N.N v. v. American Ass'n of Blood Banks

AMOS, J.,* Concurring and Dissenting.

I concur in parts II, III, and IV of the majority opinion. Otherwise, I dissent.

I write separately to express my opinion regarding the duty owed by the American Association of Blood Banks (AABB) to recipients of blood from *1401its member banks. The majority has chosen to frame the issue of duty very narrowly as “whether at the time of N.N.V.’s surgery it was reasonably foreseeable that direct questioning, directed donations and/or surrogate testing would have reduced the risk of AIDS contamination of the nation’s blood supply.” (Maj. opn., ante, at p. 1377.) While this narrow characterization of duty answers the issues in this case, it leaves open the question of whether AABB has any type of duty to recipients of blood transfusions and provides little, if any, guidance to the trial courts in the future. Further, the policy analysis engaged in by the majority suggests the AABB owes no duty to blood recipients under any circumstances. I disagree.

Role of the AABB

While courts have been reluctant to impose liability on nonprofit trade associations, two of the primary considerations in imposing liability have been the role and dominance of the association in the industry and the control over the behavior of its members. (See Note, Snyder v. American Association of Blood Banks: Expansion of Trade Association Liability—Does It Reach Medical Societies? (1997) 29 U. Tol. L.Rev. 149, 163.)

The AABB is more than a voluntary trade association. The AABB has substantial power over the operation of blood banks and is the governing body of a significantly self-regulated industry. It sets standards for the collection, screening and distribution of blood and assures compliance with those standards by accrediting and inspecting its member blood banks. The New Jersey Supreme Court and the Illinois Supreme Court have recognized the significant and influential role of the AABB.

“By words and conduct, the AABB invited blood banks, hospitals, and patients to rely on the AABB’s recommended procedures. The AABB set the standards for voluntary blood banks. At all relevant times, it exerted considerable influence over the practices and procedures of its member banks .... On behalf of itself and its member banks, the AABB lobbies legislatures, participates in administrative proceedings, and works with governmental health agencies in setting blood-banking policy. In many respects, the AABB wrote the rules and set the standards for voluntary blood banks.” (Snyder v. American Ass’n of Blood Banks (1996) 144 N.J. 269, 293 [676 A.2d 1036, 1048].)

“[United Blood Services] is a member of the AABB, an association of blood banks and blood banking professionals engaged in the collection of whole blood from volunteer donors. AABB promulgates, establishes and publishes standards and policies for the collection, processing and distribution of blood, blood components and tissue by it [sic] members. AABB also *1402inspects and accredits its members based on compliance with these standards and policies and issues advisory recommendations and guidelines. Federal and state governments generally accept AABB standards as authoritative.” (Advincula v. United Blood Services (1996) 176 Ill.2d 1, 8 [223 Ill.Dec 1, 678 N.E.2d 1009, 1013].)

In California, the AABB standards are incorporated in statutory and regulatory provisions for blood banks and blood transfusion services. (See Health & Saf. Code, § 1602.5, subd. (a)(1); Cal. Code Regs., tit. 17, §§ 1024, 1002.)

The Food and Drug Administration permits a licensed facility to adopt the procedures of the AABB as long as the procedures are consistent with, and at least as stringent as, the requirements of the Code of Federal Regulations. (Zaccone v. American Red Cross (E.D. Ohio 1994) 872 F.Supp. 457, 460; 21 C.F.R. § 606.100(d) (1999).) Further, numerous cases absolve blood banks from liability to transfusion recipients upon a showing of compliance with the guidelines of the AABB. (See Douglass v. Alton Ochsner Med. Found. (La.Ct.App. 1997) 696 So.2d 136, 138 [64 A.L.R.5th 847], and cases cited therein.)

AABB represents the interests of its members, which have a substantial financial stake in the regulation of the industry. Blood is a billion-dollar business. (Snyder v. American Ass’n of Blood Banks, supra, 676 A.2d at p. 1050.)

Application of Restatement Second of Torts Section 324A

The imposition of duty in this case requires a determination of whether the first two elements of the Restatement Second of Torts section 324A (section 324A) are applicable and an analysis of the public policy arguments tendered by AABB. A finding of negligence under section 324A requires: (1) the actor undertake, gratuitously or for consideration, to render services to another; (2) the services rendered are of a kind the actor should have recognized as necessary for the protection of third persons; (3) the actor failed to exercise reasonable care in the performance of its undertaking; (4) the failure to exercise reasonable care resulted in physical harm to the third persons; and (5) either (a) the actor’s carelessness increased the risk of such harm, (b) the undertaking was to perform a duty owed by the other to the third persons, or (c) the harm was suffered because of the reliance of the other or the third persons upon the undertaking. Recovery requires proof of each of the well-known elements of any negligence claim: duty, breach of duty, proximate cause and damages. To impose a duty, the actor must *1403specifically undertake to perform the task it is charged with performing negligently. The scope of the undertaking defines the scope of the duty. (Artiglio v. Corning Inc. (1998) 18 Cal.4th 604, 614 [76 Cal.Rptr.2d 479, 957 P.2d 1313].)

