We’ve finished reading through the New Jersey Supreme Court’s unanimous decision in Hrymoc v. Ethicon, Inc., ___ A.3d ___, 2023 WL 4714042 (N.J. July 25, 2023) (which should really be captioned “McGinnis” because plaintiff Hrymoc settled, see n.1).  The good – really good – news is that an abusively obtained nuclear ($68 million+) verdict goes bye-bye.  That alone is grounds for celebration.

Beyond that, however, much of the court’s rationale leaves us underwhelmed.  Hrymoc has a lot of “one-off” flavor about it, as it was tried under North Carolina law in late 2017.  That’s not likely to happen anymore because in 2018 the same court issued In re Accutane Litigation, 194 A.3d 503, 523 (N.J. 2018), holding (as discussed here) that New Jersey multi-county mass-tort litigation will henceforth be governed exclusively by New Jersey law, no matter where the plaintiff resided.  Id. at 523-24.  As to New Jersey – as opposed to North Carolina – law, Hrymoc is not particularly helpful.

Here’s what happened in Hrymoc.

From a bottom-line perspective, the most significant result was that evidence of the product’s 510(k) clearance was improperly excluded, requiring vacation of the verdict and a new trial. North Carolina law rejects strict liability altogether. Id. at *12. So do a number of other jurisdictions, including Pennsylvania in prescription medical product cases. In these states, product liability claims are brought as negligence actions based on the reasonableness of a defendant’s conduct, and a defendant’s compliance with applicable governmental standards is typically relevant evidence.  Hrymoc, 2023 WL 4714042, at *12-13.  See Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *6-7 (W.D.N.C. Sept. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law).

Moreover, the plaintiffs overreached.  At trial, plaintiffs not only attacked the defendant’s due care generally, they specifically assailed “the reasonableness of [the defendant’s] conduct in not performing clinical trials or studies.”  2023 WL 4714042, at *15, see id. at *6-7 (detailing the plaintiffs’ attacks and defendant’s objections).  It was thus “unfair for the trial court not to allow [defendant] to explain in response that it received 510(k) clearance to market the devices without clinical studies or trials.”  Id. at *15.  By thereby “exploit[ing] the pre-trial determination to exclude 510(k) evidence,” “plaintiffs ‘opened the door’ to the admission of 510(k) evidence, notwithstanding the trial court’s exclusion.”  Id. at *14-15. 

[I]n a products liability claim premised not only on principles of negligence, but particularly on the reasonableness of a manufacturer’s conduct in not performing clinical trials or studies, evidence of 510(k) clearance has significant probative value . . . that is not substantially outweighed by the risk of prejudice and potential juror confusion. . . .   [Defendant’s] compliance with the 510(k) process is an important piece of the evidentiary puzzle in this case because plaintiffs opened the door by arguing that [it] acted unreasonably in failing to conduct clinical trials or studies.

Id. at *15 (citations and quotation marks omitted) (emphasis original).  Because of how they chose to try their case, plaintiffs were entitled, not to exclusion, but only to a cautionary jury instruction.  Id. (“On balance, there is less risk here in permitting the jury to hear evidence of 510(k) clearance, as long as it is accompanied by an appropriate limiting instruction.”). So plaintiffs will not be able to hide the truth of FDA regulation from the jury on retrial, while misleading the jury, nor try the same trick in any other pelvic mesh case in New Jersey going forward. That’s something to cheer about.

For future cases, however, the most important holding is not so hot. In New Jersey, “510(k) evidence is generally inadmissible because the 510(k) clearance process solely determines substantial equivalency, and not safety and efficacy.”  Hrymoc, 2023 WL 4714042, at *4.  A lot of “ifs,” “ands,” and “buts” accompany that ruling, but given the Accutane choice of law ruling – which is of doubtful constitutionality, see Phillips Petroleum Co. v. Shutts, 472 U.S. 797, 823 (1985) (“Whatever practical reasons may have commended this rule . . ., we do not believe that it is consistent with the decisions of this Court.”) – medical device mass tort cases in New Jersey will be applying New Jersey law for the foreseeable future.

As to New Jersey law, which is being broadly applied after Accutane, the Hrymoc majority’s ruling was simply bad:

[T]he 510(k) process primarily focuses on equivalence; though the safety and effectiveness of a new device factors into the FDA’s 510(k) review, the analysis is comparative rather than independent.  In other words, there is no independent finding of the safety and effectiveness of a device during the 510(k) clearance process, only that a device is akin to an approved predicate device.

Id. at 11 (Lohr citation omitted).

This holding, as to New Jersey law in Hrymoc, was joined by only three of the five justices that sat on the case.  The other two concurred in the result (a new trial), but would have recognized §510(k) clearance as generally admissible, subject to cautionary jury instructions.  Id. at *22.  An unusually large contingent of three justices did not participate in the decision.

