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Certification From United States District Court for Western District of Washington v. Miles Laboratories Inc.

January 10, 1991


En Banc. Callow, C.j. Utter, Brachtenbach, Dolliver, Dore, Andersen, Durham, and Smith, JJ., concur. Guy, J., did not participate in the disposition of this case.

Author: Callow

The District Court for the Western District of Washington, pursuant to RCW 2.60.020, has certified to us the following question:

Whether, in Washington, the doctrine of strict liability is applicable to a for-profit pharmaceutical company for injuries allegedly resulting from the processing and supplying of blood products contaminated with HIV, the virus causing AIDS, where those blood products were derived from plasma obtained from compensated donors?

To answer this question, we consider first (in section II of this opinion) whether RCW 70.54.120 governs this case. By its terms, RCW 70.54.120 does not shield entities, such as defendants, which compensate their donors. The question thus arises whether the statute was intended to create strict liability for all entities which do not comply with its terms. We hold that it was not so intended. We recently noted in Howell v. Spokane & Inland Empire Blood Bank, 114 Wash. 2d 42, 48, 785 P.2d 815 (1990), that "[t]he purpose behind Washington's blood shield statute is to encourage a readily available supply of blood and blood products." Consistent with that intent, we held in Howell that strict liability should not be applied to blood and blood products. Howell, at 53. We call to the Legislature's attention the fact that strict liability is not the rule in this state regarding blood products, and suggest that it may wish to reconsider RCW 70.54.120 in that light.

The certified question must, then, be answered based on the common law. In section III, we hold that the applicable rule in Washington for blood and blood products (including factor concentrates) is comment k to the Restatement (Second) of Torts § 402A (1965). The questions whether the risk of AIDS was knowable and whether defendants

satisfied their duty to warn are negligence issues to be decided by the federal court.



Jeremy Rogers was born January 16, 1980, with severe hemophilia type B. Persons with this type of hemophilia lack a blood clotting factor known as factor IX. To control the spontaneous hemorrhaging caused by the disease, hemophiliacs such as Jeremy must use factor IX concentrates on an average of once a week throughout their lives.

Factor concentrates are produced from plasma, which factor concentrate manufacturers obtain primarily from commercial plasma centers. Because plasma donation usually takes 1 1/2 to 2 hours -- considerably longer than whole blood donation -- there would not be enough donors if plasma centers depended on volunteers. Therefore, donors are paid for their time.

Once plasma is obtained from plasma centers by a factor concentrate manufacturer, it is pooled and the clotting factors are removed. The clotting factors are then freeze-dried and packaged in powdered form. The concentrates are available to patients by prescription from their physician. The powder is mixed with sterile water prior to use, and is then administered intravenously.

The production of factor concentrates is regulated and licensed by the Food and Drug Administration's Center for Biologics Evaluation and Research. See generally 21 C.F.R. §§ 600-610, 640 (1990). Since April 1985, defendants have employed the test known as the Enzyme-Linked Immunosorbent Assay (ELISA) to detect the presence of antibodies to the HIV virus. However, prior to April 1985, no test was available to defendants in order to test plasma for the HIV virus. Moreover, it is unclear whether it will ever be possible to screen with 100 percent accuracy for the presence of the AIDS virus in blood. See, e.g., Comment, Blood

Donation: A Gift of Life or a Death Sentence?, 22 Akron L. Rev. 623, 629 (1989).

Factor concentrates possess several major advantages over other available forms of treatment for hemophilia. Factor concentrates are highly purified and thus result in fewer adverse reactions. They make it possible reliably to determine the appropriate level of clotting factor necessary to stop bleeding. Finally, they are easily stored and can be given quickly if prompt treatment is necessary.

For most of his life, Jeremy has used factor IX concentrates manufactured by defendants to treat his hemophilia. In November 1985, Jeremy tested positive for the presence of human immunodeficiency virus (HIV) antibodies. In February 1988, he was diagnosed as suffering from acquired immune deficiency syndrome (AIDS).

Plaintiff Kimberly Rogers filed this action in federal court on behalf of herself and as guardian ad litem for Jeremy against defendants Miles Laboratories and Baxter Healthcare on the tort theories of negligence and strict liability. Plaintiffs allege that Jeremy contracted AIDS as a result of using defendants' products. Defendants moved for partial summary judgment seeking dismissal of those claims brought under strict liability, and the United States District Court granted defendants' motion. Plaintiffs then filed a motion for reconsideration seeking a stay of the court's order and requested certification on the issue of strict liability.

Subsequent to the federal court's dismissal of the strict liability claim, this court issued its holding in Howell. The federal court then entered an order to stay the original holding dismissing the strict liability claim and certified the issue to this court. This opinion, therefore, addresses only the issue of whether strict liability applies to defendants in this case. Both parties recognize that the negligence claim is still available to plaintiffs.

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