Two of longest recent entries in our Post-Levine Drug/Vaccine Preemption Cheat Sheet are Pradaxa wins. Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., slip op., 2020 WL 1704646 (Conn. Super. March 13, 2020) (#106), and Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (Mag. W.D. Mo. March 16, 2020) (#108). There’s also a third recent decision, Ridings v. Maurice, 2019 WL 8223599 (W.D. Mo. Oct. 20, 2019) (which we’ll call “Ridings 0”), that was a procedural precursor to the more recent Ridings opinion. Between them, these recent Pradaxa wins provide some useful guidance about how to approach branded prescription drug preemption motions in the new post-Albrecht, “matter of law” world. We’ll go through them in order.
Note: many of the factual rulings in these cases are similar (sometimes identical) to a Pradaxa decision we already blogged about last September, Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452 (Conn. Super. Sept. 11, 2019) (#96). Today, we’re mining these opinions for more broadly applicable propositions, so this post won’t go into nearly the item-by-item detail that our Roberto post did.
In Ridings 0, the court had to reconsider a prior decision that had held preemption of the plaintiff’s warning claims to be a jury question due to disputed issues of fact. 2019 WL 8223599, at *1-2 (discussing Ridings v. Maurice, 2019 WL 4888910 (W.D. Mo. Aug. 12, 2019)). The court recognized the obvious – that the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), required those disputed issues to be decided by the court. Ridings 0, 2019 WL 8223599, at *2 (“To the extent that the Court’s order mandat[es] the submission of the preemption question to the jury, it is contrary to Albrecht.”). Thus, the court had to create a process for undertaking the preemption analysis.
For those of you who might be making similar procedural suggestions, here’s what the Ridings 0 court came up with:
- Since “fact-finding” was involved, the decision would not be made solely on the summary judgment record.
- Rather, the court set a preemption hearing at which “witnesses (including expert witnesses)” would be examined and “factual determinations based on credibility and persuasiveness” would be made.
- The hearing would “require two stages of analysis,” with a shifting burden of proof.
- “First, [plaintiff] must show that ‘newly acquired information’ existed such that [defendant] could unilaterally change its label in accordance with the CBE regulation.”
- Second, if plaintiff established newly acquired information, the defendant “may still establish an impossibility preemption defense by presenting “clear evidence” that the FDA would have rejected the labeling change.”
2019 WL 8223599, at *2-3.
This process led the Ridings court to conclude all of the plaintiff’s warning claims were preempted. Ridings, 2020 WL 1264178, at *23 (“all of [plaintiff’s] remaining claims are preempted by federal law”). But before we get to the preemption analysis, here are a few more procedural steps that Ridings took:
- “To keep the hearing focused on the actual issue in the case, the Court thus required [plaintiff] to specifically identify the warning (or warnings) that he believed should have been given by [defendant].” Id. at *4.
This requirement is significant, since plaintiffs love for their warning claims to be a constantly moving target. Consider it a collateral benefit of preemption.
- Because “it was not the usual practice to ask a party to prove a negative, . . . the best practice was to view the question of preemption in drug litigation as involving a shifting burden.” Id.
- First, the “defendant must make an initial prima facie showing of preemption for the warning it did provide.” This step was undisputed, since “the warning label for [the drug] in effect at the time [plaintiff] was using [it] had been approved by the FDA.” Id.
- Once the defendant puts preemption at issue, “a plaintiff then bears the burden of coming forward with evidence sufficient to conclude that the defendant could and should have availed itself of the [CBE] regulation and given a different warning.” Id.
- If plaintiff establishes the prerequisites to application of the CBE regulation, then “the defendant then bears the burden of coming forward with ‘clear evidence’ that the FDA – even if presented with such ‘new’ evidence – nonetheless would have rejected the warning(s) advocated by the plaintiff.” Id.
- The hearing was conducted in accordance with “the standards associated with bench trials.” Id.
- Following the hearing, “the parties submitted their respective proposed findings of fact and conclusions of law.” Id.
Ridings, 2020 WL 1264178, at *4. So if a post-Albrecht court asks “what now” in response to a preemption motion, the Ridings litigation provides a road map for how to get from here (motion filed) to there (hopefully, dismissal).
The substantive preemption portion of Ridings is 35 pages (18 Westlaw star pages) long. Here are some highlights that we find useful for defendants pursuing implied impossibility preemption in a post-Albrecht world.
