Smith v. Cutter Biological, Inc.

CONCURRING AND DISSENTING OPINION BY

MOON, J.

I concur in the majority’s decision that Hawaii’s blood shield statute precludes plaintiff’s claim for strict liability. I also concur in the majority’s opinion to the extent that it rejects the alternative liability, concert of action, and enterprise liability theories of causation. However, as to the majority’s decision to adopt the market-share theory of liability, I respectfully dissent.

The majority’s endorsement of the market-share theory of liability is contrary to established rules of statutory construction and contravenes the intent of the Hawaii legislature in enacting Hawaii’s blood shield statute. The policy considerations which underlie our blood shield law preclude the adoption of a negligence theory that abandons the fundamental principle of causation and shifts the burden to defendants to exonerate themselves. Moreover, the case law upon which the majority relies requires that Factor VIII be fungible and untraceable to specific manufacturers in order for market-share liability to be appropriate. However, Factor VIII is not fungible and it is not impossible for hemophiliacs or other Factor VIII users to identify the manufacturers of the Factor VIII concentrates they used.

Furthermore, the majority’s departure from well-established tort law in Hawaii is based on a factual record that prevents plaintiff from establishing the existence of a legal duty and breach of *441that duty, based on a provable standard of care, which is essential to the application of the market-share theory of liability.

I. Statutory Construction

Initially, it is important to note that until today, negligence liability under Hawaii law required a plaintiff to prove by a preponderance of the evidence four essential elements: 1) the existence of a legal duty; 2) breach of that duty; 3) causation; and 4) injury. Knodle v. Waikiki Gateway Hotel, Inc., 69 Haw. 376, 742 P.2d 377 (1987). However, the market-share liability theory imposes liability without requiring identification of the wrongdoers who caused plaintiff’s harm and shifts the burden to defendants to prove that they did not cause the plaintiff’s injury. Eliminating causation as an element of proof and shifting the burden to the defendant is not only a radical departure from traditional negligence law, but is inconsistent with Hawaii’s blood shield statute.

This court has stated that the fundamental starting point for statutory construction is the language of the statute itself; where the statute’s language is plain and unambiguous, this court’s sole duty is to give effect to its plain and obvious meaning. National Union Fire Ins. Co. v. Ferreira, 71 Haw. 341, 790 P.2d 910 (1990); Kaiser Found. Health Plan, Inc. v. Department of Labor and Indus. Relations, Unemployment Ins. Div., 70 Haw. 72, 762 P.2d 796 (1988).

Hawaii’s blood shield statute provides as follows:

Exemption from strict liability. No physician, surgeon, hospital, blood bank, tissue bank, or other person or entity who donates, obtains, prepares, transplants, injects, transfuses, or otherwise transfers, or who assists or participates in obtaining, preparing, transplanting, injecting, transfusing, or otherwise transferring any tissue, organ, *442blood or component thereof, from one or more persons, living or dead, to another person, shall be liable as a result of any such activity, save and except that each such person or entity shall remain liable for the person’s or its own negligence or wilful misconduct.

Hawaii Revised Statutes (HRS) § 327-51 (1985) (emphasis added).

The statute is plain and unambiguous. It protects manufacturers of blood products from all liability, with one exception: “save and except that each ... entity shall remain liable for ... its own negligence.” (Emphasis added). In other words, the statute requires proof of all elements of a negligence action, including causation.

This court has also stated that where a statute is clear on its face, there is no need to rely on legislative history to construe it. Flores v. United Air Lines, Inc., 70 Haw. 1, 11, 757 P.2d 641, 646 (1988). However, despite the clear meaning of the statute, the majority looks to the legislative history of the blood shield statute and concludes that

[t]he wording on which appellees rely so heavily, “own negligence,” is conspicuously absent from the history. Lacking that wording, or any other wording giving such an indication, we believe that the legislature has not spoken on this issue. We believe a lacuna exists, and we are free to use our own determination to explain pertinent words in the blood shield statute.

(Emphasis added.) This novel approach to statutory construction is inappropriate because it allows the majority to attain a desired result without regard to the established rules of statutory construction. Recently, Justice Scalia, in criticizing the Supreme Court’s construction of the Voting Rights Act of 1965, stated:

Today, however, the Court adopts a method [for interpreting the meaning of language in a statute] quite *443out of accord with that usual practice. It begins not with what the statute says, but with an expectation about what the statute must mean absent particular phenomena . . . and the Court then interprets the words of the statute to fulfill its expectation....
As method, this is just backwards, and however much we may be attracted by the result it produces in a particular case, we should in every case resist it. Our job begins with a text that Congress has passed and the President has signed. We are to read the words of that text as any ordinary Member of Congress would have read them ... and apply the meaning so determined.

