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As we discussed in our recent 50-state survey on failure-to-report claims, plaintiff-side allegations seeking to predicate “warning” liability on a defendant’s allegedly failing to comply with FDCA adverse event reporting claims are “relatively new.”  That’s because, like so many other novel claims we’ve seen lately, it’s a transparent dodge to avoid preemption.  We said there:

In the FDA context, the idea of a “reporting” cause of action for failure to warn is almost never seen outside of situations where a manufacturer’s traditional duty to warn is preempted by federal law.  We can count on our fingers the number of pre-preemption FDCA-based failure-to-report cases, and still have quite a few fingers left over.

In the latest development in the failure-to-report arena, the Second Circuit has certified the question whether Connecticut recognizes such a claim to the Connecticut Supreme Court:

Whether a cause of action exists under the negligence or failure-to-warn provisions of the Connecticut Product Liability Act, or elsewhere in Connecticut law, based on a manufacturer’s alleged failure to report adverse events to a regulator like the FDA following approval of the device, or to comply with a regulator’s post-approval requirements.

Glover v. Bausch & Lomb Inc., ___ F.4th ___, 2021 WL 3042364, at *12 (2d Cir. July 20, 2021) (citation omitted).

The court professed to do so out of an abundance of caution, pointing to Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), as a “cautionary tale.”  2021 WL 3042364, at *9:

The Ninth Circuit’s decision in Stengel is particularly illuminating in that regard. Several years after the Stengel court concluded that “Arizona law contemplate[d] a warning to a third party such as the FDA,” the Supreme Court of Arizona considered the issue and held that Arizona law in fact imposed no such duty to warn the FDA.

Id. (citations and quotation marks omitted).  We addressed this issue in depth in the Arizona entry of our 50-state survey.

The Second Circuit also criticized another of the cases we think (see, Mississippi in our survey) is particularly questionable, Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), for “not includ[ing] extensive discussions of whether the relevant state law provided a cause of action for failure to report adverse events to a regulator.”  2021 WL 3042364, at *8 (observing that Hughes merely “assum[ed] that a failure to warn claim may be pursued under Mississippi law without expressly addressing that issue”) (Hughes quotation omitted).

Since “neither party points to any binding Connecticut authorities on the question of whether manufacturers have a duty to warn a regulator,” id. at *8 Glover certified that question to the Connecticut Supreme Court.

We’re happy to offer our own analysis from our survey, since we believe that the Connecticut Supreme Court has actually dealt with this issue – in the child abuse context – and rejected any common-law failure-to-report claim beyond the scope of a specifically statutorily-authorized claim.


In Ward v. Greene, 839 A.2d 1259 (Conn. 2004), the Connecticut Supreme Court rejected a plaintiff’s attempt to create a tort-based duty “where a mandated reporter fails to report instances of suspected child abuse to designated officials or agencies.”  Id. at 1264.  The court found no merit in the plaintiff’s argument for a failure-to-report duty beyond what the child reporting statute allowed.  Id. at 1267.

[W]e conclude that the [statute] appears to be directed at the child, or children in the case of multiple children placed at risk in a singular incident, who should be the subject of a report of abuse or neglect under the statute and are, accordingly, in need of services.  The policy statement thus suggests that the legislature intended to focus on children who already have been exposed to conduct that amounts to a reportable event, and we do not find merit in the plaintiff’s argument that the statute creates a duty of care to every child who has been in the care of the defendant.

Id. at 1266-67.  Such a claim “depends on the intervening acts of administrative agencies and is, therefore, remote and speculative.”  Id. at 1270.  Therefore, “we cannot say that a mandated reporter owes a legally enforceable duty to children . . . where the benefit would depend entirely on the intervening acts of administrative agencies.”  Id. at 1271.  See also Lundstedt v. Deutsche Bank National Trust Co., 2016 WL 3101999, at *5 (D. Conn. June 2, 2016) (no failure-to-report claim under Bank Secrecy Act).

