Not long ago we pointed out, in our discussion of In re: Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp. ___, 2021 WL 2865869 (S.D. Fla. July 8, 2021), that court’s pithy takedown, in a preemption situation, of plaintiffs’ widespread habit of seizing upon some factual variation and calling it a new “duty” that had not yet been held preempted by prior case law. Zantac put the kibosh on this, pointing out that “mere fact patterns” are not new “duties:”
The Court rejects the Plaintiffs’ theory that “sub-duties” are cognizable (and divisible) legal duties, let alone the duties to be used for comparison in federal pre-emption analysis. . . . [T]hey do not fit within the required paradigm for pre-emption analysis.
Id. at *16-17. Bingo. Once duty to warn is held preempted (as held in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), for PMA medical devices, and in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), for generic drugs), it’s preempted, regardless of salami-slicing seeking to create claims for “warning-based design defect,” “failure to train,” “failure to test,” “failure to report,” “failure to supply medication guides,” “failure to conduct studies,” “failure to update,” and whatever other fact pattern plaintiffs dream up to disguise warning-based allegations as something other than the preempted warning claim they are.
We’ve also seen the same thing in design defect cases, which are also preempted by Riegel, for PMA devices, and by Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), for generic (and we would say all, id. at 477 (“whether generic or brand-name”)) drugs. Plaintiffs’ primary dodge has been an attempt to split the hitherto monolithic “design defect” claim into “pre-approval” and “post-approval” design defects. As have the better reasoned decisions, we’ve condemned that effort here, and in a number of other posts. It’s another transparent dodge, allowed only by courts with their own anti-preemption agendas, as we have yet to see any case drawing such a distinction in a non-preemption case.
This post is about the equally illegitimate offspring of both of the just-described trends, purported claims for “pre-approval” warning defects. We became aware of this latest attempt at a warning-based sub-duty reading the awful decision on this point in Stube v. Pfizer, Inc., 446 F. Supp.3d 424 (W.D. Ark. 2020). In response to a drugmaker’s implied preemption argument, Stube held:
Although defendants are correct in stating the labeling language must not deviate from that which was approved by the FDA, defendants still possessed the ability to implement stronger warning language into labeling by submitting stronger warning language for initial FDA approval.
Id. at 436-37 (citations and quotation marks omitted). The two cases Stube cited for this proposition are two of the most putrid cases in prescription drug preemption history, Holley v. Gilead Sciences, Inc., 379 F. Supp.3d 809, 826 (N.D. Cal. 2019), which we lambasted here and here for various sins, including being the worst trial-court level decision of the year. The other, and the one the originated the quote, is In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 60298, at *7 (W.D. La. Jan. 7, 2014). We didn’t discuss that particular decision, but we: (1) did nominate that particular MDL for ATRA’s first ever federal-court “judicial hellhole”; (2) pointed out that Actos procedural rulings were so universally viewed as unjust and prejudicial to defendants that they prompted change in the Federal Rules; and (3) slammed Actos MDL expert decisions as “a rare pentalogy of drecky decisions.” So it’s safe to say that the Actos first-ever allowance of a “pre-approval warning” claim was par for the course from an extreme pro-plaintiff judge who had no business ever running an MDL.
That’s the bad stuff.
On the sane end of the spectrum is the appellate case that Stube refused to follow – starting with In re Celexa & Lexapro Marketing & Sales Practice Litigation, 779 F.3d 34 (1st Cir. 2015). There, plaintiffs alleged “the FDA’s acceptance of the questionable data” in approving the warnings concerning a drug. Id. at 38. Because of that, plaintiffs alleged that the defendant’s labeling was defective ab initio. That claim was preempted because there was zero chance that “newly acquired information,” and thus the ability to change warnings unilaterally under the FDA’s “changes being effected” (CBE) regulation, could exist at the time of a drug’s initial FDA approval:
To the extent that the underlying policy issue is one of who decides whether and how a drug can be marketed, the line so drawn lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing the states to reach contrary conclusions when new information not considered by the FDA develops. The CBE regulation, too, covers virtually all situations in which new information indicates new or greater risks, or misleading claims of efficacy. By hinging preemption on the availability of that procedure in a particular case, [Levine] effectively reserves the launch of new drugs to the expertise of the FDA, but then preserves a wide scope for the states in requiring manufacturers to respond to information not considered by the FDA.
