Lawyer Commentary JD Supra United States Supreme Court Adopts Learned Intermediary Doctrine for Claims Against Prescription Drug Manufacturer

Supreme Court Adopts Learned Intermediary Doctrine for Claims Against Prescription Drug Manufacturer

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Was v. Medicis Pharmaceucal Corp.
Supreme Court of the State of Arizona, January 21, 2016
SUPREME COURT ADOPTS LEARNED INTERMEDIARY DOCTRINE FOR CLAIMS AGAINST PRESCRIPTION
DRUG MANUFACTURER
Was, a minor, sought medical treatment for acne and her doctor gave her a prescripon for Solodyn, a drug
manufactured by Medicis. Medicis’ full informaonal materials warned that the long-term use of minocycline,
an ingredient in Solodyn, had been associated with drug-induced lupus-like syndrome, autoimmune hepas and
vasculis, and that paents experiencing fever, rash, and other side eects should disconnue the product and
seek medical help. Was apparently did not receive this full prescribing informaon, but did receive two other
publicaons about the drug that contained some warnings. Was ulmately developed drug-induced lupus, and
sued Medicis alleging consumer fraud and product liability. She claimed Medicis misrepresented and omied facts
in the informaon she did receive, and that the drug was defecve and unreasonably dangerous.
The trial court dismissed Was’ claim pursuant to the “learned intermediary doctrine” (which the Supreme
Court had not yet addressed). To establish a product liability claim, a plain must prove that the manufacturer
had a duty to warn of the product’s dangerous propensies and that the lack of an adequate warning made the
product dangerous and unreasonably defecve. In certain contexts, the manufacturer fullls the duty by providing
adequate warning to a “learned intermediary,” who then must pass along the warning to the end user. In the
prescripon drug context, since the product can only be obtained through a prescribing physician, who is in a
posion to understand and evaluate the risks and benets, the manufacturer fullls the duty to warn by providing
adequate warnings to the physician; and the physician then has the duty to give the paent such informaon as
is deemed appropriate under the circumstances so the paent can make an informed choice. Not only does the
manufacturer lack the means to eecvely communicate with each paent, but doing so would unduly interfere
with the physician-paent relaonship.
The court of appeals reinstated Was’s case against Medicis, ruling that the learned intermediary doctrine is
inconsistent with the Uniform Contribuon Among Toreasors’ Act, and its underlying raonale “not persuasive
now.
The Supreme Court vacated the court of appeals’ decision, adopted the learned intermediary doctrine (“LID”), and
held that the LID applies to prescripon drug manufacturers. The court rejected the argument that the LID “creates
a blanket immunity for pharmaceucal manufacturers,” because the manufacturer who fails to give adequate
warning to the physician can sll be liable. The court also rejected the noon that the LID is incompable with the
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Uniform Contribuon Among Toreasors’ Act. UCATA simply requires the apporonment of damages based on
degrees of fault; and under the LID, the manufacturer that gives adequate warnings to the learned intermediary
is simply not at fault. Finally, the court rejected Was’s argument that the doctrine violates the an-abrogaon
clause in Arizona’s constuon, because (a) the LID is a common law doctrine, not a statutory limitaon and (b) the
LID does not prevent a plain from bringing a claim; it provides a means for the manufacturer to fulll its duty.
The court remanded for a determinaon of whether Medicis gave adequate warnings to the physician.
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