Today, the Tenth Circuit affirmed in part, reversed in part, and remanded the post-Levine branded drug preemption decision in Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017). You can read our discussion of the district court opinion in Cerveny here.

While any decision with a description of “affirmed in part, reversed in part, and remanded” is necessarily something of a mixed bag, we’re pleased to report that the defense side won the two most important preemption issues presented in Cerveny (preemptive effect of FDA citizen’s petition denials and of FDA “no evidence” determinations, the court dodged the third (the judge/jury issue from Fosamax), and did its reversing and remanding on issues that could still eventually be preempted, but that it thought the district court had paid insufficient attention.

Cerveny was a birth defect case, and the plaintiff’s major claim was that she took the drug before becoming pregnant. Slip op. at 2, 13 (all “parties agree that [plaintiff mother] took [the drug] before she became pregnant, but not afterward”). Plaintiff made a secondary claim – about warnings of risks that the plaintiff did not actually encounter – that if a warning the FDA had actually proposed, concerning the possibility of birth defects during pregnancy, had been included, she wouldn’t ever have taken the drug, even though she never actually took it during pregnancy. Id. at 3-4. As we recently discussed in our Smoke Screens & Side Shows post, the law overwhelmingly rejects warning claims based on risks that the plaintiff never actually encountered.

The first theory was the important one, and the Tenth Circuit affirmed preemption:

The ruling was correct on [plaintiffs’] first theory, for the undisputed evidence shows that the FDA would not have approved a warning about taking [the drug] before pregnancy.

Slip op. at 4. As for the second, stay tuned, we’ll discuss it in the order the opinion addressed the claims.

The “clear evidence” required by Wyeth v. Levine, 555 U.S. 555 (2009), existed as to plaintiffs’ before-pregnancy theory because that issue was directly presented to the FDA prior to the injuries claimed in Cerveny by a citizen’s petition that the FDA rejected for lack of evidence. Thus Cerveny presented the same “changes being effected” exception to FDA pre-approval of warning changes situation as had Levine. However, “even when this exception applies, the FDA will ultimately approve the label change only if it is based on reasonable evidence of an association.” Cerveny, slip op. at 7-8 (regulatory citation omitted).

Plaintiffs first tried to argue that there could never be preemption in branded drug warning cases, claiming that Levine’s “discussion of the “clear evidence” standard [w]as dicta.” Id. at 11. That Hail Mary pass went nowhere:

[O]ur court has relied on Levine in holding that a state tort claim is preempted if a pharmaceutical company presents clear evidence that the FDA would have rejected an effort to strengthen the label’s warnings. Thus, we must apply the “clear evidence” test.

Id. at 11-12 (citing Dobbs v. Wyeth Pharmaceuticals, 606 F.3d 1269 (10th Cir. 2010)).

Next, as this blog has discussed, while Cerveny was pending, the Third Circuit decided In re Fosamax Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), including its precedent-shattering holding that the “what the FDA might have done” question posed by Levine “clear evidence” preemption wasn’t a question of law after all. Id. at 286-89. Plaintiffs in Cerveny had not argued that proposition, but once Fosamax was decided, they belatedly tried to raise it. The Tenth Circuit was not inclined to go there.

[Plaintiffs] insist that we should adopt the Third Circuit’s approach and deny summary judgment if “no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected” the proposed label. We are reticent to take this approach, for the parties’ appeal briefs do not address this issue.

Cerveny, slip op. at 11-12. Ultimately, though, Fosamax didn’t matter because even assuming that its standard applied, preemption barred plaintiffs’ before-pregnancy warning claim.

The court first looked at the direct regulatory history of the drug, and FDA consideration of teratologically-related warnings. Not enough, the court held:

[The drug’s] regulatory history is similar to Phenergan’s [the drug in Levine]. Like Phenergan, [this drug] had appeared on the market for decades before [plaintiff mother] took [it]. And [defendant] has intermittently corresponded with the FDA about [the drug’s] labels. . . . Likewise, the FDA’s approval of [the drug’s] labels suggests only that the FDA knew about potential issues involving pre-pregnancy use . . . not that the FDA would have rejected a stronger warning if one had been proposed.

