nerve 

entrapment," and testified that he released the band to free the mesh and scar 

tissue. The postoperative diagnosis was mesh exposure with pelvic pain caused 

by scar tissue secondary to the mesh in Mrs. Hrymoc's left side. 

Mrs. Hrymoc's adverse symptoms continued. After several consultations, 

Dr. Mokrzycki performed another mesh revision on November 20, 2008. His 

postoperative diagnosis was "[m]esh complication from a previously placed 

posterior Prolift graft in the rectovaginal space. The complications include[d] 

pain and discomfort in the rectovaginal area[,] especially toward the left side[,]

and the feeling of a bulge." Dr. Mokrzycki explained that the bulge was caused 

by the mesh and connective tissue bunching up, causing pain. He said it was 

"very dangerous" to remove the mesh because it required careful dissection to 

leave enough tissue to close. Mrs. Hrymoc described the pain as intense and 

said she "would do almost anything to get some relief."

Mrs. Hrymoc returned to see Dr. Mokrzycki six days later for an 

emergency follow-up. She had experienced vaginal bleeding and lower 

abdominal pain. His examination indicated two or three prematurely broken 

sutures and no active bleeding. 
45 A-5151-17

In early December 2008, Mrs. Hrymoc saw Dr. Christopher Fabricant, a

gynecologist with a subspecialty in female pelvic medicine and reconstructive 

surgery. She complained to him of urinary problems, painful intercourse, pelvic 

discomfort, and back pain. Dr. Fabricant noted tenderness in the area of the 

anterior mesh arms and prescribed estrogen cream. 

Dr. Fabricant next saw Mrs. Hrymoc in January 2009. She complained of 

pelvic pain, scarring, exposed mesh, and obstructive urinary symptoms. He 

noted that she had "exquisite tenderness" in the proximal or upper portion of the 

Prolift anterior mesh. She wanted surgery to remove the Prolift mesh and the 

sling. He reviewed the risks and potential complications of surgery, including 

"[p]ain, bleeding, infection, injury to organ, urinary incontinence, incomplete 

removal of mesh, pneumonia, thromboembolism, recurrence of prolapse or 

incontinence." Mrs. Hrymoc explained at trial that she decided to have the 

surgery because she wanted relief from the pain and felt very tired, depressed,

and unhappy at the time. 

On March 16, 2009, Dr. Fabricant removed the sling to relieve the 

obstructive lower urinary tract symptoms. He then removed portions of the 

anterior mesh, but he encountered excessive blood loss requiring a blood 
46 A-5151-17

transfusion and stopped the procedure. No attempt was made to remove the 

posterior mesh. 

In April 2009, Mrs. Hrymoc returned to Dr. Fabricant complaining, among 

other things, of SUI. Dr. Fabricant testified that he told Mrs. Hrymoc "in clear 

terms before surgery" that the stress incontinence would recur. He ordered 

physical therapy for bladder control. He next examined Mrs. Hrymoc in July 

2009, and noted tenderness over the posterior mesh. She last saw Dr. Fabricant

in November 2009, asking for removal of the posterior Prolift and a remaining 

portion of the proximal arm on the left side of the anterior Prolift mesh. It 

appears no further procedures were done after this appointment. 

Mrs. Hrymoc testified that after Dr. Fabricant removed the TVT-O, she 

went to physical therapy to learn how to contract her muscles to improve her 

stress incontinence. The therapist also tried to improve her vaginal pain, a 

process which Mrs. Hrymoc described as "very painful" and "very unpleasant, 

and it was in a way humiliating." She ended the therapy, saying it helped a little 

to alleviate her stress incontinence, but did not improve the pain. 

At her annual exams with Katz from 2009 through 2012, Mrs. Hrymoc

reported being sexually inactive. She complained of pain during intercourse at 

her annual exams in 2015 and 2016. Katz said Mrs. Hrymoc was always in pain. 
47 A-5151-17

Mr. Hrymoc did not testify, but Mrs. Hrymoc described their marital 

relations during her trial testimony. Prior to her surgeries, Mrs. Hrymoc and her 

husband were sexually active, enjoying an intimacy that brought them "even 

close[r] together" and which Mrs. Hrymoc described as a "very important part 

of [their] life." After the surgeries, they tried numerous times to have intimate 

relations, but "[b]ecause of the pain, [they] had to stop," which Mrs. Hrymoc 

described as "very distressful" and "so sad." 

2. McGinnis

Plaintiff Mary McGinnis was born in 1947. She knew Thomas McGinnis, 

co-plaintiff in this case, as a teenager, and married him in November 1967. 

In 1977, the family moved from upstate New York to North Carolina. 

After moving, Mrs. McGinnis founded and ran a childcare program, Mary's 

Childcare, which was still operating at the time of trial. 

At her annual gynecological examination in February 2009 with Dr. 

Barbee, Mrs. McGinnis reported incontinence and "urinary urgency" that she 

found "bothersome." Following testing, Mrs. McGinnis was diagnosed with: (1)

urethral hypermobility, (2) SUI, and (3) a cystocele, which is a type of pelvic 

organ prolapse. Mrs. McGinnis was not aware she had POP until Dr. Barbee 

diagnosed it.
48 A-5151-17

Mrs. McGinnis discussed treatment options with Dr. Barbee and elected 

to proceed with surgery involving an anterior repair with mesh and a suburethral 

sling. Dr. Barbee performed surgery on Mrs. McGinnis on March 12, 2009, 

implanting two surgical mesh medical devices manufactured by Bard, 

specifically (1) the Avaulta Solo, used to correct POP, and (2) the Align TO, 

used to treat SUI. The surgery took place in Raleigh, North Carolina, and was 

an "uncomplicated" and "normal" procedure.

The Avaulta Solo and Align TO are kits that include the mesh material to 

implant, the instrument to insert the mesh, and instructions for the surgical 

procedure.

In the months following surgery, Mrs. McGinnis returned to Dr. Barbee's 

office complaining of pain, incontinence, a vaginal discharge with odor, and 

abdominal distension. Additionally, in September 2009, Mrs. McGinnis

complained of vaginal bleeding, irritation, and a burning sensation.

Mrs. McGinnis consulted Dr. AnnaMarie Connolly at the University of 

North Carolina. On December 28, 2009, Dr. Connolly performed surgery on 

Mrs. McGinnis to excise eroded vaginal mesh. Dr. Connolly found a "0.5 cm 

piece of eroded vaginal mesh along the midline anterior vaginal wall." Six 
49 A-5151-17

months later, on June 21, 2010, Dr. Connolly performed another surgery to 

remove additional eroded vaginal mesh. 

Mrs. McGinnis continued to have significant vulvar pain that could not be 

alleviated with therapy. She also had groin pain, hip pain, lower back pain, and 

pain radiating down her medial and posterior thigh. 

In February 2016, Mrs. McGinnis consulted Dr. Shlomo Raz, the director 

of pelvic medicine, reconstructive surgery at UCLA. Dr. Raz concluded that 

Mrs. McGinnis's pain was caused by the eroded mesh remaining in her body and 

that all the mesh needed to be removed. He noted that the hip, lower back, and 

thigh pain Mrs. McGinnis complained of was typical of a patient with 

"complications of obturator sling," and particularly a sling of "Avaulta type with 

needles and trocars through the obturator musculature." 

Dr. Raz examined Mrs. McGinnis and found that Align TO mesh was 

"infiltrating the vaginal wall," making the tissue the consistency of "a hard cord" 

rather than normal tissue. Dr. Raz noted that Mrs. McGinnis had severe pain 

and tenderness in the area of the Align TO mesh. Mrs. McGinnis had less pain 

in the area of the Avaulta Solo mesh. Dr. Raz concluded:

The patient had the insertion of two meshes, both of 

them with complications. One eroded around the 

vagina and the urethra, one eroded around the bladder. 
50 A-5151-17

The mesh was partially removed and she continued to 

have pain, dyspareunia, systemic symptoms, groin pain, 

leg pain, back-of-the-thigh pain, hip pain. That's all for 

me eroded, complication of erosion of mesh and 

chronic mesh infection.

Dr. Raz stated the pain Mrs. McGinnis experienced was "all mesh complication" 

with a clear "cause/effect."

Dr. Raz described locating and removing all remaining mesh in Mrs. 

McGinnis as "a very delicate, difficult surgery." He stated that removing mesh 

"is one of the most difficult operations to do." He explained that the process 

was "a very difficult and delicate dissection" because the mesh was "deep, 

adhesed," as if it was "glued or cemented to the wall of the urethra, to the pubic 

bone, to the muscles." In addition, Mrs. McGinnis's prior surgeries had left the 

mesh "fragmented," making it more difficult to remove. 

Dr. Raz also performed a reconstruction of the anterior vaginal wall, 

which was complicated because the vaginal wall was "extremely thin, infiltrated 

by the mesh." Finally, Dr. Raz performed an "injection of Botox in trigger 

points" in hopes that the injection would improve the pelvic pain in six-to-nine 

months. However, Dr. Raz acknowledged that not all patients benefited from 

the procedures he performed on Mrs. McGinnis. He explained:

We did a study of almost 700 patients. 55% of the 

patients, totally cured of mesh removal; 20 to 25% 
51 A-5151-17

improved, but 20, 25% we remove all the mesh and the 

pain continues, so there is neuropathy, nerve damage.

Following the removal surgery, Mrs. McGinnis's pain was somewhat 

improved, but she continued to have issues with incontinence. On February 23, 

2017, Dr. Raz performed another surgery to repair a prolapse using Mrs. 

McGinnis's own tissue rather than mesh. 

Mrs. McGinnis testified that, before the mesh implantation surgery, she 

had occasional back pain and "normal aches and pains" but she "never knew 

what severe pain was until [she] had the mesh." The pain she felt afterwards 

was "beyond debilitating." She testified, "It hurts so much, you can't cry, if that 

tells you anything." Mr. McGinnis testified that her pain would get worse as the 

day progressed and, "instead of walking as straight as she can," she would "start 

leaning over."

For two-and-a-half years, Mrs. McGinnis took the prescription Trileptal 

to combat nerve pain, but she found it "extremely hard to even adapt to" and she 

felt her "system was just fighting it all the way." Although it helped somewhat 

with the pain, she would still have episodes where the pain would "shoot up." 

