Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues. Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon. Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility. Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). It wasn’t. Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.” Id. at *2. Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

Louisiana’s product liability statute codifies the common causation defense that the “learned intermediary” was actually “learned.” See La. Stat. §9:2800.57(B). There is thus no duty to warn the “user or handler of the product [who] already knows or reasonably should be expected to know of the characteristic of the product.” Id. Plaintiff in Vesoulis didn’t even attempt to argue otherwise. Instead, plaintiff asserted an FDCA-based negligence per se claim.

Basing negligence per se on a purported FDCA violation in Vesoulis got nowhere under Louisiana law. The uncontested LPLA statutory defense eliminated any state-law basis for a “warning” claim. 2022 WL 989465, at *4 (the device falls within the protections of [the LPLA] and therefore [defendant] is not liable for failure to warn under Louisiana law”). That left only a naked FDCA violation, which ran afoul of there being “no private right of action to sue for violations of the FDCA.” Id. at *4. With no state-law warning claim left, there was nothing for plaintiff’s supposed “parallel” claim to parallel:

[F]ederal law does not necessarily preempt “state-law causes of actions that parallel [FDCA] requirements,” [but] it does preempt “claims [that] exist solely by virtue of … [those] requirements.” . . . [T]he court below correctly held that [the device] falls within . . . §9:2800.57(B) and therefore is not liable for failure to warn under Louisiana law. [Plaintiff’s claim] that [the device] violated the FDCA and associated regulations runs headlong into the holdings of Buckman and subsequent cases on preemption.

Id. (Buckman citations and footnote omitted). So Vesoulis is the odd PMA-approved device case that turns on implied, rather than express, preemption.

Finally, the appellate disposition of the informed consent claim against the surgeon provides a useful analogy – because under the learned intermediary rule, a manufacturer’s duty to warn is owed solely to the treating physician. Vesoulis rejected the plaintiff’s contention that the written consent form he signed did not include a statistical presentation of the risk at issue. Instead “Louisiana law does not require that specific risk percentages be disclosed to patients in order to obtain their informed consent.” Id. at *3 (citation omitted).

Louisiana’s informed-consent standard has never, to our knowledge, been held to require such fine-grained information; on the contrary, it seems sufficient that the consent form warned of death and accurately noted that such a complication was “very rare.” [Plaintiff] has identified no Louisiana decisions holding that a physician must disclose the specific number of adverse events that have occurred as a result of a procedure.

Id. Whether the risk was “less than 1 in 10,000” or “38 in 10,000” did not matter since even the higher risk was below the one-half-of-one-percent (.5%) threshold “possibility of a correctable complication” that Louisiana courts have held “would not be a determining factor to a reasonable patient.” Id. (citation omitted).

Since informed consent is essentially a failure to warn claim asserted against a physician, we think that Vesoulis is also a useful addition to the caselaw holding that, in prescription medical product liability litigation, risk statistics are not a sine qua non of an “adequate” warning. See, in addition to the cases discussed in our previous post, Amos v. Biogen Idec, Inc., 249 F. Supp.3d 690, 698 (W.D.N.Y. 2017) (“Even without additional information regarding specific risk factors, the warnings for [the drug] clearly, directly, and unequivocally informed treating physicians of the increased risk”); Ocasio v. C.R. Bard, Inc., 2015 WL 3496062, at *5 (M.D. Fla. June 3, 2015) (rejecting argument “that the IFU was inadequate because [defendant] should have additionally provided quantitative comparative failure rates”); Gentile v. Biogen Idec, Inc., 2016 WL 4128159 at *7 (Mass. Super. July 25, 2016) (same result as Amos) (applying New York law).

So, yes, Vesoulis is an admirable win, even if the court did not deign to publish the decision.