February 25, 2016 Practice Points

Arizona High Court Reestablishes the "Learned Intermediary" Doctrine

By James Neslon

The learned intermediary doctrine has been a part of American jurisprudence since the phrase first appeared in the 1966 decision by the Eighth Circuit Court of Appeals in Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). In the ensuing five decades, the vast majority of states have adopted some version of the doctrine, either statutorily or through case law established by state intermediate or Supreme Courts. Essentially, the learned intermediary doctrine provides that the manufacturer of a prescription drug or medical device discharges their duty of care to consumers by providing adequate warnings about the dangerous propensities of the drug or device to the prescribing physician. Recently, on January 21, 2016, the Arizona Supreme Court confirmed that the court is among the majority in Watts v. Medicis Pharmaceutical Corp., 2016 WL 237777 (Ariz. Jan. 21, 2016).

While Arizona technically adopted the learned intermediary doctrine in 1978 when it was used by the Arizona Court of Appeals in Dyer v. Best Pharmacal, 118 Ariz. 465, 577 P.2d 1084, 1087 (Ariz. Ct. App. 1978) to affirm a summary judgment in favor of a drug manufacturer and distributor, the doctrine was rejected by the Arizona Court of Appeals in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz. Ct. App. 2015).

In Watts, the plaintiff claimed that she developed drug-induced lupus after using Solodyn, an acne medication, for 20 weeks over two separate periods of time. She sued Medicis, alleging that it failed to warn her about the consequences of Solodyn's long-term use. Watts received information instructing her that "[t]he safety of using [Solodyn] longer than 12 weeks has not been studied and is not known," and that she should consult with a doctor if symptoms did not improve after 12 weeks. However, the full prescribing information about the drug, intended for prescribing physicians, specifically stated that the long-term use of minocycline has been associated with drug-induced lupus-like syndrome. Watts, 2016 WL 237777, at *1.

According to the Watts appellate court, the rationale for the learned intermediary doctrine was no longer "persuasive" and was inconsistent with Arizona's Uniform Contribution Among Tortfeasors Act (UCATA). Watts, 342 P.3d at 856. The UCATA is Arizona's statutory provision that apportions damages in direct proportion to a defendant's degree of fault. But, the Arizona Supreme Court disagreed on both points and reconfirmed the validity of the learned intermediary doctrine as part of Arizona law.

While the appellate court relied on reasoning from a West Virginia case (Johnson & Johnson Corp. v. Karl, 220 W.Va. 436 (W. Va. 2007)) to reject the doctrine, the Arizona Supreme Court in turn found that reasoning unpersuasive. Watts, 2016 WL 237777, at *5. Instead, the supreme court officially adopted the learned intermediary doctrine, as expressed in the Third Restatement of Torts:

A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to: (1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or (2) the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

Id. at *4 (quoting Restatement (Third) of Torts, § 6(d). Additionally, the court found that the doctrine was not incompatible with the UCATA because they address two distinct subjects, duty and fault, which are not mutually exclusive. The court confirmed that the UCATA "is premised on notions of fault, which presupposes a breach of duty," whereas the learned intermediary doctrine, if satisfied, means that there is no breach of a legal duty to the user, and hence no reason for attribution of fault to a manufacturer. Finally, the court confirmed that the learned intermediary doctrine is not an absolute immunity, as the plaintiff argued, because it has no applicability if the manufacturer fails to provide adequate warnings to the learned intermediary.

James Nelson, Sedgwick LLP, Los Angeles, CA


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