## Facts

- Two hemophiliacs received Factor VIII (a blood-derived clotting concentrate) supplied through a military hospital in Hawaii.
- They later tested HIV-positive and alleged infection occurred in 1983 from contaminated Factor VIII.
- Because they could not identify which manufacturer’s Factor VIII caused the infection, they sued four manufacturers for negligence and strict products liability and sued the United States for negligence and failure to warn.
- Plaintiffs presented evidence that by mid-1982 AIDS cases among hemophiliacs were reported, screening was urged, and heat-treatment or surrogate testing could have reduced risk by early 1983.
- Manufacturers contended that they complied with then-existing industry standards and that a medical consensus on blood-borne transmission did not exist until 1984.
- The district court granted summary judgment for all defendants, reasoning (among other grounds) that plaintiffs’ inability to identify the specific manufacturer and uncertainty about infection timing defeated negligence, and that Hawaii’s blood shield statute barred strict liability.
- On appeal, the Ninth Circuit certified questions to the Hawaii Supreme Court about the blood shield statute and alternative liability theories; the state court answered that strict liability was barred, negligence was not, and market-share liability could apply in appropriate circumstances.

## Issues

1. Whether plaintiffs’ inability to identify the specific manufacturer of the infecting Factor VIII barred recovery, or whether Hawaii law permits market-share liability for a fungible product.
2. Whether Hawaii’s blood shield statute bars strict products liability claims and/or negligence claims for injuries allegedly caused by blood products.
3. Whether disputed facts about infection timing and the state of scientific and industry knowledge in 1982–83 precluded summary judgment on negligence.

## Decision

- The Ninth Circuit reversed summary judgment for the manufacturers on negligence and remanded for further proceedings.
- The court held that, under Hawaii law (as clarified by the Hawaii Supreme Court), plaintiffs could proceed on a market-share liability theory despite being unable to identify the specific manufacturer.
- The court held that Hawaii’s blood shield statute bars strict products liability claims involving blood and blood products.
- The court held that the blood shield statute does not bar negligence claims.
- The court concluded genuine disputes of material fact existed on negligence, including what was known or reasonably knowable about AIDS transmission and what precautions were feasible, making summary judgment improper.

## Legal Principles

- When a state recognizes market-share liability for a fungible product and identification is impossible without plaintiff fault, inability to identify the specific producer does not necessarily defeat causation at the pleading/proof stage.
- A blood shield statute may treat provision of blood products as a service and thereby preclude strict products liability, while leaving negligence remedies available.
- Conflicting evidence about contemporaneous scientific knowledge, feasibility of risk-reduction measures, and reasonableness of conduct generally creates jury questions not suitable for resolution on summary judgment.
- Compliance with industry standards is evidence of due care but is not dispositive, particularly where a small group of manufacturers largely shaped those standards.

## Conclusion

The Ninth Circuit held that Hawaii law forecloses strict products liability for injuries from blood products but permits negligence claims, including market-share-based negligence where product identification is not possible, and it sent the case back for trial because key questions about knowledge, feasibility of precautions, and breach of duty were fact disputes.


Doe v. Cutter Biological, Inc., 971 F.2d 375 (9th Cir. 1992)