Id. at 41 (footnote omitted). Delimiting preemption in this fashion, made “pragmatic sense” to the First Circuit. Id. There was “no precedent” allowing CBE changes based on the evidence “known to the FDA at the time of approval.” Id. at 43.
Numerous other cases, however, are in accord with Celexa’s refusal to allow an unpreempted pre-approval warning claim. Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 660 (S.D.N.Y. 2017), aff’d, 919 F.3d 699 (2d Cir. 2019), which Stube clumsily attempted to distinguish without admitting it, was actually adverse, 446 F. Supp.3d at 437 n.7, in fact roundly rejected purported warning defects at the pre-FDA-approval stage. Reading Levine, Mensing, and Bartlett “holistically,” Utts concluded:
[F]ederal law preempts all pre-FDA approval failure to warn and design defect claims for branded prescription medication. . . . [B]rand name drug manufacturers lack the authority to alter a drug’s design or a label’s warnings at the time the NDA approval process concludes. State law claims that challenge labeling that FDA approved after being informed of the relevant risk are preempted.
251 F. Supp. at 660 (citations and quotation marks omitted).
In Mitchell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 5617473, at *4-5 (W.D. Tenn. Nov. 21, 2017), the court recognized that attacking a drug warning prior to FDA approval was preempted by the fact of FDA approval of the exact labeling:
[A]ny claim that Plaintiff has made against Defendant based on the alleged inadequacy of the initial FDA approved label fails as a matter of law because Defendant was required to use that label when it first marketed [the drug] and could not have changed the label after FDA approval based on alleged pre-launch data that was known to the FDA at the time of the approval. . . . The FDA’s premarket approval of a new drug application includes the approval of the exact text in the proposed label. . . . Thus, [the drug] would have been misbranded if, upon approval, Defendant had marketed [it] with labeling other than what the FDA approved. . . . Accordingly, Plaintiff’s allegation that [the drug] was unreasonably dangerous because of its labeling at the time it was first marketed on August 1, 2014, and the allegation that [defendant] should have provided a different label . . . on August 1, 2014, is preempted by federal law.
Id. at *4-5 (citations and quotation marks omitted). Other decisions reaching the same result concerning the same claims about the same drug are: McGee v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 1399237, at *4 (N.D. Ala. March 20, 2018) (“To the extent [plaintiff] asserts that [defendant] should have alerted the FDA about [the drug’s claimed] risk before [its] approval, the claim is preempted because the claim is essentially one of failure to communicate with the FDA. Federal law preempts state-law claims based on a defendant’s failure to communicate with the FDA.”); MacMurray v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 11496825, at *5-6 (D. Utah Dec. 6, 2017) (“To the extent that Plaintiff’s failure-to-warn claims are premised on the adequacy of the label as approved by the FDA when [the drug] was first marketed in the United States, they are preempted.”)
Similarly, In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761 (D.S.C. 2016), held that attacks on labeling statements that the FDA “specifically approved” was preempted. Id. at 669. Following Celexa, Lipitor confirmed that “any claim that a drug label should be changed based on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.” Id. See also Maze v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 1062387, at *3 (E.D. Tenn. March 6, 2019) (“any claim asserted by [plaintiff] and based on information known to the FDA as of [the date] − when the label at issue here was approved − is plainly preempted by federal law”); In re Genentech Herceptin (Trastuzumab) Marketing & Sales Practices Litigation, 2017 WL 9939631, at *4 (N.D. Okla. May 8, 2017) (“communications occurring prior to FDA approval are not relevant to impossibility preemption”); In re Plavix Product & Marketing Cases, 2017 WL 6812239, at *3 (Cal. Super. Dec. 1, 2017) (“an attack on the initial label is preempted”).
As recognized by the Supreme Court four times now (in Levine, Mensing, Bartlett, and Albrecht) there is only one way for a plaintiff to avoid preemption in a prescription drug case involving warning – to show “newly acquired information” such that the defendant could have unilaterally made the label change at issue under the FDA’s CBE regulation without the need to seek prior FDA approval. Otherwise, simultaneous compliance with federal and state law is impossible. Such newly acquired information evidence, by definition, cannot exist at the moment of FDA approval. Therefore, novel theories asserting some sort of separate claim for “pre-approval warning defect” are necessarily preempted.