Arizona Supreme Court Poised to Consider “Learned Intermediary” Doctrine

The Arizona Supreme Court has agreed to hear an appeal of the Court of Appeals’ January 2015 decision regarding the longstanding “learned intermediary” doctrine. In January, the lower court held that the doctrine was inconsistent with Arizona’s system of pure comparative fault.

Under the widely adopted learned intermediary doctrine, a drug manufacturer, for example, is not required to inform a patient of the dangers of a prescription drug as long as it provides an adequate warning to the prescribing physician. The physician is expected to act as an intermediary between the manufacturer and the patient. The burden shifts to the physician to disclose any drug-related risks once the manufacturer adequately informs the physician, because the physician is the most direct contact between a manufacturer and the patient and the physician is better informed about her patient’s care.

In Watts v. Medicis Pharmaceuticals, plaintiff Watts’s medical provider prescribed her two twenty-week courses of treatment with the drug Solodyn, to treat her chronic acne. Watts alleges she received two informational publications regarding Solodyn: a “MediSAVE” card from her doctor outlining a discount purchase program and warning that the safety of the drug beyond twelve weeks had not been studied and was unknown; and an informational insert from her pharmacy about Solodyn’s possible side effects and safety conditions. It also warned that patients should consult a doctor if symptoms do not improve within twelve weeks.

The two publications provided to Watts did not contain the same possible side effects or warnings stated on the FDA-approved patient labeling or the full prescribing information provided to her medical provider. The full prescribing information provided to the medical provider warned that lupus-like syndrome and autoimmune hepatitis are possible results associated with the “long term” use of Solodyn.

A few months after Watts’s second course of treatment, she was hospitalized and diagnosed with drug-induced lupus and drug-induced hepatitis allegedly stemming from her use of Solodyn. Watts filed a complaint against Medicis alleging consumer fraud, product liability, and punitive damages claims. The trial court dismissed Watts’s product liability claim on the basis of the learned intermediary doctrine. On appeal, Watts argued that the learned intermediary doctrine is legally inconsistent with the Uniform Contribution Among Tortfeasors Act and outdated in light of direct to consumer advertisement under modern medical practice. The Arizona Court of Appeals agreed with Watts and vacated the trial court’s judgment for dismissal. The Arizona Supreme Court granted Medicis’ petition for review.

Oral argument will be held November 17, 2015.