Also, she felt like there was "a constant veil" over her mentally, where she was

"doing everything in slow motion" and was "still hav[ing] the pain."
52 A-5151-17

In April 2014, Mrs. McGinnis began doing sessions with a physical 

therapist, who would "work on the left side inside the vagina" and manipulate 

to "soften" the obturator muscles. Mrs. McGinnis found the process "more 

invasive than going to a gynecologist," saying that "on the human level, you 

never get used to it." However, her therapy kept her "pain level more even" and 

she continued to do it. 

At the time of trial in 2018, Mrs. McGinnis continued to have severe pain. 

Sometimes she had an "attack," in which sharp pains "shoot up in the vagina and 

the pubic bone" and radiate to other areas of her body. She also felt "burning" 

that was "horrible." She had difficulty sitting because of an increased burning 

sensation and stiffness. She stated, "I've got to keep stretching my legs out to 

the side and everything, and it's just easier to stand up."

Additionally, after the implantation surgery Mrs. McGinnis could no 

longer operate Mary's Childcare without help. She could no longer lift the 

children, get on the floor to play with them, or dance with them. However, she 

did not want to close her childcare business because working with the children 

gave her "enrichment" and gave her "a reason to get out of bed in the morning." 

Mr. McGinnis consequently became involved in Mary's Childcare, obtaining 

training and certifications and, at the time of trial, Mr. and Mrs. McGinnis were 
53 A-5151-17

operating the business together. Mrs. McGinnis typically needed to lay down 

"for an hour or two" during the day and when the workday was done.

Mr. McGinnis also took on more household duties after his wife's 

implantation surgery. Among other things, he testified he now does all the 

lifting, cleaning, laundry, cooking, and grocery shopping. Before the surgeries, 

Mrs. McGinnis would do the shopping, which enabled Mr. McGinnis to do other 

things. He also commented that the two of them would sometimes argue over 

whether she was able to resume such activities. 

Throughout their marriage before the implantation surgery, Mr. and Mrs.

McGinnis were sexually active, and she experienced no pain from it. After the 

surgery, they attempted to have sex on one occasion, but it was too painful for 

her, so they did not try again. Mrs. McGinnis testified that "even being held 

tight is hard," and she had to be gentle in hugging her husband or other people. 

She felt "very guilty" that she was unable to be intimate with her husband. 

Nevertheless, they continued to have a good relationship and to hold hands.

Mr. McGinnis testified that "the sexual intercourse part" of their marriage 

was "gone," and he could no longer hug his wife tightly without causing her pain 

to "kick up." He also testified that, before the implantation surgery, he and his 

wife would often dance together. They also would "go on rides" of a few 
54 A-5151-17

hundred miles to "see some of the country that was around us and see some of 

the small towns that people talked about," staying overnight. They "did that 

quite a bit." Following the implantation surgery, they could no longer do these 

activities.

E. The Trials

At the respective trials, plaintiffs, represented by the same law firm in 

both cases, presented fact and expert witnesses supporting their claims that 

defendants were liable under two separate theories of products liability: namely, 

defective design and inadequate warning. Plaintiffs contended there were 

feasible and safer alternative designs for the mesh products, and, furthermore, 

that the product warnings unreasonably failed to alert their physicians and them 

of the severity of the dangers associated with the devices. 

Defendants countered with their own series of fact and expert witnesses, 

who contended the devices were reasonably designed and safe as a treatment for 

prolapse, and that the warnings sufficiently alerted plaintiffs and their doctors 

to the risks of harm.

By agreement of counsel, the substantive issues were tried under the law 

of New Jersey in Hrymoc, and under the law of North Carolina (plaintiffs' home 
55 A-5151-17

state) in McGinnis. In both trials, also by agreement, the issue of punitive 

damages was tried under New Jersey law.

In Hrymoc, the jury found: (1) Prolift was defectively designed; (2) 

Prolift's defective design was a proximate cause of plaintiff's injury; (3) Prolift's 

warnings were inadequate; (4) Prolift's inadequate warnings were a proximate 

cause of plaintiff's injury; (5) TVT-O's warnings were inadequate; but (6) TVTO's inadequate warnings were not a proximate cause of plaintiff's injury. The 

jury awarded compensatory damages of $5 million ($4 million for Mrs. Hrymoc 

and $1 million for her husband), plus punitive damages of $10 million, with $7.5 

million allocated to plaintiffs' design defect claim and $2.5 million to their 

failure-to-warn claim.

In McGinnis, the jury found defendants liable under the North Carolina

product liability statute for both design and warning defects. The jurors awarded 

plaintiffs $68,026,938.38, consisting of (1) $23 million in compensatory 

damages and $26,938.38 in stipulated medical expenses to Mrs. McGinnis; (2)

$10 million in loss of consortium damages to Mr. McGinnis; and (3) $35 million 

in combined punitive damages to both plaintiffs.
56 A-5151-17

F. Post-Trial Motions

Defendants in both cases unsuccessfully moved for a new trial, judgment 

notwithstanding the verdict, and remittitur of the damages. The trial judges 

denied those motions.

More specifically, the judge in Hrymoc concluded there was sufficient 

evidence for the jury to find that Prolift posed an unreasonable risk of harm, that 

there were feasible and safer alternative designs, and that Prolift's design and 

mesh were the cause of plaintiff's injuries. The judge denied defendants' 

reliance upon a state-of-the-art defense, finding their proofs essentially focused 

on the dangers of alternative surgical procedures and not on the state of the art 

of the technology for Prolift and its components.

The Hrymoc judge also ruled that the evidence supported the jury's 

failure-to-warn verdict. The judge found plaintiffs established that the Prolift 

Instructions for Use ("IFU"), patient brochure, and other materials contained 

"partial and vague warnings" regarding the extent of the risks. Citing the 

testimony of plaintiffs' experts, the judge noted the risks were "much greater 

than those typically associated with surgically implantable materials." The 

judge concluded that the evidence did not support defendants' claim that pelvic 

surgeons, including Dr. Mokrzycki, knew all of the unwarned-of risks. 
57 A-5151-17

Further, the Hrymoc judge ruled that the evidence supported the jury's 

award of damages. The judge noted the jury heard substantial evidence from 

plaintiff about her physical and emotional suffering. In addition, plaintiff

testified "extensively" about the duration of her marriage, the strong bond with 

her husband, and the importance of their intimate life. The judge found nothing 

to suggest it would be manifestly unjust to sustain the award of $4 million to 

plaintiff and $1 million to her husband. She also deemed the evidence more 

than sufficient to establish defendants' willful and wanton disregard to sustain 

the award of punitive damages in an amount that was two times the 

compensatory award.

The trial judge in McGinnis cited similar reasons for denying defendants' 

post-trial motions. The judge found that plaintiffs "presented more than 

sufficient evidence to support their claim that Bard's design[] was inadequate 

and that Bard knew that the design of the Avaulta Solo and the Align TO were 

unreasonable and dangerous." The judge also found plaintiffs had presented 

"sufficient evidence to support the jury's determination to award punitive 

damages." The judge declined to remit any of the damages awards.
58 A-5151-17

G. These Appeals

The present appeals ensued. With this court's permission, several business 

organizations filed amicus briefs in support of the defense.

7

 The appeals were 

argued before this court in tandem.

In their main overlapping argument, defendants contend the trial judges 

each committed reversible error by excluding the FDA 510(k) clearance 

evidence from both the liability and punitive damages portions of the trials. 

Defendants also contest as excessive the amount of the damages awards.

Additionally, defendants in Hrymoc argue plaintiffs failed to establish 

feasible alternative designs that would have eliminated the harm, and that the 

trial judge erred in rejecting their request for a jury instruction on a state-of-theart defense. They further argue, with respect to the failure-to-warn claim in 

Hrymoc, that plaintiffs did not prove proximate causation from any warning 

inadequacies because Dr. Mokrzycki would have prescribed the mesh implant 

surgery even if the products came with a stronger warning. Defendants also 

7

 The amici are: (1) the Product Liability Advisory Council, Inc., (2) the 

HealthCare Institute of New Jersey, and (3) the Advanced Medical Technology 

Association, Chamber of Commerce of the United States of America, and the 

National Association of Manufacturers. No amici appeared in support of 

plaintiffs. By agreement of counsel, one attorney participated in oral argument 

on behalf of all amici, and he addressed the FDA 510(k) evidence issue.
59 A-5151-17

argue the trial judge in Hrymoc erred in allowing plaintiffs to present evidence 

of the spoliation of certain company records.

Defendants in McGinnis do not raise issues on appeal concerning the 

merits. They do claim unfair prejudice, however, from the court's exclusion of 

the 510(k) evidence. They also contest the admission of improper opinion 

testimony from Mrs. McGinnis's surgeon and her chiropractor. As to the 

damages, they argue the compensatory damages awarded, particularly the per 

quod damages awarded to Mr. McGinnis, were excessive, and that the punitive 

damages were unjustified and exorbitant.

II.

The main issue for our consideration, one common to both appeals, is the 

trial court's exclusion of any evidence or information about the 510(k) FDA 

clearance of defendants' mesh products. To analyze that key issue, some 

regulatory background is in order.
60 A-5151-17

A. The FDA 510(k) Clearance Process

1. General Requirements

The Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040, as 

amended, 21 U.S.C. §§ 301-399i ("FDCA"), mandated a premarket approval 

process for new drugs, but it did not do the same for new medical devices.8 The 

Medical Device Amendments to the FDCA, 90 Stat. 539, now codified at 21 

U.S.C. §§ 360c-360k ("MDA"), took effect on May 28, 1976, and those 

provisions conferred upon the FDA regulatory control over medical devices. 

The MDA was enacted "to provide for the safety and effectiveness of 

medical devices intended for human use." 90 Stat. 539. As explained in the 

FDA's July 28, 2014 publication entitled "The 510(k) Program: Evaluating 

Substantial Equivalence in Premarket Notifications [510(k)]; Guidance for 

Industry and Food and Drug Administration Staff" (the "510(k) Guidance 

Document"):

The MDA directed FDA to issue regulations that 

classify all devices that were in commercial distribution 

at that time into one of three regulatory control 

categories: Class I, II, or III, depending upon the degree 

of regulation necessary to provide reasonable assurance 

of their safety and effectiveness.

8

 The statutory history of the FDCA and relevant amendments was detailed by 

the U.S. Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-80 (1996), 

and later in Riegel v. Medtronic, Inc., 552 U.S. 312, 315-20 (2008).
61 A-5151-17

[510(k) Guidance Document, at 2.]

