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Kelley v. C.R. Bard, Inc., 2023 WL 2565853 (N.D. Ga. March 17, 2023), reconsideration denied, 2023 WL 3032063 (N.D. Ga. April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible.

Kelley was actually decided a couple of months ago, but due to Reed Smith’s involvement in the case, we could not blog about it until the matter recently settled.

As is often the case, Kelley involved a plaintiff’s motion in limine arguing “that the §510(k) evidence is not relevant to her claims and would be prejudicial if allowed.”  Id. at *1.  The defendant argued otherwise:

Defendant contends that a manufacturer’s compliance with industry standards and regulations can be a factor considered under Georgia law for a design defect claim, and might implicate any alternative designs identified.  For the failure to warn claim, Defendant argues that Section 510(k) clearance shows that the [product’s] labelling was regulatorily compliant and may be used to respond to the OHSA-related MSDS evidence Plaintiff likely will submit.  Finally, Defendant argues that Georgia law permits regulatory compliance to generally rebut the high willfulness requirement for punitive damages.


The Kelley court agreed with the defendant.  First, “Georgia law applies a totality of the circumstances test in a design defect claim,” and “it is certainly relevant for a jury to consider whether a manufacturer has complied with federal regulations for a design defect claim.”  Id. (citation omitted).  Second, “[w]hat this regulatory compliance actually entails (i.e., safety or equivalence or both) is a question of evidentiary weight.”  Id. (footnote omitted).  Third, “Section 510(k) compliance would be relevant to rebut the MSDS disclosures for Plaintiff’s failure to warn claim and as a consideration for punitive damages. Fourth, and finally:

510(k) evidence is not unfairly prejudicial.  Plaintiff’s primary argument is that regulatory compliance is not dispositive in a design defect claim. . . .  [W]hile the Court is unpersuaded that [such a] holding makes the FDA evidence inadmissible, the Court will consider issuing a limiting instruction cautioning that Section 510(k) approval should not be given dispositive weight.

Id. at *2 (citations omitted).

We view Kelley as significant, particularly because it is a Georgia court applying Georgia law.  One of the major early pelvic mesh cases to the contrary was In re C.R. Bard, Inc., 810 F.3d 913, 921-22 (4th Cir. 2016), in which the Fourth Circuit purported to apply Georgia law, and excluded the same evidence – involving the different mesh product manufactured by the same defendant.  On reconsideration, Kelley expressly rejected that rationale as “an overly restrictive reading of what can be considered for the ‘federal regulation’ factor in Georgia’s risk-utility analysis for design defect claims.”   Kelley v. C.R. Bard, Inc., 2023 WL 3032063, at *2 (N.D. Ga. April 21, 2023) (rejecting “the [Pelvic Mesh] MDL court’s determination that relevant and non-prejudicial regulatory evidence must involve regulations pertaining to the ‘safety’ of a device at issue”).

The Court, however, disagrees that only regulations dealing explicitly with safety are relevant for the design defect claims. . . .  Defendant’s compliance with the FDA process for bringing the [product] to market − even if by FDA 510(k) clearance − is a relevant consideration in the Georgia design defect analysis.  The differences between the approval and clearance processes can be adequately addressed on cross-examination or through a limiting instruction without overt prejudice or misleading the jury.

Id. at *4

Kelley thus adds to the increasing list of courts that – both inside and outside of pelvic mesh litigation – that have found FDA §510(k) clearance admissible in recent years, notwithstanding the result-oriented misapplication of the evidentiary rules in the Pelvic Mesh MDLs.  Here’s a list of cases since 2020.  See Hrymoc v. Ethicon, Inc., 249 A.3d 191, 211-12 (N. J. Super. App. Div. 2021), certification granted, 261 A.3d 349-50 (N.J. 2021); In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2023 WL 3853004, at *2-3 (S.D. Ohio June 6, 2023); Dalbotten v. C.R. Bard, Inc., 2023 WL 1808396, at *2 (D. Mont. Feb. 7, 2023) (admissible as to fraud and punitive damages, but not as to pre-tort-reform Montana law, which excluded compliance evidence generally in strict liability); Ruberti v. Ethicon, Inc., 2022 WL 17887527, at *3-4 (M.D. Ala. Dec. 22, 2022) (rejecting similar motion in limine); Mixson v. C.R. Bard, Inc., 2022 WL 7581737, at *3 (N.D. Fla. Sept. 23, 2022) (same); In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2021 WL 5588563, at *4-5 (S.D. Ohio Nov. 30, 2021); In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2021 WL 5071825, at *6 (S.D. Ohio Nov. 2, 2021); Couturier v. Bard Peripheral Vascular, Inc., 2021 WL 3187368, at *3 (E.D. La. July 28, 2021); In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2021 WL 2643114, at *5 (S.D. Ohio June 28, 2021); Nolen v. C.R. Bard, Inc., 2021 WL 2115788, at *3-4 (M.D. Tenn. May 25, 2021); Keen v. C.R. Bard, Inc., 480 F. Supp.3d 646, 650 (E.D. Pa. 2020); In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2020 WL 6603657, at *8 (S.D. Ohio Oct. 20, 2020).  For older cases reaching the same result, see Bexis’ Book, §11.01[1], at n.14.

You may notice a certain defendant’s name appearing in many of these cases. We’re doing our best to restore this issue back to where it should be. We encourage our readers to do the same.