[Drug and Device Law] M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case
Today’s case gives us a lesson and a laugh. The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes. The laugh comes from watching plaintiff lawyers invoke preemption [!] to keep frail claims alive. The case is Small v. Amgen, Inc., et al., Case No. 2:12-cv-476 (M.D. Florida Sept. 25, 2015). You can read the slip opinion here. The plaintiff claimed that Enbrel, which she was taking to treat her rheumatoid arthritis, eventually caused her to suffer from a diverticulitis infection. Before we get to the matters at hand in this opinion, we learn that the court had earlier dismissed claims for negligence per se and negligent failure to test or inspect. That’s a nice start. [These earlier decisions in the Small case were mentioned here and here.] Now the defendants moved for summary judgment on the remaining claims, arguing that they were barred by the learned intermediary doctrine.
The Small case looks like it should be a big problem for the plaintiff, since the Enbrel package insert identified infections as a primary risk. The defendants also distributed an FDA-approved medication guide that warned patients of the risk of serious infection. Moreover, before starting her Enbrel treatment, the plaintiff was given a consent form that warned of “life-threatening infections.” The plaintiff attempted to vault past these inconvenient facts by pointing out that there were no warnings that Enbrel could cause “asymptomatic serious infections,” and that the defendants failed to school doctors and patients “on how to mitigate and manage the risks associates with the use of Enbrel.” None of that should matter, because the treating doctor was very knowledgeable and testified that any of this new information would not have changed her mind about prescribing Enbrel. Under the learned intermediary rule (Florida is not one of those screwy states that abrogated the learned intermediary rule or cobbled together a silly exception), the failure to warn claims should fail.
And here is where the plaintiff’s argument took a comical turn. According to the plaintiff, the FDA’s medication guide regulations (21 CFR sections 208 et seq.) created a duty for manufacturers to provide pertinent safety information directly to consumers where special circumstances required it. In this through-the-looking-glass world, those regulations supersede or preempt the learned intermediary rule. The court rejected the plaintiff’s argument for various reasons. First, the plaintiff was essentially endeavoring to construct a private right of action out of the medication guide, a no-no pretty much everywhere, including Florida. “Furthermore, the FDA explicitly stated that it did not intend to change or expand state tort law when it promulgated the medication guide regulations.” The plaintiff never managed to identify “any cases supporting their theory that FDA regulations ‘inactivate’ the learned intermediary doctrine.” Then, to cap things off and make our mirth complete, the court cited Wyeth v. Levine against the plaintiff’s argument, reasoning that the Supreme Court “concluded that neither Congress nor the FDA intended the FDA’s drug labeling requirements to occupy the field.” When have we ever before found a reason to applaud the majesty of Wyeth v. Levine? The Small court also observed that the plaintiff’s preemption theory seemed more than a little improbable considering that “the learned intermediary doctrine and the medication guide regulations have coexisted since 1998.” [By the way, the Bexis drug and medical device desk book lists a couple of other cases that have rejected plaintiff-side attempts to use preemption to undermine the learned intermediary rule: Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1287 (11th Cir. 2002); Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp.2d 1018, 1031-32 (S.D. Ill. 2001).]
The plaintiff also argued that the treating doctor could not be treated as a learned intermediary because the defendants’ pharmaceutical sales representative advised the doctor that it was safe to resume the plaintiff’s Enbrel treatment. Whatever the sales rep said apparently rendered the doctor unlearned. (It’s like watching a reality tv program, where the hour actually shaved points off your IQ.) But any representations made by the defendants’ sales representative were irrelevant if the treating doctor “had independent knowledge of the possibility that Enbrel could cause the injuries sustained” by the plaintiff – which was, in fact, the case.
After preserving the sanctity of the learned intermediary rule, the Small court then smacked down the typical plaintiff maneuver of finding something-anything that wasn’t in the warning. Here, the plaintiff argued that even though the label clearly warned of serious infections, it was inadequate because it failed to provide guidance on resuming treatment with Enbrel after an infection. But as the court concluded, “[t]he problem with this theory is that manufacturers are only required to warn the prescribing physician of the possibility that the drug may cause the injury alleged by the plaintiff. There is no duty to provide guidance under Florida law.” That is a clear-eyed view of what constitutes an adequate warning. (We’ll even forgive that misplaced “only.”) Maybe plaintiff lawyers can always, like Oliver Twist, ask for more. But it does not mean they should get it. If the risk allegedly suffered by the plaintiff is identified in the label, warning adequacy is established. A court need not entertain a demand that the warning should be elaborated or embroidered.
The reasoning of the Small case suits us right down to the ground. It is no small favor.
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Posted By Steve McConnell to Drug and Device Law at 9/30/2015 07:30:00 AM --
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