## Facts

- Gene Earl Willett and Mrs. Albert Spriggins received Edwards Duromedics bileaflet mechanical aortic heart valves implanted by a New Orleans cardiovascular surgeon in January 1988.
- The valves were made of pyrolytic carbon and were designed with two leaflets that open and close with blood flow.
- Baxter voluntarily suspended marketing the valve after reports of “leaflet escape” (fracture or dislodgment), which could cause catastrophic failure and sudden death.
- After reading news of the suspension in June 1988, Willett sued; Spriggins and her husband intervened. Their claimed damages primarily consisted of present mental anguish and fear of future valve failure.
- Defendants submitted studies and affidavits indicating (i) 17 failures among roughly 20,000 implants and (ii) all known failures involved valves manufactured before an April 1986 manufacturing change; plaintiffs’ valves were manufactured after that change.
- Plaintiffs’ expert theorized that the manufacturing process could create “soot pockets” (voids) that might weaken leaflets, but did not identify such defects in plaintiffs’ valves, show abnormal functioning, or provide a feasible safer alternative design or material.
- At all relevant times, both implanted valves were functioning normally and neither plaintiff had suffered physical injury from valve malfunction.

## Issues

1. Whether plaintiffs produced sufficient evidence to create a genuine dispute that their implanted valves were defective (manufacture, design, or warnings) under Louisiana products-liability standards.
2. Whether Louisiana law permits recovery for fear of future device failure and related mental anguish absent proof that plaintiffs’ own valves were defective or had caused physical injury.

## Decision

- The Fifth Circuit affirmed summary judgment for the defendants.
- Plaintiffs failed to present competent evidence from which a reasonable jury could find that their specific valves were defective when they left the manufacturer’s control.
- Because defect evidence was insufficient, the court found it unnecessary to decide whether Louisiana categorically allows a stand-alone claim for fear of future failure without physical injury.
- Plaintiffs’ warning-based theory also failed to create a triable issue under the learned-intermediary framework and on causation.

## Legal Principles

- Under Louisiana products-liability law applicable to the claims, a plaintiff must offer evidence that the specific product at issue was unreasonably dangerous due to a recognized defect (manufacture, design, or warnings) and that the defect existed when the product left the manufacturer.
- Speculative or purely theoretical expert opinions, untethered to the condition or performance of the plaintiff’s actual product, are insufficient to defeat summary judgment.
- For alleged design defects, Louisiana’s risk–utility approach requires proof that the product’s risks outweigh its utility, commonly including evidence of a feasible safer alternative available at the time of manufacture.
- For prescription medical devices, the duty to warn generally runs to the treating physician (learned-intermediary doctrine); a plaintiff must also show causation between an inadequate warning and the asserted injury.
- Fear-of-future-harm damages are not recoverable absent a legally cognizable predicate injury; without proof of defect or malfunction in plaintiffs’ devices, generalized fear based on failures in other products is too remote.

## Conclusion

The court affirmed dismissal because plaintiffs’ evidence did not support a finding that their implanted heart valves were defective; without proof of defect in their devices, their fear-based damages and related theories could not survive summary judgment.


Willett v. Baxter Int’l, Inc., 929 F.2d 1094 (5th Cir. 1991)