Cerveny, slip op. at 17. So, if that was all the regulatory history, the defendant would have lost. – but it wasn’t.

Enter the citizen’s petition.

A plaintiff’s lawyer brought a citizen’s petition seeking to force the FDA to add a pre-pregnancy birth defect warning to the drug after the use at issue in Cerveny. Id. at 14 & n.8, 18-19. That petition was denied in 2009 (the use in Cerveny occurred in 1992). Id. at 19. Critically, the FDA denied that petition for lack of scientific basis – using the same regulatory standard of proof applicable if the manufacturer had sought the same change.

The FDA concluded that . . . “the scientific literature [did] not justify ordering changes to the labeling that warn of such risks beyond those presently included in labeling”. . . . [Petitioner] sought reconsideration, which he twice supplemented with more information. The FDA declined to reconsider, explaining that the original denial had “appropriately applied the standards in the [FDCA].

Cerveny, slip op. at 19.

The petition denial satisfied Levine’s “clear evidence” standard. Plaintiffs’ “failure-to-warn claims are based on the same theories and scientific evidence presented in [the] citizen petition.” Id.

Cerveny rejected plaintiffs’ argument that citizen’s petitions shouldn’t count. First, label changes are serious business. “[T]he FDA views overwarnings as problematic because they can render the warnings useless and discourage use of beneficial medications.” Id. at 20. Second, “the FDA standard for revising a warning label does not discriminate between proposals submitted by manufacturers and proposals submitted by citizens.” Id. at 21 (regulatory citation omitted). Arguments that the FDA nonetheless differentiated between manufacturers and independent petitioners didn’t hold water:

[Plaintiffs] suggest that the FDA disobeys its own regulations to apply different standards depending on the source of the proposed change. But we do not presume that the FDA deviates from regulatory requirements.

* * * *

[plaintiffs] hypothesize that the FDA would be more receptive to a manufacturer’s request to strengthen a warning than to a citizen’s effort to compel a stronger warning. But a factual dispute cannot be based on speculation that the FDA would jettison its legal requirements and rubber-stamp [defendant’s] hypothetical proposal notwithstanding the risk of overwarning.

Under the same standard for manufacturer-initiated changes, the FDA rejected a citizen petition containing arguments virtually identical to [plaintiffs’]. We will not assume that the FDA would have scuttled its own regulatory standard if [defendant] had requested the new warning. Thus, we reject [plaintiff’s] challenge to [defendant’s] reliance on [the] citizen petition.

Id. at 21, 23 (citations and alternative explanations for FDA conduct omitted). Third, even under a Fosamax standard, the FDA’s rejection of the citizen’s petition was a “smoking gun” that “foreclose[d] any reasonable juror from finding that the FDA would have approved” the label change advocated by plaintiffs. Id. at 23 n.11.

Thus a no-evidence rejection of a comparable warning change was preemptive. There was no “bright-line rule” that such a rejection was insufficient to constitute “clear evidence” satisfying Levine. Thus, Cerveny rejected contrary cases, including one that we have criticized – slip op. at 25-27 (rejecting Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015), Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F. Supp.2d 1125, 1133 (D. Minn. 2011), and Forst v. Smithkline Beecham Corp., 639 F. Supp.2d 948, 954 (E.D. Wis. 2009)) − and distinguished others. Slip op. at 24-25, 27 (distinguishing Mason v. SmithKline Beecham Corp., 596 F.3d 387, 396 (7th Cir. 2010), Koho v. Forest Laboratories, Inc., 17 F. Supp.3d 1109, 1117 (W.D. Wash. 2014), Dorsett v. Sandoz, Inc., 699 F. Supp.2d 1142, 1158-59 (C.D. Cal. 2010), and Hunt v. McNeil Consumer Healthcare, 6 F. Supp.3d 694, 700-01 (E.D. La. 2014)). Critically, Cerveny distinguished Mason because there, the petition “had been rejected before the plaintiff’s injury.” Cerveny, slip op. at 24 (emphasis original). The “bright line” were interested in – that an FDA insufficient-evidence rejection after a plaintiff’s injury is necessarily preemptive, since even less evidence would have existed at any earlier time – remains intact in Cerveny.