See also 21 U.S.C. § 360c(a)(1) (identifying the three "classes of devices 

intended for human use"). 

Class I devices were "subject to a comprehensive set of regulatory 

authorities called general controls that [we]re applicable to all classes of 

devices." 510(k) Guidance Document, at 2; see also 21 U.S.C. § 360c(a)(1)(A). 

Examples of such general controls include "prohibitions against adulteration and 

misbranding; records and reports; and good manufacturing practices." 510(k) 

Guidance Document, at 2 n.1. 

Class II included devices "which cannot be classified as a [C]lass I device 

because the general controls by themselves [we]re insufficient to provide 

reasonable assurance of the safety and effectiveness of the device, and for which 

there [wa]s sufficient information to establish special controls to provide such 

assurance." 21 U.S.C. § 360c(a)(1)(B). Following amendments to the MDA in 

1990, special controls could include, in particular, "the promulgation of 

performance standards as well as postmarket surveillance, patient registries, 

development and dissemination of guidelines," and other actions deemed 

necessary by the FDA. 510(k) Guidance Document, at 2 n.2.
62 A-5151-17

Lastly, Class III devices were those "for which general controls, by 

themselves, [we]re insufficient and for which there [wa]s insufficient 

information to establish special controls to provide reasonable assurance of the 

safety and effectiveness of the device." Id. at 2; see also 21 U.S.C. §

360c(a)(1)(C). Class III devices that were on the market or were marketed after 

the MDA took effect had to go through the FDA's premarket approval (often 

referred to as "PMA") process. 510(k) Guidance Document, at 2-3; see also 21 

U.S.C. § 360e(b)(1). 

Any new medical device introduced after May 1976 was deemed 

"automatically" to be in Class III and was required to undergo PMA or 

reclassification by the FDA before it could be marketed, unless one of two 

exceptions applied. 510(k) Guidance Document, at 3. In particular, PMA or 

reclassification was not required for a device that either: (1) was "a type of 

device that was in commercial distribution prior to May 28, 1976," and was 

substantially equivalent to "another such device," or (2) was substantially 

equivalent to a type of device that was reclassified into Class I or II after May 

28, 1976. Ibid. New Class III devices were typically subject to PMA even if 

they were substantially equivalent to a device already on the market, although 

some exceptions applied. Id. at 2, 2 n.3.
63 A-5151-17

2. Substantial Equivalence

Since the adoption of the MDA, a manufacturer seeking to market a new 

medical device in the United States for which PMA is not required goes through 

a process known as 510(k) clearance and submits a "premarket notification" to 

the FDA. 510(k) Guidance Document, at 2-3. The 510(k) submission has to 

contain information about the device for which clearance is sought (the 

"submission device") and whether it is substantially equivalent to another device 

that is already on the market (the "predicate device"). Id. at 3. 

To demonstrate substantial equivalence, the 510(k) submission has to 

show that the submission device has the same intended use as the predicate 

device, and that it has either: (1) the same technological characteristics of the 

predicate device, or (2) different technological characteristics but not in a way 

that "raises different questions of safety and effectiveness than the predicate 

device." 21 U.S.C. § 360c(i). 

If the FDA reviews a 510(k) submission and determines that the 

submission device is substantially equivalent to the predicate device, the 

submission device is classified into the same class and is subject to the same 

requirements as the predicate device. 510(k) Guidance Document, at 3. 

Conversely, if substantial equivalence is not established, the submission device 
64 A-5151-17

is classified as Class III and is subject to PMA. Ibid. "Thus, 510(k) review is 

both the mechanism by which a manufacturer seeks marketing authorization for 

a new device and by which FDA classifies devices into their appropriate 

regulatory category." Ibid.

B. The FDA's Classification of Surgical Mesh and FDA Guidance

"Surgical mesh" was a general category of device already in existence 

when the MDA took effect. The FDA formally classified surgical mesh into 

Class II in 1988. 21 C.F.R. § 878.3300 (identifying surgical mesh as "a metallic 

or polymeric screen intended to be implanted to reinforce soft tissue or bone,"

such as in hernia repair and orthopedic surgery).9

In addition to the general 510(k) Guidance Document, the FDA published 

"Guidance for the Preparation of a Premarket Notification Application for a 

Surgical Mesh" (the "FDA Mesh Guidance"). The FDA Mesh Guidance 

provided "specific guidance regarding the information to be contained in a 

premarket notification submission for general surgical meshes described in 21 

CFR 878.3300." FDA Mesh Guidance, at 1. The FDA Mesh Guidance advised 

9

 See also Effective Date of Requirement for Premarket Approval for Surgical 

Mesh for Transvaginal Pelvic Organ Prolapse Repair, 81 Fed. Reg. 364 (Jan. 5, 

2016) (the "Reclassification Action Summary") (summarizing the history of 

surgical mesh and transvaginal mesh classifications) (codified at 21 C.F.R. § 

884.5980 (2016)).
65 A-5151-17

manufacturers to identify and describe the device, state its intended use, specify 

all material components, provide manufacturing and sterilization details, and 

include all labeling. Id. at 1-6. The FDA also advised the manufacturer to 

include a "[s]ummary of information regarding safety and effectiveness upon 

which an equivalence determination can be made, or a statement that such 

information will be made available to interested persons upon request." Id.

at 1.

Beginning in 1992, the FDA cleared 510(k) submissions for surgical mesh 

intended for POP repair under the general Class II surgical mesh regulation. See

Reclassification Action Summary. By January 2016, the FDA reportedly had 

cleared over one-hundred 510(k) submissions "for surgical mesh with a POP 

repair indication." Ibid. 

C. FDA 510(k) Clearance of Prolift

As represented by Ethicon, in May 2000, the FDA classified its Modified 

Prolene Soft mesh, the same material used in Prolift, as a Class II surgical mesh 

device and cleared it for use under the 510(k) process.10

10

 The facts described here are taken from defendants' proffer of FDA evidence 

in Hrymoc. Defendants submitted the proffer to the trial judge for the record 

because she had excluded all evidence of the FDA's regulation of Ethicon 

devices. These facts consequently were not presented to the jury. A similar 

effort was made by Bard in McGinnis to present evidence of the 510(k) process.
66 A-5151-17

In November 2001, Ethicon submitted to the FDA a 510(k) premarket 

notification for the sale of its Prolift Soft mesh for pelvic floor repair, and to 

market it for this new purpose as Gynemesh Prolene Soft ("Gynemesh PS"). On 

January 8, 2002, the FDA placed Gynemesh PS in Class II and Ethicon obtained 

510(k) clearance from the FDA to use it in the pelvic floor. The FDA found that 

the product was substantially equivalent to another post-1976 surgical mesh 

device.

Ethicon started marketing Prolift in 2005 without first submitting to the 

FDA any premarket notification. See Kaiser v. Johnson & Johnson, 947 F.3d 

996, 1005 (7th Cir. 2020) (describing this history). About two years later, in 

September 2007, Ethicon submitted a 510(k) premarket notification for the 

Gynecare Prolift system. As explained in Ethicon's and J&J's proffer of FDA 

evidence in Hrymoc, the mesh was identical to Gynemesh PS in material and 

composition, and "[t]he only modification was that it was provided in a preformed shape and that the system included a set of instruments—a guide, 

cannulas, and a retrieval device—to facilitate the mesh implant placement." 

As explained in the Seventh Circuit's opinion in Kaiser, the "2007 

submission asserted that Prolift was substantially equivalent to three devices: 

the Gynecare Gyn[e]mesh PS Prolene Soft mesh; the AMS Apogee Vault 
67 A-5151-17

Suspension System; and the AMS Perigee System," and that "Prolift had the 

same technological characteristics as these predicates." 947 F.3d at 1005. 

On May 15, 2008, the FDA granted 510(k) clearance to Prolift as a Class 

II device, finding it was "substantially equivalent" to another predicate Class II 

surgical mesh device. 

Three years later, the FDA undertook more vigorous action. As the court 

noted in Kaiser, "in 2011 the FDA ordered Ethicon and other transvaginal mesh 

manufacturers to submit plans for postmarket studies of the devices." 947 F.3d

at 1006. 

Ethicon discontinued the Prolift device after the FDA rejected its plan in 

2012. Ibid. Ultimately, "[i]n 2016 the FDA reclassified all transvaginal mesh 

into Class III." Ibid. (citing 21 C.F.R. § 884.5980). 

D. FDA 510(k) Clearance for Avaulta Solo and Align TO

Bard likewise provided 510(k) submissions to the FDA for the Avaulta

Solo and Align TO devices. For the Avaulta Solo, Bard's "510(k) Summary of 

Safety and Effectiveness Information" portion of its submission stated that (1) 

the intended use and fundamental scientific technology were the same for the 

Avaulta Solo as for the predicate device, and (2) "[t]he appropriate testing to 

determine substantial equivalence" was conducted. 
68 A-5151-17

Similarly, Bard's "510(k) Summary of Safety and Effectiveness 

Information" portion of the submission for the Align TO indicated that (1) the 

intended use and fundamental scientific technology were the same for the Align 

TO as for the predicate device, and (2) "[t]he appropriate bench testing to 

determine substantial equivalence" was conducted.

For both products, the predicate device was an earlier version of the samenamed device marketed by Bard, which was cleared under the 510(k) process by 

establishing substantial equivalence to another predicate device.

Bard received clearance from the FDA to market the Avaulta Solo on 

January 15, 2009. The clearance letter stated, in pertinent part:

We have reviewed your Section 510(k) premarket 

notification of intent to market the device referenced 

above and have determined the device is substantially 

equivalent (for the indications for use stated in the 

enclosure) to legally marketed predicate devices

marketed in interstate commerce prior to May 28, 1976, 

the enactment date of the Medical Device Amendments, 

or to devices that have been reclassified in accordance 

with the provisions of the Federal Food, Drug, and 

Cosmetic Act (Act) that do not require approval of a 

premarket approval application (PMA). 

You may, therefore, market the device, subject to the 

general provisions of the Act.

[(Emphasis added).]
69 A-5151-17

The clearance letter included this caveat: "Please be advised that FDA's 

issuance of a substantial equivalence determination does not mean that FDA has 

made a determination that your device complies with other requirements of the 

Act or any Federal statutes and regulations administered by other Federal 

agencies."

Bard received the same form of FDA clearance letter granting permission 

to market the Align TO on May 7, 2010.