Chisom v. Roemer, 111 S. Ct. 2354, 2369 (1991) (Scalia, J., dissenting) (emphasis added).

Hawaii’s blood shield statute, enacted in 1971 as House Bill No. 666, was entitled:

A BILL FOR AN ACT PROVIDING THAT PERSONS ENGAGED IN THE TRANSPLANTATION OR TRANSFUSION OF HUMAN TISSUES AND RELATED PURPOSES SHALL NOT BE LIABLE FOR DAMAGES EXCEPT FOR THEIR OWN NEGLIGENCE OR WILLFUL MISCONDUCT.

(Emphasis added.) The majority’s conclusion that “ ‘own negligence,’ is conspicuously absent from the history” is erroneous because the title to the bill demonstrates that the statute was intended to insulate manufacturers, like the defendants, from any liability, “except for their own negligence.” See Honolulu Star Bulletin, Ltd. v. Burns, 50 Haw. 603, 606, 446 P.2d 171, 173 (1968) (the title of an act may be referred to as an aid in construing a statute). Moreover, the Standing Committee Report of the Senate Judiciary Committee clearly underscores the legislature’s intent to protect those who prepare blood components. The Committee noted that “the purpose of this bill is to limit the legal liability *444arising out of certain scientific procedures . . . and further explained that

[t]his bill would provide an exception to the doctrine of strict liability on tort when there is a transfer of part of the human organism from one person to another. It is felt that the imposition of strict liability upon persons or organizations engaged in scientific procedures dealing with donating, obtaining, preparing, transplanting, injection, transfusing, or otherwise transferring of human tissue, organ, blood or component thereof could inhibit, at the expense of the health and welfare of the people of Hawaii, the exercise of sound medical judgment in this area and may restrict the availability of important scientific knowledge and skills.

Sen. Stand. Comm. Rep. No. 773, in 1971 Senate Journal, at 1135 (emphasis added). Thus, review of the legislative history clearly demonstrates that, contrary to the majority’s view, the legislature has “spoken on this issue.”

When the legislature enacted Hawaii’s blood shield law in 1971, it was confronted with the doctrine of strict liability in tort, which had recently been adopted in 1970 by this court in the products liability case of Stewart v. Budget Rent-A-Car Corp., 52 Haw. 71, 470 P.2d 240 (1970). The legislature considered this expansive theory of products liability, which deviated from traditional negligence law, and specifically chose to eliminate it from the blood shield statute. In view of such explicit legislative action, it is unreasonable for the majority to claim that “a lacuna exists” where the market-share theory of liability poses the identical concerns the legislature faced when it exempted strict liability from the blood shield statute.

Hawaii’s blood shield statute is similar to blood statutes enacted in virtually all states. Even in the absence of legislative history, the underlying purpose of such statutes is obvious. In *445Zichichi v. Middlesex Memorial Hospital, 204 Conn. 399, 528 A.2d 805 (1987), the Connecticut Supreme Court stated:

Our conclusion is also consistent with policy behind the enactment of the blood shield statute. Although the legislative history of § 19a-280 [Connecticut’s blood shield statute] is virtually nonexistent, one of the driving forces behind the promulgation of “blood shield” statutes, such as § 19a-280, is to ensure that certain medical services, namely, the provision of blood and tissue, remain available to citizens in need of such services. As one court aptly stated, “[t]he public policy represented by these statutes is not difficult to discern: blood transfusions are essential in the medical area____” These statutes reflect a legislative judgment that to require providers to serve as insurers of the safety of these materials might impose such an overwhelming burden as to discourage the gathering and distribution of blood.

Zichichi, 204 Conn. at 409, 528 A.2d at 810 (quoting Garvey v. St. Elizabeth Hosp., 103 Wash. 2d 756, 759, 697 P.2d 248, 249 (1985)) (emphasis added).

