Hrymoc v. Ethicon, Inc.

• Decision Date: 02 March 2021
• Docket Number: DOCKET NO. A-5151-17, A-1083-18
• Citation: 249 A.3d 191,467 N.J.Super. 42
• Parties: Elizabeth HRYMOC and Tadeusz Hrymoc, Plaintiffs-Respondents, v. ETHICON, INC., Ethicon Women's Health and Urology, a Division of Ethicon, Inc., Gynecare, and Johnson & Johnson, Defendants-Appellants. Mary McGinnis and Thomas Walsh McGinnis, Plaintiffs-Respondents, v. C. R. Bard, Inc., Defendant-Appellant, and Bard Medical Division, a Division of C. R. Bard, Inc., and Bard Urological Division, a Division of Bard Medical Division, Defendants.
• Court: New Jersey Superior Court — Appellate Division

467 N.J.Super. 42

249 A.3d 191

Elizabeth HRYMOC and Tadeusz Hrymoc, Plaintiffs-Respondents,

v.ETHICON, INC., Ethicon Women's Health and Urology, a Division of Ethicon, Inc., Gynecare, and Johnson & Johnson, Defendants-Appellants.

Mary McGinnis and Thomas Walsh McGinnis, Plaintiffs-Respondents,

v.C. R. Bard, Inc., Defendant-Appellant,andBard Medical Division, a Division of C. R. Bard, Inc., and Bard Urological Division, a Division of Bard Medical Division, Defendants.

DOCKET NO. A-5151-17, A-1083-18

Superior Court of New Jersey, Appellate Division.

Argued January 25, 2021

Decided March 2, 2021

Maha M. Kabbash, Morristown, 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,Morristown, 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, Newark, and David R. Kott, of counsel and on the brief; Natalie H. Mantell, Newark, and Steven H. Del Mauro, on the brief).

Adam M. Slater, Roseland, argued the cause for respondents Elizabeth Hrymoc and Tadeusz Hrymoc 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, Roseland, 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, Newark, 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, Newark, on the brief).

Before Judges Sabatino, Currier and Gooden Brown.

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 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.

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.

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 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

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 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...