E. The Trial Judges' Exclusion of 510(k) Clearance Proof

Plaintiffs in Hrymoc moved in limine before trial to bar defendants from 

presenting the jury with any evidence of the FDA's 510(k) clearance of Prolift. 

Defendants, in response, argued they were entitled to present such evidence.

In an order addressing this issue and over a dozen other pretrial 

applications, the Hrymoc judge granted plaintiffs' motion in limine to preclude 

a defense based on 510(k) clearance because it was not equivalent to the FDA's 

premarket approval process. The judge briefly stated in one paragraph of her 

lengthy in limine order these reasons for her ruling:

Only the premarket approval process can find a medical 

device safe and effective. The Prolift and TVT-O were 

classified as Class II devices, which did not have to 

undergo the premarket approval process of a Class III 

medical device. The FDA only conducts scientific and 

regulatory review to evaluate the safety and 
70 A-5151-17

effectiveness of Class III medical devices. As such, 

[t]he Prolift and TVT-O cannot be presented to the jury 

as being approved by the FDA as safe and effective.

Several months later, the judge in McGinnis likewise granted plaintiffs' 

motion in limine. He reviewed decisions from other jurisdictions, most of which 

had barred similar evidence. The judge acknowledged that some courts had 

allowed the evidence, but he did not find the reasoning in those cases persuasive.

The McGinnis judge reviewed Bard's 510(k) materials "in connection with 

both the Avaulta and the Align" products, including its submissions to the FDA 

and the FDA's correspondence and clearance. The judge noted in his oral 

decision that "what strikes me in reading [the FDA's] determinations is not that 

they are a determination as to safety but they are 'a determination solely as it 

related to substantial equivalency.'" The judge further observed:

What is clear to me, based upon the submissions, is that 

the process is solely to determine substantial 

equivalency and not safety and efficacy. . . . [T]he 

individual who performed the review was only 

concerned about whether the other products that came 

before this product [were] substantially equivalent to 

either the Align or the Avaulta product. 

In his written decision on the issue, the McGinnis judge further

elaborated:

The FDA 510(k) clearance process is not equivalent to 

a premarket approval process. The premarket approval 
71 A-5151-17

process determines a medical device's safety and 

efficacy. The Avaulta and Align products, which are 

the subject of this action, were classified as Class II 

devices and did not have to undergo the premarket 

approval process. The FDA conducts scientific and 

regulatory review to evaluate the safety and efficacy of 

Class III medical devices.

The judge rejected Bard's argument that the application of North Carolina 

law distinguished the McGinnis case from those he found persuasive, finding 

that the 510(k) clearance process was "not a government standard for purposes 

of the North Carolina Product Liability Act."

11

Alternatively, the judge held that the FDA 510(k) evidence should be 

excluded under the balancing test of N.J.R.E. 403, finding that any probative 

value under N.J.R.E. 401 was substantially outweighed by possible prejudice 

and juror confusion. The judge endorsed the concern raised in some cases from 

other jurisdictions that admitting evidence of the 510(k) clearance process 

"would result in a mini trial about the strengths and weaknesses of the process[,]

initiating a battle of the experts." In addition, the judge concluded:

Further, even if this court were to find that the §510(k) 

process had some probative value, its probative value is 

substantially outweighed by the prejudice and 

confusion that it would cause to the jury which, on the 

one hand, is being told it is not a government standard 

11

 This argument will be more fully addressed in Part II(F)(5) of this opinion, 

infra. 
72 A-5151-17

while at the same time having Bard argue that it 

complied with the §510(k) process. The court 

considered whether a limiting instruction would cure 

the issue and determined that such limiting instruction 

would only further confuse the jury.

[(Emphasis added).]

Accordingly, the McGinnis judge held that no references to the FDA could be 

made during the liability trial.

Shortly before the McGinnis trial, Bard moved for partial summary 

judgment, contending that punitive damages were precluded under the New 

Jersey Products Liability Act ("PLA"), N.J.S.A. 2A:58C-1 to -11. They argued 

the PLA barred punitive damages because the Avaulta Solo and Align TO, as 

"the subject of 510(k) clearance by the FDA," were "approved, licensed or 

generally recognized as safe" by the FDA. The judge rejected this argument, 

explaining in his oral ruling:

The [c]ourt in connection with various motions 

considered the impact of 510(k) and noted that it 

applies so long as the device is, quote, substantially 

equivalent to a pre-1976 device already in use. The 

device which proceeds under 510(k) may be marketed 

without, quote, pre-market approval as required by the 

FDA. Again, I will not reiterate all of the reasons but 

will indicate simply that, in my view, as in the view of 

others, 510(k) is not a safety and efficacy device. It is 

essentially an exemption to allow things—to allow 
73 A-5151-17

products to go to market without running the gauntlet 

of the pre-market approval process.

[(Emphasis added).]

The judge held the pelvic mesh products were not "approved" or "generally 

recognized as safe and effective" by the FDA as those terms are used in the PLA. 

Similarly, the judge held that the products were not "licensed" by the FDA as 

that term is used in the PLA.

Having failed in their PLA argument to be shielded from punitive damages 

outright, defendants moved again to admit the 510(k) evidence before the 

punitive damages phase of the trial. The judge denied the motion, essentially 

for the same reasons he had articulated previously. 

F. Analysis

We review this pivotal issue of 510(k) admissibility mindful of several 

principles that guide the scope of appellate review of evidentiary rulings by a 

trial court. For one thing, subject to constitutional requirements, we must 

enforce statutes, rules, or other provisions that mandate the admission or 

exclusion of certain proofs.12 

12

 See, e.g., N.J.R.E. 101 (instructing that, except for enumerated categorical 

exceptions, the New Jersey Rules of Evidence "shall apply in all proceedings, 

whether civil, criminal, family, municipal, tax, or any other proceeding 
74 A-5151-17

Where no such codified mandate exists, and the governing law instead 

reposes discretion in the trial court, our appellate courts generally afford 

considerable deference to the exercise of that discretion. Green v. N.J. Mfrs. 

Ins. Co., 160 N.J. 480, 492 (1999). In examining whether a trial court 

misapplied its discretion, we also cannot lose sight of the fact that a hallmark of 

our system of civil justice is fairness. Pasqua v. Council, 186 N.J. 127, 146 

(2006); see also N.J.R.E. 102 (instructing, among other things, that the evidence 

rules are to be construed to "administer every proceeding fairly" and "eliminate 

unjustifiable expense and delay," "to the end of ascertaining the truth and securing a 

just determination"). We fall short of our institutional obligations and aspirations 

if the process that generated a civil judgment is not one that gave the parties a 

fair opportunity to present, within the confines of the Rules of Court and Rules 

of Evidence, their own "side of the story." See Old Chief v. United States, 519 

conducted by or under the supervision of a court"); N.J.R.E. 408 (prohibiting 

the admission of offers of compromise "either to prove or disprove the liability 

for, or invalidity of, or amount of the disputed claim"); N.J.R.E. 411 (declaring 

that "[e]vidence that a person was or was not insured against liability is not 

admissible on the issue of that person's negligence or other wrongful conduct"); 

N.J.R.E. 601 (declaring that "[e]very person is competent to be a witness,"

unless specified exceptions are satisfied); N.J.R.E. 802 (mandating that

"[h]earsay is not admissible except as provided by these rules or by other law").
75 A-5151-17

U.S. 172, 187 (1997) (highlighting the importance of "narrative" in trial 

practice). 

1. Other Jurisdictions

The admissibility of 510(k) evidence in products liability cases involving 

surgical mesh products has been hotly debated in a few cases in other 

jurisdictions. As the McGinnis judge noted, it appears that the bulk of the 

opinions that have addressed the issue have favored the exclusion of such 510(k) 

evidence. They have generally done so on the grounds of potential juror 

confusion and consumption of time, although several of those cases have 

acknowledged the 510(k) evidence has some probative value. 

That said, the case law from outside of New Jersey is not uniform on the 

subject. Most of these cases were decided, at the federal district court level, by 

Judge Joseph Goodwin, the judge assigned to oversee cases filed in the 

transvaginal mesh multidistrict litigation in the Southern District of West 

Virginia (the "federal MDL"). 

In In re C.R. Bard, Inc., 810 F.3d 913, 917 (4th Cir. 2016) ("Cisson"), the 

Fourth Circuit Court of Appeals affirmed Judge Goodwin's evidentiary ruling in 

the case that produced the first jury verdict arising from the federal MDL. The 

plaintiff in Cisson was implanted with Bard's Avaulta Plus device, and the jury 
76 A-5151-17

awarded her both compensatory and punitive damages on her design defect and 

failure-to-warn claims. Id. at 917-19. Bard argued to the Fourth Circuit that 

Judge Goodwin erred in excluding evidence of the 510(k) clearance process 

under Fed. R. Evid. 402 for lack of relevance and under Fed. R. Evid. 403 for 

being substantially more prejudicial than probative. Id. at 919. 

The Fourth Circuit held that, even assuming the evidence was relevant, 

Judge Goodwin had discretion to exclude the evidence as more prejudicial than 

probative. Id. at 922-23. The appeals court observed that, "[w]hile some courts 

have found evidence of compliance with the 510(k) equivalence procedure 

admissible in product liability cases, the clear weight of persuasive and 

controlling authority favors a finding that the 510(k) procedure is of little or no 

evidentiary value." Id. at 920. The court reasoned that "although the [510(k)] 

process is certainly not a rubber stamp program for device approval, it does 

operate to exempt devices from rigorous safety review procedures." Ibid. 

"[T]he district court [wa]s entitled to put 510(k) evidence before the jury, but it 

[wa]s not obligated to do so." Id. at 922. 

