The Learned Intermediary Doctrine

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The doctrine is commonly used to show to whom a defendant—usually a prescription drug manufacturer—owes the duty to adequately warn. The doctrine bars a plaintiff’s claims if she cannot show that the allegedly inadequate warning was a producing cause of her injury. Relators argued that the learned intermediary doctrine does not apply to claims under the FCA. Specifically, Relators argued that SPI cannot rely on the learned intermediary doctrine because there is no causal connection between the warnings given by the prescribing physicians and the alleged FCA violations. SPI, on the other hand, argued that, at trial, Relators should be forced to account for the role of the learned intermediary. The court ultimately denied Relators’ motion