Given the events of the last eleven months or so, we give ourselves and other legal commentators a preemptive pass for the following situation: you read a case, you think about how you would describe it, and you see that you have described similar cases in a similar way more than once. This could be due to low batteries in our déjà vu detector or that there is so much repetition from day to day to week to month that it interferes with the detector. Either way, we can crank up another detector, our retrospectoscope for legal trends, and see that there seem to be many cases these days where a plaintiff argues for an exception to the learned intermediary doctrine. Like a plaintiff advocating a novel theory of causation/defect in court, we require no study or statistics to support our assessment of a trend. Instead, we can declare it to be true based on an anecdote or two and, hearing no disproof on our precise terms, turn to speculating about the factors contributing to the trend.
Mockery aside, we do think there are some reasons for the trend, although it is hardly something we have seen over just the last year. First, pretty much everywhere has adopted the learned intermediary doctrine by now. When we started tracking it on this Blog back in 2007, it was a majority, but even laggards like Arizona and Wisconsin have joined the learned intermediary party. The next step in the world where plaintiffs never stop trying to sue is to argue exceptions. Second, a generally good trend—there we go again—on preemption for warnings claims against makers of prescription drugs, generic drugs, and PMA devices has pushed plaintiffs to seek out new claims that they hope will not be preempted. Warnings-based claims that involve communications with patients may be less likely to get preempted, assuming they can get a court to carve out an exception for them. Third, the law has also been moving in a good place—there is some other term for that—when it comes to what a plaintiff has to prove in terms of proximate cause for failure to warn when the focus is on a prescribing physician. The plaintiff may be more willing to testify that an additional warning would have changed her behavior than would a licensed medical provider who should actually be keeping up with the medical literature and making individualized risk-benefit decisions. Fourth, Erie restraint does not seem to be highlighted in the training of federal district judges these days, so, if a case ends up in federal court on diversity, then why not try and make some new state law if it helps your case?
We declare these all to be plausible reasons for more attempts, particularly in federal court, to create exceptions to the learned intermediary doctrine in ways that would help prescription medical product plaintiffs avoid summary judgment. Trying does not always make it so and, two years ago, we reported on summary judgment for the makes of a prescription contraceptive device in a case called Ideus. We lauded the district court's rejection of an argued contraceptive exception to Nebraska's learned intermediary doctrine. Well, two years was a long time ago, long enough for us to forget about the prior decision while the appeal to the Eight Circuit was pending.
Ideus v. Teva Pharms USA, Inc., __ F.3d __, No. 19-1361, 2021 WL 415774 (8th Cir. Feb. 8, 2021), is a short and forceful opinion affirming the decision below. The facts are relatively straightforward, at least for the issue on appeal. While conceding that the physician labeling was adequate, the plaintiff contends that the patient package insert ("PPI") that accompanied her prescription intrauterine device ("IUD") was somehow inadequate and contributed to her needing to have the IUD surgically removed at some later point. As the court says of the PPI, "Before implanting the device, physicians are supposed to give plaintiffs time to read [the PPI], discuss it with them, and answer any questions." Id. at *1. That makes it hard to separate out completely the warnings to the physicians and their interaction with patients, but we can set that aside for now. If the Nebraska Supreme Court would apply the learned intermediary doctrine to this case, then plaintiff had no claim.
The starting point was that the Nebraska Supreme Court had already adopted the learned intermediary doctrine, as set out in Restatement (Third) of Torts, § 6(d), in a prescription drug case called Freeman v. Hoffman-La Roche, Inc., 618 N.W. 827 (Neb. 2000). Predictably, plaintiff started by arguing that Freeman applied only to prescription drugs, not prescription devices, so it was the defendant who wanted to extend Nebraska law, instead of her trying to create a new exception. Nope. On its face, section 6(d) applies to "[a] prescription drug or medical device." Id. at *2. We think "prescription" modifies both "drug" and "medical device" in 6(d), so this is even more of a no-brainer than the Eighth Circuit made it. The court noted that, "just like [the drug in Freeman], [the device in Ideus] is prescribed by physicians, so it fits within the rationale for the rule: they will be 'in the best position to' advise their patients about the risks of using it." Id. (citing Freeman).
Plaintiff did not give up, focusing her request for adoption of a contraceptive exception on one Massachusetts case and two Michigan federal cases, all from 1985. Noting that later Michigan federal cases and the Sixth Circuit had come out the other way, the court declared that "The bottom line is that Massachusetts stands alone in unequivocally adopting" an exception. Id. We would throw in that the well-known Michigan product liability statute in place since 1996 was another strike against the older predictions of Michigan law. But this was not nearly as important as the explicit rejection of the Massachusetts cases by more than a dozen other states and many federal courts. (Our post on the decision below contains a more complete collection.) In product liability law, if a decision from a state high court has been around for thirty-five years without being followed by another state high court or any federal appellate court, then it is decidedly an outlier. There was no reason to believe Nebraska would go that route. Id. at *3.
Plaintiff's last chance was to point out that the Eight Circuit had predicted in 1989 that Arkansas would not apply the learned intermediary doctrine in an IUD case. However, in the interim, Nebraska had adopted the majority position and majority position had been strengthened considerably. Id. (Arkansas had too, back in 1991.) So, the court had no compunction about affirming. Id.
We do have one complaint, though, which you might have guessed. In the discussion of predicting what the Nebraska high court would do, there is no discussion of Erie restraint. There is a dissent that argues that a question should have been certified for the Nebraska Supreme Court itself. While certified questions are a useful procedure that probably should be used more often by courts sitting in diversity, the existence of the Freeman decision made possible a prediction consistent with Erie restraint, a concept the dissent also ignored.
This article is presented for informational purposes only and is not intended to constitute legal advice.
