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Regular readers of the blog know and appreciate our focus (fixation?) on the learned intermediary rule.  Not because it is fun to say and makes us feel smart.  No, we follow and write on the learned intermediary rule because it is a cornerstone of the law on allegedly inadequate drug and device warnings.  It holds most everywhere that a drug or device manufacturer’s duty to warn runs to the prescribing physician (the learned intermediary), not to the patient.  The result is that a plaintiff lacking evidence that additional or stronger warnings would have altered the physician’s decision to prescribe the drug or device should not get past summary judgment on warnings-based claims.  It just makes so much sense. 

The learned intermediary rule is alive and well, but not without efforts in many places to weaken it.  We wrote on the Ninth Circuit’s recent order certifying a question to the California Supreme Court asking whether a patient can avoid summary judgment with evidence that a different warning would have impacted the patient’s decision to accept the treatment, as opposed to the physician’s decision to prescribe the product.  We don’t know how the California Supreme Court will answer that question, but we sure know how we would.

Now comes Alabama.  The Supreme Court of Alabama has been no great friend to prescription drug manufacturers—most notably with the notorious (or as Bexis would say “execrable”) Wyeth v. Weeks opinion adopting innovator liability in 2014.  The current assault comes in Blackburn v. Shire, which holds: (1) that a prescription drug manufacturer can have a duty to warn not only of drug risks, but also to provide instructions on how to mitigate those risks, and (2) that a plaintiff can prove that an inadequate warning caused his or her injuries with evidence that the prescribing physician would have altered his treatment or monitoring of the patient in some way, even when the physician still would have prescribed the same drug.  Blackburn v. Shire U.S., Inc., 2022 WL 4588887, at *1 (Ala. Sep. 30, 2022) (to be published in So. 3d). 

We have been following Blackburn for more than two years (see here and here), and the Eleventh Circuit’s opinion undermining summary judgment and certifying these questions to the Alabama Supreme Court came in at number three on our list of 10 worst cases for 2021.

We suspect that the Alabama Supreme Court’s opinion will similarly land among the year’s 10 worst.  The plaintiff in Blackburn took the defendant’s prescription drug for Crohn’s disease and allegedly developed kidney disease as a result.  Id. at *1.  The product’s drug labeling disclosed the kidney risk, and it also recommended that the patient “have an evaluation of renal function prior to initiation of [the drug] and periodically while on therapy.”  Id.  As we have repeated on a number of occasions (such as here, here, and here), manufacturers do not have any duty to tell physicians how to practice medicine.

According to the plaintiff, however, just recommending a test was not good enough.  And in addressing the first certified question on the scope of the duty to warn, the Alabama Supreme Court held that the plaintiff might be right.  The court ruled that an adequate drug warning can involve disclosing the drug’s risks—and also “instructions for mitigating those side effects.”  Id. at *7.  As the dissenting opinion points out, this is a dangerous intrusion into the physician-patient relationship.  It also strikes at the core of the learned intermediary doctrine by creating a duty to instruct an intermediary that is trained in medicine and is already assumed to be “learned.” 

On the second certified question on causation, the Alabama Supreme Court’s opinion erodes long-held principles of causation.  When the evidence shows that different or additional warnings would not have altered a physician’s decision to prescribe, the plaintiff cannot show causation on warnings-based claims.  The Alabama Supreme Court, however, saw it differently and expanded the ways a plaintiff can prove causation.  It held that a plaintiff can demonstrate proximate cause by showing that a new warning would have altered the physician’s treatment of the plaintiff “in some way,” even if the physician still would have prescribed the drug.  Id. at *10-*13. 

This deflects the inquiry away from the prescribing decision and into any number of methods for monitoring and treating patients.  It also weakens the learned intermediary doctrine by allowing plaintiffs to introduce evidence, for example, that “had the physician known” additional information, he or she would have ordered additional tests, or have seen the plaintiff more frequently, or have given the plaintiff additional warnings and instructions. 

That is all fine and good, but we do not see an obvious causal link in the Alabama Supreme Court’s analysis.  The Alabama Supreme Court intimates, without really saying, that causation can be established only when the physician’s different behavior would have led to a different outcome, but how different?  Now we are talking about hypothetical changes to treatment in a “but for” world where the physician still prescribed the drug, but the plaintiff may or may not have avoided his or her alleged complication.  What if the physician did not read the drug labeling before prescribing the product or the plaintiff did not follow up with his or her physician even when ordered?  (Both were true in Blackburn.)  We recently took a deposition where opposing counsel asked whether the doctor would have monitored the plaintiff’s kidney function “had he known” certain information, but the doctor was already monitoring the plaintiff’s kidney function for other reasons.  What happens then?  We foresee dueling experts. 

We do not want to overstate things.  The learned intermediary rule is still a vital doctrine in nearly every jurisdiction, and any honest analysis of warnings causation will vigorously test the link between the allegedly inadequate warnings on the one hand and the alleged injury on the other, even in Alabama.