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Lewis v. Baker, Richardson-Merrell, Inc.

Supreme Court of Oregon
243 Or. 317 (1966)
ELI5:

Rule of Law:

A manufacturer of a prescription drug is not strictly liable for breach of warranty for adverse effects if the drug was properly tested, labeled with appropriate warnings, and approved by a federal regulatory agency, unless the plaintiff proves the drug was impure, the labeling was inadequate, or the manufacturer committed fraud or culpable nondisclosure in obtaining or retaining that approval.


Facts:

  • Plaintiff took MER/29 (triparanol), a prescription drug manufactured by the defendant, to treat a medical condition.
  • Plaintiff allegedly suffered damages and adverse side effects as a result of using the drug.
  • The drug had been approved for marketing by the United States Food and Drug Administration (FDA) in June 1960.
  • At the time Plaintiff took the drug in October 1961, the FDA-approved labeling warned of certain potential side effects, including skin reactions.
  • There was no evidence that the drug was defectively manufactured or that its harmful effects were caused by impurities.
  • The drug had known propensities to cause undesired reactions in some users.
  • The manufacturer withdrew the drug from the market in April 1962.

Procedural Posture:

  • Plaintiff brought an action in a state trial court against a drug retailer and the drug's manufacturer, alleging negligence and breach of warranty.
  • Plaintiff voluntarily dismissed the claim against the retailer.
  • At trial, the court withdrew the breach of warranty claim against the manufacturer from the jury's consideration.
  • The jury returned a verdict in favor of the manufacturer on the remaining negligence claim.
  • The trial court entered a judgment for the manufacturer based on the jury's verdict.
  • Plaintiff (appellant) appealed the judgment to the state's highest court, arguing the trial court erred by withdrawing the warranty claim. The manufacturer is the appellee.

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Issue:

Is a manufacturer of a prescription drug that is properly tested, labeled with appropriate warnings, and approved by the Food and Drug Administration (FDA) strictly liable for breach of warranty for adverse effects suffered by a user?


Opinions:

Majority - Goodwin, J.

No. A manufacturer of a prescription drug is not strictly liable for breach of warranty when the drug is properly tested, labeled with appropriate warnings, and approved by the FDA. Such a drug is considered, as a matter of law, a reasonably safe product. The court aligns this holding with the concept of "unavoidably unsafe products" detailed in Comment k to Section 402A of the Restatement (Second) of Torts, which recognizes that some products, particularly drugs, carry inherent risks that are justified by their therapeutic benefits. This protection from strict liability is not absolute; it does not shield a manufacturer who markets a drug that is impure or who engages in fraud or culpable nondisclosure to obtain or maintain FDA approval. In this case, the jury's verdict for the defendant on the negligence claim effectively found that there was no culpable nondisclosure in the drug's labeling. Therefore, the trial court's withdrawal of the separate breach of warranty claim was not a reversible error, as the factual basis for that claim (inadequate warning) was implicitly decided in the defendant's favor.



Analysis:

This decision establishes a significant 'safe harbor' for pharmaceutical manufacturers under strict products liability law. It shields them from liability for 'unavoidably unsafe' prescription drugs, provided they comply with the comprehensive federal regulatory scheme overseen by the FDA. The ruling effectively shifts the burden to the plaintiff, who cannot merely show injury but must prove a specific defect, such as impurity, inadequate labeling, or fraud upon the FDA. This aligns Oregon law with the widely adopted Comment k defense, balancing consumer protection with the public interest in encouraging the development and marketing of new, potentially life-saving medications that may carry inherent risks.

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