Finally, some clarity for the “clear evidence” standard.

However, the court reversed dismissal of the plaintiffs’ weaker claim, that if they had received a stronger warning about a birth-defect risk existing only during pregnancy, they wouldn’t have taken the drug at all (even before pregnancy) and thus the injury wouldn’t have occurred. As to that risk, they could point to a label change proposed (but not required) by the FDA. Slip op. at 28-29. That proposal “d[id] not suggest that the FDA would have approved a warning about taking [the drug] prior to pregnancy,” id. at 29, and thus did not affect preemption of plaintiff’s pre-pregnancy claims. Id.

Plaintiffs’ pre-pregnancy claim is exactly the sort of attenuated allegation that we addressed at length in our Smoke Screens & Side Shows post – that the plaintiff mother “would not have taken [the drug], even pre-pregnancy, if [defendant] had used the FDA’s proposed wording” about post-pregnancy risks. Id. at 32. The problem on appeal in Cerveny was that dismissal had been sought from, and granted by, the trial court solely on preemption grounds, whereas (as our post demonstrates) the best defense was that remote causation claims did not exist under state law. Id. at 34.

The Tenth Circuit cut plaintiffs a break. Even though the district court had pointed out that it “would be a nonsensical result if a plaintiff could avoid a preemption defense by arguing that a drug label could have been strengthened in any form, regardless of its relevance to the plaintiff’s case,” id. at 34 (quoting Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203, 1220 (D. Utah 2016)), the appellate court decided that wasn’t enough to affirm dismissal on non-preemption grounds.

In sum, the district court did not consider whether it could rest on Utah law when deciding a summary judgment motion that had relied solely on federal preemption. Because the district court did not consider this question and it has not been fully briefed on appeal, we leave this question for the district court to address on remand.

Cerveny, slip op. at 36. So much for affirming on any ground. Strange things happen in tort preemption cases. At least the blog’s already done some of the defendant’s research (although we didn’t find any Utah cases, unfortunately).

The last bit was the disposition of plaintiffs’ fraud, misrepresentation, and implied warranty claims. The district court had dismissed them as just preempted warning claims under different names. Id. at 37. Again the court cut the plaintiffs a break, holding that any preemption dismissal needed to address those claims separately:

[W]e reverse and remand the award of summary judgment on the claims of fraud, negligent misrepresentation, and breach of an implied warranty. We do not foreclose the possibility that these claims might be preempted. But on remand, the district court should explain the effect of preemption on th[os]e claims.

Id. at 38. Finally, the Tenth Circuit held that plaintiffs were not entitled to additional discovery before preemption was decided. Id. at 38-41. At least, on remand, the defendant won’t be forced to incur additional discovery costs before teeing up preemption again.

Although not every claim was held preempted on appeal, in our books Cerveny is a significant defense win. It finds “clear evidence” as a matter of law to preempt the plaintiffs’ main claim. It holds that citizen’s petition denials are as preemptive as any other form of FDA decisionmaking. It affirms the importance of overwarning, and thus that an inadequate-information FDA label change preempts all prior claims where there can be no claim of additional information being discovered in the interim.

We wonder whether plaintiffs will appeal. There is now a direct conflict between Cerveny (a court of appeals) and Reckis (a state high court) on FDA citizen’s petition denials being “clear evidence” under Levine. We’ve thought from day one that Levine was appallingly reasoned and should be reconsidered, and maybe this is the vehicle. We also think that Justice Gorsuch, a textualist, won’t put much stock in the Reckis (and plaintiffs’ in Cerveny) rationale that the identical FDA standard doesn’t mean the same thing depending on who is submitting a proposed label change.

Do plaintiffs roll the dice?