AABB undertook to render services to others (its blood bank members) by setting standards for screening, obtaining and distributing blood and by monitoring the application of those standards through its accreditation process. The ultimate beneficiaries are the patients receiving blood transfusions and AABB recognizes this in its mission statement, where it refers to the “highest standards of care for patients and donors.” AABB acknowledges its services benefit these patients. Thus, the first two elements of section 324A are satisfied and a duty should be imposed unless an exception applies for public policy reasons.

In FNS Mortgage Service Corp. v. Pacific General Group, Inc. (1994) 24 Cal.App.4th 1564 [29 Cal.Rptr.2d 916], the court reversed a summary judgment and held the International Association of Plumbing and Mechanical Officials (IAMPO), a nonprofit association controlled by officials engaged in the enforcement of local plumbing codes, had a duty to consumers who acquired and utilized the pipe bearing a “UPC” designation indicating compliance with IAMPO standards. In imposing a duty the court noted, “the question of duty must be considered in light of the existing law, rather than as a novel abstraction,” as set out in section 324A. (FNS Mortgage Service Corp., supra, at p. 1571.) The situation here is similar. An association that sets the standards in a particular industry and asserts substantial influence over that industry and its members seeks to avoid the imposition of duty to the ultimate consumer. As in FNS, the application of section 324A and the policy considerations require imposition of a duty.

The majority distinguishes the holding in FNS applying section 324A because that case “did not address the liability of a trade association based on its professional judgment in recommending standards to be used in the industry” and the policy considerations are different here. (Maj. opn., ante, at p. 1376.) In applying section 324A, the FNS court did consider the application of standards and noted, “IAPMO has undertaken to render the service of inspecting pipe manufacturers and delisting those who are unwilling or unable to adhere to standards it has promulgated.” (FNS Mortgage Service Corp. v. Pacific General Group, Inc., supra, 24 Cal.App.4th at p. 1572, italics added.) Here, AABB has undertaken to set standards and assure compliance through accreditation.

Policy Considerations

The majority concludes imposition of a duty upon AABB will not serve to prevent future harm since the state of the knowledge in this area was *1404evolving and AABB should not incur liability for choosing the wrong side in an ongoing scientific debate. In addition, the majority concludes imposition of a duty will place a significant burden on AABB as a result of increased litigation and the creation of a new, more onerous standard for medical professionals that would require extraordinary skill, knowledge and insight. The majority confuses the issue of duty with breach. A duty is breached under section 324A when one fails to exercise reasonable care in the performance of its undertaking. If a duty were imposed on AABB, it would not be breached if there was an ongoing debate and the state of knowledge in a particular area was still evolving. Nor would the standard of care be changed. In determining whether a breach had taken place, AABB would still be held to a professional standard of care in accordance with current case law. (Spann v. Irwin Memorial Blood Centers (1995) 34 Cal.App.4th 644, 654 [40 Cal.Rptr.2d 360]; Osborn v. Irwin Memorial Blood Bank (1992) 5 Cal.App.4th 234, 271-272 [7 Cal.Rptr.2d 101].)

The majority also concludes imposition of a duty on AABB would chill scientific and medical debate and would hinder reconsideration of established standards. This argument has been rejected by the two courts that have had occasion to consider it. (Snyder v. American Ass’n of Blood Banks, supra, 676 A.2d at p. 1049; Weigand v. University Hosp. (1997) 172 Misc.2d 716, 722 [659 N.Y.S.2d 395, 399].) These concerns are outweighed by the devastating risks from the receipt of tainted blood. If no duty is imposed, the business and cost considerations of the members of AABB are likely to play a significant role in the decision making process and may pose an obstacle to change or reconsideration of standards. AABB bears the burden of demonstrating the exception from liability it seeks is clearly supported by public policy. (FNS Mortgage Service Corp. v. Pacific General Group, Inc., supra, 24 Cal App.4th at p. 1571.) AABB has failed to meet its burden to establish it is entitled to a public policy exclusion.

To put the argument in perspective, one must consider whether AABB had a duty to recommend the ELISA test after it was discovered and kits were available to test for AIDS. Under the majority’s analysis, the answer would be “no.” Yet, as soon as ELISA testing supplies became commercially available, blood facilities had a duty to test all blood supplies for antibodies to the AIDS virus. (Kirkendall v. Harbor Ins. Co. (8th Cir. 1989) 887 F.2d 857, 860.) To impose a duty on the AABB at this stage of the medical research process is both reasonable and fair.

When the role of the AABB is considered along with the risks from the receipt of tainted blood, a duty should be imposed on the AABB to set adequate standards for the screening, testing and distribution of blood. In *1405establishing those standards, it is appropriate to apply a professional standard of care. However, because of the evolving state of knowledge in December 1994, there was no breach of that duty. On that ground, I would affirm the judgment.

The petition of plaintiff and appellant for review by the Supreme Court was denied January 19, 2000.

Judge of the San Diego Superior Court, assigned by the Chief Justice pursuant to article VI, section 6 of the California Constitution.