Arizona Supreme Court to Decide Applicability of Learned Intermediary Doctrine in Acne Medication Lawsuit

NOVAMOXIN_antibioticIn Watts v. Medicis Pharmaceuticals, the plaintiff was prescribed a course of treatment involving the drug Solodyn for her chronic acne. According to the plaintiff, she received two publications providing information about the drug. The first document was a MediSAVE card that outlined a program for discounted purchases of the drug and warned that the drug’s safety beyond a 12-week period had not been studied. The second document was an information insert provided at the pharmacy, detailing Solodyn’s possible side effects and safety conditions. The insert also instructed takers of the drug to contact their physician if any side effects or symptoms persisted past a 12-week period.

According to the plaintiff, the two pieces of information provided to her, the card and the insert, did not bear the same warnings and possible side effects as the FDA-approved patient label or the full prescribing information that the medical provider received with Solodyn. According to the full prescribing information, for example, the drug could potentially lead to autoimmune hepatitis or a lupus-like syndrome when the drug was ingested over a long period of time.

Shortly after taking her second round of treatment, the plaintiff was diagnosed with drug-induced hepatitis and lupus, which doctors attributed to her use of Solodyn. The plaintiff filed a complaint against the defendant drug manufacturer, alleging product liability and other theories of recovery. The defendant moved to dismiss the case, alleging that the plaintiff failed to state a claim. The trial court granted the motion, based partly on the learned intermediary doctrine. According to this theory, a manufacturer cannot be held liable for failing to warn a consumer of the potential side effects and risks of a drug if the manufacturer provided the appropriate warnings to a patient’s treating physician.

After the trial court denied the plaintiff’s motion for a new trial, the plaintiff appealed, contending that the learned intermediary doctrine is not consistent with Arizona’s standing laws on tortfeasor liability and is an outdated theory based on the prevalence of direct-to-consumer advertising that has come to predominate in pharmaceutical sales. The appellate court reversed the lower court’s ruling that the learned intermediary doctrine is an outdated theory and inconsistent with the state’s use of pure comparative fault. In a case applying the learned intermediary doctrine, a prescribing doctor could end up bearing full responsibility for the plaintiff’s damages, even when a consumer receives a sufficient warning about the treatment and even when the manufacturer was partly responsible for the inadequacy of the warning.

The court also reversed based on Arizona’s consumer fraud protection laws, concluding that consumers have a choice when it comes to purchasing and using certain drugs that have been prescribed and that this choice renders consumers susceptible to fraudulent misrepresentations. The court further concluded that the plaintiff had pled a sufficient claim under Arizona’s Consumer Fraud Act by alleging that she had relied on marketing materials for Solodyn and the label indicating that the drug’s safety beyond a 12-week period was uncertain.

The defendants filed a petition for review with the Arizona Supreme Court, which was granted. Oral argument is set for November 17, 2015.

If you or someone you know has suffered injuries after taking a pharmaceutical medication, you may be entitled to compensation. At Moll Law Group, our product liability lawyers have represented numerous victims throughout the nation, including in New York, Florida, and California, from our headquarters in Chicago. Call us at 312-462-1700 or contact us online to set up a free consultation.