The Fourth Circuit found that the probative value of the evidence was 

slight, stating that "[w]hile 510(k) clearance might, at least tangentially, say 

something about the safety of the cleared product, it does not say very much that 
77 A-5151-17

is specific." Ibid. By contrast, the court echoed Judge Goodwin's concern that 

admitting the evidence would result in a "mini-trial" about the strengths and 

weaknesses of the 510(k) process because Bard "was prepared to characterize 

the review process as 'thorough' and 'robust' and the FDA's clearance of the 

Avaulta Plus as 'an affirmative safety . . . decision' based on 'specific safety and 

efficacy findings,'" while the plaintiff argued "that these characterizations 

wildly inflate[d] the significance of the process." Id. at 921-22.13 

In a similar vein, the Eleventh Circuit Court of Appeals, reviewing a 

federal MDL case that had been consolidated with three other similar matters 

and transferred to the Southern District of Florida for trial, affirmed Judge 

Goodwin's exclusion of the 510(k) evidence under Fed. R. Evid. 403, relying on 

the reasoning of Cisson. Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304, 1318-19 

(11th Cir. 2017). The court also noted "the PMA and 510(k) processes have 

distinct requirements and different goals" and that "[t]hese differences are 

13

 See also Huskey v. Ethicon, Inc., 848 F.3d 151, 160 (4th Cir.) (noting that 

510(k) evidence was properly excluded under Fed. R. Evid. 403 because "[w]e 

see no reason to distinguish Cisson here"), cert. denied, ___ U.S. ___, 138 S. Ct. 

107 (2017); Campbell v. Bos. Sci. Corp., 882 F.3d 70, 77 (4th Cir. 2018) 

(rejecting argument that changes over time to the 510(k) process made evidence 

more significant and noting that "[a]dmitting the evidence on these grounds 

would invite a battle of the experts regarding the exact meaning of 510(k) 

approval in these circumstances, and would risk the same jury confusion we 

feared in Cisson").
78 A-5151-17

reflected in the intensity of review" during each process. Id. at 1317. 

Accordingly, the Eleventh Circuit affirmed the exclusion of the 510(k) evidence 

for failing to meet the relevance threshold of Fed. R. Evid. 402. Id. at 1318-

19.14

The Seventh Circuit Court of Appeals has also upheld the district court's 

discretionary exclusion of evidence regarding the 510(k) clearance process in a 

trial in the Northern District of Indiana relating to a surgical mesh device. 

Kaiser, 947 F.3d at 1018. The court noted that the device at issue "face[d] the 

same categorical problem as any device cleared to market through substantial 

equivalence: The FDA expressly disclaims any intent of 'approving' devices 

through the § 510(k) process." Ibid. (citing 21 C.F.R. § 807.97).

On the flip side, the judges in several other federal cases, including a 

reported district court opinion from Arizona, have ruled that evidence of the 

510(k) clearance process should be admitted, with a limiting instruction for the 

jury. In the Arizona opinion, In re Bard IVC Filters Prods. Liab. Litig., 289 F.

14

 See also Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 755-56 (S.D. W. 

Va. 2014) (federal MDL case finding that the 510(k) process "is not a safety 

statute or administrative regulation" and excluding evidence regarding it under 

both Fed. R. Evid. 402 and Fed. R. Evid. 403); Albright v. Bos. Sci. Corp., 58 

N.E.3d 360, 370 (Mass. App. Ct. 2016) (noting that the trial judge "would have 

been well within her discretion to exclude all reference to the § 510(k) clearance 

. . . because of its potential to mislead the jury and confuse the issues").
79 A-5151-17

Supp. 3d 1045, 1047-48 (D. Ariz. 2018) ("Booker"), the district court found that 

the plaintiffs were correct "that the 510(k) process focuses on device 

equivalence, not device safety," but that difference of focus "d[id] not render 

evidence of the 510(k) process irrelevant." The court noted that a jury deciding 

a design defect claim may consider whether a manufacturer "acted reasonably 

in choosing a particular product design," id. at 1047 (quoting Banks v. ICI Ams., 

Inc., 450 S.E.2d 671, 673 (Ga. 1994)), and it held that a defendant's compliance 

with the 510(k) process "may not render a manufacturer's design choice immune 

from liability, but it can be a 'piece of the evidentiary puzzle.'" Ibid. (quoting 

Doyle v. Volkswagenwerk Aktiengesellschaft, 481 S.E.2d 518, 521 (Ga. 1997)).

As to the balancing test of Fed. R. Evid. 403, the Booker court recognized

the plaintiffs' concern that "admission of such evidence would cause the case to 

devolve into a series of mini-trials regarding the 510(k) process and [the 

defendants'] compliance with it," but it held that the concern could be 

"adequately addressed without excluding relevant evidence to the detriment of 

[d]efendants." Id. at 1048-49. The court determined that "any potential 

confusion can be cured, if necessary, by a limiting instruction regarding the 

nature of the 510(k) process." Id. at 1049. 
80 A-5151-17

Moreover, the Booker court held that the defendants would not be 

permitted "to present evidence or argument that the FDA 'approved' the [device]

for market, or that clearance of the device under 510(k) review constitute[d] a 

finding by the FDA that the [device] [wa]s 'safe and effective.'" Ibid.15

In making its Fed. R. Evid. 403 assessment, the Booker court noted that 

"[m]any of the relevant events in this case occurred in the context of FDA 510(k) 

review, and much of the evidence is best understood in that context." Ibid. 

Because of that, the court was concerned that excluding the evidence "would run 

the risk of confusing the jury as well" and "[a]ttempting to remove any 

references to the FDA from the trial would risk creating a misleading, 

incomplete, and confusing picture for the jury." Ibid.

The Booker court was also concerned that some evidence provided by the 

FDA and unrelated to the 510(k) clearance process was significant in the case, 

so it was "not convinced that all FDA-references could be removed" even if it 

excluded the 510(k) evidence. Ibid. Juror confusion or speculation could result 

15

 Some unpublished district court opinions, which we will not cite here in 

accordance with Rule 1:36-3, have reached a result similar to Booker. At least 

one of those unpublished opinions suggested, like Booker, the use of a limiting 

instruction to guide the jurors. We are aware of, and likewise will not cite to, 

unpublished opinions supplied to us by plaintiffs that adopt the contrary view.
81 A-5151-17

"if the evidence was half-baked, containing some references to the FDA but not 

explaining what role the FDA played with respect to" the device at issue. Ibid.

2. Weighing of Probative Value Against Offsetting Factors

Mindful that the case law from other jurisdictions is divided on the 

subject, albeit not evenly, we conduct our own independent analysis of the 

admissibility issue. As we do so, certain points are salient.

We agree with plaintiffs and the two Law Division judges that the FDA's 

regulatory clearance of a Class II medical device through the 510(k) review 

process is not a plenary determination of that device's safety and effectiveness. 

Instead, the clearance process simply confirms that the device maker's own 

product is "substantially equivalent" to a so-called predicate device that already 

has been reviewed by the FDA or otherwise has been allowed to be sold. 

As case law has recognized, it is beyond reasonable dispute that the FDA's 

510(k) clearance process is far less rigorous than the more elaborate and timeconsuming process for obtaining the FDA's premarket approval of a Class III 

device. Indeed, the 510(k) clearance process is controversial, and it has been 

criticized by some as too weak and too frequently used.16

16

 See, e.g., Inst. of Med., Medical Devices and the Public's Health: The FDA 

510(k) Clearance Process at 35 Years 196 (2001) (report of the National 
82 A-5151-17

Although it has evolved over the years, the process for obtaining 510(k) 

clearance requires an applicant to address a lengthy checklist of filing 

requirements. See FDA, Guidance for Industry and Food and Drug 

Administration Staff: Refuse to Accept Policy for 510(k)s 20-34 (last updated 

Sept. 13, 2019). Among other things, the FDA's review can encompass whether 

any differences in the submission device from the predicate device affect its 

safety and effectiveness, detailed information or data concerning adverse health

effects, and, in some instances, clinical or scientific data, depending on if the 

applicant contends its device has the same technological characteristics as the 

predicate. See 21 U.S.C. § 360c(i)(1); 21 C.F.R. § 807.87; 21 C.F.R. § 807.92.17

Academy of Sciences which, among other things, pointed out various perceived 

shortcomings of the 510(k) clearance process for Class II devices and 

recommended replacement of the "substantial equivalence" standard with "an 

integrated premarket and postmarket regulatory framework that effectively 

provides a reasonable assurance of safety and effectiveness throughout the 

device life cycle"). Although the parties and amici have cited other more recent 

articles on the subject, we do not cite them here because they generally postdate the clearances of the devices at issue in these two cases.

17

 Plaintiffs argue in their briefs that some of these considerations that appear 

in the regulations do not pertain here, because defendants submitted their 510(k) 

clearance documents under 21 U.S.C. § 360c(i)(1)(A)(i), which applies to 

applications based on devices claimed to have the same characteristics as the 

predicate device, rather than the more robust criteria of 21 U.S.C. § 

360c(i)(1)(A)(ii). Neither trial judge addressed this technical point, and we 

decline to resolve it here except to note the subject can be addressed in a fulsome 

manner in a Rule 104 hearing on remand. 
83 A-5151-17

We must bear in mind that clearance through the less-rigorous 510(k) 

FDA review process does provide evidence that a device manufacturer obtained 

regulatory authorization to market the product at issue. We are persuaded, as 

several of the federal cases have noted, that evidence of such authorization does 

have probative value in evaluating the company's design and sale of the devices. 

The bar for relevancy under N.J.R.E. 401 only requires a "tendency in 

reason" for evidence to prove or disprove a fact of consequence to the case. In 

making this determination, a court's "inquiry focuses on 'the logical connection 

between the proffered evidence and a fact in issue.'" Furst v. Einstein Moomjy, 

Inc., 182 N.J. 1, 15 (2004) (quoting State v. Hutchins, 241 N.J. Super. 353, 358 

(App. Div. 1990)). The evidence "need not be dispositive or even strongly 

probative in order to clear the relevancy bar." State v. Buckley, 216 N.J. 249, 

261 (2013); see also Biunno, Weissbard & Zegas, Current N.J. Rules of 

Evidence, cmt. 1 on N.J.R.E. 401 (2021) ("The test for relevance is broad and 

favors admissibility.").

On the other hand, we also recognize courts have the discretion to exclude 

relevant evidence under N.J.R.E. 403 if the opposing party establishes that its 

probative value is "substantially outweighed" by countervailing considerations. 

Such countervailing factors may include the risks of undue prejudice, confusing 
84 A-5151-17

or misleading jurors, or undue delay and waste of time. N.J.R.E. 403. "[T]he 

more attenuated and the less probative the evidence, the more appropriate it is 

for a judge to exclude it" under Rule 403. Green, 160 N.J. at 499-500 (quoting 

State v. Medina, 201 N.J. Super. 565, 580 (App. Div. 1985) (alteration in 

original)).

