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A federal court applying Florida law has refused to dismiss fraud and misrepresentation claims brought by a patient against a medical-device manufacturer, rejecting the manufacturer’s contention that such claims are categorically barred by the learned-intermediary doctrine.

It is perhaps telling that the decision, Pirlein v. Ethicon, Inc., Med. Devices Rep. ¶ 24,799 (S.D. Fla. 2021), cites no Florida case in support of its conclusion.

According to the court, the plaintiff’s fraud and negligent misrepresentation claims were based “not the information that she received or did not receive from the Defendants, but rather the information that Plaintiff’s implanting physician possessed when informing Plaintiff of all the risks associated with implantation of the [defendant’s vaginal mesh] devices.”

Seeking dismissal of the claims, the defendant manufacturer argued that “the learned intermediary doctrine precludes Plaintiff from asserting claims for common law fraud and negligent misrepresentation where she was not the direct recipient of the purported misrepresentations and thus did not personally rely on any such misrepresentations.”

Pointing to two federal cases, the court rejected the defendant’s argument, holding that “the learned intermediary doctrine does not automatically preclude Plaintiff’s fraud and negligent misrepresentation claims.” The court cited Mardegan v. Mylan, Inc., 2011 WL 3583743, at *5 (S.D. Fla. 2011), for the proposition that a “patient’s negligent misrepresentation claim based on [a] failure to warn is not barred as a matter of law by the learned intermediary doctrine.” And quoting Geery v. Ethicon, Inc., 2021 WL 2580167, at *2 (M.D. Fla. 2021), the court found that the defendant manufacturer’s “proposed interpretation of the law ‘would automatically bar most negligent misrepresentation or fraud claims against a medical manufacturer, no matter how egregious the conduct, because the person who suffered the injury (the patient) is not the one who received the information from the manufacturer (the doctor).’”

The court’s use of Mardegan and Geery accurately reflects what was said in those cases, each of which allowed fraud and misrepresentation claims to proceed notwithstanding the learned-intermediary doctrine. But it is not clear that those decisions accurately reflect Florida law. Like Pirlein, they cite no Florida cases, only federal cases, some of which did not even purport to apply Florida law.

That is problematic, particularly as to proper application of the Erie doctrine requiring federal courts exercising diversity jurisdiction not to predict expansions of state law.  If Florida law allows patients to assert fraud and misrepresentation claims based on representations made not to them but to their physicians, one would expect a Florida court to have said so. The fact that neither Pirlein nor Mardegan nor Geery cites such a case makes one wonder whether Florida truly allows such claims.

In states where they have been adopted, Restatement (Second) of Torts §§ 310 and 311 would support fraud and misrepresentation claims based on representations made to a patient’s doctor rather than directly to the patient. It seems, however, that Florida has not adopted either provision as its own. A pair of pre-Buckman cases rejecting fraud-on-the-FDA claims as not recognized under Florida law state that “Florida has not adopted Restatement (Second) of Torts Section 310.” Prado v. Danek Med., Inc., 1999 WL 33537324, at *2 (M.D. Fla. 1999); accord Wilson v. Danek Med., Inc., 1999 WL 1062129, at *8 (M.D. Fla. 1999). Even now, more than two decades later, a diligent search reveals no Florida court explicitly adopting (or rejecting) § 310 or § 311.

The lack of on-point Florida law leaves Pirlein, Mardegan, and Geery on shaky ground.

But even if Florida’s learned-intermediary doctrine does not categorically bar patients from asserting fraud and misrepresentation claims based on representations made to their physicians, a patient bringing such a claim must, at minimum, allege and ultimately prove that their physician relied on a misrepresentation when deciding on their treatment and that they were injured as a result of that decision.