- In general, “under Mensing and similar cases, federal law preempts any state law claim requiring a drug manufacturer to change its labeling” subject to “limited opportunities [for] a drug manufacturer to unilaterally change a drug label that can, in some cases, effectively undercut any claim of impossibility.” Ridings, 2020 WL 1264178, at Id. *12.
- “[T]he determination of preemption will often require the Court to make factual determinations based on competing and contradictory evidence.” Id. at *14 n.27.
- “[T]he issue of ‘newly acquired information,’ [requires that] the Court consider whether there is adequate proof that [defendant] was in possession of such information, and that such information was reasonable evidence of an association of a serious hazard with [the drug] sufficient to require [defendant] to unilaterally revise its label to include a warning.” Id. at *15.
- “[N]ewly acquired information must provide reasonable evidence of a causal association of a clinically significant adverse reaction linked to a drug. A clinically significant adverse reaction has a significant impact on therapeutic decision-making, such as a risk that is potentially fatal or otherwise serious.” Id. (regulatory citations and quotation marks omitted) (emphasis original).
This is another point that warrants emphasis. In some situations, the requirement of a “clinically significant” risk can be of critical importance.
- The FDA’s requirement that “there must be sufficient evidence of a causal association between the drug and the information sought to be added” enforces the Agency’s objective of preventing overwarning. Id. (citation and quotation marks omitted) (emphasis original).
- “[S]tudies concluding that it ‘remains unknown’ whether a drug is linked to a particular adverse reaction or risk or that ‘further studies are required to address possible clinical consequences’ do not constitute reasonable or well-grounded scientific evidence of ‘clinically significant adverse effects’ under the CBE regulation.” Id.
That’s another ruling with broad importance, since these kind of tentative studies are frequently all plaintiffs have in prescription drug product liability litigation.
- While “it is clear that newly acquired information may encompass a new analysis of old data . . . studies published after a plaintiff’s injury are not relevant to constitute newly acquired information.” Id. (citations and quotation marks omitted).
- “[A] claim that a drug label should be changed based solely on the 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. at *16 (citation and quotation marks omitted).
- “[W]arnings approved for a foreign label are not in and of themselves newly acquired evidence when they are based on consideration of substantially similar information. Foreign drug labeling is the product of different and distinct regulatory standards and decisions.” Id. at *17.
- [R]ejection of bad ideas is as important to the process as the confirmation and embracing of good ideas. [A withdrawn patent] was a bad idea that simply did not pan out. It does not constitute newly acquired evidence under the CBE regulation.” at *18.
- An article concluding “that there is no single . . . optimal benefit-risk [point] for all patients . . . does not establish any “risks of a different type or greater severity or frequency.” Id. at *20 (citation, footnote, and quotation marks omitted).
- “[P]reliminary discussions do not provide reliable evidence of new risks. They are essentially uncorroborated trial balloons.” Id.
We think that Ridings is thus brimming with favorable points and usable quotes. In particular, we recommend the holdings that articles concluding only “we’re not sure” and “conduct more research” and “preliminary discussions” are all too tentative to be newly acquired information, and thus insufficient to prevent preemption are important, since so much of the other side’s arguments are based on taking precisely this sort of material out of context.
Finally, Ridings took a stab at “clear evidence” as an alternative holding. Even though the defendant hadn’t submitted to the FDA the language that plaintiff claimed was necessary to have an adequate warning, Ridings found “clear evidence” that the FDA would not have allowed it. Ridings, 2020 WL 1264178 at *21. As we’ve pointed out elsewhere, plaintiffs now claim that Albrecht requires actual submission and rejection of a warning proposal for “clear evidence” to exist. Not so – at least on the well-developed regulatory record in Ridings:
[T]he Court wishes to be clear – it should not always be the case that simple inaction by the FDA in light of submitted data will always be “clear evidence” that the FDA would reject a particular warning. In this case, however, in light of the known issues and the ongoing give-and-take between [defendant] and the FDA on these issues . . . the FDA’s continued inaction does represent clear evidence under these facts.
Id. (emphasis original).
