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AZ Adopts Learned Intermediary Doctrine in Drug-Induced Lupus Case

Piece of Paper reading "lupus" with pills and syringes surrounding it

The Arizona Supreme Court has reinstated a case brought by a young woman against Medicis Pharmaceutical Corporation for her diagnoses of drug-induced lupus that is allegedly a side effect from the acne medication Solodyn.

The court for the first time recognized the learned intermediary doctrine, which states that a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the prescribing physician.

Amanda Watts completed her first round of treatment as a minor when she was prescribed the medication for 20 weeks. Two years later, Watts was prescribed the medication again for another 20 weeks.

Upon initially receiving Solodyn, Watts did not receive the full prescribing informational materials that indicated the long-term use of the medication had been associated with “drug-induced lupus like syndrome, autoimmune hepatitis, and vasculitis.”

No drug-induced lupus warning

Watts only received a “MediSAVE” card from her medical provider stating the safety of using the medication longer than 12 weeks was unknown.  Watts also received an insert that warned patients should consult a doctor if symptoms did not improve within 12 weeks.

After taking the medication for a second time, she was hospitalized and diagnosed with drug-induced lupus and hepatitis as side effects of Solodyn. Watts has recovered from the hepatitis, but doctors expect her to have lupus for the rest of her life.

Watts sued Medicis for consumer fraud and product liability under the Consumer Fraud Act (CFA) for the misrepresentation and omission of material information on the MediSAVE card.  She also sued Medicis for failure to warn her of the defective and unreasonably dangerous nature of long-term use of the medication.

Learned intermediary doctrine adopted

[sws_pullquote_right] See our earlier article: Arizona Court Revives Product Liability Case, Abolishes Learned Intermediary Doctrine [/sws_pullquote_right]

A trial court granted Medicis' motion to dismiss.  The court of appeals vacated the dismissal and remanded the case.  The court found that the learned intermediary doctrine (LID) was no longer viable and incompatible with the Uniform Contribution Among Tortfeasors Act (UCATA).

The UCATA allows a tortfeasor to seek contribution from other tortfeasors, specifying how liability is apportioned among the them.  The court of appeals also found that the CFA was applicable to the case.

The Arizona Supreme Court granted review because the legal issues in the case are of “statewide importance and likely to recur.”  The high court had never before addressed the learned intermediary doctrine, but joined the majority of other states in adopting the Third Restatements expression of the LID.

The supreme court found the reasoning of the lower appeals court, that the LID was incompatible with the UCATA, to be flawed. The court wrote that the LID and the UCATA address two distinct issues and are not in conflict with each other.

The LID addresses whether a manufacturer satisfied its duty to warn a product user by properly warning the learned intermediary.  The UCATA specifies comparative liability given a determination that multiple parties are at fault.

Product liability claim revived

The court vacated the trial court’s dismissal of Watt’s product liability claim and remanded for further proceedings, finding that Watt had properly alleged that Medicis breached its duty to warn if it gave inadequate or defective warnings to Watt’s prescribing physician about the use of Solodyn for more than 12 weeks.

The court found that the LID could apply if Medicis can establish that it provided complete and adequate warnings to the prescribing providers.

The high court affirmed the appeals court finding that the CFA was applicable to the case because prescription pharmaceuticals are considered merchandise under the act.

The court also affirmed that Watt’s has an actionable claim because Medicis misrepresented Solodyn on the MediSAVE card by stating the safety of use of the drug for longer than 12 weeks was unknown, even though they were aware that extended use could cause drug-induced lupus.

The case is Amanda Watts v. Medicis Pharmaceutical Corporation, Case number CV-15-0065-PR, in the Supreme Court of the State of Arizona.

 

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