Ortho Pharmaceutical Corp. v. Heath

Supreme Court of Colorado, En Banc · 1986 · Torts

TortsProducts LiabilityDesign DefectPrescription DrugsStrict Liabilitystrict liabilitydesign defectprescription drug

Facts

Heath used Ortho-Novum oral contraceptives for years and, after reporting one incident of break-through bleeding in 1972, her physician increased her dosage from Ortho-Novum 1/50 to Ortho-Novum 1/80. She continued taking Ortho-Novum 1/80 until November 1974, when she became critically ill with acute kidney failure and later required a kidney transplant. Heath's experts testified that her kidney failure was caused by malignant hypertension or hemolytic uremic syndrome induced by Ortho-Novum 1/80, while Ortho's experts disagreed. Heath also claimed that Ortho-Novum 1/80 was defectively designed because the additional estrogen created risks that outweighed its benefits, and Ortho sought a comment k instruction based on the drug's utility and unavoidable risks.

Issue

Whether Heath presented sufficient evidence of causation and design defect to submit the case to the jury, and whether the trial court erred by instructing the jury on design defect under a consumer-expectation formulation rather than a risk-benefit test and by refusing to instruct on comment k. The court also considered whether the design defect claim was untimely raised.

Rule

In prescription-drug design defect cases involving a product manufactured exactly as intended but alleged to be unreasonably dangerous, the proper standard is the Barker-style risk-benefit test rather than the consumer expectation test. Under that test, if the plaintiff proves that the product's design proximately caused injury, the defendant must prove, in light of relevant factors, that the benefits of the challenged design outweigh its inherent risks. A manufacturer is entitled to a comment k instruction when there is evidence supporting the factors stated in Belle Bonfils: the product's utility must greatly outweigh the risk created by its use, the risk must be known, the product's benefits must not be achievable in another manner, and the risk must be unavoidable under the present state of knowledge.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Denver, Marisa Lopez sued Silver Mesa Therapeutics after suffering liver damage allegedly caused by a prescription acne medication that had been manufactured exactly as intended. Her theory was that the drug's formula used a dosage level whose risks exceeded its therapeutic benefits. At trial, the judge instructed the jury only that the drug was defective if it was more dangerous than an ordinary consumer would expect.

If Silver Mesa appeals, what is the strongest argument regarding the design-defect instruction?

Explanation. For prescription-drug design defect claims involving a product made exactly as intended but alleged to be unreasonably dangerous by design, the majority held that the consumer-expectation test is inadequate. The proper standard is the Barker-style risk-benefit test. Thus an instruction limited to ordinary consumer expectations is reversible error. (Derived from Ortho Pharmaceutical Corp. v. Heath (n.d.).)