## Facts

- Lynda Riley, a 23-year-old ICU nurse, used an Angiocath IV catheter manufactured by Becton Dickinson to initiate an IV line.
- After initiating the IV, Riley was stuck by the used catheter needle and later contracted HIV.
- The Angiocath’s needle remained exposed after withdrawal from the catheter, permitting a needle-stick injury.
- Riley claimed the catheter was defectively designed because a feasible alternative design existed in which the needle retracts into a plastic sheath during withdrawal.
- Becton Dickinson acknowledged the device could cause injury because a sharp needle was integral to its function, but denied the design was defective.
- Evidence indicated needle-stick HIV infections associated with the device were extremely rare relative to its volume of use; the proposed alternative would reduce the already-low risk but would cost more, require additional training, and perform less effectively.

## Issues

1. Whether the IV catheter’s exposed-needle design made the product “unreasonably dangerous” under Pennsylvania strict-liability design-defect law.
2. Whether federal regulatory decisions regarding protective sheathing on needles precluded, or should materially influence, a state-law design-defect determination.

## Decision

- The court granted the defendant’s motion for summary judgment on the strict-liability design-defect claim.
- The court held the Angiocath was not “unreasonably dangerous” as a matter of law under Pennsylvania’s risk–utility approach.
- The court did not hold that federal regulatory action preempted the claim, but treated regulatory judgments as relevant to the overall assessment.

## Legal Principles

- Under Pennsylvania strict-liability design-defect doctrine (as applied by the court), a product is defective only if its design renders it “unreasonably dangerous,” assessed through a risk–utility analysis.
- A product’s capacity to cause harm does not alone establish a design defect; the magnitude and probability of harm must be weighed against the product’s utility and the burdens of safer alternatives.
- The existence of an alternative, safer design does not automatically establish defectiveness; costs, performance tradeoffs, and implementation burdens are part of the risk–utility calculus.
- When professional users can mitigate risks through training and precautions, that context may inform whether residual risks make a design unreasonably dangerous.
- Regulatory judgments may be considered as evidence bearing on the reasonableness of design choices, even when they do not bar state-law claims.

## Conclusion

Applying a risk–utility analysis under Pennsylvania law, the court concluded that the catheter’s exposed-needle risk—though capable of causing severe injury—was statistically rare and outweighed by the device’s utility and the cost and performance drawbacks of the proposed safer alternative, warranting summary judgment for the manufacturer.


Riley v. Becton Dickinson Vascular Access, Inc., 913 F. Supp. 879 (E.D. Pa. 1995)