The Eleventh Circuit has lately become a bit like Forest Gump's box of chocolates—you never know what you're going to get. The news today is positive. The Eleventh Circuit recently issued a gem of an opinion on the learned intermediary doctrine under the law of Alabama, which also happens to be the home of the aforementioned Mr. Gump.
The Eleventh Circuit is not always so good. While the court got everything right in Tutwiler v. Sandoz, Inc., No. 17-13985, 2018 WL 1719024 (11th Cir. Apr. 9, 2018), readers of our 2017 Ten Worst post will recall that the Eleventh Circuit issued three of the ten worst drug and device opinions of 2017, making it 2017's most noteworthy performer among the circuits. Maybe we can read something into that. Or maybe it was fate, like a feather floating in the wind. After all, if Forest Gump taught us anything, it was that history is arbitrary and that sometimes bad things happen to good people. The latter, of course, is a reference to Forest's hard-luck childhood friend Jenny, played beautifully by a young Robin Wright in a performance that was both poignant and memorable. (Much different, by the way, from Wright's more recent portrayal of an Amazon warrior in 2017's reboot of Wonder Woman, which awkwardly fell flat in what was otherwise a perfectly decent superhero film. We have not yet binged the last season of House of Cards on Netflix, so we will withhold comment on Wright as the relentlessly power-hunger President Claire Underwood. But we digress.)
So what flavor did the Eleventh Circuit recently give us on the learned intermediary doctrine? A good one, or two, or even three. In Tutwiler, the plaintiff alleged that she suffered pulmonary issues as a result of taking generic amiodarone for non-life threatening atrial fibrillation. 2018 WL 1719024, at *1. According to the plaintiff, she did not receive the patient Medication Guide that the manufacturer allegedly made available to distributors and thus did not know that her doctor prescribed the drug off label. Id.
The district court dismissed the plaintiffs' failure-to-warn claims on two bases: (1) federal regulation of generic drug warnings impliedly preempted the state-law warnings claims and (2) the learned intermediary doctrine barred the plaintiff's claims absent allegations that inadequate warnings to the physician proximately caused the alleged injury. Id.. The Eleventh Circuit affirmed under the learned intermediary doctrine. This is slightly surprising, given that the Supreme Court's opinion in PLIVA v. Mensing provides such a clear path to implied preemption in failure-to-warn claim involving generic drugs.
Regardless, the Eleventh Circuit's opinion on Alabama's learned intermediary doctrine is in equal parts concise and well reasoned. There are three takeaway points. First, the plaintiff alleged that her physician prescribed the drug off label. But that did not make a difference to her failure-to-warn claims, nor should it have made a difference. We have seen other plaintiffs try to establish or amplify failure-to-warn claims by highlighting that their physicians prescribed drugs off label. It usually does not work, for the simple reason that a prescription drug manufacturer has a duty to warn about known and reasonably knowable risks, not uses. Of course, some states' laws might impose a duty to warn regarding dangers of a product's foreseeable misuse. Be that as it may, a bare allegation of off-label use does not an inadequate warning make.
Second, and most importantly in our view, the Eleventh Circuit rejected the argument that the learned intermediary doctrine did not apply because the drug manufacturer did not adequately warn the plaintiff's physician—and all other physicians—of the drug's dangers. In other words, the physician lacked sufficient information to be considered a "learned" intermediary. Id. at *3.
We have seen this argument before too, and a small number of courts have regrettably fallen for it. It is nonsense. The learned intermediary doctrine is not so named because drug and medical device manufacturers have a duty to create "learned intermediaries." The manufacturer's duty is to warn about a product's known and knowable risks, and the learned intermediary doctrine defines to whom that duty is owed—highly educated physicians who are already "learned." This in turn defines the two critical elements of a warnings claim in drug and medical device cases: (1) whether the warnings are adequate and (2) whether any inadequacy in the warnings caused the alleged injury. Those elements are defined by reference to a reasonable physician's skill and knowledge (his or her "learnedness") and the warnings' impact on the prescribing physician's conduct.
The Eleventh Circuit explained it this way:
[I]n Alabama, the manufacturer's duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product. The adequacy of the manufacturer's warning is "measured by its effect on the physician, [ ] to whom it owed a duty to warn, and not by its effect on the consumer."
. . . . In such a situation [where the patient alleges inadequate warnings] the patient must show that: "[T]he manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient's injury. In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient."
Id. at **2-3 (citations and quotations omitted). In Tutwiler, the plaintiffs alleged that the drug warnings were insufficient, but that alone does not erase the learned intermediary doctrine. She also had to allege causation. That is where she failed:
On appeal Ms. Tutwiler again argues that the learned intermediary doctrine does not apply because she alleged that [the manufacturer] did not adequately warn Dr. Plumb. This argument, however, does not address Alabama's separate requirement that she also plead proximate causation—that Dr. Plumb would not have prescribed her amiodarone had he known of its dangers.
Id. at *3. Because the plaintiffs did not allege that different or additional warnings would have changed her physician's prescribing physician, she failed to allege causation, and the learned intermediary doctrine barred her claim. Id.
Which brings us to our third takeaway. The plaintiff could not avoid the learned intermediary doctrine by alleging that she would have avoided the drug had she known of its dangers. "Regardless of what Ms. Tutwiler would or would not have done with the information, Alabama law requires a showing of what Dr. Plumb would have done with it." Id. (emphasis in original). Plaintiffs routinely give self-serving testimony or execute affidavits attesting that they would not taken the drug "had they known." That won't work, at least not in Alabama.
The opinion's only drawback is that it is not published. Still, the Eleventh Circuit has set a tone that we hope will continue throughout 2018 and beyond. Run Forest Run.
This article is presented for informational purposes only and is not intended to constitute legal advice.
