A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues.
In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court dismissed as preempted a complaint concerning vision loss from defective intraocular lenses implanted during cataract surgery. Plaintiff developed “Z syndrome,” permanently impairing her vision, and sued the manufacturer under the Connecticut Product Liability Act (CPLA) for failing to warn. She alleged the defendant had failed to report prior Z Syndrome cases to the FDA, as required by the Federal Food, Drug, and Cosmetic Act (FDCA).
On appeal, the Second Circuit ruled that preemption depended on a question of Connecticut law for which there was no controlling precedent – whether traditional state law that predated the FDCA recognized a claim for failure to report adverse events to a regulator. It certified that state law question to the state court.
Only the Second Circuit did not frame the question that way. Under Buckman Co. v. Plaintiffs Steering Committee, 531 U.S. 341, 352-53 (2001), a parallel state law claim is one “based on traditional state tort law which … predated the federal enactments in question.” Whether a duty to report to a regulatory body is deemed justified by state policy and precedent in 2022 is not the question. Parallel claims, by Buckman’s definition, are recognized, not created. Accordingly, the question certified – whether a state cause of action “exists” for failure to report adverse events to a regulator – was misguided from the jump.
Explaining that the question of preemption was not before it, the Connecticut court proceeded to answer the certified question, as framed, in the affirmative. 343 Conn. 513, 519 (2022). But its analysis demonstrates that the Court was deciding the question as a matter of first impression. The court cited no case law predating the FDCA, and for the first time construed the provisions of the CPLA that the manufacturer is required to devise warnings “to communicate with the person best able to take or recommend precautions against the potential harm” (General Statutes §52-572q(d) (emphasis added)) to encompass a duty to provide adverse event reports to a regulator.
The framing error could have been overcome with an even-handed analysis of the question. But the court’s opinion is rife with result-oriented, question-begging superficial generalities, and falls short on incisive analysis. The court first observed that the CPLA and its legislative history did not “clearly and unambiguously” include a claim for failure to report. Consequently, the court supported the duty by invoking, at a high level of generality, “fundamental polic[ies] of the law.”
Not surprisingly, all “policy” roads were deemed to lead to liability.
- Manufacturers are normally expected to take all reasonable steps to transmit safety information to the person best situated to assure safe use. Yes, under the learned intermediary doctrine that person is ordinarily the prescribing doctor, but it is not exclusively the doctor. Rather, where there are “upstream obstructions to the flow of information about the known dangers of the product” that person could be a regulator.
- Public policy favors providing healthcare providers with “accurate, current and complete information” about risks of medical devices.
- Considering whether adopting a duty would result in “increased litigation,” the court dismissively noted that failure to warn litigation generally “is already a familiar feature of the Connecticut legal landscape” and there was no policy reason to exempt litigation against medical devices.
Like any self-respecting supreme court eyeing the imposition of a new tort duty, the court then examined the case law in other jurisdictions. But again, the analysis was quintessentially result-oriented. In support of a duty, the court identified decisions from ten federal district courts and three intermediate state courts of appeal. Five of those decisions were concededly or arguably inconsistent with other decisions in the same jurisdiction. Two were decisions authorizing a failure to report as evidence supporting a failure to warn claim, not a freestanding failure to report cause of action. One relied on a now discredited Ninth Circuit decision (Stengel, discussed here). Objectively, not a persuasive body of authority.
In contrast, the numerous federal and sister state decisions finding no duty to report adverse events to the FDA were deemed “unpersuasive.” In particular, the court discounted these opinions to the extent their analyses were “intertwined” with the issue of federal preemption, because preemption was not before the Connecticut court – even though the court also independently noted the obvious, that the duty and preemption issues are, in fact, intertwined.
Ultimately, the court found the pro-duty cases more persuasive because their analyses were “generally consistent with ours” and with the broad remedial purpose of the CPLA.
For better or worse (worse, we think), Connecticut tort law now includes an actionable duty to report adverse event reports to the FDA. But given the Connecticut Supreme Court’s “totality of the circumstances” analysis, reliance on broad policy considerations, and failure to cite any prior Connecticut case law evidencing an existing duty, it is apparent that it announced a new rule of state law, rather than locate a traditional state tort rule that predated the FDCA. Accordingly, whatever its merit, the decision should not avoid preemption.
Nevertheless, the Second Circuit recently read the opinion as confirming a failure to report cause of action was “rooted in traditional Connecticut tort law.” It did not substantively address whether the duty “predated” the FDCA. And the Second Circuit rejected the argument that the CPLA cause of action was derived from the FDCA, notwithstanding the Connecticut court’s acknowledgment that “it is obviously true that Connecticut law would not impose a duty on a manufacturer of a medical device to report adverse events associated with the device to the FDA in the absence of [the FDCA requirement].” 43 F.4th 304, 307 (2d Cir. 2022). That should have been preemption game over.
In the end, Glover stands as an example of the importance of accurately framing the issue and adjusting one’s analytical lens to the proper level of specificity, and of the unfortunate consequences of blurring preemption analysis.
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