We write a lot about the learned intermediary rule. It’s a fundamental aspect of the defense of drug and device cases, it’s grounded in the realities of the physician-patient relationship, and it tends to produce a lot of cases worth blogging about. We also refer to it as a rule (e.g., here, here, here, and here), rather than a doctrine, because that’s what it is. We particularly like it when courts dismiss warnings claims based on the learned intermediary rule at the pleadings stage. Today’s case is one of those. Plaintiff filed a shoddy complaint, was able to amend in response to an initial motion to dismiss, and then saw his warnings claims dismissed with prejudice under Alabama’s learned intermediary rule.
In McCrackin v. Rex Medical L.P., 2026 WL 66797 (N.D. Ala. Jan. 8, 2026), the plaintiff alleged he received an Option retrievable IVC filter in 2012. Twelve years later, he allegedly suffered complications when a “leg” from the filter fractured and penetrated a vein, with the further allegation that his spine grew around the fractured leg. He sued based on allegations that the device was marketed as permanent when it should have been temporary, and that there were not adequate warnings about the risk of “tilt, fracture, migration and/or perforation.” Id. at *1. Plaintiff previously obtained leave to file an amended complaint in response to an initial motion to dismiss, so this was his second bite at the apple. The defendant who marketed and distributed the device moved to dismiss.
The court started with the easy part. To the extent plaintiff claimed the defendant had a duty to warn him directly, he was wrong. That duty is owed only to physicians. Not individual patients.
The court then turned to plaintiff’s claim that the defendant failed to warn the implanting physician. But the complaint did not sufficiently plead that any alleged failure to warn was the actual and proximate cause of plaintiff’s injury:
[Plaintiff] has not sufficiently pleaded that [defendant’s] breach caused his injuries. No facts allege that had [Plaintiff’s] physician known about the alleged risks, the physician would have taken a different course of treatment or not used the Option IVC filter. [Plaintiff] outlines no factual allegations that show his doctor relied on [defendant’s] representations or acted because of [defendant’s] failure to warn.
Id. at *2. The court dismissed the failure to warn claims with prejudice.
The defendant—as the marketer and distributor of the IVC filter—also raised Alabama’s Innocent Seller Act as an affirmative defense and sought dismissal of the remaining counts. That statute insulates distributors from liability absent “independent acts of negligence, wantonness, warranty violations, or fraud.” The decision suggests that plaintiff failed to plead any facts sufficient to trigger a distributor’s liability under the statute. Despite that, the court held that a motion to dismiss is “generally not the proper vehicle to assert an affirmative defense,” and that the allegations in the complaint did not have to negate an affirmative defense. Id. The defendant will have to renew that defense in a later motion.
Finally, the court revisited the plaintiff’s warranty claim—which it previously dismissed with prejudice in response to the defendant’s initial motion to dismiss. Plaintiff must have included the warranty claim in his amended complaint, because the court dismissed it with prejudice, again. We’re not sure there’s a precise legal term for that, but seems like “double whammy dismissal with prejudice” should suffice.