In 1988, the American Medical Association reported that “in the pharmaceutical industry, meaningful product liability insurance has all but disappeared.” A.M.A., Report of the Board of Trustees on Impact of Product Liability on the Development of New Medical Technologies 2 (1988). This lack of insurance is largely due to the development of nonidentification theories of liability.1

*446The application of the market-share liability theory may result in liability being placed on defendants bearing no responsibility for the defective product and may create unpredictable costs to innocent parties. In enacting HRS § 327-51, the Hawaii legislature unquestionably sought to guard against the risk of adversely affecting the supply of blood and blood components. However, the majority’s decision imposes that very risk and may not only jeopardize the supply of blood products which protect the “health ... of the people of Hawaii,” but may also “restrict the availability of important scientific knowledge and skills.” I submit that had the legislature intended to sanction such an expansive theory of liability as that advocated by the majority, it would not have used the restrictive phrase “own negligence” in the statute nor would we find the legislative history so consistent with the statute’s language.

II. DES Case Law

The primary authority cited by the majority in support of its position is the DES case of Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, cert. denied, 449 U.S. 912 (1980), which was the first to judicially promulgate the market-share liability theory. In Sindell, the “DES daughter” plaintiff sought to recover damages for injuries resulting from cancer caused by DES, a miscarriage preventative. The mother ingested the drug over twenty years prior to the cause of action being filed. The trial court dismissed the action on the ground that plaintiff had conceded that the specific manufacturers of the drug could not be identified.

On appeal, the Supreme Court of California adopted the market-share liability theory, which relieved plaintiff of the burden of identifying which of over 200 companies manufactured the DES drug ingested by her mother. The court, in reaching this *447conclusion, reasoned: “In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer.” Sindell, 26 Cal. 3d at 610, 607 P.2d at 936, 163 Cal. Rptr. at 144. The court determined that two essential factual elements, fungibility and the inability to identify specific producers, must be present in order for the market-share liability theory to be appropriate. Both elements are glaringly absent in the Factor VIII case before us.

A. Fungibility

The Sindell court determined that DES was fungible or interchangeable because all DES companies produced the drug from an identical formula; it was usually manufactured as a “generic” drug, without regard to the actual manufacturer. Thus, one manufacturer’s DES was equally as likely to have produced the injury as any other manufacturer’s DES. In other words, each DES manufacturer’s product posed the same risk of harm to users.

Unlike DES, Factor VIII is not a generic, fungible drug. Each processor prepares its Factor VIII concentrate by its own proprietary processes using plasma collected from its own sources. Each firm’s Factor VIII concentrate is clearly distinguishable by brand name, package color, lot number, and number of units of Factor VIII per vial; each firm’s Factor VIII concentrate is separately licensed by the Food and Drug Administration. There is no evidence that all Factor VIII products caused or were equally capable of causing HIV infection. Thus, the risk posed by the different brands of Factor VIII is not identical.

The majority here admits that Factor VIII is not fungible, that is, it does not pose the same risk of harm to users because, as the majority states, “[t]he reason is obvious — the donor source of the plasma is not constant. Therefore, Factor VIII is only harmful if *448the donor was infected; DES is inherently harmful.” (Emphasis added.) However, having conceded that Factor VIII is not fungible, the majority disregards the fungibility requirement, which under Sindell renders market-share inapplicable.

The Sindell court reasoned that imposing liability based on market share was justified because every DES pill could potentially cause harm to the entire general population of users. In other words, every DES pill, which contained a component common to all DES pills, posed the same risk to consumers. In contrast, no two manufacturers’ Factor VIII concentrates were equally capable of causing HIV infection, and in fact, most vials were not harmful at all. By eliminating the fungibility requirement, as the majority does, the whole concept of market-share liability is destroyed.

B. Inability to Identify Specific Producers

The second prerequisite of applying market-share liability is that the product “cannot be traced to any specific producer.” Sindell, 26 Cal. 3d at 610, 607 P.2d at 936, 163 Cal. Rptr. at 144. The Sindell court noted that the circumstances of plaintiff’s injury appeared to render identification of the manufacturer of the drug ingested by her mother impossible due to the time lapse between ingestion and manifestation of plaintiff’s injury. The court stated, “[c]ertainly there can be no implication that plaintiff is at fault in failing to [identify the specific manufacturer] — the event occurred while plaintiff was in útero, a generation ago.” Sindell, 26 Cal. 3d at 600-01, 607 P.2d at 930, 163 Cal. Rptr. at 138 (footnote omitted). Here, the majority dilutes the second prerequisite by merely requiring a showing that “it is difficult for the consumer to identify the source of the product. . ..” (Emphasis added.) Difficulty in identifying a wrongdoer is clearly an insufficient and unreasonable basis to distort Hawaii’s tort law and adopt the market-share liability theory.

