The plaintiff in Salinero v. Johnson & Johnson, __ F.3d __, No. 20-10900, 2021 WL 1681237 (11th Cir. Apr. 29, 2021), tried a new twist to get around the learned intermediary rule—and it did not work.  The district court rejected the plaintiff’s attempt to graft a “financial bias” exception onto Florida’s learned intermediary rule, and the Eleventh Circuit affirmed the order with a published opinion stating correctly that no such exception exists.

Here is what happened.  The plaintiff was treated with the defendant’s implanted mesh device and a few years later experienced symptoms that she attributed to the device.  After a second procedure by the same surgeon, the plaintiff sued the device’s manufacturer for various claims, including failure to warn.  Id. at *2.  The defendant moved to dismiss based on Florida’s learned intermediary doctrine, which is similar to other states:  In cases involving medical products, the duty of a device manufacturer to warn of dangers runs to the physician who prescribed the device—the learned intermediary.  Id. at *4.  As a result, “a plaintiff must show that her treating physician would not have used the product had adequate warnings been provided.”  Id.

We call this warning causation, indeed we have been accused of fixating on warning causation, but only because it can be a winning issue with the right physician testimony or when there is no physician testimony at all.  The implanting surgeon testimony in Salinero was about as strong as it gets:

As he clearly stated in his deposition, an improved IFU [or instructions for use] would not have change his choice of implant for the surgery. . . . [¶]  [The prescribing surgeon] was also clear that an IFU containing more information on the risks posed by [the device] would not have altered his decision to use the implant in [Plaintiffs’] surgery. . . . [¶]  Furthermore, and perhaps most importantly, [the surgeon] provided explicit, uncontroverted testimony that he believed his decision to use [the device] as the mesh implant for [Plaintiff] was correct.

Id. at *5.  There you have it.  Additional or different warnings from the defendant would not have made any difference, and the surgeon said after the fact that he would not do anything differently.  Indeed, the device remained his “preferred implant” for similar procedures.  Id.  The plaintiffs therefore could not meet their causation burden under the undisputed facts.

Since the plaintiffs clearly lost on the facts, they tried to change the law, specifically by urging the district court to create a “financial bias” exception to the learned intermediary doctrine.  Under this proposed exception, “financial ties between the treating physician and the manufacturer [would] defeat the assumption of objectivity underlying the defense.”  Id. at *6.  The plaintiffs’ argument was quite similar to, and cited the same bad cases as, our prior post on this precise subject.

You can see the plaintiffs’ tack.  They had no evidence to dispute the surgeon’s testimony, so they attacked his motives with evidence that he had served as a consultant and an expert for the manufacturer and had earned substantial fees in the process.  Id. at *3.  The problem for plaintiffs was there is no such exception to the learned intermediary rule:

The trouble with the argument is that no Florida court, as best we can tell, has ever recognized, let alone adopted, a “financial bias” exception to the learned intermediary doctrine with respect to prescription drugs or medical devices . . . .  For us to create a wholly new doctrine, virtually out of whole cloth, would work a profound change in Florida’s law.  Sitting in diversity, we are Erie bound to follow Florida’s courts as they expound on tort law and nothing we can discern in Florida’s case law would suggest, let alone enable us to predict, this is a path its courts are likely to go down.

Id. at *6.  The plaintiffs therefore had neither the facts nor the law on their side, and we commend the Eleventh Circuit for its Erie restraint.  The plaintiffs cited an asbestos case from Florida Supreme Court, Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015).  But that case concluded only that a manufacturer may not be able to reasonably rely on an intermediary supplier to pass on necessary warnings that would render the product less valuable.  Id. at *7.

The Aubin case did not create a “financial bias” (or any) exception to the learned intermediary doctrine, and it arose “in a sharply different context.”  Id.  The following quote distinguishes Aubin, but also underscores the Eleventh Circuit’s understanding of the rationale behind the learned intermediary rule in the first place:

[A] physician who has significant education and training and understands the complexity of a medical drug or device is in a profoundly different position than an intermediary manufacturer of construction materials that include asbestos.  In this case, and on this record, we are satisfied that [the surgeon] did just what is expected of physicians.  He used his individualized medical judgment to determine what treatment to offer [Plaintiff].

Id.  Again, what we like most about this opinion is that both the district court and the Eleventh Circuit declined invitations to create new Florida law without Florida precedent.  That was the position we took in our prior post.  And in the process, the courts correctly applied the learned intermediary doctrine to undisputed facts to reach the correct result.