## Facts

- In 1983, Judy M. Khan underwent open-heart surgery and received a Bjork–Shiley convexo-concave mechanical mitral valve manufactured by Shiley Incorporated.
- Before surgery, she was advised of general mechanical-valve risks (e.g., clotting, rejection, lifelong anticoagulation) but was not told the valve could fracture.
- In 1985, her surgeon told her the implanted valve was within a recalled group due to a propensity to fracture and that reported failures could occur without warning and could be fatal.
- Manufacturer information reported a statistical fracture rate and advised heightened attention to possible malfunction; medical judgment indicated prophylactic replacement surgery carried greater risk than leaving the valve in place.
- Khan’s valve never malfunctioned, but after learning of the recall she reported severe anxiety, sought mental-health treatment, and experienced physical symptoms associated with anxiety.
- Khan and her husband sued Shiley and its parent corporation, seeking damages including for severe emotional distress based on the risk of catastrophic valve failure.

## Issues

1. Whether a recipient of a recalled implanted medical device may recover for serious, present emotional distress caused by a documented risk of catastrophic future failure when the device has not yet malfunctioned.
2. Whether such emotional-distress damages are barred as speculative or premature absent present physical injury or proof that the specific device will probably fail.

## Decision

- The Court of Appeal reversed the summary judgment for defendants and remanded for further proceedings.
- The trial court applied incorrect legal principles by treating plaintiffs’ injury as merely the possibility of future valve failure rather than present severe emotional distress.
- Evidence of recall, reported fracture rates, and potentially fatal consequences supported a triable issue on the reasonableness and seriousness of Khan’s fear and resulting emotional injury.
- Defendants’ evidence (that all valves carry some risk, that fracture risk decreased over time, and that Khan’s valve had not failed) did not negate emotional distress as a matter of law.

## Legal Principles

- In a products-liability action, serious emotional distress can constitute a current, compensable injury even if the product has not yet malfunctioned and no physical injury has occurred.
- A claim is not automatically speculative or premature because the feared physical harm may occur in the future; the inquiry focuses on whether the fear is objectively reasonable and the distress is severe and genuine.
- Summary judgment is improper where the record permits a factfinder to conclude that a demonstrably defective product and its associated substantial risk caused present severe emotional distress.

## Conclusion

The court held that plaintiffs presented evidence of a present injury—severe emotional distress grounded in an objectively supported risk arising from a recalled implanted heart valve—and therefore their claims could not be dismissed at summary judgment as speculative solely because the valve had not yet failed.


Khan v. Shiley Inc., 266 Cal. Rptr. 106 (Ct. App. 4th Dist. 1990)