Photo of Bexis

We have been consistently critical of the MDL system for encouraging judges presiding over such massive aggregations to manipulate the applicable law to create settlement pressure on defendants.  We’ve seen that with federal preemption, willingness to create novel state-law causes of action, choice of law, and trial consolidation of multiple plaintiffs.  But perhaps none has been more blatant than the exclusion of all mention of FDA medical device clearance on the bogus rationale that, because it is not “rigorous” enough to be preemptive of state-law claims under the obsolete decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), it isn’t relevant enough to be admitted at all.

That wasn’t the law anywhere until the Pelvic Mesh MDLs, as we set forth here.  Then Pelvic Mesh cases decided that it would be a great settlement tool to deprive defendants of the jury knowing that their products had, in fact, received FDA’s permission to be marketed, and that FDA saw no reason to require clinical trials before that happened.  E.g., Kaiser v. Johnson & Johnson, 947 F.3d 996, 1018 (7th Cir. 2020); Campbell v. Boston Scientific Corp., 882 F.3d 70, 77 (4th Cir. 2018); Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1318-19 (11th Cir. 2017); In re C.R. Bard, Inc., 810 F.3d 913, 922-23 (4th Cir. 2016); Sanchez v. Boston Scientific Corp., 38 F. Supp.3d 727, 744 (S.D.W. Va. 2014); Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 755-56 (S.D. W. Va. 2014).  Of course, by the time that appellate courts were able to review this Pelvic Mesh FDA gag rule (years after the fact, another problem with MDLs) hydraulic pressure to affirm existed, since to restore the law to where it belonged would have resulted in throwing out years of MDL activity – and affirm they did.

These cases turned FDA medical device regulation, particularly concerning design defect, into an all-or-nothing game.  Either, the FDA’s decision was preemptive, as with PMA medical devices, or such decisions weren’t admissible at all.  That’s a neat trick, from the plaintiffs’ perspective, because it also had the effect of repealing a dozen states’ pro-defendant compliance presumptions, since when FDA compliance was either preemptive or inadmissible, there was no situation in which such a presumption could ever come into play.  E.g., Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 963-64 (S.D.W. Va. 2016) (effectively nullifying Texas compliance statute); but see Ocasio v. C.R. Bard, Inc., 2020 WL 3288026, at *5-6 (M.D. Fla. June 18, 2020) (refusing to nullify Florida compliance statute) (discussed here).  These cases also created a “heads plaintiffs win; tails defendants lose” situation with the FDA – so that the FDA did not exist, except when a plaintiff wanted it to exist (when the FDA did something unfavorable to the defense), as we described here.

But particularly outside of the settlement uber alles context of the Pelvic Mesh MDL, there has been a fair amount of push-back against this blatantly pro-plaintiff manipulation of the rules of evidence.  We have discussed several such cases rejecting the Pelvic Mesh FDA gag rule, Keen v. C.R. Bard, Inc., 480 F. Supp.3d 646, 650-51 (E.D. Pa. 2020) (here); In re Cook Medical, Inc., IVC Filters Marketing, Sales Practices & Products Liability Litigation, 2018 WL 6617375, at *1-2 (S.D. Ind. Dec. 18, 2018) (here); In re Bard IVC Filters Products Liability Litigation, 289 F. Supp. 3d 1045, 1047-48 (D. Ariz. 2018) (here); Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *5-7 (W.D.N.C. Sept. 22, 2015) (here); McCracken v. DePuy Orthopaedics, Inc., 2013 WL 12141334, at *4-5 (N.D. Ohio July 26, 2013) (here).  See also In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2020 WL 6603657, at *7-8 (S.D. Ohio Oct. 20, 2020); Retractable Technologies, Inc. v. Becton, Dickinson & Co., 2013 WL 4101810, at *2 (E.D. Tex. Aug. 12, 2013).

We’re pleased to report that the first state appellate court has agreed with us and refused to follow the same FDA gag rule even in Pelvic Mesh cases.  In Hrymoc v. Ethicon, Inc., ___ A.3d ___, 2021 WL 787039 (N.J. Super. App. Div. Mar. 2, 2021), a unanimous panel of the Appellate Division of New Jersey’s Superior Court recognized that exclusion of FDA device clearance was unduly prejudicial to defendants.  Refusing to bow to the inherent pressure to affirm, Hrymoc reversed two verdicts by juries deprived of FDA clearance information that had hit two different pelvic mesh manufacturers with multi-million dollar awards.  Hrymoc refused to inflate the no-preemption decision in Lohr to into a no-FDA-evidence-at-all gag rule:

[T]he 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.  But that does not make a total ban on disclosure to the jury of the FDA’s actual involvement fair or appropriate.

