We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak. We think design defect claims usually are clearly preempted in this context and warnings claims will often be preempted too, even with Levine’s high “clear evidence” hurdle. Cases about thrombotic risks with hormonal contraceptives have featured prominently in such posts, like this opus, precisely because design is not the issue and FDA has long been intimately involved with labeling of these products.
Another obvious fertile ground for preemption has been with gastrointestinal bleeding with anticoagulants, something of the therapeutic flip side to the risk of thrombosis. First, it is a well-known issue. Our quick PubMed searches easily got us to articles about this from the 1950s. Second, this risk has been described in drug labels for a long time. We easily found this as the first warning in prescription labels as early as 1998, although we suspect they had been around for a few decades by that point. Third, this risk has been seen with every anticoagulant since there have been anticoagulants. We have no doubt that any anticoagulant drug coming to market gets a thorough review of its bleeding risk and its labeling about that risk by FDA. This surely includes attention to any differences in the labeling of the different anticoagulants and whether any post-approval studies or adverse events merit changes. These facts should make it hard to articulate, let alone prove, a design defect claim that gets by Bartlett or a warning claim that gets by Levine, unless Buckman gets ignored.
We say “should,” but, in all fairness, it certainly depends on where the case is and who is deciding it. Even in the nascent era of drug and device product liability litigation where cases should pretty much be in federal court unless they are in state court in the defendant’s true home state, the court can be all but determinative of the decisions on litigation-altering issues. The selection of court can, in turn, depend on the selection of the MDL’s home in litigations where the lawyer advertising drums up enough cases to get the JPML’s attention. We were going to contrast cases decided by different MDL courts overseeing product liability litigation over the bleeding risk of relatively new prescription anticoagulants. Instead, we will be discussing one decision addressing allegations we think are pretty typical of what is getting offered up elsewhere and our dear readers can draw their own conclusions.
Fortner v. Bristol-Myers Squibb Co., No. 17cv1562 (DLC), MDL No. 2754, 2017 U.S. Dist. LEXIS 117030 (S.D.N.Y. July 26, 2017), comes out of the Eliquis MDL. Based on the JPML’s statistics, when decided, there were 23 pending cases out of a total of 69 ever-filed cases in this relatively young MDL. The drug was approved in 2012 with extensive warnings about the risk of bleeding. Plaintiffs in the MDL offered various allegations about how the drug was defectively designed because it had a clotting risk, was not accompanied by a drug-specific clotting test, was not accompanied by an “antidote,” and was to be taken twice a day. These same criticisms were offered as warnings claims, but there were no allegations that the manufacturer had received post-approval safety information triggering some alleged duty to try to change any aspect of the label through the CBE process. The manufacturers challenged whether these allegations stated any state law claim that was not preempted and, before there was even an MDL established, dismissed a number of cases without prejudice in Utts I, which we discussed here. After the MDL was established, the plaintiffs got another shot with amended complaints and still came up short in Utts II, this time with prejudice. The court, in an exercise of magnanimity, invited the remaining plaintiffs to see if they could come up with complaints that stated a non-preempted claim. That is how we get to Fortner, who alleged a variety of claims under Tennessee law based on the same allegations about the drug, manufacturers, and FDA that most of the remaining plaintiffs apparently offered.
As is often the case with pleading around statutes of limitation—complaints with dates for everything but when plaintiff’s alleged injury occurred—it looks like the fourth attempt at a complaint was modified to be vague, repeating allegations “in less detail and without identifying or appending the specific studies from which these allegations are drawn.” Id. at *7. The Fortner court saw through this “pleading tactic” of “masking the basis for her claim”: The complaint’s “claims do not become more plausible simply because the plaintiff has omitted from the FAC the sources upon which her conclusory factual allegations are based.” Id. at **7-8. Well stated and clearly correct, but many courts let uncertainty work to the plaintiff’s advantage in this posture, despite TwIqbal’s requirement of factual allegations that plausibly state a claim.
The critical aspect of Fortner’s approach is that the court required the plaintiff to plead a warning claim based on “sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.” Id. at *8. This, in turn, flowed from the court’s prior decisions holding that “post-approval failure to warn claims are preempted unless the plaintiff can plausibly allege that there existed ‘newly acquired information’ such that, pursuant to the Changes Being Effected (‘CBE’) regulation, the defendants could independently have updated the Eliquis label to include such warnings.” Id. at *5. There is no such thing as a pre-approval warning claim—absent an allegation that the launch label resulted from fraud-on-the-FDA that side-stepped Buckman—so this is a pretty good statement of what a non-preempted prescription drug warnings claim should allege.
By contrast, under the court’s prior analysis, there is no such thing as a non-preempted post-approval design defect claim because “FDA regulations prohibit a change of the type implicated by the claim.” Id. Here, the first urged defect was twice daily dosing—which is a design issue if the plaintiff alleges the product should have been designed to deliver the effective dose by taking it once a day, for instance, and something that clearly cannot be changed without a new NDA. The other urged defects are things we see as more labeling than design issues—lack of a drug-specific clotting test or an “antidote” to the drug that could be recommended or sold with the drug. Even if such a test or antidote existed, it could not be sold with the drug based on anything the manufacturer could have done independent of FDA action. In reaffirming its prior decision on the preemption of pre-approval design defect claims, the Fortner court noted that Yates was the only appellate court to address the issue and no binding authority disagrees with its analysis.
Based on a trio of preemption rulings at the pleading stage, it looks like the Eliquis MDL will be short lived. That is not always the case with MDL proceedings based on dubious claims, where the burden of one-sided discovery and the weight of the docket tend to dictate the result more than anything approaching the merits. In terms of issues that seem as obvious to us as preemption of pre-market prescription drug design defect—we note that “duh” and “no duh” mean the same thing, like “regardless” and “irregardless” or “flammable” and “inflammable”—it will help to have more appellate courts follow Yates.