*449Unlike the DES situation, this is not a case where product identification, and thus proof of causation, is impossible because a generation has lapsed between exposure and injury. By the time the harm caused by DES manifested itself, generally no prescription records were available. Here, however, the period of time from plaintiffs claimed exposure to the HIV virus, between 1983 and 1984, to the time he tested positive for HIV antibodies in 1986, was no more than two to three years. Also, unlike the DES plaintiffs who were in útero and could not identify the source of DES used by their mothers, plaintiff here could have identified the Factor VIII he used. Unfortunately, through no fault of the defendant processors, plaintiff failed to observe and record the name and lot numbers of the Factor VIII he used and the dates he used them.

As noted by defendant Armour Pharmaceutical Company (Armour) in its answering brief,

most hospitals and pharmacies maintain records of therapeutic materials purchased and dispensed. The fact that the particular pharmacy where Smith received his Factor VIII did not keep such records long enough or in a form appropriate to meet Smith’s litigation requirements is not an inherent circumstance of all AIDS cases involving hemophiliacs which would justify a new mle of law.
Smith lived at home with his parents until September 1985, as did his brother, former plaintiff “James Jones.”2 It was entirely undisputed that plaintiff Smith used the same Factor VIII concentrate as did his brother, and they kept their shared supply in the refrigerator at home. While plaintiff Smith’s own medical records were claimed to be missing, the medical records of Smith’s brother, with whom Smith had shared the same supply of *450Factor VIII concentrate, are available and do not mention Armour or reflect any use of Armour concentrate during any of the years 1982, 1983, 1984 or 1985. Smith’s mother likewise did not recall Armour’s concentrate as one which she had ever seen in the refrigerator used to keep her sons’ supplies.

(Emphasis in original, citations omitted.) Under these facts, James Jones may not have been able to recover from Armour because records were kept in his case. However, in Smith’s case, the majority’s market-share liability theory would shift the burden and litigation cost to defendant Armour, and Armour would be required to exculpate itself merely because it had a market share of Factor VIII concentrates. If unsuccessful, defendant Armour would be required to pay or contribute to payment for injuries, which its product may not have caused, simply because it could not prove the negative. The difficulty in identifying the wrongdoer here is individual to plaintiff’s own case and should not be used as a reason to justify applying a new rule of law in this jurisdiction.

Based on the foregoing discussion, I submit that the majority’s reliance on DES cases to support its decision to adopt the market-share theory of liability is misplaced.

*451III. Standard of Care

The majority’s caveat that “we recognize that our opinion is limited to the facts presented to us,” is ironic because the facts before us do not allow for the application of a market-share theory. The market-share theory of liability eliminates the element of causation but still requires plaintiff to prove the first two elements fundamental to a negligence cause of action — the existence of a legal duty and breach of that duty.

The majority states, “[a]s we see that the lack of screening of donors and failure to warn are the breaches alleged, appellant’s argument for not using DES theories (because Factor VIII is not fungible) is not convincing.” The reference to plaintiff’s allegations of defendants’ breach of duty in screening donors and failure to warn infers that proof at trial may be forthcoming to show that each defendant herein equally breached a duty of care. That proof would then somehow establish that all Factor VIII concentrates manufactured subsequent to the breach posed the same risk of harm to all users. With the techniques now available to screen donors and identify infected plasma, this proposition may presumably have merit. However, the fact that Smith has not shown when or even how he became infected precludes him from being able to establish any breach of duty based on a provable standard of care.

Smith was diagnosed as a hemophiliac in 1964 and began using Factor VIII concentrates in 1972 from unidentified sources. He moved to Hawaii in late 1982 and received Factor VIII concentrates from Tripler Hospital between 1982 and 1985. For the first time in 1986, Smith’s blood was tested for the HIV virus. The test was positive. Smith claims that his exposure to the virus occurred in 1983 or 1984. However, there is no evidence that Smith did not contract the HIV virus from other activities or sources, including blood products manufactured by companies other than the defendants. As noted by the majority (citations omitted):

*452AIDS is an infectious disease caused by a virus ... [which] . . . was uniquely recognized in June and July, 1981. There are several modes of infection: 1. sexual intercourse, 2. sharing infected syringes, 3. receipt of human tissue, blood, etc., and 4. childbirth or breast feeding. Once infected, a victim will not test positive for HIV during a “window” period, which lasts between six weeks and six months — although some researchers say the window period may be several years. Although testing positive, a person may continue to be asymptomatic for seven to ten years.

