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Torts—Product Liability—Duty to Warn—Prescription Drugs—Learned Intermediary Doctrine—Consumer Fraud Act

Posted by Ted A. Schmidt | Feb 10, 2016 | 0 Comments

Watts v. Medicis Pharmaceutical Corp., 730 Ariz. Adv. Rep. 26 (January 21, 2016) (VCJ Pelander)

DRUG MANUFACTURER PROTECTED FROM LIABILITY TO CONSUMER UNDER LEARNED INTERMEDIARY DOCTRINE IF IT ADEQUATELY WARNS PRESCRIBING PHYSICIANS OF SIDE EFFECTS/A DRUG IS “MERCHANDISE” AND THUS COVERED UNDER ARIZONA'S CONSUMER FRAUD ACT

Plaintiff, a minor, had acne. She was given a prescription for Solodyn, from her treating physician and ultimately developed hepatitis and lupus—known side effects of the drug. Both the physician and plaintiff received some warning from the defendant. The question was whether it was adequate.  

Plaintiff sued the defendant pharmaceutical company for product liability—failure to warn, and consumer fraud.  The trial court dismissed her complaint pursuant to Ariz. R. Civ. Pro. 12(b)(6).  The Arizona Court of Appeals vacated the judgment and remanded the case holding the Learned Intermediary Doctrine [LID] inconsistent with the Uniform Contribution Among Tortfeasors Act [UCATA]. The Arizona Supreme Court affirmed the court of appeals in part and vacated in part.

Under the learned intermediary doctrine ("LID"), a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the specialized class of persons who may prescribe or administer the product. We hold today that the LID generally applies to a prescription drug manufacturer. We further conclude that the LID is not displaced by the Uniform Contribution Among Tortfeasors Act ("UCATA"), A.R.S. §§12-2501 through -2509.  Finally, we hold that prescription drugs are "merchandise" for purposes of the Consumer Fraud Act ("CFA"), A.R.S. §§44-1521 through -1534, and the CFA does not require a direct merchant consumer transaction to support a patient's statutory claim against a drug manufacturer.

The court adopted the Third Restatement § 6 for a precise articulation of how the LID should  be applied:              

A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to: (1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or (2) the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

Therefore the court of appeals ruling is vacated and the matter is remanded for further proceedings concerning plaintiffs' claim the warnings issued by defendant were inadequate. If the warnings were inadequate to properly inform the prescribing physician the claim against the defendant should go forward; if the physician was adequately informed the defendant's duty has been met and the plaintiff's product liability claim must fail.

Lastly, the plaintiff's CFA count is viable. Plaintiff alleges that the pharmaceutical warnings stated it was unknown what effects might follow using the product for more than 12 weeks when in fact the defendant knew that prolonged use increased the risk of dangerous side effects like lupus and hepatitis.

About the Author

Ted A. Schmidt

Ted's early career as a trial attorney began on the other side of the fence, in the offices of a major insurance defense firm. It was there that Ted acquired the experience, the skills and the special insight into defense strategy that have served him so well in the field of personal injury law. Notable among his successful verdicts was the landmark Sparks vs. Republic National Life Insurance Company case, a $4.5 million award to Ted's client. To this day, it is the defining case for insurance bad faith, and yet it is only one of several other multi-million dollar jury judgments won by Ted during his career. He is certified by the State Bar of Arizona as a specialist in "wrongful death and bodily injury litigation".

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