HRYMOC v. ETHICON, INC.

085547 A-21/23 September Term 2021.

297 A.3d 1245 (2023)

254 N.J. 446

Elizabeth HRYMOC and Tadeusz Hrymoc, Plaintiffs, v. ETHICON, INC., Ethicon Women's Health and Urology, a Division of Ethicon, Inc., Gynecare, and Johnson & Johnson, Defendants. Mary McGinnis and Thomas Walsh McGinnis, Plaintiffs-Appellants/Cross-Respondents, v. C. R. Bard, Inc., Defendant-Respondent/Cross-Appellant, and Bard Medical Division, a Division of C. R. Bard, Inc., and Bard Urological Division, a Division of Bard Medical Division, Defendants.

Supreme Court of New Jersey.

Decided July 25, 2023.


Attorney(s) appearing for the Case

Adam M. Slater , Roseland, argued the cause for appellants/cross-respondents (Mazie Slater Katz & Freeman, attorneys; Adam M. Slater and Christopher J. Geddis , on the briefs).

David R. Kott , Newark, argued the cause for respondent/cross-appellant (McCarter & English, attorneys; David R. Kott and Natalie H. Mantell , of counsel and on the briefs, and Meghan McSkimming and Benjamin D. Heller , on the briefs).

Jared M. Placitella argued the cause for amicus curiae New Jersey Association for Justice (Cohen, Placitella & Roth, attorneys; Jared M. Placitella and Christopher M. Placitella , of counsel and on the brief).

Daniel B. Rogers (Shook, Hardy & Bacon) 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 National Association of Manufacturers (Shook, Hardy & Bacon, attorneys; Philip S. Goldberg , on the letter-brief).

Charles W. Cohen argued the cause for amicus curiae New Jersey Defense Association (Hughes Hubbard & Reed, attorneys; Charles W. Cohen and Eric Blumenfeld , on the brief).

Ryan J. Kurtz argued the cause for amicus curiae New Jersey Civil Justice Institute (Patterson Belknap Webb & Tyler, attorneys; Ryan J. Kurtz and Michelle M. Bufano , of counsel and on the brief).

Ronald J. Levine , Newark, submitted a letter-brief on behalf of amicus curiae Product Liability Advisory Council, Inc. (Herrick, Feinstein, attorneys; Ronald J. Levine , on the letter-brief).

Beth S. Rose , Newark, submitted a letter-brief on behalf of amicus curiae Healthcare Institute of New Jersey (Sills Cummis & Gross, attorneys; Beth S. Rose , on the letter-brief).


This products liability matter1 involving "pelvic mesh" medical devices poses two questions surrounding evidence of "Section 510(k) clearance," see 21 U.S.C. § 360c, which allowed the devices to be marketed without premarket clinical trials...

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