Hrymoc continued the trend, primarily in pelvic-mesh cases, of misapplying Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), outside of the (now obsolete) presumption against preemption context in which it occurred − making FDA compliance an all-or-nothing proposition in medical device cases.  Either FDA compliance is preemptive, and plaintiffs are out of court altogether (as is the case in PMA preemption cases), or it is not even admissible (in §510(k) device cases), with little if any middle ground.  As the concurrence pointed out, “most of” the exclusionary precedent in federal court “stem[s] from the rulings of one district court judge assigned to oversee the . . . multidistrict litigation,” which was “unfortunate[]” as it “has led to trial courts undervaluing, or indeed entirely discounting, the probative value of 510(k) evidence.”  Hrymoc, 2023 WL 4714042, at *19-20 (concurring opinion).

But, as mentioned above, another “if” now exists that can allow admission of §510(k) evidence, even in a New Jersey strict liability case.  If plaintiffs seek to make to make hay with purported lack of product testing, the defendant gets to explain that the §510(k) route to market does not require it.

A third way that the middle ground of admissibility, but not preemption, of FDA medical device compliance can be expanded to embrace §510(k) clearance as evidence is for plaintiffs to seek punitive damages.  Here, they did, and the jury awarded $35 million.  But first, Hrymoc effectively nullified a New Jersey statute in medical device cases.  Part of the state’s product liability act provides:

Punitive damages shall not be awarded if a . . . device . . . which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration . . . and was approved or licensed . . . pursuant to conditions established by the federal Food and Drug Administration and applicable regulations, including . . . labeling regulations.

N.J. Stat. §2A:58C-5(c).  Hrymoc held that, because §510(k) clearance “does not in any way denote official approval of the device,” this section of the statute has no effect – it “does not bar plaintiffs’ recovery of punitive damages.”  2023 WL 4714042, at *16.

That’s a terrible ruling.  Frankly, it’s dishonest.  This aspect of Hrymoc ignored altogether one of the express statutory terms – “licensed.”  A §510(k) device might not be “approved” by the FDA, but it is certainly “licensed” so that it can be marketed.  What did Hrymoc say about “licensed”? 

Nothing at all.  The majority simply ignored that aspect of the statute.

Moreover, by holding this section of the statute inapplicable in §510(k) cases, Hrymoc effectively nullified another statutory term:  “device.”  In pre-market approval cases, FDA compliance is controlling − a ground for preemption − so courts and juries never try those cases.  After Hrymoc’s holding that this section did not apply to §510(k) cases, there is no longer any type of “device” that the section protects by precluding plaintiffs from seeking punitive damages at trial.  Section 2A:58C-5(c) thus becomes a dead letter in medical device cases, despite legislature’s inclusion of statutory language expressly encompassing such cases.

However, Hrymoc does, at least, recognize that any kind of governmental compliance is necessarily relevant to punitive damages.

[T]he [punitive damages statute] explicitly mandates that the trier of fact consider “all relevant evidence” in determining whether punitive damages are to be awarded. That includes . . . the defendant’s state of mind.  When the 510(k) clearance process is pertinent to the defendant’s state of mind in marketing a device and will refute the plaintiffs contention that the defendant acted willfully or wantonly, 510(k) evidence is admissible in determining whether punitive damages should be awarded.

2023 WL 4714042, at *17 (citation omitted).  That’s a good ruling.  Section 510(k) evidence “would also be admissible . . . as relevant to whether [defendant’s] failure to do clinical trials or studies amounted to “actual malice” or “a wanton and willful disregard.” Id. (quotation marks omitted).  Any other result would be incongruous. Cf. Rivera v. Valley Hospital, Inc., 280 A.3d 299, 312-13 (N.J. 2022) (relying on FDA evidence to preclude punitive damages claim against healthcare providers, who aren’t even regulated by the FDA).

So this is the third way that §510(k) compliance can be admissible − under New Jersey law, but only if plaintiffs seek punitive damages.  This “if” also comes with a “but,” however.  “Evidence relevant only to the issue of punitive damages that was inadmissible in the first stage is admissible in the second stage.”  Id. at *16.  New Jersey law allows bifurcation of punitive damages at a defendant’s option.  Id. (citing N.J. Stat. § 2A:15-5.13(a)).  Going forward, if medical device defendants choose bifurcation in New Jersey, they face the prospect of losing the ability to admit evidence of FDA §510(k) compliance.

So, we’re pleased with Hrymoc to the extent that it vacated a nuclear verdict that the plaintiffs obtained by exploiting an improper evidentiary exclusion.  We’re also okay with the opinion recognizing several bases for §510(k) admissibility.  But beyond that, particularly considering the Accutane choice of law rule, don’t look for Hrymoc on our annual top ten list.