The other major recent Pradaxa opinion is Adkins, 2020 WL 1704646, decided by the same judge who issued Roberto. As we would expect, Adkins does a lot of quoting from and citing to Roberto. However, Adkins also adds some independently useful points. First, Adkins rejects the plaintiff’s argument that, by only addressing the “clear evidence” prong of impossibility preemption, Albrecht impliedly eliminated all other bases for preemption. Not at all:
The plaintiff claims that in this context a “state law claim is preempted only when there is ‘clear evidence’ that the FDA would not have approved a change to the drug’s label.” . . . This statement . . . is not correct. There are actually two theories of preemption. . . . The first, or threshold, theory addresses whether the pharmaceutical company had authority under federal law to change the label on its own to conform to the plaintiff’s state law demands. If it did not, then it would also be impossible for the company to comply with state law.
Adkins, 2020 WL 1704646, at *2 (footnote omitted). Plaintiff’s warning claims must navigate the “lengthy and complex” CBE regulation, of which “newly acquired information” is “the key component.” Id. at *3 & n.4. Albrecht didn’t have to address the requirements that the FDA wrote into its CBE regulation because the defendant in that case “conceded that the FDA’s CBE regulation would have permitted [it] to try to change the label.” Id. at *4 (quoting Albrecht). Further, a plaintiff cannot simply declare ex cathedra the s/he has “newly acquired information” – the “basic adversary nature of our judicial system” affords defendants the right to dispute plaintiffs’ claims of purportedly newly acquired information. Id. at *4 n.6.
Also, after Albrecht, a “factual dispute” does not end, but only begins, the court’s inquiry:
[T]he plaintiff’s brief repeatedly asserts that the court should deny the summary judgment motion because there are factual disputes, implicitly suggesting that these factual disputes should be resolved at trials. . . . These positions are obviously contradictory [with Albrecht].
Adkins, 2020 WL 1704646, at *5 (footnote omitted). All aspects of preemption post-Albrecht, not just “clear evidence,” are legal questions for judges to decide. Id. (“[I]t seems unlikely that the Supreme Court would hold that the first prong is triable to the jury while the second prong is not. Both prongs involve complicated legal analysis,”). Interestingly, Adkins relies in part on Ridings 0 for support of this proposition. Id.
Adkins followed the same shifting burden of proof as previously stated in Roberto, and similar to that utilized in Ridings (although Ridings was not decided on summary judgment):
For a case, such as the present one, arising on summary judgment, our courts have traditionally applied a burden-shifting approach in which the defendant must initially make a showing of entitlement to judgment as a matter of law and the plaintiff must then show a genuine issue of material fact. That approach applies even when the defendant seeks summary judgment on an affirmative defense.
Adkins, 2020 WL 1704646, at *6 (citations omitted). “[T]here is no need to assign a burden of proof and the court’s only task is decide how the law applies in this context.” Id. The defendant rebuts any “presumption against preemption . . . by showing that the plaintiff’s proffer does not constitute newly acquired information.” Id.
Adkins evaluates essentially the same purported “newly acquired information” as Roberto and Ridings, so we won’t repeat what we’ve already covered in discussing those cases. Adkins did criticize plaintiff for indiscriminately claiming all sorts of things as “newly acquired information” and not adequately briefing most of them. Id. at *6-7. Typical plaintiff behavior in our experience. From our non-Pradaxa-specific vantage point, the rest of Adkins is notable chiefly for coming to the same conclusion about medical literature with “further study” conclusions as previously stated in Ridings:
[T]he commentary’s rather tentative statement . . . and its conclusion that its proposal for monitoring “lends itself to further clinical trials” do not establish newly acquired information with any reliability. The article presents a proposal rather than making a finding. . . . Given the inconclusive nature of the commentary . . . it is simply unclear what change to the label the [article] would have permitted the defendants to make. The court concludes that [it] does not constitute newly acquired information.
Adkins, 2020 WL 1704646, at *13 (citations and footnote omitted).
Ridings and Adkins are chock full of useful propositions and refutations of plaintiffs’ overreaching post-Albrecht procedural arguments. Like the Gadolinium litigation we’ve discussed recently, the factual and legal weaknesses of the plaintiffs’ Pradaxa preemption positions confirm the statement we made last year about why we think Albrecht, on balance, will be quite beneficial to defendants. “In 95% of preemption cases (at least), we think defendants have the better side of the regulatory record, thus we should win most straight-up preemption arguments.”