Moreover, the majority acknowledges that only in 1982 was there an understanding that AIDS might possibly be transmitted via blood products; and also that “[t]he concensus that AIDS was blood transmissible finally came in 1984;” but that scientists did not develop seriologic testing to detect antibodies until 1985.

The evidence shows that Smith, who began using Factor VIII in 1972, may have received infected Factor VIII concentrates before the possibility of HIV transmission through blood products was ever known. Moreover, having tested positive in 1986 in no way demonstrates that Smith was infected with the HIV virus only after coming to Hawaii. The nature and history of AIDS indicates that Smith was as likely to have contracted the virus months or even years before coming to Hawaii.

The majority cites a Florida United States District Court case that approved the application of the market-share liability theory in a Factor VIII case at the summary judgment stage. In Ray v. Cutter Laboratories, 754 F. Supp. 193 (M.D. Fla. 1991), the court relied upon Conley v. Boyle Drug Co., 570 So. 2d 275 (Fla. 1990), a Florida Supreme Court decision, which had adopted the market-share liability theory in a DES case. However, the district court’s premise for applying market-share liability in Ray is faulty because it distorts the fungibility requirement and fails to recog*453nize that plaintiffs would not have been able to establish a standard of care.

In Ray, the court noted that DES met the prerequisite of market-share liability by creating the same risk of harm to all users because it was produced using the same formula. The court then acknowledged that Factor VIH may differ from one batch to the next, depending on the pool of plasma donors. However, it then erroneously concluded that “while one Factor VHI product may have been infected with the AIDS virus while another may not have been, the risk that infection was present was the same from product to product during the period of time prior to initiation of screeningfor donors at risk of having AIDS.” 754 F. Supp. at 196 (emphasis added). The Ray court goes on to state:

At the time the Ray boys allege they were infected, not only did no test for AIDS exist, the AIDS virus itself had not even been identified. Thus, it will never be possible for the Plaintiffs to identify which particular batch or batches of Factor VIII caused their respective AIDS infections.”

Id.

The obvious problem in the Ray court’s analysis is that 1) Factor VIII concentrates do not pose the same risk if one product is infected and another is not, and 2) it calls for absolute liability, unlike market-share liability, which still requires a showing of the existence of a duty of care and a breach of that duty. No standard of care existed when the Ray plaintiffs allege they were infected. Thus, there could be no showing of a breach of duty.

Similarly in this case, Smith is unable to prove when or even how he was infected with the HIV virus. That inability, coupled with the fact that information regarding AIDS and its relationship to Factor VIII use was just being developed in the early 1980’s, leaves to pure speculation what applicable standards, if any, should *454have been imposed on defendants regarding the duty to screen donors or to warn users of its Factor VIII concentrates. Thus, under the facts of this case, plaintiff cannot establish a standard of care, and consequently, there can be no showing of a breach of duty.

IV. Judicial Restraint

The majority’s primary reason for adopting the market-share liability theory, in a form that is even more expansive than in Sindell, is that “the harshness of the result, that is, burdening the innocent plaintiff without a remedy, to us seems totally unfair and out of step with current efforts to allow recovery when the proper case is brought.”

I, too, sympathize with Smith’s tragic situation. However, this court has been faced with similar situations and has applied judicial restraint by declining to expand established principles of the common law merely to provide a remedial measure. Recently, in Winters v. Silver Fox Bar, 71 Haw. 524, 797 P.2d 51 (1990), we were presented with a certified question from the United States District Court for the District of Hawaii that gave us an opportunity to expand our dram shop law to allow a wrongful death cause of action for the family of a deceased minor. In declining to expand our dram shop law we stated that the question of

whether some remedial measure can be found in further modifying the common law by shifting the burden and responsibility of injuries to minors resulting from their voluntary consumption of alcohol to the commercial seller of liquor is best left to the wisdom of the Legislature and its process.
It is within the legislature’s province to weigh and balance the far reaching social, economic and legal *455consequences of modifying the common law as Appellant urges.

Id. at 535, 797 P.2d at 56.

