In Cajun French "tracas" means trouble, or so the Internet says.
Bexis is updating the learned intermediary rule section of his product liability treatise, and he noticed a little tracas brewing in Louisiana. We're calling it out so that defense counsel litigating in Louisiana are aware of it and (we hope) can do something about it.
Plaintiffs in Louisiana semaglutide litigation are attempting turn the learned intermediary rule into an "affirmative defense." But it isn't, hasn't been, and never should be. Three recent decisions – all in the same litigation – all have the same bogus holding:
The learned intermediary doctrine is an affirmative defense on which defendant bears the burden of proof. Brocato v. DePuy Orthopaedics, Inc., 2015 WL 854150, at *6 (E.D. La. Feb. 25, 2015) (citing Ebel v. Eli Lilly and Co., 536 F. Supp.2d 767, 772 (S.D. Tex. 2008)).
See Breaux v. Novo Nordisk Inc., 2023 WL 8606799 at *3 (W.D. La. Dec. 12, 2023); Bjorklund v. Novo Nordisk A/S, ___ F. Supp.3d ___, 2023 WL 8528445 at *2 (W.D. La. Dec. 8, 2023); Bjorklund v. Novo Nordisk A/S, 2023 WL 8584961 at *2 (W.D. La. Dec. 11, 2023). That's the sum total of the discussion in those cases.
So we next look at Brocato. The discussion in Brocato was also a single sentence, supported by two citations:
The "learned intermediary doctrine" is an affirmative defense under which Defendants bear the burden of establishing that they adequately informed the intermediate physician of the risks associated with use of their product. See, e.g., Ebel v. Eli Lilly and Co., 536 F. Supp.2d 767, 772 (S.D. Tex. Jan. 29, 2008) (citing Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974) ("Defendant has the initial burden of proving that decedent received the medication through a physician with whom the decedent had a physician-patient relationship and that the warning Defendant provided to the prescribing physician was adequate.").
2015 WL 854150, at *6.
But neither Ebel nor Reyes applied Louisiana law. They were both diversity cases predicting and applying Texas law. Reyes, 498 F.2d at 1271 (applying "those principles of products liability law we conclude would be applied by the courts of Texas"); Ebel, 537 F. Supp. at 772 (interpreting "[t]he Texas learned intermediary doctrine"). Applying Louisiana law, however, the Fifth Circuit has held that the burden of proof in learned intermediary cases remains where it is supposed to be – on the plaintiff:
[T]here is a two-prong test governing inadequate-warning claims under the LPLA when the learned intermediary doctrine is applicable. First, the plaintiff must show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product that was not otherwise known to the physician. Second, the plaintiff must show that this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff's injury.
Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 265 (5th Cir. 2002) (applying Louisiana law) (emphasis added). Stahl cited Willett v. Baxter International, Inc., 929 F.2d 1094 (5th Cir. 1991), for these propositions, and did so correctly:
To recover for a failure to warn under this [learned intermediary] doctrine, a plaintiff must show: (1) that the defendant failed to warn the physician of a risk associated with the use of the product, not otherwise known to the physician, and (2) that the failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff's injury. Because the defective aspect of the product must cause the injury, the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e. that but for the inadequate warning, the treating physician would not have used or prescribed the product.
Willett, 929 F.2d 1094, 1098-99 (emphasis added).
How about Louisiana state appellate courts? Louisiana has followed the learned intermediary rule in multiple cases since 1983. See Ezeb v. Sandoz Pharmaceuticals, 50 So.3d 166, 170 (La. App. 2010); Stanley v. Wyeth, Inc., 991 So. 2d 31, 33-34 (La. App. 2008); Kampmann v. Mason, 921 So.2d 1093, 1094 (La. App. 2006); Marks v. Ohmeda, Inc., 871 So.2d 1148, 1157 (La. App. 2004); Brown v. Glaxo, Inc., 790 So.2d 35, 38 (La. App. 2000); Calhoun v. Hoffman-LaRoche, Inc., 768 So.2d 57, 61 (La. App. 2000); Mikell v. Hoffman-LaRoche, Inc., 649 So.2d 75, 79-80 (La. App. 1994); Rhoto v. Ribando, 504 So.2d 1119, 1123 (La. App. 1987); Kinney v. Hutchinson, 468 So.2d 714, 717 (La. App. 1985); Cobb v. Syntex Laboratories, Inc., 444 So.2d 203, 205-06 (La. App. 1983). None of these cases has considered the learned intermediary rule to be an "affirmative defense." None of these decisions have held that defendants, not plaintiffs, have the burden of proving the factual prerequisites of the rule. To the contrary, they hold, like the Fifth Circuit, that plaintiffs retain their ordinary burden of proof.
