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.
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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).
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).
JUSTICESOLOMON delivered the opinion of the Court.
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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