Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
An Arizona Supreme Court ruling last week brought the state in line with a number of other states in terms of its use of the “learned intermediary doctrine,” under which drug manufacturers satisfy their duty to warn consumers about their products by giving appropriate warnings to a prescribing physician or other health care provider.
The case under review, known as Watts v. Medicis Pharmaceutical Corporation, pitted Amanda Watts, who developed lupus and hepatitis after taking Medicis’ acne drug Solodyn, against the drugmaker, claiming that Medicis (which was acquired by Valeant Pharmaceuticals in 2012) failed to provide adequate safety warnings about the drug.
Watts’ lawsuit was initially dismissed by a country superior court judge, but that decision was later reversed by the Arizona Court of Appeals.
Now, the state Supreme Court has weighed in, saying Watts’ consumer-fraud claim can proceed in superior court, though it rejected her claim that this learned intermediary doctrine (LID) “creates a blanket immunity for pharmaceutical manufacturers,” because a manufacturer that fails to give adequate warnings to the physician or health-care provider can still be liable.
The LID, which has been adopted in a number of states, makes clear that a manufacturer of a product has fulfilled its duty when providing all of the necessary information to a "learned intermediary," such as a doctor, who then interacts with the consumer of a product.
One of Medicis’ attorneys, Lori Voepel, explained to Focus: “Drug manufacturers will clearly continue to rely on the LID to defend against drug liability claims in Arizona. I say ‘continue to rely’ because up until last year when the Arizona Court of Appeals rejected the LID in Watts, Arizona courts followed the LID for 37 years based on the 1978 Arizona Court of Appeals Opinion in Dyer. A number of subsequent Arizona Court of Appeals opinions also followed the LID under Dyer until last year. The Arizona Supreme Court had never ruled on the LID until now, however, and it was important for it to do so given that the vast majority of jurisdictions in the US follow the LID.”
The Supreme Court expressly left two issues open for further litigation: whether the materials relied upon by Watts constituted “advertising” and whether her state consumer fraud claim is pre-empted by federal law. The court also remanded the case to the trial court for a determination of whether Medicis gave adequate warnings to Watts’ physician or health care provider, according to Voepel’s firm Jones, Skelton & Hochuli.
And pharmaceutical manufacturers operating in A
“The Arizona Supreme Court Opinion simply brings Arizona back into alignment with virtually every other state in following the LID,” Voepel told us. “I don’t expect labeling or warnings to change as a result of its Opinion, because the LID simply says the drug manufacturer meets its duty to warn a consumer of risks associated with a prescription drug by providing complete, accurate warnings to medical providers, which they already do through their FDA approved warnings/labeling.”
Arizona Supreme Court Ruling
JSH Attorneys Lori Voepel, Don Myles & Josh Snell Obtain Favorable Opinion From the Arizona Supreme Court
Tags: Valeant, learned intermediary doctrine, pharmaceutical warning labels