Law

According to Black's Law Dictionary, "a fortiori" is legal Latin meaning:

By even greater force of logic; even more so it follows .

We've been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), were first decided that − because they apply implied impossibility preemption − the principles that these cases enunciate are equally applicable to non-generic drug products, such as branded drugs and §510k-cleared medical devices.  Some cases have agreed with us.  You can find those (at least as to innovator drugs) on our post-Levine drug preemption cheat sheet.

The contrary cases, and there are a number of them, largely refuse to evaluate implied preemption on its merits.  Instead, they state that innovator drugs/§510k medical devices are "not generic drugs" and leave it at that.  E.g., Shipley v. Forest Laboratories, Inc., 2015 WL 4199739, at *9 (D. Utah July 13, 2015); In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 WL 3557392, at *10-11 (N.D. Tex. July 18, 2014); In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 60298, at *8 (W.D. La. Jan. 7, 2014).  Occasionally a court gets into more detail, and the result is really hard to follow.  For example, Mullins v. Ethicon, Inc., ___ F. Supp.3d ___, 2015 WL 7761033 (S.D.W. Va. Dec. 2, 2015), gets off on the wrong track by holding the express preemption analysis in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), "directly applicable" to implied impossibility preemption.  Mullins, 2015 WL 7761033, at *5.  Cf. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001) ("neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles") (citation and quotation marks omitted).  Then Mullins invoked the "uniqueness" of generic drugs to reject preemption of design claims even though it was undisputed that the FDA would have to approve a supplement before the design change could be implemented:

The impossibility in Mensing arose from the unique "duty of sameness" imposed on generic drugs, which has no corollary in the medical device context. . . .  The Supreme Court has cited Mensing in two subsequent majority opinions, but has nowhere referred to "special permission and assistance" in a preemption analysis. . . .  In Mensing, there was no official regulatory process by which a generic could change its label, so the generic manufacturer was "barred" from taking the action state law required.  This is completely different from the defendants' situation . . . [where] [t]he law simply requires that manufacturers making a "significant change" submit another 510(k) notification, which the FDA will clear if  making a "significant change" submit another 510(k) notification, which the FDA will clear if it determines the device is substantially equivalent to a device already on the market.

Mullins, 2015 WL 7761033, at *5-6 (citations omitted).

Mullins and similar cases, however, do not accurately describe either Mensing or Bartlett.

What Mensing really held was this:

If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. . . .  Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.

*          *          *          *

The question for "impossibility" is whether the private party could independently do under federal law what state law requires of it.

131 S. Ct. at 2578-79.

What Bartlett really stated was that it was equally "impossible" to comply with an immediate state-law duty to change a design where FDA pre-approval was required, because "[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes."  Id. at 2471.  The manufacturer could not "independently chang[e]" its product, "[t]hus, federal law prohibited [defendant] from taking the remedial action required to avoid liability under [state] law."  Id. at 2476.  "When federal law forbids an action that state law requires, the state law without effect."  Id. at 2477 (citation and quotation marks omitted).

However, it's getting harder for courts to stick their fingers in their ears and chant "not generic, not generic, not generic" in response to preemption arguments based on agency pre-approval arguments.  As we've already chronicled, two courts of appeals have previously made the easiest jump – the one mentioned in Bartlett – and have applied Mensing/Bartlett impossibility preemption to innovator drugs.  See Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F. 3d 281 (6th Cir. 2015); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015).

Now there are three, and the latest is the most a fortiori of the lot.

The Third Circuit has applied the Mensing/Bartlett impossibility preemption rationale outside of the FDCA altogether, to preemption of design defect claims involving airplanes.  Sikkelee v. Precision Airmotive Corp., ___ F.3d ___, 2016 WL 1567236 (3d Cir. April 19, 2016).  Since the Mensing/Bartlett preemption rationale can apply to a completely different statutory scheme – a fortiori it applies to other FDCA-governed and FDA-regulated products such as innovator drugs and §510k medical devices.

After rejecting a field preemption argument under the Federal Aviation Act (something with no FDCA-related analogy), Sikkelee turned to impossibility preemption:

In addition to field preemption, federal law may supersede state law through conflict preemption.  This occurs when a state law conflicts with federal law such that compliance with both state and federal regulations is impossible[.]  PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577 (2011).

Sikkelee, 2016 WL 1567236, at *5.