In reviewing these offsetting considerations here, we consider not only the 

pretrial in limine rulings of the trial judges on the 510(k) evidence, but how 

those rulings actually played out in these two trials. As defendants have 

emphasized, plaintiffs' counsel in both cases took considerable advantage of the 

judges' exclusion of the FDA clearance proof, by telling and reminding the 

jurors that defendants performed no clinical studies of the pelvic mesh devices 

before they were implanted in these patients.

As just a few examples, plaintiffs' counsel in McGinnis argued to the jury 

in opening and in summation that clinical studies were "needed" and "clearly 

required," and also made similar insinuations when cross-examining company 

officials. Similarly, plaintiffs' counsel in Hrymoc stressed in summation that 

the jury "never heard a witness . . . explain why [a study] wasn't done, why it 

wasn't necessary" before the product was marketed. In addition, plaintiffs' 

counsel in Hrymoc exhorted the jury to impose punitive damages to "punish" 
85 A-5151-17

defendants so they would "do clinical studies." We do not consider these 

arguments inappropriate, but defendants should have been permitted to try to 

counter them by allowing the jurors to at least know about the 510(k) clearance 

process and the fact that the FDA did not require such clinical studies.

To be sure, the absence of such a regulatory testing requirement does not 

preempt the ability of state law to impose liability upon manufacturers for 

selling a defective and unsafe product. Lohr, 518 U.S. at 493-94. But that does 

not make a total ban on disclosure to the jury of the FDA's actual involvement 

fair or appropriate. Many jurors in our present society would naturally expect 

that the FDA would have some involvement in the regulation of a new medical 

product being implanted in patients, and that the FDA would have had some 

oversight role concerning bringing a product to market.

18

 We are not satisfied 

that the trial courts' apparent advice to potential jurors during voir dire to ignore 

the possible role of the FDA in regulating these devices was a fair or adequate 

solution, given how the cases were thereafter tried.

18

 Such a common expectation would be apt to be even more prevalent for cases 

to be tried after the current COVID-19 pandemic and the FDA's widely 

publicized involvement in approving COVID-19 vaccines and reviewing testing 

data from clinical studies.
86 A-5151-17

The inherent unfairness of the situation as it unfolded is perhaps most 

pronounced in connection with the punitive damages aspect of these cases. 

Under the New Jersey Punitive Damages Act ("PDA"), punitive damages may 

be imposed if the jury finds a defendant behaved with "actual malice" or a 

"wanton and willful disregard of persons who foreseeably might be harmed" by 

that wrongful behavior. N.J.S.A. 2A:15-5.12(a). The PDA calls for the trier of 

fact to "consider all relevant evidence" on the subject, including such topics as 

the defendant's state of mind and the severity and duration of the conduct. Ibid.

Although we stop short of ruling that the PLA mandated the admission of 

the 510(k) evidence in these cases, we have substantial concerns that the 

complete exclusion of any mention of defendants' passage of the FDA clearance 

process could have easily led some jurors to incorrectly presume that defendants 

recklessly sold their defective mesh products to the public without any restraint 

or oversight whatsoever.19 That is not true, even if the FDA's 510(k) clearance 

process comparatively was not as rigorous as premarket approval.

19

 For an analogy, see, e.g., Model Civil Jury Charge 5.40D-4, which explains 

to jurors the limited significance of FDA approval of drug warnings and 

instructions, and that the jury may find the manufacturer's warnings were 

inadequate despite that FDA approval. The instruction reads:
87 A-5151-17

3. Limiting Instructions and Other Judicial Measures

Rather than adopt a categorical ban, we believe the more reasoned 

approach is for our courts to explore whether a limited amount of 510(k) 

information, through a well-crafted stipulation or a modest presentation of 

evidence by both sides, along with a cautionary instruction from the judge, could 

help assure a fair trial. 

For instance, the judge could impose reasonable limits on the number of 

witnesses and the amount of trial time expended on the subject. The judge could 

also explain to the jury—in a neutral manner—the basic and rather 

Defendant has offered evidence that the warnings and 

instructions were approved or prescribed by the Federal 

Food and Drug Administration. Plaintiff . . . contends 

that even if so approved, the warnings were still 

inadequate. Compliance with F.D.A. warnings and 

instructions does not mean necessarily that the 

warnings were adequate, but such compliance, along

with the other evidence in this case, may satisfy you 

that they were. Defendant has the burden of proving 

that the warnings and instructions were approved by the 

F.D.A. If there has been compliance with the F.D.A. 

action, th[e]n [plaintiff] has the burden of proving that 

the approved warnings or instructions were, 

nevertheless, inadequate. You may find that the 

warnings or instructions were inadequate despite the 

F.D.A. approval.

[Ibid. (emphasis added).] 
88 A-5151-17

understandable conceptual difference between Class II "substantial 

equivalency" clearance and the more rigorous Class III premarket approval that 

evaluates a device's safety and effectiveness in depth. As part of that 

explanation, the judge should consider advising the jurors that, as provided by 

an FDA regulation, "[a]ny representation that creates an impression of official 

approval of a device because of complying with" the 510(k) process "is 

misleading and constitutes misbranding." 21 C.F.R. § 807.97. Within such an 

instruction, the judge might helpfully clarify for the jurors that the FDA only 

concluded defendants' devices were substantially equivalent to a device already 

on the market, and it did not conduct an independent evaluation of the devices' 

own safety and effectiveness.

On the discrete subject of the absence of clinical trials, the trial court may 

consider specifically whether to allow disclosure (or admit proof) of portions of 

the pertinent FDA documents. For instance, in McGinnis, the FDA reviewer 

who recommended 510(k) clearance for Bard's device noted on the clearance 

form that "clinical data" was not "necessary to support the review." It is unclear 

from the appellate record the basis for that reviewer's assertion of non-necessity, 

and whether it stems from a finding of technological equivalence under §

360c(i)(1)(A)(i). The trial court may perform a similar review in Hrymoc of the 
89 A-5151-17

pertinence of language within the FDA clearance form for Prolift, which has not 

been furnished in our appellate record.

The judge further could impose limitations on demonstrative aids or forms 

of argument or questioning that might mislead the jurors about the limited 

significance of a 510(k) disclosure and any evidence admitted on the subject. 

Ideally, the judge, with the benefit of a Rule 104 hearing, could fashion a 

proposed stipulation and jury instruction that might curtail either party from 

allowing this subject to dominate the trial.

We should not underestimate the intelligence and conscientiousness of 

jurors. In fact, in her oral opinion denying defendants' post-trial motions, the 

Hrymoc judge remarked on how impressed she was with the jurors, noting they 

were "extraordinarily attentive" and "took copious notes." It is wrong to 

presume the jury would not have been able to understand and follow a limiting 

instruction from the judge about the proper use of 510(k) evidence. Jurors have 

a sworn obligation and assumed capability to abide by the court's guidance.

Indeed, "[o]ne of the foundations of our jury system is that the jury is presumed 

to follow the trial court's instructions." State v. Burns, 192 N.J. 312, 335 (2007).

As we noted in our introduction of this opinion, we believe the revelation 

of the FDA's 510(k) clearance of these devices can be conveyed to the jurors 
90 A-5151-17

effectively and plainly without extensive elaboration. The subject need not 

devolve into a "mini-trial" before the jury. Prudent oversight measures by the 

court can assure that neither side goes too far in presenting evidence or making 

arguments to the jury about the 510(k) process. The playing field can be leveled 

without a dramatic alteration of the overall contest. 

We join with other courts that have expressed similar confidence in the 

capacity of the judges to manage the process and the capacity of jurors to 

understand the concepts.

4. Rule 104 Proceedings

All of these matters are best addressed by the trial court in a fulsome 

pretrial Rule 104 proceeding. Although both judges here entertained argument 

on the topic (along with a host of other pretrial applications), they did not have 

the benefit of a more in-depth exploration at a Rule 104 hearing of exactly what 

proofs and counterproofs20 about 510(k) clearance might be appropriately 

presented, what constraints on counsel might be sensible, and what the precise 

wording of a limiting instruction might contain. These cases should be 

20

 For instance, without resolving the question here, plaintiffs might want the 

jurors to know that Ethicon initially began to market Prolift without first

submitting a premarket notification to the FDA. That is precisely the sort of 

question that can be resolved by the court ahead of trial in a Rule 104 hearing.
91 A-5151-17

remanded for new trials preceded by such Rule 104 hearings, ideally by a single 

judge whose rulings would govern both retrials and other MCL cases involving 

these devices.

In sum, we conclude the trial courts' complete ban on any disclosure of 

the 510(k) clearance process to the jurors, and the manner in which plaintiffs 

took undue tactical advantage of that exclusion, had the clear capacity to lead to 

possibly unjust results.21 R. 2:10-2. The judgments are therefore vacated, and 

the matters scheduled for retrial preceded by Rule 104 proceedings in 

conformance with this opinion. We do not intimate in advance the proper 

outcome of the remand hearing, but simply convey our guidance that a 

categorical ban needs to be more deeply reconsidered, particularly with respect 

to the punitive damages issue. Specifically, the trial judge must consider the 

extent of admissibility of the 510(k) evidence for both the liability and punitive 

damages phases of the trial, as the analysis may differ under the application of 

the pertinent standards.

21

 Given the nature of the proofs we have described from these trials, it is 

certainly conceivable that new juries might reach comparable verdicts, even if 

they are made aware of the 510(k) clearance process. We do not forecast the 

outcome or opine on the possibilities. Our point is that defendants should be 

given a fair opportunity to have the trial court reconsider on remand the 

complete ban on disclosure to the jurors.
92 A-5151-17

5. Related Statutory Issues

That all said, we should note for sake of completeness that we concur with 

the trial judge's rejection of Bard's argument in McGinnis that Section 99B-6(b)

of the North Carolina Products Liability statute compels admission of 510(k) 

clearance evidence. That statute treats, as one of a litany of several factors, "the 

extent to which the design or formulation [of a product] conformed to any 

applicable government standard." N.C.S.A. § 99B-6(b)(3). The 510(k) 

clearance process does not oblige a device manufacturer to design a device in a 

particular way. It does not, for example, require that a device possess the same 

technological characteristics as a predicate device. We decline to construe the 

North Carolina statute as broadly as Bard wishes, and they cite to no reported 

opinion from that state adopting their interpretation. We instead regard the 

relevance of the proof as falling within the discretionary balancing-test ambit of 

Evidence Rules 401 and 403.

