Arizona High Court Adopts Learned Intermediary Doctrine; No Conflict With Tort Law

PHOENIX — (Mealey’s) The Arizona Supreme Court on Jan. 21 adopted the learned intermediary doctrine and said it can be used by drug manufacturer Medicis Pharmaceutical Corp. to defend against a drug liability claim (Amanda Watts v. Medicis Pharmaceutical Corporation, No. CV-15-0065-PR, Ariz. Sup.). 

(Opinion available.  Document #28-160204-001Z.) 

The high court also said the Arizona Consumer Fraud Act does not exclude prescription drugs and that the consumer law does not require a direct-to-consumer transaction to support a plaintiff’s drug claim against a manufacturer. 

The ruling reverses an Arizona Court of Appeals ruling last year that the state’s law eliminating joint-and-several liability supersedes the learned intermediary doctrine. 

Antibiotic Injury Claimed

Plaintiff Amanda Watts was prescribed the tetracycline antibiotic Solodyn to treat acne.  The drug’s label warned that long-term use is associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. 

Watts took Solodyn twice for 20 weeks each.  In 2010, she was diagnosed with drug-induced lupus and hepatitis.  She recovered from hepatitis but is expected to have lupus for the rest of her life. 

In 2012, Watts sued Medicis Pharmaceutical Corp., an Arizona drug company that made Solodyn.  The Maricopa County Superior Court granted Medicis’ motion to dismiss.intermediary doctrine is inconsistent with the Arizona Uniform Contribution Among Tortfeasors Act (UCATA), the law that did away with joint-and-several liability.

Learned Intermediary Adopted

Watts appealed, and the Court of Appeals vacated dismissal and remanded the case.  It found the learned

Watts appealed to the Supreme Court. 

Noting that it has never ruled on the learned intermediary doctrine, the Supreme Court adopted the doctrine as it appears in the Restatement (Third) of Torts. 

The high court clarified that the learned intermediary doctrine “does not create a blanket immunity for pharmaceutical manufacturers” because they can still be liable for failing to provide adequate warnings to a learned intermediary.  It said Medicis acknowledge that possibility. 

The Supreme Court disagreed that the learned intermediary doctrine is no longer viable.  

No Direct-To-Consumer Exception

The high court rejected Watts’ argument that Arizona adopt a direct-to-consumer advertising exception to the learned intermediary doctrine, as did the New Jersey Supreme Court in 1999.  The Arizona court said the Third Restatement provides an exception for inadequate warnings which protects consumers. 

The Supreme Court disagreed with the Court of Appeals that the UCATA undermines the learned intermediary doctrine.  It said the two theories address “two distinct subjects” and “are not mutually exclusive.” 

The learned intermediary identifies circumstances when a manufacturer has met it duty to warn and is not at fault, the court said.  The UCATA does not identify the scope of duties or when parties are at fault..

Instead, the court said the UCATA specified how liability is apportioned among multiple tortfeasors once fault is determined.  “In sum, the [learned intermediary doctrine] neither insulated a manufacturer from liability in proportion to its share of fault nor shifts a disproportionate share of liability to someone else,” the court wrote. 

Preserves Right To Damages

Watts and her amicus curiae argued that the learned intermediary violates the anti-abrogation clause in Article 18, Section 6, of the Arizona Constitution, which says the right to recover damages for injuries shall never be abrogated.  The high court said the clause does not preclude the court from “declaring, clarifying, or modifying the common law,” such as the learned intermediary. 

The learned intermediary doctrine also does not abrogate the right to recover, the court continued, but instead provides a manufacturer with a means to fulfill its duty to warn.  The court reiterated that a consumer can sue a drug manufacturer for inadequate warnings to learned intermediaries. 

Plaintiffs may also sue drug prescribers, the court said. 

Viewing Watts’ complaint in the most favorable light, the Supreme Court said the plaintiff implies that Medicis failed to give appropriate warnings to her health care provider.  The court vacated the dismissal of Watts’ product liability claim and remanded for further proceedings. 

Consumer Fraud Claim Reinstated

On remand, it said Medicis can argue that it provided “complete, adequate” warnings to Watts’ doctor and that it is protected by the learned intermediary doctrine. 

The court also reversed dismissal of Watts’ Consumer Fraud Act claim, saying the law does not expressly require direct merchant-to-consumer transaction.  It said she alleged an actionable claim under the consumer law. 

The high court cautioned that it did not address two other issues not raised by the parties:  whether a drug savings card given to Watts was an advertisement under the consumer law and whether federal law preempts the consumer claim. 

Vice Chief Justice John Pelander wrote the opinion.  He was joined by the other four justices. 

Counsel

Watts is represented by Mick Levin and Michael D. Malin of Mick Levin P.L.C. in Phoenix.  Medicis is represented by Donald L. Myles Jr., Lori L. Voepel and Joshua M. Snell of Jones, Skelton & Hochuli in Phoenix. 

Amicus curiae State of Arizona is represented by Attorney General Mark Brnovich, Solicitor General John R. Lopez IV and Assistant Attorneys General David W. Garbarino and Stephen J. Emedi of the Attorney General’s Office in Phoenix.  Amicus Arizona Association for Justice /Arizona Trial Lawyers Association are represented by Stanley G. Feldman of Haralson, Miller, Pitt, Feldman & McAnally in Tucson, Ariz., and David L. Abney and Dana R. Roberts of Knapp & Roberts in Scottsdale, Ariz. 

Amicus Product Liability Advisory Council Inc. is represented by Wayne D. Struble of Bowman and Brooke in Phoenix.  Amici Pharmaceutical Research and Manufacturers of America, the United States Chamber of Commerce Chamber Litigation Center, the Arizona Chamber of Commerce & Industry and the Arizona Manufacturers Council are represented by Alan Blankenheimer of Covington & Burling in Los Angeles, Michael X. Imbroscio and Paul W. Schmidt of Covington & Burling in Washington, D.C.

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