Johnson v. American Cyanamid Co.
718 P.2d 1318, 66 A.L.R. 4th 55, 239 Kan. 279 (1986)
Rule of Law:
A manufacturer of an unavoidably unsafe product, such as a prescription vaccine, is not subject to strict liability for a design defect and fulfills its legal duty if it provides the prescribing physician (the 'learned intermediary') with an adequate warning of the product's known risks. The adequacy of such a warning is judged by a reasonableness standard of negligence.
Facts:
- On September 26, 1975, Emil E. Johnson's infant daughter, Laurie, was administered Orimune, a live oral polio vaccine manufactured by American Cyanamid.
- The vaccine was administered by the child's pediatrician, Dr. Vernon Branson.
- The vaccination series continued on November 24, 1975, and January 14, 1976.
- In December 1975, Johnson became ill and was subsequently diagnosed with bulbar paralytic poliomyelitis.
- Johnson contracted the disease through contact with his recently vaccinated daughter, a phenomenon known as 'contact polio'.
- The risk of contact polio from the Sabin-type live vaccine (Orimune) was a known, albeit rare, risk since the vaccine's introduction.
- American Cyanamid provided a package insert with the vaccine that warned physicians of the risk that persons in close contact with vaccinees could contract paralytic disease.
- Dr. Branson did not convey any warning about the risk of contact polio to Johnson.
Procedural Posture:
- Emil E. Johnson sued Dr. Vernon Branson and American Cyanamid Company in a Kansas state trial court for personal injuries.
- The case was tried before a jury, which was instructed on the comparison of fault between the two defendants.
- The jury returned a verdict assessing 0% fault to Dr. Branson and 100% fault to American Cyanamid.
- The jury awarded Johnson $2,000,000 in actual damages and $8,000,000 in punitive damages against American Cyanamid.
- The trial court denied American Cyanamid's motion for a directed verdict.
- Judgment was entered against American Cyanamid based on the jury's verdict.
- American Cyanamid (appellant) appealed the judgment against it to the Supreme Court of Kansas, but did not appeal the finding of zero fault for Dr. Branson. Johnson is the appellee.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Is a manufacturer of a live-virus polio vaccine liable for injuries caused by a known and disclosed risk of the vaccine when it provided a package insert warning the prescribing physician of that specific risk and its statistical probability?
Opinions:
Majority - McFarland, J.
No. A manufacturer of an unavoidably unsafe product that is properly prepared and marketed is not liable for resulting harms as long as it provides an adequate warning of the known risks to the prescribing physician. The Orimune vaccine is an 'unavoidably unsafe product' as described in comment k to Restatement (Second) of Torts § 402A. As such, the manufacturer cannot be held strictly liable for a design defect for choosing to produce the Sabin-type live virus vaccine over the Salk-type killed virus vaccine, especially when the Sabin vaccine was recommended by public health authorities. The manufacturer's liability hinges on the adequacy of its warning, which is analyzed under a negligence standard. The duty to warn extends to the 'learned intermediary,' the physician, not the end user. Here, the warning explicitly stated that paralytic disease could occur in persons in close contact with vaccinees and provided the best available statistics on the frequency of such occurrences. This warning was adequate as a matter of law because it clearly and accurately communicated the exact risk that materialized. Therefore, the trial court erred in denying American Cyanamid’s motion for a directed verdict.
Dissenting - Prager, J.
Yes. The manufacturer can be held liable because the adequacy of a warning is a question of fact for the jury, and there was substantial evidence for the jury to find the warning inadequate. The majority improperly usurped the jury's function by deciding the adequacy of the warning as a matter of law. The warning's language was subdued and misleading, stating that reported symptoms were 'minor and apparently unrelated' and that only 'some' believed the vaccine caused the paralysis, which downplayed a known causal link. Crucially, an adequate warning should have informed the physician of reasonably available alternative products, such as the Salk vaccine, which carried no risk of causing paralysis. The warning's failure to mention this alternative deprived the physician and patient of the ability to make a fully informed choice. Expert testimony, including from the treating physician, supported the view that the warning was inadequate, creating a clear issue of fact that the jury rightfully decided against the manufacturer.
Analysis:
This case solidifies the application of the 'unavoidably unsafe product' doctrine (comment k) and the 'learned intermediary' rule to prescription vaccines. It establishes a high bar for plaintiffs by treating the adequacy of a factually accurate warning that discloses the specific risk as a matter of law, rather than a jury question. The decision reflects strong judicial deference to public health policy, effectively shielding manufacturers who comply with federal regulations and provide scientifically accurate warnings from tort liability based on design defect claims. This approach limits a jury's ability to second-guess the choice between different approved medical products and reinforces the physician's role as the recipient of complex medical warnings.
