Photo of Andrew Tauber

A relatively short post about Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law.

The plaintiff received a vena cava filter manufactured by the defendant. Surgically implanted in the vena cava vein, the filter is designed to reduce the risk of pulmonary embolism, a potentially dangerous condition caused by blood clots. According to the plaintiff, he suffered bodily injury when filter shifted after implantation. He sued, alleging that the manufacture had not adequately warned of that danger.

The district court dismissed the failure-to-warn claim under New Jersey law and the Third Circuit affirmed on that basis in a brief per curiam decision.

The court explained that under New Jersey law, “‘[i]f the warning’” at issue was “‘given in connection with a [device] has been approved or prescribed by the [FDA],’” then there is “‘a rebuttable presumption … that the warning or instruction is adequate.’” 2022 WL 1261318, at *1 (quoting N.J. Stat. Ann. § 2A:58C-4). The court further explained that, “[t]o overcome this presumption,” which has been called the “compliance presumption, “a plaintiff must plead specific facts alleging ‘deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process[.]’” Id. (quoting Cornett v. Johnson & Johnson, 48 A.3d 1041, 1056 (N.J. 2012), abrogated on other grounds by McCarrell v. Hoffmann-La Roche, Inc., 153 A.3d 207 (N.J. 2017)).

Employing a two-step analysis, the court “agree[d] with the District Court that [the plaintiff failed to state a claim because the warnings provided by [the manufacturer] in connection with the [device] were adequate as a matter of law.” 2022 WL 1261318, at *2. First, finding it “undisputed that the [device at issue] is subject to FDA oversight,” the court held that the manufacturer’s warnings were “subject to the ‘super-presumption’ in [N.J. Stat. Ann.] § 2A:58C-4.” Id. Second, the court “concluded that [the plaintiff] failed to plead facts sufficient to rebut the presumption” because he did “not allege that [the manufacturer] deliberately concealed or withheld known harmful effects associated with the [device], or that [the manufacturer] manipulated the post-market regulatory process.” Id. Because the plaintiff failed to overcome the presumption, the court held that he had failed to state a failure-to-warn claim under New Jersey law.

That is clearly the correct outcome under New Jersey law. We have no complaints as to the result.

We do, however, have reservations about N.J. Stat. Ann. § 2A:58C-4, the statute that yielded the result.

Do not misunderstand, the presumption established by the statute is not only appropriate but also helpful. As we observed before, the presumption makes it much harder for medical-device and prescription-drug plaintiffs to plead and ultimately prove a failure-to-warn claims in New Jersey. No complaints on that score. Anything to reduce the burden of typically meritless claims is welcome.

But consider how the presumption is rebutted—by pleading, and ultimately presenting evidence of, “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process.” N.J. Stat. Ann. § 2A:58C-4. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability. But state-law claims that rest on alleged fraud on the FDA are 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).

The Fifth and Sixth Circuits have some understanding of this, having respectively held in Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012), and Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), that provisions allowing the rebuttal of a compliance presumption based on alleged fraud on the FDA are preempted unless the FDA itself finds fraud. We don’t think that goes far enough, but at least those courts recognize that Buckman preempts rebuttal provisions in at least some circumstances. The same cannot be said of the Second Circuit, which reached the contrary—and erroneous—conclusion in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by an equally divided court sub nom. Warner-Lambert Co., LLC v. Kent, 552 U.S. 440 (2008)).

We’ll take what we can get, but we are entitled to more when it comes to the preemption of rebuttal provisions.