## Facts

- Amanda Watts, a minor in 2008, was prescribed Solodyn (minocycline) by her medical provider for acne and used it as directed for 20 weeks.
- In 2010, the provider again prescribed Solodyn, and Watts used it for another 20 weeks.
- Watts received a “MediSAVE” discount card stating the safety of use beyond 12 weeks had not been studied and a pharmacy insert advising consultation if symptoms did not improve within 12 weeks.
- Watts did not allege she received FDA-approved patient labeling or full prescribing information provided to physicians warning that long-term minocycline use can cause lupus-like syndrome and autoimmune hepatitis and advising patients to stop the drug and seek medical help if symptoms occur.
- In October 2010, Watts developed severe joint pain and was diagnosed with drug-induced lupus and drug-induced hepatitis; she recovered from hepatitis but alleged lupus may be permanent.
- Watts sued the manufacturer, Medicis Pharmaceutical Corporation, alleging product-liability failure to warn and violations of the Arizona Consumer Fraud Act based on misleading or incomplete patient-facing materials; she also sought punitive damages.
- The trial court dismissed under Rule 12(b)(6); the court of appeals vacated and remanded; the Arizona Supreme Court granted review.

## Issues

1. Whether Arizona recognizes the learned intermediary doctrine for prescription drug manufacturers and whether it required dismissal of Watts’s failure-to-warn claim.
2. Whether the Uniform Contribution Among Tortfeasors Act (UCATA) displaced the learned intermediary doctrine.
3. Whether prescription drugs are “merchandise” under the Arizona Consumer Fraud Act and whether a direct manufacturer-to-patient transaction is required for a statutory claim.

## Decision

- The Arizona Supreme Court held the learned intermediary doctrine generally applies to prescription drug manufacturers in Arizona.
- The Court held UCATA did not abrogate or modify the learned intermediary doctrine.
- The Court held prescription drugs are “merchandise” under the Consumer Fraud Act and that the Act does not require a direct merchant-consumer transaction.
- The Court reversed the Rule 12(b)(6) dismissal, affirming in part and vacating in part the court of appeals, and remanded for further proceedings because Watts plausibly pleaded failure-to-warn and consumer-fraud claims.

## Legal Principles

- Under the learned intermediary doctrine, a prescription drug manufacturer generally satisfies its duty to warn by providing adequate warnings to the prescribing or administering medical professional, who is positioned to assess patient-specific risks and benefits.
- The learned intermediary doctrine allocates the recipient of the warning duty; it does not bar claims alleging the manufacturer failed to adequately warn the medical professional or used misleading patient-directed communications.
- UCATA governs allocation of fault and contribution among tortfeasors and does not, absent clear legislative intent, eliminate common-law doctrines defining the scope of duty such as the learned intermediary doctrine.
- The Arizona Consumer Fraud Act applies to deception or omission of material facts in connection with the sale or advertisement of “merchandise,” and prescription pharmaceuticals fall within the statutory definition.
- A Consumer Fraud Act claim may be brought against a manufacturer based on marketing or informational representations even without a direct purchase transaction between the patient and manufacturer.
- On a Rule 12(b)(6) motion, courts accept well-pleaded facts and reasonable inferences; dismissal is improper where the complaint plausibly alleges inadequate warnings and materially misleading omissions or representations.

## Conclusion

Arizona adopted the learned intermediary doctrine for prescription drugs but held it neither foreclosed failure-to-warn claims alleging inadequate physician warnings or misleading patient materials nor limited statutory consumer-fraud claims; prescription drugs qualify as “merchandise,” no direct transaction is required, and Watts’s complaint could proceed past the pleading stage.


Watts v. Medicis Pharm. Corp., 365 P.3d 944 (Ariz. 2016)