If a court acknowledges that no state or federal appellate courts in the jurisdiction have addressed the question before it, we think at a minimum there also should be an acknowledgement of the Erie doctrine. Yet, in the case of Fogel v. Sorin Group USA, Inc., 2018 WL 4680022 (S.D.N.Y. Sep. 28, 2018) you get the former without the latter. Fogel is one of our least favorite types of decisions, one that claims to be a prediction of state law but instead over reaches to create new liability where it did not previously exist. That is not the job of federal courts interpreting state law.
Under the Erie doctrine, in the words of the Supreme Court:
[a] federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.
Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975). And, not surprisingly, the Second Circuit agrees. See Runner v. New York Stock Exchange, Inc., 568 F.3d 383 (2d Cir. 2009) (“our role as a federal court sitting in diversity is not to adopt innovative theories that may distort established state law”). But Fogel disregarded Erie and then disregarded that New York has not recognized a failure to warn claim based on failure to report adverse events to the FDA.
Here are the facts. Defendant manufacturers a heart valve that underwent pre-market approval by the FDA. Fogel at *1. Plaintiff’s child underwent surgery in which her pulmonary heart valve was replaced with defendant’s valve. Two years later, the valve failed and plaintiff’s child had to undergo revision surgery during which complications occurred that caused permanent injuries. Id. at *2.
In deciding defendant’s motion to dismiss, the court found several of plaintiff’s claims were preempted. A fraud allegation that defendant concealed information from the FDA during the PMA process was preempted under Buckman as fraud-on-the-FDA. Id. at *4. Design defect was preempted under Riegel because the valve’s design was approved by the FDA and any challenge to that design would impose state law requirements that are “different from or in addition to” FDA requirements. Id. Manufacturing defect failed because plaintiff “failed to plausibly allege a manufacturing defect that violated FDA requirements.” Id. at *5. A conclusory allegation of a deviation was insufficient.
That leaves failure to warn – where the decision goes astray. As with Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc) and Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the Fogel court recognizes that a traditional state law failure to warn claim must be preempted under Riegel. “To the extent Plaintiff claim[s] that the [device’s] warning label was inadequate . . ., like the design-defect claim, must fail because the warning was approved by the FDA.” Fogel at *5. That should be the end of the story. Because “any attempt to predicate the  claim on an alleged state law duty to warn doctors directly would have been expressly preempted.” Stengel, 704 F.3d at 1234. So let’s call failure-to-report claims what they really are – a sidestep around preemption. Frankly, they shouldn’t even get that far because what they really are are attempts at private enforcement of FDA reporting requirements which should be impliedly preempted under Buckman and 21 U.S.C. § 337(a).
That’s certainly the case in New York where a failure-to-report claim has not been recognized under state law. In fact, had the district court engaged in an Erie analysis it would have found that in other contexts New York has actually rejected state-law tort claims predicated on failure to report something to a governmental body. See Heidt v. Rome Memorial Hospital, 724 N.Y.S.2d 139, 787 (N.Y. App. Div. 2007) (“Plaintiff has cited no authority to support the proposition that a physician has a common-law duty to report actual child abuse, let alone suspected child abuse. There are good reasons for the absence of such a duty.”); Diana G-D v. Bedford Central School Dist., 932 N.Y.S.2d 316, 329 (N.Y. Sup. 2011), aff’d, 961 N.Y.S.2d 305 (N.Y. App. Div. 2013) (“there is simply no evidence that defendants’ failure to make such a report was knowingly and willful,” which was required for civil liability under child abuse reporting statute); In re Agape Litigation, 681 F. Supp.2d 352, 360-61 (S.D.N.Y. 2010) (rejecting private cause of action premised on federal reporting requirements in Bank Secrecy Act). A more fulsome discussion of these analogous cases in other states can be found in our post here.
District courts faced with an undecided state law question are not allowed to create liability where it did not previously exist. It was not the district court’s job to expand New York’s duty to warn the medical community to include the FDA.
The federal requirements require that adverse events and other reports be made to the FDA. While New York law may require manufacturers to warn the medical profession, that is not the same as a duty to report to the FDA.
Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188, 201 (E.D.N.Y. 2015)(rejecting failure-to-report claims as preempted and not valid under NY law). So, under existing New York law, failure to warn physicians imposes an obligation different from and in addition to the FDA’s requirement to report adverse events. Making the claim both preempted as non-parallel and as purely FDCA-based.