In this age of scrolling news, headline news, pop-up news, instant alerts – it’s tough to stay current. For instance, if you were getting Masters updates on Sunday, the last few hours of lead changes, dropped strokes, balls in the water on 12, and nearly every swing Tiger made on the last 4 holes probably had your phone pinging like a pinball machine. And, if that wasn’t what was blowing up your phone Sunday, it was likely GOT countdowns, conjecture, and general fandom camaraderie. Whatever it was – it was always changing. The unfortunate side of real time reporting (often combined with 260 character reporting), is that it can be out-of-date as soon as you hit send.
That’s what happened to us last week. No sooner had our post on Lempa v. Eon Labs, Inc., 2019 U.S. Dist. LEXIS 54868 (N.D. Ill. Mar. 29, 2019) hit the blog touting that it’s holding was in opposition to the two circuit court of appeals decisions on the same issue then we learned that a third appellate court had weighed in. Fortunately, it too leaves Lempa as an outlier.
We posted about the district court’s dismissal of Bean v. Upsher-Smith Pharms., 2017 WL 4348330 (D.S.C. Sept. 29, 2017) here. The district court dismissed plaintiff’s failure to warn and off-label promotion claims both as preempted and barred by the learned intermediary doctrine. Plaintiff only appealed the dismissal of his failure to warn claim and the Fourth Circuit only reached the learned intermediary issue finding it was unnecessary to reach preemption. Bean v. Upsher-Smith Pharms., 2019 U.S. App. LEXIS 10260, *3 (4th Cir. Apr. 8, 2019).
Like the other amiodarone cases we’ve discussed, plaintiff’s decedent was prescribed the drug off-label and suffered pulmonary toxicity leading to his death. Id. at *2. Also like the other cases, plaintiff did not allege that defendant failed to warn the prescribing physician of the risk of pulmonary toxicity. Instead, plaintiff alleged his father was not provided with the Medication Guide. Essentially that is a claim that the manufacturer had some duty to ensure that the end-user of a drug received a warning. But the appellate court found that South Carolina recognizes the learned intermediary doctrine – “a duty to warn that extends only to physicians” or other learned intermediaries. Id. at *4. It is then up to the physician to use his/her “knowledge, training, and experience to provide the patient” with appropriate information so the “patient can make an informed choice.” Id. at *5 (following the Restatement (Third) of Torts version of learned intermediary). In this case it was undisputed that the prescribing physician was aware of the risk of pulmonary toxicity. Id. at *6. Therefore, defendant satisfied its duty to warn.
Since plaintiff could not demonstrate that the warnings provided to the prescribing physician were inadequate, he argued that they were “ineffective” due to the manufacturer’s off-label promotion. Id. at *6-7. But plaintiff explicitly chose not to appeal his off-label promotion claim. A failure to warn claim concerns “a misrepresentation of risks.” Id. at *7. Plaintiff was arguing a misrepresentation of benefits. He knew that was a separate claim when he filed his lawsuit. He pleaded it that way. Then he chose not to appeal it. “[H]e cannot revive it now, repackaged as a response to the manufacturer’s invocation of the learned intermediary doctrine.” Id.
And, even if he could, there is no direct-to-consumer exception to the learned intermediary doctrine. While it is true that the FDA required end-users to receive a Medication Guide, it was “the FDA’s intent that the Medication Guide rule not ‘alter the duty, or set the standard of care for manufacturers.” Id. at *9 (citing 63 Fed. Reg. 66378, 66384 (Dec. 1, 1998)).
At the risk of dating this post too, we now have two circuits finding the medication guide claim barred by the learned intermediary doctrine – Fourth and Eleventh – and one that found it preempted – Sixth. If this post becomes outdated by more decisions like these, we don’t mind pinging you again.