United States: A Mixed R&R From The Abilify MDL

Outside of the law, if you hear "R&R," you might think of "rest and relaxation" or the original military term "rest and recuperation." For many of us, the last year has had plenty of rest, but maybe not much true relaxation or recuperation. As in-person trials are set and the world inches toward a "return to normality" (or the Hardingesque "normalcy"), many of us may not really be ready to rock and roll or rush and return just yet. In litigation, "R&R" also means a "Report and Recommendation" issued by a magistrate judge under Fed. R. Civ. P. 72, which does not use the term. We do not tend to write up R&Rs because they may be modified by the district judge in short order. For some reason, though, this week's batch of "bloggable" cases included two R&Rs and we picked one of them. A fascinating insight into the sausage making of the Blog, for sure, but there is also a connection to the actual decision we will be discussing below. In our experience, R&Rs often are a "mixed bag" or involve a fair amount of "baby splitting." Could this be because magistrate judges spend much of their time conducting court-ordered settlement conferences and the spirit of compromise lingers? Or maybe the prospect of objections makes magistrates even more hesitant than district judges to have one side win a motion completely? We do not really have proof either way and there are no defined burdens here.

In In re Abilify (Aripiprazole) Prods. Liab. Litig., MDL No. 2734, No. 3:19-cv-22 (N.D. Fla. Feb. 10, 2021), the magistrate judge considered a motion for summary judgment on referral. The results were predictably mixed. The facts were relatively straightforward: the plaintiff was prescribed and took a prescription antipsychotic medication, both the branded and generic versions, for about three years, during which time FDA issued a safety communication about the risk of "uncontrollable urges to gamble, binge eat, shop, and have sex" with the medication and the branded label was updated to reflect these issues. Id.at *1. Plaintiff claimed to have "engaged in compulsive gambling, experienced hypersexuality, and struggled with substance abuse." Id. He blamed the drug and asserted a number of claims under Rhode Island law. (Rhode Island has not recognized innovator liability, so we assume the particular companies sued were the ones whose medications plaintiff actually took.) Defendants moved for summary judgment on all of them.

After a few walk-overs, the magistrate turned to the contested claims. We will follow the order of his analysis. First up was failure to warn. We like that the magistrate made clear that Rhode Island law requires the plaintiff to prove proximate cause. We also like that the magistrate predicted that it was highly likely that the Rhode Island Supreme Court would adopt the learned intermediary doctrine, citing the same two prior federal decisions we do in our tally on the issue, and noting that the court had endorsed it implicitly. Id. at *3. We are less enthused by the failure to mention Erie restraint-see, it goes both ways-and the transition to discussing proximate cause. When the magistrate writes "Some states have applied the learned intermediary doctrine to bar claims based on allegedly inadequate instructions or warnings accompanying a drug when there is no evidence that the prescriber read or relied on the drug's label or instructions," he is not describing a "bar" but a failure of the plaintiff to carry her burden. This kind of language often presages an analysis of the evidence that tilts in favor of the plaintiff.

Here, although the court's original recitation of the law made clear that plaintiff had the burden, consideration of burden seemed to go out the window.

Id. (citation omitted). We also know that the plaintiff was in fact continued on the medication well after literature reports and the FDA's communication on the compulsive behaviors at issue. Yet, the one-sided evidence on (lack of) proximate cause for failure to warn was not enough. This started with magistrate citing three old cases for the proposition that

Id. (emphasis added). Not only is that statement backwards-plaintiffs routinely try to carry their burden based on a prescriber's hindsight guess about a change in behavior from a hypothetical warning-but the cases cited hardly establish a routine. Suffice it to say that they date from 1984, 1991, and 1992, all involve federal courts applying state law, and at least one is probably not good law anymore.

With this background, the magistrate considered the evidence "equivocal at best." Id. at *4. The prescriber testified that "he would have heeded the FDA's instruction" to monitor for the development of new risks-which does not relate to the decision to prescribe. Id. And his answer on whether he would have done anything different with plaintiff was that he was "not sure." Rather than seeing this as a failure of plaintiff to carry his burden with record evidence, the magistrate found a triable issue on proximate cause, citing a Rhode Island procedural decision that summary judgment should only be granted "when the facts are undisputed and are susceptible of but one inference." Id. (citation omitted). Sitting in diversity, though, only substantive state law applies along with Fed. R. Civ. P. 56 and the federal cases the decision had cited interpreting it.

The rest was better. On design defect, Rhode Island's consumer expectation test required a "strong likelihood of injury" due to the alleged defect. Id. (citation omitted). Plaintiff failed to introduce evidence "that [impulsivity disorder] rendered Abilify unreasonably dangerous because it presents a 'strong likelihood' of injury." Id. Merely identifying a risk now described in the label was not enough.

Negligent misrepresentation fared no better. Plaintiff claimed a misrepresentation in the air-the generalized promotion of the drug as "safe" without warning of the risk of impulsive disorders. While the magistrate noted that plaintiff had disclaimed in deposition that he had relied on any statement from defendants-defeating one of the elements of the claim-he went further in rejecting that there was evidence in the record of a misrepresentation. Id. at *5. Specifically, the fact that medication was still on the market supported that it was "safe" and alleged omissions in the label did not equate to misrepresentations of anything. Id. If we are being picky, then we would say that we would like to see some consideration of how the learned intermediary doctrine affects the misrepresentation claim.

We will also get picky on the fraudulent concealment "claim," even though summary judgment was granted on this one too. This is not a claim, but a count included on many MDL template complaints as a way of seeking relief from the operation of a statute of limitation. Too often, these poorly pleaded counts linger because individual complaints are rarely tested in MDLs. As far as we can tell, though, defendants did not claim the case was time barred, so an exception to a defense was not really implicated.

Last up were claims for express and implied warranties. The magistrate punted on whether the requirement of "reasonable notice" could be met by the filing of the lawsuit (without pre-suit notice) more than five years after starting the medication and more than two years after stopping it. Id. Instead, these claims fell on their merits. An implied warranty claim required proof of product defect, so the summary judgment on the design defect claim applied. An express warranty claim required proof of reliance on some statement from a defendant, so the summary judgment on the misrepresentation claim applied. Overall, this bag is quite mixed from our perspective, but the plaintiff was left with a single claim of failure to warn that requires the jury to convert "equivocal" prescriber testimony into a finding of proximate cause. From the defendants' perspective, this bag may not be so mixed after all.

This article is presented for informational purposes only and is not intended to constitute legal advice.