The Arizona Supreme Court issued an opinion in favor of Medicis Pharmaceutical Corp. and clarified prescription drug manufacturers’ responsibility for warning patients about the potential side effects of their products, reports the Phoenix Business Journal.
The court’s opinion pertains to a consumer-fraud claim Amanda Watts filed in 2012 against Medicis, which is now a subsidiary of Valeant Pharmaceutical Corp. Watts said in the lawsuit that she developed drug-induced lupus and autoimmune hepatitis after taking two 20-week courses of Solodyn, a time-released acne treatment containing minocycline. She claimed Medicis was responsible because the company did not provide sufficient warnings about all of the drug’s possible side effects.
Watts received the first round of treatment in 2008, when she was 16, and the second round in 2010. She said her doctor’s office gave her a Medicis drug discount card stating that the safety of using the drug longer than 12 weeks had not been studied and was unknown. She said her pharmacist gave her a paper insert with the prescription that instructed patients to consult a physician if their symptoms did not improve within 12 weeks.
In the claim, Watts said Medicis knowingly misrepresented and omitted material facts on its discount card. She said she never received the full prescribing information, which does state that long-term use of minocycline has been associated with “drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis."
An attorney with the law firm that represented Medicis in the lawsuit said the court’s opinion clarified that a drug manufacturer fulfills its responsibility to caution a consumer about potential risks associated with its prescription drugs when the manufacturer provides full, adequate warnings to the consumer’s medical provider. Other states have established similar guidelines for drugmakers.