ELIZABETH HRYMOC VS. ETHICON, INC. MARY MCGINNIS VS. C.R. BARD, INC. (L-13696-14 AND L-17543-14, BERGEN COUNTY AND STATEWIDE) (CONSOLIDATED)

NOT FOR PUBLICATION WITHOUT THE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,
APPROVED FOR PUBLICATION
v. AS REDACTED
March 2, 2021
ETHICON, INC., ETHICON APPELLATE DIVISION
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
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 jury verdicts in
favor of plaintiffs in two product liability actions involving pelvic mesh medical
A-5151-17
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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.
A-5151-17
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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.
A-5151-17
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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:58C-
3(a), and thus no jury charge on that defense was warranted; and (3) plaintiffs
A-5151-17
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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
A-5151-17
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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 non-
precedential, we do not discuss or quote from it here. R. 1:36-3.
A-5151-17
8
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
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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
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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.
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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.
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from informing the juries of that subsequent remedial measure. See N.J.R.E.
407. Plaintiffs have not cross-appealed that ruling.
[At the court's direction pursuant to Rule 1:36-3, the
published version of this opinion omits Parts I(C)(1)
and (2), which discuss: the development of the
Prolift and TVT-O devices by Ethicon and the
Avaulta Solo and Align TO devices by Bard;
internal company communications concerning
product design, safety, and marketing; product
warnings; FDA Section 510(k) clearance; patient
complications; and the eventual removal of these
devices from the market.]
D. Plaintiffs' Backgrounds, Product Usage, and Medical Complications
[At the court's direction, the published version of
this opinion omits Parts I(D)(1) and (2), which
discuss the respective plaintiffs' backgrounds and
medical conditions, the surgical implant of Prolift
and TVT-O in Mrs. Hrymoc in June 2008 and of
Avaulta Solo and Align TO in Mrs. McGinnis in
December 2009, their ensuing adverse medical
complications and surgeries to remove the devices,
and lifestyle impacts upon them and their spouses.]
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,
A-5151-17
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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
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 p roximate
cause of plaintiff's injury; (5) TVT-O's warnings were inadequate; but (6) TVT-
O'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.
A-5151-17
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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.
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
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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.
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
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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.
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 trial s.
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-the-
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.
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art 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
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.
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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).
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[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.
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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.
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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
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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)).
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23
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.
A-5151-17
24
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 pre-
formed 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
A-5151-17
25
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.
A-5151-17
26
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 same-
named 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).]
A-5151-17
27
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
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28
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
A-5151-17
29
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.
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30
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
products to go to market without running the gauntlet
of the pre-market approval process.
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31
[(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
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
A-5151-17
32
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
U.S. 172, 187 (1997) (highlighting the importance of "narrative" in trial
practice).
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").
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33
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
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
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34
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 n o
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, s ay
something about the safety of the cleared product, it does not say very much that
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
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35
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
reflected in the intensity of review" during each process. Id. at 1317.
Accordingly, the Eleventh Circuit affirmed the exclusion of the 510(k) evidence
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").
A-5151-17
36
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.
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
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").
A-5151-17
37
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.
Moreover, the Booker court held that the defendants would not be
permitted "to present evidence or argument that the FDA 'approved' the [device]
A-5151-17
38
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
"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.
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.
A-5151-17
39
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 time-
consuming 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
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
A-5151-17
40
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
We must bear in mind that clearance through the less-rigorous 510(k)
FDA review process does provide evidence that a device manufacturer obtained
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 post -
date 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.
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41
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 establishe s that its
probative value is "substantially outweighed" by countervailing considerations.
Such countervailing factors may include the risks of undue prejudice, confusing
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
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42
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"
defendants so they would "do clinical studies." We do not consider these
arguments inappropriate, but defendants should have been permitted to try to
A-5151-17
43
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.
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
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.
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44
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:
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
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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
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
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).]
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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
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
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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
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
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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 counterproofs 20 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
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.
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.
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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.
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)
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.
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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
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
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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
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.
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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
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
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53
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.
"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
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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
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
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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
"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
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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
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
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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
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
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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
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
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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 . . . ."
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.
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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
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.
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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, o r
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
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
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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.
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
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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).
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
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64
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
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
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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 failure-
to-warn claim.
C. Other Issues
[At the court's direction, the published version of
this opinion omits Part III(C), which discusses issues
concerning other alleged evidential errors, as well as
defendants' challenges to the juries' respective
awards of compensatory and punitive damages.]
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.
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