We likewise are unpersuaded by defendants' argument that Section 5 of 

the New Jersey PLA, N.J.S.A. 2A:58C-5(c), precludes their liability for punitive 

damages because they obtained the FDA's 510(k) clearance to sell the pelvic 

mesh devices. The cited New Jersey provision covers drugs or devices that were 

"subject to premarket approval or licensure" by the FDA. For the reasons we 
93 A-5151-17

have already explained, the 510(k) process is not one of substantive "premarket 

approval" or "licensure." In fact, FDA regulations disallow a manufacturer from 

making such a mischaracterization. See 21 C.F.R. § 807.97 (declaring such 

representations of the FDA's "official approval of the device" to be "misleading" 

and to constitute "misbranding"). 

Nor, for the reasons we have explained above, does 510(k) clearance 

signify the FDA has "generally recognized" a medical device to be "safe and 

effective" within the meaning of N.J.S.A. 2A:58C-5(c). The devices only have

been found to be substantially equivalent to a predicate device, which is not the 

same rigorous test as a finding of safety and effectiveness. Hence, as the 

McGinnis judge correctly found, neither portion of Section 5 provides 

defendants with immunity from punitive damages here.

III.

Although it is not vital for us to do so in light of our vacature of the 

judgments on other grounds, we address defendants' remaining arguments. 

A. Design Defect and State-of-the-Art Issues in Hrymoc

Defendants in Hrymoc argue that plaintiffs failed to present sufficient 

proof of feasible alternative designs to Prolift, and therefore fell short of their 

burden of proving a design defect under N.J.S.A. 2A:58C-2 and -3. In a related 
94 A-5151-17

argument, defendants maintain they were entitled to have the court issue a jury 

charge on a state-of-the-art defense under N.J.S.A. 2A:58-3(a)(1). The trial 

judge soundly rejected these arguments, and we adopt her determinations.

Section 2 of the PLA imposes liability for a design defect if the plaintiff 

establishes by a preponderance of the evidence that a "product causing the harm 

was not reasonably fit, suitable or safe for its intended purpose because it . . . 

was designed in a defective manner." N.J.S.A. 2A:58C-2(c). The decision 

whether a product is "not reasonably fit, suitable and safe" requires a risk-utility 

analysis to determine whether it creates a risk of harm that outweighs its 

usefulness. Jurado v. W. Gear Works, 131 N.J. 375, 385 (1993) (quoting 

O'Brien v. Muskin Corp., 94 N.J. 169, 181 (1983)). A plaintiff who asserts that 

the product could have been designed more safely must prove under a risk-utility 

analysis the existence of an alternative design that was both practical and 

feasible at the time the product left the manufacturer's control. Lewis v. Am.

Cyanamid Co., 155 N.J. 544, 571, 574-55 (1998). 

Viewing the Hrymoc record, as we must, in a light most favorable to 

plaintiffs, we agree with the judge's post-trial assessment that plaintiffs 

presented the jury with more than ample evidence to establish that Prolift was 

defectively designed. Plaintiffs presented extensive expert and factual proof of 
95 A-5151-17

several alternative designs to Prolift that a jury could have logically found were 

reasonably safer than the product implanted in Mrs. Hrymoc, including a Prolift 

without arms and a Prolift composed of UltraPro mesh. The witnesses provided 

competing testimony about the risks and benefits of those two alternatives as 

compared with the product as sold, and the jury had ample grounds to find those 

alternatives were superior. We need not reach defendants' contention that the 

third option posed by plaintiffs, i.e., traditional surgical repairs, was not truly an 

alternative product "design." The evidence concerning the other two options 

was clearly sufficient as a matter of law.

The judge rightly declined to provide the jury with an instruction about a 

state-of-the-art defense. The statute affords such a defense only if "[a]t the time 

the product left the control of the manufacturer, there was not a practical and 

technically feasible alternative design that would have prevented the harm [to 

the plaintiff] without substantially impairing the reasonably anticipated or 

intended function of the product." N.J.S.A. 2A:58C-3(a)(1). Here, as the trial 

judge correctly found, defendants did not present evidence contesting the 

technical feasibility of designing the Prolift without arms or using a different 

kind of mesh. The defense instead argued that such alternative designs were not 

practical and would have had their own downsides. 
96 A-5151-17

"The hazard in giving the state-of-the-art instruction in a case in which 

the manufacturer challenges only the alternative device's practicality is apparent 

because . . . the defendant has the attendant burden to 'prove' the state-of-the-art 

when that instruction is given." Cavanaugh v. Skil Corp., 164 N.J. 1, 9 (2000). 

The court did not err in declining to give the instruction on the record presented. 

"A jury instruction that has no basis in the evidence is insupportable, as it tends 

to mislead the jury." Lesniak v. Cnty. of Bergen, 117 N.J. 12, 20 (1989) 

(citations omitted). 

Defendants argue that a state-of-the-art instruction was warranted because 

plaintiffs did not offer evidence that their proposed alternative designs would 

have "prevented the harm," invoking that phraseology from N.J.S.A. 2A:58C-3. 

They contend that design alternatives would have presented their own safety 

risks and thus would not have "prevented" harm. This argument misconstrues 

the statute. 

A plaintiff with a design defect claim only needs to prove the 

manufacturer's product was not "reasonably" safe, see N.J.S.A. 2A:58C-2, not 

that other design alternatives were completely safe. The phrase "would have 

prevented the harm" within the state-of-the-art provision, N.J.S.A. 2A:58C-3, 

logically must be read to mean "prevented the degree of harm" caused by the 
97 A-5151-17

defendant's product, rather than total elimination of risk. Virtually all products 

have some inherent risk of harm. If we were to read the state-of-the-art 

provision as defendants here suggest and require plaintiffs to posit risk-free 

alternatives, that could eviscerate strict liability in design defect cases.

In sum, the design defect proofs were sufficient, and the court did not err 

in declining to issue the jury a state-of-the-art instruction.

B. Proximate Causation in Hrymoc

In an effort to overturn the Hrymoc jury's independent finding of 

inadequate warnings, defendants assert plaintiffs failed to show that more 

detailed warnings advising of Prolift's dangers were a proximate cause of their 

injuries. Relying on the role of her surgeon, Dr. Mokzrycki, as a "learned 

intermediary," defendants contend that stronger warnings could not have 

affected the decision to have Prolift surgically implanted in Mrs. Hrymoc. The 

trial judge correctly rejected this contention in her post-trial rulings, as there 

was ample evidence of proximate causation.

The PLA imposes strict liability if a product manufacturer or seller has 

failed to provide adequate warnings concerning the dangers posed by a product's 

use. Koruba v. Am. Honda Motor Co., 396 N.J. Super. 517, 524 (2007). It 

provides that a manufacturer shall be liable for harm caused by a product that 
98 A-5151-17

"was not reasonably fit, suitable or safe for its intended purpose" because it 

"failed to contain adequate warnings or instructions." N.J.S.A. 2A:58C-2(b). In 

a failure-to-warn strict liability case, a manufacturer has a duty to warn 

foreseeable users of the dangers of using its product. Campos v. Firestone Tire 

& Rubber Co., 98 N.J. 198, 207 (1984). 

With respect to drugs and medical devices, our state law has adopted the 

"learned intermediary" doctrine, under which "a pharmaceutical manufacturer 

generally discharges its duty to warn the ultimate user of prescription drugs by 

supplying physicians with information about the drug's dangerous propensities." 

Perez v. Wyeth Labs. Inc., 161 N.J. 1, 10 (1999) (quoting Niemiera by Niemiera

v. Schneider, 114 N.J. 550, 559 (1989)). This doctrine "recognizes that a 

prescribing doctor has the primary responsibility of advising the patient of the 

risks and benefits of taking a particular medication." In re Accutane Litig., 235 

N.J. 229, 239 (2018). Thus, "it is the physician's responsibility to pass on to the 

parties the information that enables the patient to use the product safely." 

Niemiera, 114 N.J. at 565-66. 

The PLA incorporates the "learned intermediary" doctrine through 

N.J.S.A. 2A:58C-4, under which a pharmaceutical manufacturer or seller is not 
99 A-5151-17

liable if the product "contains an adequate warning or instruction" about the 

product's dangers. The PLA defines "an adequate warning or instruction" as

one that a reasonably prudent person in the same or 

similar circumstances would have provided with 

respect to the danger and that communicates adequate 

information on the dangers and safe use of the product, 

taking into account the characteristics of, and the 

ordinary knowledge common to, the persons by whom 

the product is intended to be used, or in the case of 

prescription drugs, taking into account the 

characteristics of, and the ordinary knowledge common 

to, the prescribing physician. 

[N.J.S.A. 2A:58C-4.]

Where a failure-to-warn case involves something advised by a physician, 

such as a prescription drug or a medical device, "the issue is whether the warning 

should have been given to the prescribing physician." London v. Lederle Labs., 

290 N.J. Super. 318, 327 (App. Div. 1996), aff'd as modified sub nom. Batson 

v. Lederle Labs., 152 N.J. 14 (1997). A plaintiff must prove that the lack of a 

warning was a proximate cause of the harm. Ibid.; Sharpe v. Bestop, Inc., 314 

N.J. Super. 54, 63 (App. Div. 1998), aff'd, 158 N.J. 329 (1999). 

It suffices if the proximate cause is a "substantial contributing factor to 

the harm suffered." Perez, 161 N.J. at 27 (emphasis added). Patients deprived 

of reliable medical information may "establish that the misinformation was a 
100 A-5151-17

substantial factor contributing to their use of a defective pharmaceutical 

product." Id. at 31 (emphasis added).

Defendants first argue that plaintiffs did not prove causation because Dr. 

Mokrzycki allegedly did not rely on the IFU in recommending the device or in 

warning plaintiff of its risks. Specifically, they argue that Dr. Mokrzycki 

testified that he did not rely on IFUs in selecting treatment for his patients and 

that he read the Prolift IFU once years earlier only in response to Ethicon's 

request for feedback. Instead, they claim he relied solely on medical literature,

the patient's presentation, and his own training and experience. 

Contrary to defendants' assertions, Dr. Mokrzycki testified that he 

reviewed the IFU "[a]s part of the process of learning about the Prolift," which 

also included training and testing the Prolift. He further acknowledged 

reviewing the IFU as an evaluator for Ethicon as part of a particular protocol. 

Moreover, he testified that he reviewed the draft IFU and suggested that Ethicon 

add something about bowel function.

