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Several weeks ago, we reported on Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), in which the Third Circuit affirmed dismissal of a failure-to-warn claim because the plaintiff had failed to allege facts sufficient to overcome New Jersey’s “compliance presumption,” a statutory presumption (adopted by numerous states) under which a medical product’s warnings are presumptively adequate if those warnings were approved by the FDA. Today’s post is a follow-up to that post.

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. We explained that the exception is contrary to Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), which concluded that fraud-on-the-FDA claims are impliedly preempted because they “inevitably conflict” with the FDA’s regulatory discretion under 21 U.S.C. § 337(a).

Today’s post focuses not on the exception to the compliance presumption but on the antecedent issue of when the presumption applies.

As an astute reader of the blog, Blank Rome’s Terry Henry, noted that Greisberg applied the presumption to a 510(k) device, i.e., a device that had received premarket clearance rather than premarket approval. The court held that the presumption applied because it was “undisputed that the [device] is subject to FDA oversight.” 2022 WL 1261318, at *2.

Application of the compliance presumption to a 510(k) device is notable because certain other courts have refused to apply it to 510(k) devices. This unfortunate tendency can be seen in the pelvic-mesh litigation, where the MDL court and several transferor courts rejected application of the compliance presumption, and excluded evidence of 510(k) clearance, on the factually erroneous ground that the 510(k) process “is focused on” the device’s “equivalency” to a prior device “and not safety.” Kaiser v. Johnson & Johnson, 2018 WL 1358407, at *3 (N.D. Ind. 2018), aff’d, 947 F.3d 996 (7th Cir. 2020).

That oft repeated error “all starts with Medtronic, Inc. v. Lohr, 518 U.S. 470, 492 (1996).” Kaiser, 2018 WL 1358407, at *3. Looking at what was already then an outdated version of the 510(k) process, Lohr found that claims challenging the safety of devices cleared through the 510(k) process are not preempted by 21 U.S.C. § 360k(a) because, said the court, unlike devices that receive premarket approval under 21 U.S.C. § 360e, devices cleared through the 510(k) process “have never been formally reviewed for safety or efficacy.” Lohr, 518 U.S. at 493. Pointing to this language, various courts have held various states’ variously worded compliance presumptions “inapplicable” to 510(k) devices. Hackney v. Bos. Sci. Corp., 2016 WL 2343891, at *4 (S.D.W. Va. 2016).

As we have previously explained, even if Lohr accurately described the 510(k) process in place prior to 1990, it does not accurately describe the 510(k) process since then. In 1990, Congress enacted the Safe Medical Devices Act of 1990 (“SMDA”), Pub. L. 01-629, 104 Stat 4511 (Nov. 28, 1990). Since at least then, the 510(k) process, like the PMA process, has been designed “to provide reasonable assurance of safety and effectiveness.” 21 U.S.C. § 360c(f)(2)(A)(v).

Although issued in 1996, Lohr was decided under the pre-1990 regime because the FDA had cleared the device at issue in 1982 (see Lohr v. Medtronic, Inc., 56 F.3d 1335, 1340 (11th Cir. 1995), aff’d in part, rev’d in part, 518 U.S. 470 (1996)), or eight years before enactment of the SMDA. Thus, although it recognized the SMDA’s enactment (see 518 U.S. 480 n.4), Lohr neither described nor analyzed the new 510(k) process that it established.

Thus, the proposition that compliance presumptions do not apply to 510(k) devices, and that evidence of compliance with the 510(k) process is excludable, because the 510(k) process is purportedly “focused on equivalency and not safety” (Kaiser, 2018 WL 1358407, at *3) rests on an abrogated statutory provision that has not been in force for over three decades.

Antiquated when written, Lohr’s characterization of the 510(k) process has long outlived its statutory foundation. A disturbing number of courts quote Lohr but fail to recognize its factual predicate, and thus fail to appreciate that what it says about the 510(k) process does not control cases involving devices cleared since 1990.

Fortunately, there also are cases like Greisberg, the case we reported on several weeks ago, that do not hesitate to apply a state compliance presumption to 510(k) device. We are aware of three other cases applying state compliance statutes to 510(k) devices. In Vicente v. Johnson & Johnson, 2020 WL 7586907, at *13 (D.N.J. 2020), the court applied New Jersey’s presumption to dismiss a failure-to-warn claim where the plaintiff “alleged no facts” sufficient to overcome the presumption. In Seavey v. Globus Med., Inc., 2014 WL 1876957, *10 (D.N.J. 2014), the court applied the New Jersey presumption when granting summary judgment on a failure-to-warn claim, finding that the plaintiff had “not produced evidence sufficient to hurdle the presumption of adequacy accompanying warning labels approved by the FDA.” And in Heath v. C.R. Bard Inc., 2021 WL 3172315, at *6 (M.D. Tenn. 2021), the court denied the defendant manufacturer summary judgment but held that ultimately it “may be able to establish that it is entitled to a presumption in its favor” under Tennessee law.

We would like to track cases such as these. If you are aware of others, please let us know.

In the meantime, make sure courts understand that Lohr has nothing to say about the current 510(k) process.