Roundup Preemption Decision Also Helps with FDCA

This post is not from the Bryan Cave side of the Blog.

The Third Circuit’s preemption decision in Schaffner v. Monsanto Corp., ___ F.4th ___, 2024 WL 3820973 (3d Cir. Aug. 15, 2024), is certainly a big deal in that litigation.  As observed in the Bloomberg story about the decision, carried in the August 19, 2024 edition of the Philadelphia Inquirer, Schaffner’s ruling that “federal regulation requires health warnings on pesticide labels to conform to those approved by the Environmental Protection Agency” creates a circuit split with other Roundup decisions that we’ve criticized:

The ruling potentially sets up the case for review by the U.S. Supreme Court.  In February, another federal appeals court in Atlanta rejected the German company’s argument that federal law preempts, or trumps, state law on what warnings must be posted on pesticides. The ruling creates a split among the federal appellate courts.

But there are other implications of the Schaffner decision that have received less attention, and involve prescription medical product liability litigation.  That’s what this post is about.

First, what is not in Schaffner?  Any mention of a presumption against preemption.  Not one word.  That shouldn’t be a shock.  After all the Supreme Court explicitly killed it in express preemption cases (which is the kind of preemption Schaffner employed, 2024 WL 3820973, at *7 n.8) in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115, 125 (2016).  But contrary to every other circuit court in the federal system, a footnote in Shuker v. Smith & Nephew, PLC, refused to take the Supreme Court at its word – refusing to inter the presumption in “matters of health and safety, such as . . . products liability claims.”  885 F.3d 760, 711 n.9 (3d Cir. 2018).  Schaffner also involved product liability claims, and the erstwhile presumption was nowhere to be found.  If anything, the opposite is true.  Where “uniformity” is one of the things Congress intended to achieve, preemption “best achieves [that] stated aim.”  2024 WL 3820973, at *21.

Second, Schaffner rejected the use of offensive non-mutual collateral estoppel in MDLs – something else we’ve criticized.  One of the adverse preemption decisions that Schaffner disagreed with arose in the context of the Roundup MDL.  Plaintiffs in Schaffner contended that the Third Circuit was bound to follow that decision due to collateral estoppel or “law of the case.”  Schaffner held otherwise.  Law of the case exists only in the context of the “same case.”  2024 WL 3820973, at *5.  The Supreme Court has held that individual MDL plaintiffs’ cases “retain their separate identities,” so an appellate decision in one MDL case had no effect on any other.  Id. (quoting Gelboim v. Bank of America Corp., 574 U.S. 405, 413 (2015)).  That ruling may help us, or hurt us, in any particular MDL, but given the widespread use of the law itself (preemption, public nuisance, other novel state-law theories, restrictive evidentiary rulings) as a settlement weapon in MDLs, on balance we favor that position.

Offensive, non-mutual collateral estoppel is even worse, and Schaffner refused to employ it to legal questions, such as preemption:

Applying issue preclusion to a pure question of law . . .  risks impeding a court from discharging its function of developing the law. . . .  [This] identifies an equitable factor that courts may consider in deciding whether to apply issue preclusion non-mutually. . . .  [W]e conclude that both circumstances requiring that the rule of preclusion should ordinarily be superseded are present.  The appellate courts to which appeals were taken . . ., the Court of Appeals for the Ninth Circuit and this Court −  have coordinate jurisdiction.  And the issue presented by this case, which is clearly of general interest, has yet to be decided by the highest court capable of resolving it − the United States Supreme Court.  We therefore . . . exercise[e] our broad discretion . . . [and] decline to apply issue preclusion and instead develop the law of express preemption . . . ourselves.

2024 WL 3820973, at *6 (citations and quotation marks omitted).

Third, while we have serious issues with “parallel requirements” as an express preemption test, given that it was merely dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), by now it is so deeply entrenched now that only the Supreme Court could change it.  Schaffner applied such a test, 2024 WL 3820973, at *7, and did so in a defense friendly fashion.  The Third Circuit recognized that the FDCA “closely echo[s] the language employed by FIFRA’s preemption provision.”  Id. at *13.  Both use the operative phrases “in addition to” and “different from” to define the state “requirements” that are preempted, only in different order.  Id.  “Like pesticides, medical devices must be reviewed and approved before being marketed, and once approved they cannot be modified unless the proposed modification is itself reviewed and approved.”  Id.