The same result was reached in Norman v. Bayer Corp., 2016 WL 4007547 (D. Conn. July 26, 2016):

A tort for failure to warn a victim exists under Connecticut law.  But this is a duty to the plaintiff herself, not to some third party, who might then report the danger to the plaintiff.  There is no general or background duty under Connecticut law to report risks to a regulatory body.

Id. at *4 (emphasis original).  Norman recognized the inapplicability of Restatement [(Second) of Torts §388 [1965] to this situation and criticized Stengel for attempting to analogize the two:

[I]t does not follow from this principle [Restatement §388, comment n] that defendants had a state-law duty to warn the FDA, a third party with no relationship to plaintiff.  The analogous party to the shop owner in [comment n] is plaintiff’s doctor − who had a direct relationship with plaintiff and provided the device − not the FDA.  Further, because of the FDA’s independence and bureaucratic process, defendants hardly would have had any “reasonable assurance” that the reported information would have reached plaintiff.  Absent the specific reporting requirements of the FDCA, no Connecticut court would have imposed a duty on defendants to report adverse events to the FDA, rather than alter the warning label or communicate with plaintiff and her doctor.

Id.  Accord Pratt v. Bayer Corp., 2020 WL 5749956, at *8 (D. Conn. Sept. 25, 2020) (“there is no general or background duty under Connecticut law to report risks to a regulatory body”) (quoting and following Norman); Doe v. Bausch & Lomb, 443 F. Supp.3d 259, 273 (D. Conn. 2020) (failure-to-report claim was “wholly derivative of the FDCA”; finding no “duty under Connecticut law that required the Defendants to warn or communicate adverse events to the FDA”) (following Norman); D’Addario v. Johnson & Johnson, 2020 WL 3546750, at *5 (D.N.J. June 30, 2020) (finding “no separate state law duty to warn the FDA”) (citation omitted) (applying Connecticut law); Simoneau v. Stryker Corp., 2014 WL 1289426, at *10 (D. Conn. March 31, 2014) (plaintiff “identifies no separate state law duty to warn the FDA”).  See also [In re Allergan Biocell Textured Breast Implant Products Liability Litigation], 2021 WL 1050910, at *29 [((D.N.J. March 19, 2021)] (following Norman).

We note that Doe v. Bausch & Lomb, 443 F. Supp.3d 259 (D. Conn. 2020), cited above, is the decision that was appealed in Glover, the plaintiffs having evidently abandoned their attempt to proceed pseudonymously.

In addition to failure to report, the Second Circuit certified a second question to the Connecticut Supreme Court, concerning whether the Connecticut product liability statute subsumes claims under Connecticut’s consumer protection statute.  The product liability statute states that it “shall be in lieu of all other claims against product sellers, including actions of negligence, strict liability and warranty, for harm caused by a product.”  Conn. Gen. Stat. Ann. §52-572n(a).  Despite alleging failure to warn and design defect claims, plaintiffs tried to shoehorn their consumer protection claims into an exception for improper promotion of non-defective products for “illegal purposes” recently created in Soto v. Bushmaster Firearms International, LLC, 202 A.3d 262, 295 (Conn. 2019).  For reasons that are less than clear, since every Connecticut case cited in Glover rejects “claim[s] based on an allegedly defective product” from being encompassed by the Soto decision, 2021 WL 3042364, at *10-11, and the claim is probably preempted in any event, id. at *9-10, the Second Circuit also certified that question:

Whether the Connecticut Product Liability Act’s exclusivity provision, bars a claim under the Connecticut Unfair Trade Practices Act, based on allegations that a manufacturer deceptively and aggressively marketed and promoted a product despite knowing that it presented a substantial risk of injury.

Id. at *12 (citations omitted).

Frankly, we don’t see either question as that unsettled to be deserving of certification − given the Connecticut precedent discussed above, and the lack of any caselaw extending Soto, in defiance of a strong exclusivity clause, to products that plaintiffs claim are defective − but since the undermanned panel (one judge died in the interim) decided to punt to the Connecticut Supreme Court, we’ll root for the defense to prevail there.