Plaintiffs in (mostly) prescription drug cases have tried, with decreasing success, to limit the scope of implied impossibility preemption under the Mensing/Bartlett line of supreme court precedent to generic drugs. It's not a particularly satisfying rationale, but the simple claim that "those were generic drug cases" did at least convince some courts that really wanted to be convinced. In response to that, we highlighted (among other things) Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 702-03 (3d Cir. 2016), which applied Mensing/Bartlett preemption principles outside of the FDCA context altogether – to a product liability case involving an airplane crash.

The proposition is that of course implied impossibility preemption principles, as enunciated by Mensing and Bartlett, apply to non-generic drugs. Implied preemption principles are not governed by any particular statutory scheme, so not only does Mensing/Bartlett preemption apply to all aspects of the FDCA, they apply to any statutory scheme presenting similar federal/state conflict issues.

Well, now we have another example of a fortiori application. The same impossibility preemption rationale, based mostly on Bartlett, applied recently to a case that didn't even involve product liability, but rather banking. See Anderson v. Wells Fargo Bank, N.A., 2019 WL 4773972 (D.S.D. Sept. 30, 2019). Anderson involved purported wrongful discharge claims by certain bank employees based on those employees' past criminal records. Here is the conflict:

A federal statute . . . requires [defendant] to investigate an individual's criminal history before hiring them. [Defendant] may not hire individuals convicted of certain offenses without [prior agency] consent.

Id. at *1 (citations omitted). Plaintiffs all had disqualifying convictions that they did not disclose and that were missed in an earlier, less comprehensive background check. Id. at *2. Once a better database became available, defendant rescreened plaintiffs (with their consent). The rescreening revealed the disqualifying convictions, and as required by federal statute, plaintiffs were discharged. Id.

Plaintiffs' suit for supposed "fraudulent" termination ran headlong into preemption under Bartlett.

State law is "impliedly pre-empted where it is impossible for a private party to comply with both state and federal requirements." Plaintiffs here assert [defendant] should not have fired them when it became clear they were . . . ineligible. . . . If the court concluded plaintiffs' state law liability claims were not preempted, [defendant] would be confronted with an impossible choice: face potential federal liability under . . . for employing ineligible individuals or face state law liability for "fraudulently" terminating employees. [The federal statute] "prohibited [defendant] from taking the remedial action required to avoid liability under" plaintiffs' theory of the case.

Anderson, 2019 WL 4773972, at *6 (two Bartlett citations omitted). Because defendant "cannot comply both with [federal law] and with the state law fraud statutes as plaintiffs construe them" the claims in Anderson were preempted. Id.

While the statute provided an exception if prior agency consent was obtained, such consent had not been sought, and after the fact that pre-approval requirement. Defendant "did not have an option to suspend plaintiffs' employment to allow them to obtain a waiver." Id. at *7. The case thus presented a classic Mensing/Bartlett impossibility preemption situation, where immediately applicable common-law claims had to give way in the face of mandatory pre-approval by a government agency. There was no "general fraud exception" to impossibility preemption. Id. ("Plaintiffs do not cite any authority for a more general fraud exception to preemption law and the court is aware of none.").

Our non-generic prescription drug preemption cheat sheet demonstrates that plaintiffs have been increasingly unsuccessful in their attempts to cabin Mensing/Bartlett preemption to generic drugs only. That is as it should be. Since implied preemption principles apply to all federal regulations, even banking, a fortiori Mensing/Bartlett preemption applies to other parts of the FDCA.

This article is presented for informational purposes only and is not intended to constitute legal advice.