[Riegel’s] conclusions and reasoning shed light on whether, in general, a “requirement” exists within the meaning of a similar preemption provision, such as FIFRA’s, where an agency reviews regulated products for safety before they may be marketed, then prohibits modifications of those products absent an additional safety review.

Id.  In Schaffner, the cancer warning plaintiffs advocated would have changed an agency-approved “precautionary statement” (that is, a warning), and thus could not escape preemption as a “minor” modification.  2024 WL 3820973, at *10.  In both the FIFRA and FDCA regulatory schemes, only minor modifications can be made without prior agency pre-approval.

Fourth, Schaffner held that the entire panoply of agency regulatory decisions – not just the broad, vague provision of the FIFRA statute’s “misbranding” provision – apply in the determination of what is expressly preempted.  As was unsuccessfully attempted in Schaffner, prescription medical product plaintiffs often try to use the FDCA’s equally broad and vague misbranding or adulteration provisions, standing alone, to avoid preemption.  Schaffner said no.

If [federal] regulations specifically identify the contents required to be included on a pesticide label, a state-law requirement is preempted unless it is equivalent to that specific regulatory requirement.  The state-law duty cannot survive preemption simply because its standard of liability is equivalent to the broad statutory definition of misbranding.

2024 WL 3820973, at *15.  Where agency regulations and approvals have “give[n] content to [statutory] misbranding standards,” then “any equivalence between the state-law duty and the statutory definition of misbranding does not prevent the preemption of state law.”  Id.

Fifth, in PMA preemption cases, one of the pitched battles that plaintiffs and defendants fight in almost every case, is whether claimed violations of non-specific FDA manufacturing practice regulations, that could be read to require different things in different cases, are sufficient to state parallel claims.  The same problem arose in the FIFRA context in Schaffner, and the Third Circuit resolved it in favor of preempting non-specific violation claims.  “If state-law duties to warn can survive preemption so long as they are equivalent to . . . broad” enactments, then “[s]tate-law duties framed in these vague and broad terms would produce considerable heterogeneity.”  Id. at 17.  Preemption is necessary because “different factfinders deciding different individual cases might reasonably disagree about whether a particular warning was necessary to protect health.”  Id.  That’s exactly the problem posed by purported FDCA parallel violation claims predicated on vague FDA CGMPs.  Now, in the closely analogous FIFRA context, Schaffner has resolved the same issue in favor of allowing only specific violation claims to escape preemption.  The claim in Schaffner was “preempted because of the specific requirement imposed through” the product’s approval process, “which prohibits the modification of [the] Label without further [regulatory] approval.”  Id. at *19.

Sixth, and finally, Schaffner held that “force of law” was not a prerequisite to express preemption.  2024 WL 3820973, at *20.  That requirement originated in Wyeth v. Levine, 555 U.S. 555 (2009).  But Levine “did not interpret a statutory provision that expressly preempted state law” – only  “the distinct doctrine of implied preemption.”  2024 WL 3820973, at *20.  Where Congress has imposed preemption expressly, the preemption provision itself supplies the requisite preemptive effect:

[W]hen Congress has expressly authorized the preemption of state law by statute, the meaning of the express-preemption provision triggers preemption.  [A court’s] role when confronted with an express-preemption provision is to apply the text that embodies Congress’s decision. . . .  [A]s Congress has decreed in the text of that provision that federal “requirements” have preemptive force, no further analysis is necessary.

Id. (citations and quotation marks omitted).

Just as the aviation preemption decision in Sikkelee v. Precision Airmotive Corp., 907 F.3d 701, 707 (3d Cir. 2018), disposed of the contention that Pennsylvania law allowed product liability claims based on failure to report adverse events to a federal agency, these six points in Schaffner should, by analogy, control in express preemption cases involving FDA-regulated medical devices and over-the-counter drugs.  Defense counsel practicing in Third Circuit district courts should definitely study the Schaffner decision.