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Today’s case is not new to us. A year and a half ago we were extolling the virtues of Blackburn v. Shire U.S., Inc., 2020 WL 2840089 (N.D. Al. June 1, 2020), for granting summary judgment where the testimony from plaintiff and his prescribing physician shot holes in proximate causation too large for a triable issue of fact to remain.  But that was then, and this is now. Plaintiff appealed and the Eleventh Circuit granted a partial reversal of summary judgment and certified two issues to the Alabama Supreme Court.

Plaintiff was prescribed a drug to treat his Crohn’s disease. The drug carries a warned of risk of kidney disease, including a recommendation that patients’ renal function be tested before starting the drug and “periodically while on therapy.”  Blackburn v. Shire U.S., Inc., — F.4th –, 2021 WL 5563732, at *2 (11th Cir. Nov. 29, 2021). Plaintiff does not dispute that the risk of kidney disease is warned of on the drug’s labeling. His argument is that the labeling should have included more detailed instructions for how to mitigate the risk, such as more frequent testing.

In the first part of its decision, the Eleventh Circuit looks at the district court’s decision on proximate cause. The district court determined that based on the record, plaintiff had failed to meet his burden of showing that his prescriber would have chosen not to prescribe the medication if defendant had included a different warning. That decision was based on the court’s findings that the prescriber did not read the label before prescribing the drug to the plaintiff, that the prescriber never tested plaintiff’s renal function, and plaintiff failed to attend his follow-up appointment. Id. at *6.

Conducting a de novo review, the Eleventh Circuit reached a different conclusion. First, while the prescriber did not read the defendant’s labeled warnings before prescribing to plaintiff, that was because he was already familiar with them. Id. The prescriber, in fact, testified that he might have altered his behavior based on a different warning. But the district court discounted that testimony as motivated by “self-interest” because the prescriber was trying to minimize his own fault for the injuries. The Eleventh Circuit said the doctor’s self-interest went to credibility, not usefulness of the testimony at the summary judgement stage. Id.

The appellate court also found plaintiff’s doctor had provided credible support for why he did not test plaintiff’s renal function, including that plaintiff moved and transferred to a new doctor. Id. at *7. Finally, as to the missed follow-up appointment, the appellate court concluded that missing a follow-up that plaintiff believe was to check on side effects he was not experiencing was different than missing an appointment for blood work. It was improper for the district court of infer that plaintiff would have not gone to an appointment if he knew his renal function would be tested. Id. Therefore, on the issue of proximate cause the Eleventh Circuit found a genuine issue of material fact that precluded summary judgment.

That left the issue of the scope of the duty to warn under the learned intermediary doctrine. Defendant made two legal arguments that the Eleventh Circuit determined were not settled under Alabama law. First, defendants discharged their duty to warn by warning of the risk of renal impairment. Having so warned, it is up to the doctor to assess and mitigate that risk. Here we are talking about the line between providing risk information to a doctor so that he/she can make an informed treatment decision and telling doctors how to practice medicine. A defendant’s duty extends to the former; the latter goes too far. All the reasons that learned intermediary is sound policy support that drug manufacturers should not be responsible for advising doctors how to mitigate a warned of risk. Prescribers have both the scientific knowledge and knowledge of the patient to make those treatment decisions themselves.

Defendant’s second argument was that to establish proximate cause for failure to warn, plaintiff must demonstrate that his prescriber would not have prescribed the drug if the warning had been adequate. Plaintiff contends he need only show that after prescribing the drug, his doctor would have pursued a different course of testing or mitigation. Id. While both sides cited case law in support, the defense relied on a more recent Alabama Supreme Court decision holding that “the patient must show that, but for the . . . warning, the prescribing physician would not have prescribed the medication to his patient.”  Id. at *8.  Nonetheless, the Eleventh Circuit called for a tie breaker.

Now we have to wait to see what the Alabama Supreme Court does.