The record reasonably supports plaintiffs' contention that Dr. Mokrzycki 

relied on the information in the IFU for his understanding of Prolift's risks and 

benefits. He assumed the information in the IFU was accurate. He took the 

section on adverse reactions and risks very seriously, explaining that as a doctor 
101 A-5151-17

he needed to know about them to protect patient safety. He explained that if 

something was "important enough that it was on the IFU and communicated to 

me, that would tell me at least the company has a significant amount of 

information that they're concerned about it, so, minimally, I would need to be 

concerned about it and translate that to the patient."

The trial testimony also shows Mrs. Hrymoc was familiar with the Prolift 

procedure and its disclosed risks. She testified that Dr. Mokrzycki discussed the 

patient brochure with her, including potential complications, and that when she

expressed some reluctance, he assured her that "all these risks [we]re very easily 

fixable." 

Dr. Mokrzycki explained that he learned how to perform the Prolift 

procedure by going through training and testing the instrument, not just by 

opening the IFU and reading it. Nonetheless, he said it was important for the 

IFU to contain accurate information that fairly represented the risks and benefits 

of the procedure. He described the risks as "always number one" to know before 

he counseled a patient. As he elaborated in his testimony, "It's a combined 

decision. It's my responsibility to explain the reality of those risks, but, 

ultimately, the patient makes the decision . . . ." 
102 A-5151-17

Thus, the record amply establishes that Dr. Mokrzycki relied on the IFU 

as well as the patient brochure to identify all adverse events and risks associated 

with the Prolift system, so that he could discuss them with Mrs. Hrymoc and she 

could consider them in making her decision. 

Defendants further contend that Dr. Mokrzycki would not have changed 

his decision to prescribe and implant Prolift even if they had given more 

stringent warnings. They argue that plaintiffs did not meet their burden of proof 

because Dr. Mokrzycki testified that he did not "think" he "would be 

comfortable using a product" where there was a serious permanent injury, and 

that he would need more information. This argument is without merit.

The trial judge observed the proofs showed that Dr. Mokrzycki was not 

aware of the unwarned-of risks. He did not know about plaintiff's "long-term 

results" or "about certain complications until this case was brought to his 

attention." When asked whether he would have wanted to use Prolift if Ethicon 

had told him the outcome for some of his patients, he answered no. 

The evidence, reasonably construed, shows that Ethicon knew about 

additional material risks before the Prolift launch, but it did not include them in 

the IFU. Such undisclosed risks included mesh contraction, chronic pain, 

vaginal distortion, dyspareunia, and the need for additional surgery. Indeed, a 
103 A-5151-17

company official proposed an additional warning for the IFU concerning 

complications that could impact a woman's ability to have sexual relations, but 

Ethicon did not include it in the 2004 IFU, because it had already printed the 

launch stock. 

The record further supports a finding that Dr. Mokrzycki was not aware 

of all the material risks of patient harm known by Ethicon at the time of 

plaintiff's surgery. For example, Dr. Mokrzycki testified that Ethicon did not 

tell him about the risks of bridging fibrosis, scar plating and contraction, or 

about the risks associated with the removal of Prolift's arms. He also was not 

told that the French transvaginal mesh group had asked for a safer mesh before 

Prolift went on the market, that its study had shown a 20% exposure rate at one 

year, that it had recommended Prolift only for women with Stages III or IV 

prolapse and not for primary repair, or that its study found that 19.6% of patients 

suffered from painful vaginal examinations due to retraction. Moreover, 

according to his testimony, Dr. Mokrzycki did not know before plaintiff's 

surgery that Prolift could cause permanent and severe dyspareunia and that a 

patient might need multiple surgeries to treat recurrent mesh erosions. Ethicon 

also did not tell him that even if implanted properly, the Prolift arms could 

become scarred, contracted and tense, or provide him with guidance on how to 
104 A-5151-17

safely remove the arms if complications occurred. Dr. Mokrzycki described 

many of these issues as significant for him, saying he wanted more information. 

Dr. Mokrzycki testified that if he had known about the unwarned-of risks, 

he would have considered them in his risk/benefit analysis. If Prolift put a 

patient at significant risk for problems, Dr. Mokrzycki did not know "if [he]

would even offer it to a patient." He said his "biggest problem" after learning 

about the unwarned-of risks was "the word permanent." As Dr. Mokrzycki 

explained: 

I would need to know the number of people, you know, 

numerator and denominator that it happens in, and I 

would be very anxious about the word permanent, 

because anything that I do in a patient, I understand 

there may be issues, there may be complications, but 

I'm under the assumption that I should be able to get out 

of that, that I should be able to at least reverse what I've 

done and get the patient back to square one.

So I don't think I've—I would be comfortable 

using a product where there is any serious permanent 

injury . . . .

The surgeon further explained that it would have been important to know 

about the unwarned-of risks because they would have impacted his decision on 

whether to offer Prolift to his patients, including plaintiff. He would have 

wanted to tell plaintiff about all the known risks so she could factor them into 

her decision on whether or not to use Prolift. 
105 A-5151-17

Defendants' focus on Dr. Mokrzycki's isolated statement that he did not 

"think" he would be comfortable using Prolift does not fairly consider his entire 

testimony. To the contrary, the evidence supports the finding that Dr. 

Mokrzycki would not have recommended Prolift to plaintiff if Ethicon had 

disclosed all known risks, especially the ones that could cause permanent and 

life-changing injuries. 

We are mindful that under New Jersey law, the inadequacy of a warning 

cannot be the proximate cause of an injury where there is an intervening cause, 

that is, that the physician either did not read the warning, or had independent 

knowledge of the risks. Perez, 161 N.J. at 28. However, our case law also 

instructs that in order for dismissal of the lawsuit to be warranted on this basis, 

the evidence must be clear and unequivocal. See Strumph v. Schering Corp., 

256 N.J. Super. 309, 323-28 (App. Div. 1992) (Skillman, J., dissenting) 

(concluding that "a defendant drug manufacturer may not be held liable for an 

alleged inadequate warning where the only evidence on the issue of causation is 

the prescribing doctor's unequivocal testimony that his or her decision to 

prescribe the drug was not affected by the warning") (emphasis added), rev'd on 

dissent, 133 N.J. 33, 34 (1993).
106 A-5151-17

As a leading treatise has noted: 

Where the plaintiffs' prescribing physicians 

unequivocally testify that they had full knowledge of 

the dangers associated with a drug and that neither that 

knowledge nor anything in the enhanced post-injury 

warnings supplied by the manufacturer would have 

altered their decision to prescribe it, the plaintiff has 

failed to show that inadequate warnings are a proximate 

cause of injury and there must be a verdict for 

defendant.

[Dreier, Karg, Keefe & Katz, N.J. Products Liability & 

Toxic Torts Law § 8:3-2 at 203 (2020) (emphasis 

added).]

"Where such a statement is not unequivocal the matter is properly for the jury. "

Ibid. The evidence here was by no means unequivocal.

Further, the "prescribing decision," insofar as it logically entails both a 

physician's recommendation and a patient's assent to follow that 

recommendation after being apprised of the pertinent risks, can be causally 

affected by the absence of stronger warnings. Although a physician can function 

as a "learned intermediary," it should not be assumed that a doctor will issue a 

prescription—let alone perform surgery upon—an informed patient who is 

unwilling to risk a medical product's side effects. 

At the very least, the evidence shows that Dr. Mokrzycki would have 

informed plaintiff about the unwarned-of risks so she could have considered 
107 A-5151-17

them in her decision-making process. Niemiera, 114 N.J. at 565-66. Plaintiff 

testified that she would not have agreed to the Prolift procedure if she had known 

all the risks. 

Defendants' failure to provide adequate warnings to Dr. Mokrzycki was 

reasonably found to be a substantial factor in not alerting plaintiff about the risk 

of permanent and life-changing complications, depriving her of the opportunity 

to avert the "medical catastrophe" that occurred. Id. at 566. The proof of 

proximate causation was more than ample to support the verdict on the failureto-warn claim.

C. Other Issues

The balance of defendants' arguments do not require in-depth discussion. 

We very briefly mention them here for guidance to the parties.

The compensatory damages awarded in both cases, viewed in a light most 

favorable to plaintiffs, were reasonably supported by the evidence. Cuevas v. 

Wentworth, 226 N.J. 480, 488 (2016). They should not be set aside had we not 

ordered retrials because of the 510(k) issue. 

The loss-of-consortium damages awarded to both Mr. Hrymoc and Mr. 

McGinnis, while substantial, were justified in light of the compelling testimony 

that showed the lasting detrimental impact their spouses' post-surgical 
108 A-5151-17

complications had on their intimacy, family life, and personal relationships. See

Anderson v. A.J. Friedman Supply Co., 416 N.J. Super. 46, 71 (App. Div. 2010)

(observing "[a] spouse is entitled to loss of consortium [recovery] upon showing 

of several factors, including a strong emotional reliance on each other, a 

relationship of long duration, and a high degree of mutual dependence"). It was 

not necessary for Mr. Hrymoc to provide cumulative testimony to corroborate 

his wife's own narrative on the subject.

Subject to this court's previous comments about the likely impact of the 

exclusion of the 510(k) evidence, the punitive damages in both cases, though 

sizeable, were reasonably supported by the trial proofs concerning defendants' 

conduct and knowledge of the products' dangers. The amounts awarded did not 

transgress the United States or New Jersey Constitutions. The awards were 

within the mathematical limits prescribed by N.J.S.A. 2A:15-5.14(b). 

None of the other evidentiary items argued by defendants warrant 

reversal. The spoliation evidence presented in Hrymoc was sufficiently relevant 

to be admitted, and the trial judge imposed reasonable limits on its presentation 

and use, in lieu of more severe sanctions. Rosenblit v. Zimmerman, 166 N.J. 

391, 404 (2001). 
109 A-5151-17

Also, the fleeting opinion testimony of Mrs. McGinnis's implanting 

surgeon with her views about defendants' corporate ethics and by her 

chiropractor about the perceived extent of her injuries did not manifestly 

produce harmful error, although should not be repeated on retrial.

We have fully considered all other arguments raised on appeal and find 

them without sufficient merit to require discussion. R. 2:11-3(e)(1)(E). 

IV.

The judgments are vacated and remanded for new trials preceded by Rule 

104 hearings on the 510(k) clearance evidence. In all other respects, affirmed.