The learned intermediate [sic] doctrine states that the drug manufacturer has no duty to warn the customer directly and that the manufacturer's duty is fulfilled when the prescribing or treating physician is informed of the risks from the drug use. It is then the physician's responsibility to advise the patient. However, there is a two-prong test in failure to warn LPLA claims. First, the plaintiff must show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product that was not otherwise known to the physician. Second, the plaintiff must show that this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff's injury.
Ezeb, 50 So.3d at 170 (La. App. 2010) (citing and quoting Stahl) (emphasis added).
That should be quite enough, but there's more. The two Texas decisions mentioned above, Reyes and Ebel, are not even accurate as to Texas law. Subsequent to those two decisions, the Texas Supreme Court has flatly rejected the contention that the learned intermediary rule was an affirmative defense – explicitly and at length:
IV. The Learned Intermediary Doctrine Within the Prescription Drug Context Is Not a Common–Law Affirmative Defense
The parties dispute whether the learned intermediary doctrine is an affirmative defense, which would shift to [defendant] the burden to plead, prove, and request jury findings on the learned intermediary doctrine at trial. We agree with [defendant] that, within the prescription drug context, the learned intermediary doctrine is more akin to a common-law rule rather than an affirmative defense.
* * * *
[F]or more than forty-five years, courts have applied the learned intermediary doctrine within products-liability claims against prescription drugs manufacturers. We have repeatedly referenced the doctrine's commonly recognized application in the prescription drug context. . . . [D]octors have a legal duty to pass prescription drug warnings on to their patients. And as the official comment to the Restatement (Second) of Torts notes, the learned intermediary doctrine applies particularly to the medical field and unavoidably unsafe products like prescription drugs, which, by law, cannot go from the manufacturer to the end user except through a prescribing physician.
* * * *
Here, it is undisputed that [plaintiff] received [the drug] through a physician-patient relationship. . . . [T]he underlying basis for the . . . claims stems from [defendant's] alleged failure to warn [plaintiff] of the risks and dangers associated with [the drug]. Therefore, as in most failure-to-warn cases, the [plaintiffs] had to prove that [defendant's] warning was inadequate. While the learned intermediary doctrine shifts the manufacturer's duty to warn the end user to the intermediary, it does not shift the plaintiff's basic burden of proof. Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case − that the product warning was inadequate. The burden on defendants in other industries to show reasonable reliance on an intermediary to effectively deliver a warning has no application in products-liability cases against a prescription drug manufacturer when the plaintiff received the drug through the existence of a physician-patient relationship.
Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 164-67 (Tex. 2012) (citations and footnotes omitted) (emphasis added).
And there's even more. In the Ebel litigation itself, the Fifth Circuit expressly held that – contrary to any purported "affirmative defense" – the plaintiff retains the burden of proof in learned intermediary cases. "When, as here, the learned intermediary doctrine applies, 'a plaintiff must show that (1) the warning was defective, and (2) the failure to warn was a producing cause of the injury.'" Ebel v. Eli Lilly & Co., 321 Fed. Appx. 350, 355 (5th Cir. 2009) (emphasis added) (quoting Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 208 (5th Cir. 2008)).
Finally, just to make the rubble bounce, we point out that the California Supreme Court reached the same conclusion in its recent Himes decision (discussed generally here). California's highest court reached the same result as all the appellate decisions we discussed above, rejecting any argument that the learned intermediary rule was an affirmative defense:
[T]he learned intermediary doctrine is neither a defense nor an exception to a traditional duty rule, and it does not cease to apply where a plaintiff alleges that a manufacturer failed to provide an adequate warning to the patient's physician. It instead defines the scope of a manufacturer's duty to warn in context of prescription drugs or medical devices by providing that the manufacturer's duty to warn runs to the physician, not to the patient.
Himes v. Somatics, LLC, 549 P.3d 916, 924 (Cal. 2024) (citations and quotation marks omitted).
Thus, the identical statements in the three recent Louisiana semaglutide decisions, and in the earlier Brocato case, that the learned intermediary rule is an "affirmative defense" are completely wrong – what we call "spherical error" because they are erroneous any way you look at them. In the future, counsel litigating in Louisiana should point this out loud and clear.
This article is presented for informational purposes only and is not intended to constitute legal advice.