As we demonstrated in a post back in 2013, FDA compliance evidence generally − and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically – had for decades been admissible evidence in product liability litigation involving FDA-regulated drugs and devices.  In 2013 we found a half dozen §510k cases directly on point. Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1047 (D. Minn. 2013); Placencia v. I-Flow Corp., 2012 WL 5877624, at *6 (D. Ariz. Nov. 20, 2012); Musgrave v. Breg, Inc., 2011 WL 4620767 (S.D. Ohio Oct. 3, 2011); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. Apr. 18, 2012); Miller v. Stryker Instruments, 2012 WL 1718825, at *9 (D. Ariz. Mar. 29, 2012); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 658 (E.D. Pa. 1995); Strum v. Depuy Orthopaedics, Inc., 2013 WL 3184765, at *1 (Ill. Cir. March 8, 2013).

Then, in the Mesh litigation, rulings began to change the law on the premise that, because the United States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had held that §510k clearance was not preemptive – that is, not entitling a defendant to judgment as a matter of law – it was not even relevant in product liability litigation.  This argument turned on taking a phrase from Lohr out of context:  “[T]he 510(k) process is focused on equivalence, not safety” (id. at 493) and applying it in the evidence context.  As we had pointed out, so doing was contrary to the Supreme Court’s Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), decision holding that §510(k) clearance was intended “to ensure . . . that medical devices are reasonably safe and effective.” Id. at 349-50.  Our more recent blogposts have pointed out:  (1) that the FDA now considers §510k clearance to involve considerations of safety and effectiveness, and that (for a variety of reasons) the continued viability of Lohr itself is open to question.

Nonetheless, defendants in mesh litigation have largely been deprived of well-established FDA compliance evidence, and based on the capacious abuse of discretion standard applicable to evidentiary decisions at trial, such rulings have been upheld on appeal. See Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1317-18 (11th Cir. 2017) (discussed here); In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Systems Products Liability Litigation, 810 F.3d 913, 921-22 (4th Cir. 2016) (discussed here) (“Cisson”); but see Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (rejecting MDL rulings and admitting §510k clearance evidence in mesh case).

Yesterday, however another MDL judge considered the admissibility of §510k evidence, and held it admissible, flatly rejecting the Mesh decisions.  See In re Bard IVC Filters Products Liability Litigation, 2018 WL 582542 (D. Ariz. Jan. 29, 2018).  In IVC Filters, Judge David Campbell allowed the defendant’s “FDA defense,” ruling that the jury should be allowed to hear about §510k devices’ FDA pedigree.  Id. at *2.  Such evidence was doubly relevant under relevant state law:

  • “Georgia courts have adopted a risk-utility analysis for design defect claims. . . . One of the many factors a jury may consider in its reasonableness determination is the manufacturer’s compliance with federal regulations.” Id. at *2 (citation omitted).
  • “The evidence is also relevant to Plaintiff’s punitive damages claim. Under Georgia law, . . . [c]ompliance with federal regulations is not sufficient to preclude an award of punitive damages, but it is probative.” Id.

Coincidentally, Cisson also purported to interpret Georgia law, but reached a diametrically opposite conclusion.

IVC Filters rejected the false equivalence between preemption and relevance, and Mesh courts’ misapplication of Lohr:

Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence, not device safety.  [Lohr citation omitted]  But this does not render evidence of the 510(k) process irrelevant to the reasonableness of [defendant’s] conduct.  The FDA grants 510(k) clearance only where the device “is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii).  The 510(k) process may not speak directly to the applicable standard of care . . ., but it does have probative value in the determination of this action.

Id. at *2 (citation omitted).  See also Id. at *3 n.2 (a preemption decision does “not address[] any evidentiary issue” and even as to preemption “the 510(k) process can in some circumstances preempt state law claims”) (citations omitted).

The excuses given for exclusion in Cisson, the jury giving clearance undue weight and a possible “mini-trial” regarding compliance, could “be adequately addressed without excluding relevant evidence to the detriment of Defendants.”  Id. at *3.  Reasonable “time limits” for each side’s evidence would prevent FDA issues from devolving into any “mini-trial.”  Id. at *4.  On the merits:

Both sides, through appropriate expert testimony or other admissible evidence, will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices such as IVC filters, and [defendant’s] participation in the 510(k) process and its compliance (or lack thereof) with that process.

Id.  “[A]ny potential confusion” did not require exclusion, but only “a limiting instruction regarding the nature of the 510(k) process.”  Id. Indeed, IVC Filters correctly observed that the issue of jury confusion more likely cuts the other way – in favor of admission of FDA evidence:

[T]he absence of any evidence regarding the 510(k) process would run the risk of confusing the jury as well.  Many of the relevant events in this case occurred in the context of FDA 510(k) review, and much of the evidence is best understood in that context. Attempting to remove any references to the FDA from the trial would risk creating a misleading, incomplete, and confusing picture for the jury.

Id.  “[I]f the evidence was half-baked, containing some references to the FDA but not explaining what role the FDA played with respect to the [IVC] filters, the jury would be left to speculate about the FDA’s involvement and conclusions.”  Id.

Until IVC Filters, we had feared that a single mass tort, under a discretionary standard of review and with the unwillingness of appellate courts to require MDL do-overs, could tilt the evidentiary playing field towards what IVC Filters cogently described as “a misleading, incomplete, and confusing picture for the jury” that excluded §510k clearance evidence that previously been admissible almost as a matter of course.  Now our side has a clearly articulated and compelling opposing view to argue.