Skikelee held that Mensing/Bartlett impossibility preemption would preempt "analogous" design defect claims that FAA regulations classified as "major" and thereby must be approved by the FAA before being implemented:

[W]hen confronting an analogous preapproval scheme for pharmaceutical labeling, the Supreme Court has held that, where manufacturers are unable to simultaneously comply with both federal and state requirements, state law design defect claims are conflict preempted. . . .  [citing Mensing and Bartlett].  Before a new drug may legally be distributed in the United States, both its contents and its labeling must be preapproved by the FDA. . . .  [C]laims against generic drug manufacturers cannot survive a conflict preemption analysis because the generic manufacturers are bound by federal law to directly mimic their brand-name counterparts.  [citing Mensing and Bartlett].  Ultimately, where a party cannot "independently do under federal law what state law requires of it," the state law is conflict preempted.  [citing Mensing].

Sikkelee, 2016 WL 1567236, at *18 (emphasis added) (various citations and footnote omitted).

There's that "independent" action implied preemption principle again.

That principle – that mandatory agency action prior to approval equals impossibility preemption − applies equally to airplanes subject to FAA pre-approval design requirements for "major" design changes:

The same considerations apply to the case before us.  The FAA's preapproval process for specifications . . . precludes a manufacturer from making at least "major changes" to a design aspect without further preapproval, means a manufacturer may well find it impossible to simultaneously comply with both [FAA] specifications and a separate − and perhaps more stringent − state tort duty.  Thus, there may be cases where a manufacturer's compliance with both the [FAA] and a state law standard of care "is a physical impossibility". . . .  In such cases, the state law claim would be conflict preempted.  For, even if an alternative design aspect would improve safety, the mere "possibility" that the FAA would approve a hypothetical application for an alteration does not make it possible to comply with both federal and state requirements: As the Supreme Court observed in [Mensing], if that were enough, conflict preemption would be "all but meaningless."

Sikkelee, 2016 WL 1567236, at *19 (emphasis added) (various citations and footnote omitted).

But what about Lohr?  Sikkelee addressed the difference between express and implied preemption as well:

Together these cases [Lohr and Riegel] reflect a narrow, rather than sweeping, approach to analyzing the preemptive contours of a federal premarket approval scheme. . . .  Here, confronted with a similarly exhaustive preapproval process governing aircraft manufacture and design and no express preemption clause, we see no justification for going further than the Supreme Court elected to go in Riegel or Lohr. . . .

Sikkelee, 2016 WL 1567236, at *19.  Therefore, while there was no "field" preemption of product liability claims under the FAA, there could be implied preemption of particular design claims where prior FAA approval precluded immediate adoption of a plaintiff's supposedly safer design under state law.

We thus read Riegel not to bestow field preemptive effect on [aircraft designs], but rather to counsel in favor of narrowly construing the effect of federal regulations on state law − much like the conflict preemption analysis undertaken in Bartlett and [Mensing].

Id.

As a last gasp, the plaintiffs in Sikkelee criticized the quality of FAA oversight, much as our opponents have criticized the FDA.  Once again, the Third Circuit recognized that the two situations were analogous:

This very same argument, however, was raised in Bartlett and failed to carry the day.  While the dissenters decried that granting "manufacturers of products that require preapproval . . . de facto immunity from design-defect liability" would force the public "to rely exclusively on imperfect federal agencies with limited resources," the majority held that because generic drug manufacturers are required to directly mirror the preapproved labels of their brand-name counterparts and are thus "prohibited from making any unilateral changes" to their labels, state law design defect claims were foreclosed by "a straightforward application of pre-emption law". . . .  Thus, the reasoning of the Bartlett majority, and the consideration we must give to the FAA's views under separation of powers principles, lead us to conclude that the FAA's preapproval process for aircraft component part designs must be accorded due weight under a conflict preemption analysis.

Sikkelee, 2016 WL 1567236, at *23 (emphasis added) (citations omitted).  Thus, while there is no field preemption of product liability claims under the FAA, like there isn't under the FDCA, design claims remain "subject to traditional conflict preemption principles."  Id.

While not accepting the defendants' field preemption arguments, Sikkelee is a resounding reaffirmance of the universality of implied conflict preemption principles.  Since Mensing/Bartlett impossibility preemption applies to airplanes – governed by a totally separate statutory scheme – "by even greater force of logic" those same principles must apply to other FDA-regulated products, such as innovator drugs and §510k medical devices, whenever plaintiffs contend that some state-law duty forces these products' manufacturers to make an immediate product alteration that, under the FDCA, requires prior FDA approval.