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January 21, 2016

Arizona Supreme Court Upholds the Validity of Learned Intermediary Doctrine in Watts v. Medicis Pharmaceuticals

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Late last fall, the Arizona Supreme Court heard argument in Watts v. Medicis Pharmaceuticals, a case challenging the validity of the Learned Intermediary Doctrine (LID) in Arizona. The Watts case provides important protection to drug and device manufacturers with cases in Arizona as it adopts the Restatement (Third) of Torts conclusion that the manufacturer fulfills its duty to warn by providing adequate warnings to physicians. It is then the physician's responsibility to provide the appropriate warnings and information to his or her patients.

This case arose out of a patient's claim that she developed drug-induced lupus after using Solodyn, a Medicis acne medication that contains minocycline. Watts, the patient, received a "MediSAVE" card instructing her that "[t]he safety of using [Solodyn] longer than 12 weeks has not been studied and is not known." But the full prescribing information about the drug, which is meant for prescribing physicians, specifically stated that the long-term use of minocycline has been associated with drug-induced lupus-like syndrome. 

After Watts was diagnosed with drug-induced lupus, she sued Medicis, claiming failure to warn and violation of Arizona's Consumer Fraud Act (CFA) by supplying false information in connection with the sale of “merchandise.” The trial court granted Medicis's motion to dismiss. The court of appeals, however, vacated the judgment, concluding that the learned intermediary doctrine is inconsistent with Arizona's comparative fault statutes (UCATA), and that a pharmaceutical is merchandise for the purposes of the consumer fraud act.

The Arizona Supreme Court accepted review of the case, and this morning, issued an opinion vacating in part and affirming in part the court of appeals decision. In a detailed and well-reasoned discussion, it rejected the court of appeals' conclusion that the LID is inconsistent with UCATA. The LID pertains to duty, whereas UCATA pertains to allocation of fault once a duty has been breached. Expressly adopting the Third Restatement, (which applies to prescription medical devices as well as to drugs), the Arizona Supreme Court concluded that "if the manufacturer provides complete, accurate, and appropriate warnings about the product to the learned intermediary, it fulfills its duty to warn the consumer."

The Court noted, however, that a plaintiff may still recover directly from the manufacturer if the manufacturer does not provide adequate warnings to the intermediary or if the manufacturer knows or has reason to know that providers will not be in a position to reduce the risk of harm in accordance with instructions. Notably, the Court explicitly rejected an exception to the LID when the manufacturer engaged in direct-to-consumer marketing. It held, rather, that the Third Restatement provides sufficient protection by including an exception to the LID 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.”

Reading the complaint in the light most favorable to plaintiffs, the Court found that the plaintiff had “implied” that Medicis failed to deliver adequate warnings to her doctor, vacated the dismissal on this ground, and remanded for further proceedings.

Although the Court rejected the court of appeals' abrogation of the learned intermediary doctrine, it agreed that prescription drugs are merchandise for the purposes of the CFA notwithstanding the absence of a direct manufacturer to consumer sale. Accordingly, a plaintiff who shows that the manufacturer made a false promise or misrepresentation in connection with a sale of a drug, as well as proximate cause, can state a claim. This is a departure from the view expressed in some court of appeals opinions that privity is a requirement to state a valid CFA claim.

The CFA issue raises an interesting potential wrinkle. Given that this claim was based on a direct-to-consumer statement (on the MediSAVE card), future plaintiffs may try to use consumer fraud as an end-run around the LID. They may argue that it permits them to hold the manufacturer liable for “affirmative misrepresentations” directly to the plaintiff, even if they delivered an adequate warning to the physician. The CFA holding arguably is at odds with the Court’s embrace of the LID and rejection of an exception when the manufacturer conducts direct-to-consumer advertising.

At oral argument, counsel for Medicis argued that neither a warnings defect nor a consumer fraud act claim could arise from the warnings or the MediSAVE card because the information that they contained was approved and mandated by the FDA. Because Medicis did not raise a federal preemption argument either at the trial court or in the court of appeals, the Supreme Court declined to address it.

Bowman and Brooke LLP participated in briefing on behalf of the Product Liability Advisory Council, which filed an amicus brief in the Arizona Supreme Court.

Read our previous coverage on Watts v. Medicis Pharmaceutical