Hrymoc, 2021 WL 787039, at *15 (Lohr citation omitted).  The FDA’s §510(k) process was different now.  “Following amendments to the MDA in 1990, [FDA] special controls could include . . . ‘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.’”  Id. at *7 (quoting FDA, “The 510(k) Program:  Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff,” at 2 (2014)) (for more on the 1990 amendments see our post, here).

Hrymoc found the Pelvic Mesh FDA gag rule unfair to defendants and misleading to juries.  Calling out the Pelvic Mesh MDL judge by name, 2021 WL 787039, at *12, Hrymoc disagreed with those cases, and held the same blanket exclusion of FDA device clearance evidence to be an abuse of discretion under New Jersey law.  A “complete ban on any disclosure of the 510(k) clearance process to the jurors” was reversible error because it “had the clear capacity to lead to possibly unjust results.”  Id. at *17 (footnote omitted).

While it is true that §510(k) clearance “is far less rigorous than the more elaborate and time-consuming process for obtaining the FDA’s premarket approval,” id. at *14, it is hardly a rubber stamp or unconcerned with safety.  As “it has evolved over the years”:

[T]he process for obtaining 510(k) clearance requires an applicant to address a lengthy checklist of filing requirements.  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.

Id. (citations and footnote omitted).

That §510(k) clearance is “less rigorous,” does not make it irrelevant.  The FDA’s clearance nonetheless “provide[s] evidence that a device manufacturer obtained regulatory authorization to market the product at issue.”  Id.  That’s all that relevance requires.  “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.”  Id.

Nor was there a valid argument that the obvious relevance of FDA device clearance was “substantially outweighed” by any “countervailing considerations” under Rule 403 (New Jersey’s evidence rules essentially reflect the federal rules in this area).  2021 WL 787039, at *15.  Many (if not most) jurors know about the FDA and would expect to hear about it in this type of case:

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.

Id.  Simply telling jurors “to ignore the possible role of the FDA” was neither a “fair” nor “adequate solution.”  Id.

Nor did “waste of time” or “jury confusion” justify an FDA gag rule.

[T]he 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.

Hrymoc, 2021 WL 787039, at *16.  “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.” Id. at *17.

[W]e 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 arguments to the jury about the 510(k) process.


We bloggers think the whole “mini trial” argument is ridiculously overblown in §510(k) cases anyway – since plaintiffs’ counsel in other MDLs have no compunction about raising absurdly complex FDA-based liability theories.  The Zantac MDL is but one recent example of the other side’s digging deeply into FDA regulatory workings whenever it suits their purposes.  Their regulatory experts are often walking, talking “mini trials” in their own right.  Thus, we agree that, as to FDA evidence, “[t]he playing field can be leveled without a dramatic alteration of the overall contest.”  Hrymoc, 2021 WL 787039, at *17.

And of course plaintiffs’ counsel at the two trials engaged in their usual hijinks once the FDA gag rule was in effect.  Their “undue tactical advantage,” id. at *17, included arguing that pre-marketing clinical trials were “needed” and “required” – as if these cases involved PMA devices – while the defendants were prohibited from telling the jury that the FDA did not require such costly and time-consuming testing.  Id. at *15.  Moreover, “[t]he inherent unfairness of the situation [was] perhaps most pronounced in connection with the punitive damages aspect of these cases.”  Id. at *16.  Plaintiffs’ counsel “exhorted the jury to impose punitive damages to punish’ defendants so they would ‘do clinical studies.’”  Id. at *15.

Plaintiffs’ trial conduct made it particularly egregious to exclude an FDA document in which “the FDA reviewer who recommended 510(k) clearance for [one] device noted on the clearance form that ‘clinical data’ was not ‘necessary to support the review.’”  Id. at *17.  Hymoc recognized that the defendants had been forced by the FDA gag rule to litigate with one hand tied behind their backs.  “[D]efendants should have been permitted to try to counter [those arguments] 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.”  Id. at *15.

Thus, in future New Jersey trials involving §510(k) cleared medical devices, instead of “complete ban” on FDA evidence, Hrymoc encouraged trial judges to conduct preliminary proceedings under Rule 104 to consider such evidence judiciously.  Id. at *17.  Such hearings would allow:

a more in-depth exploration . . . of exactly what proofs and counterproofs 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.


There are various and sundry other rulings in Hrymoc that are not as helpful to defendants, see, id. at *18-23, but they are minor and case-specific compared to the court’s resounding rejection of the Pelvic Mesh FDA gag rule.  At least in New Jersey a serious, ongoing injustice has – albeit belatedly − been righted.

Full disclosure:  Reed Smith has been involved in this litigation representing both defendants.  Reed Smith has also been involved in Pelvic Mesh litigation generally.