## Facts

- In September 1983, Jane Doe experienced severe post-partum bleeding and was treated in a Maryland emergency room.
- Her physician ordered administration of 500 units of “Konyne,” a Factor IX blood-clotting concentrate manufactured by Miles Laboratories, Inc., Cutter Laboratories Division.
- Konyne was derived from pooled plasma donations from many donors and was administered as part of Doe’s medical treatment.
- In the months after treatment, Doe developed illnesses and was diagnosed with HTLV‑III infection and AIDS-Related Complex; she alleged no other AIDS risk factors besides exposure to blood products.
- In July 1986, Jane and John Doe sued Miles alleging strict liability (including failure to warn), negligence, breach of express and implied warranties, loss of consortium, and punitive damages.
- Miles moved for summary judgment primarily targeting strict-liability and warranty theories and derivative claims dependent on them.

## Issues

1. Whether Maryland law at the time of the 1983 administration permitted strict products-liability claims against a manufacturer of a blood-derived product, or instead barred such claims by statute or Restatement (Second) of Torts § 402A comment k.
2. Whether breach-of-warranty claims could be maintained against the manufacturer when the product was provided to the patient through medical treatment rather than a direct sale.
3. Whether loss of consortium and punitive damages could proceed to the extent they depended on strict-liability or warranty theories.

## Decision

- Summary judgment standard: the court applied Rule 56, viewing evidence in the nonmovant’s favor, but requiring more than a mere scintilla to create a triable issue.
- Strict liability (including failure to warn): denied; the court held that Maryland law did not, at the relevant time, exempt blood or blood-product manufacturers from strict liability, and later statutory protections did not apply retroactively.
- Comment k: the court declined to treat blood-derived products as categorically exempt from strict liability as “unavoidably unsafe,” allowing plaintiffs to pursue a defect theory based on viral contamination.
- Breach of warranty: granted; the court held warranty theories failed as a matter of law because the administration occurred within medical services and lacked the necessary buyer–seller/contractual basis for U.C.C.-style warranties against the manufacturer.
- Derivative claims: permitted only insofar as they were tied to surviving theories (e.g., strict liability and any remaining negligence claims), and barred to the extent premised on dismissed warranty theories.

## Legal Principles

- Summary judgment is appropriate only when there is no genuine dispute of material fact and the movant is entitled to judgment as a matter of law; the nonmovant must present evidence sufficient for a reasonable jury to find in its favor.
- Absent applicable statutory immunity, a commercially manufactured blood-derived concentrate may be treated as a “product” potentially subject to strict products liability under Restatement (Second) of Torts § 402A.
- Restatement § 402A comment k does not automatically immunize all medically beneficial but risky products from strict liability; whether it applies depends on the product and the alleged defect.
- Warranty claims require a sufficient sales/contract relationship; when a product is supplied to a patient as part of medical treatment, warranty theories against a remote manufacturer may fail as a matter of law.
- Derivative claims (e.g., consortium and punitive damages) rise or fall with the viability of the underlying substantive theories on which they depend.

## Conclusion

The court allowed the plaintiffs to proceed on strict products-liability theories against the manufacturer of a Factor IX concentrate alleged to have transmitted an AIDS-related virus, but rejected warranty claims because the product was administered through medical services rather than sold to the patient; derivative claims survived only to the extent grounded in remaining viable causes of action.


Doe v. Miles Lab'ys, Inc., 675 F. Supp. 1466 (D. Md. 1987)