I submit that this court is again confronted with an issue which it is ill-equipped to rule upon. There are too many unanswered questions of social, economic, and legal import, which only the legislature, with its investigative powers and procedures, can determine. Deference to the legislature is especially appropriate due to the legislature’s enactment of the blood shield statute and the impact that any nonidentification theory such as market share may have on the blood products industry.

Furthermore, I disagree with the majority’s statement that Hawaii would be “out of step with current efforts to allow recovery when the proper case is brought.” As defendant Cutter Biological notes in its answering brief, since the initial adoption of market-share liability in Sindell, the highest courts of only four other states have adopted that theory. Conley v. Boyle Drug Co., 570 So. 2d 275 (Fla. 1990) (DES case); Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 541 N.Y.S.2d 941, 539 N.E.2d 1069, cert. denied, 493 U.S. 944, 1 110 S. Ct. 350 (1989) (DES case); Collins v. Eli Lilly Co., 116 Wis. 2d 166, 342 N.W.2d 37, cert. denied, 469 U.S. 826, 105 S. Ct. 107 (1984) (DES case); Martin v. Abbott Laboratories, 102 Wash. 2d 581, 689 P.2d 368 (1984) (DES case). In no state was that theory applied in the face of a contrary statute similar to Hawaii’s blood shield law.

Four state supreme courts have rejected the market-share theory of liability doctrine: Smith v. Eli Lilly & Co., 137 Ill. 2d 222, 560 N.E.2d 324 (1990) (DES case); Shackil v. Lederle Laboratories, 116 N.J. 155, 561 A.2d 511 (1989) (DPT vaccine case); Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67 (Iowa 1986) (DES case); and Zafft v. Eli Lilly & Co., 676 S.W.2d 241 (Mo. 1984) (DES case).

*456A number of federal courts have also rejected the doctrine: Tidler v. Eli Lilly & Co., 851 F.2d 418 (D.C. Cir. 1988) (DES case); Morton v. Abbott Laboratories, 538 F. Supp. 593 (M.D. Fla. 1982) (DES case); Mizell v. Eli Lilly & Co., 526 F. Supp. 589 (D.S.C. 1981) (DES case); Ryan v. Eli Lilly & Co., 514 F. Supp. 1004 (D.S.C. 1981) (DES case). An empirical study of this issue concluded that “[i]n the last several years decisions in a number of jurisdictions clearly indicate that courts are in no mood to extend that expansionary doctrine [market-share liability] any further.” Henderson & Eisenberg, The Quiet Revolution in Products Liability: An Empirical Study of Legal Change, 37 U.C.L.A.L. Rev. 479, 492 (1990) (emphasis added).

The Iowa Supreme Court in Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67 (Iowa 1986), aptly states some of the basic reasons why nonidentification theories, which eliminate causation as an element of plaintiff’s proof, should not be adopted by the courts:

We acknowledge that plaintiff in a DES case with an unidentified product manufacturer presents an appealing claim for relief. Endeavoring to provide relief, courts have developed theories which in one way or another provided plaintiffs recovery of loss by a kind of court-constructed insurance plan. The result is that manufacturers are required to pay or contribute to payment for injuries which their product may not have caused.
This may or may not be a desirable result. We believe, however, that awarding damages to an admitted innocent party by means of a court-constructed device that places liability on manufacturers who were not proved to have caused the injury involves social engineering more appropriately within the legislative domain. In order to reach such a determination, three broad policy questions must be answered. One is whether the burden *457of damages for these injuries should be transferred in a constitutional manner to the industry irrespective of an individual manufacturer’s connection with the particular injury. If so, the second question relates to the principles and procedures by which the burden would be transferred. Finally, how do we ascertain the extent of damages to be assessed against each manufacturer? ...
Plaintiffs request that we make a substantial departure from our fundamental negligence requirement of proving causation, without previous warning or guidelines. The imposition of liability upon a manufacturer for harm that it may not have caused is the very legal legerdemain, at least by our long held traditional standards, that we believe the courts should avoid unless prior warnings remain unheeded. It is an act more closely identified as a function assigned to the legislature under its power to enact laws.

Id. at 75-77.

V. Conclusion

Leaving plaintiff without a remedy is a harsh result. However, this is not the proper case upon which this court should innovate and radically change the existing law. The application of market-share liability in the context of this case would essentially make each defendant manufacturer an insurer of any infected individual who “might” or “could” have used its Factor VIII concentrate. Not only would such an approach directly contravene Hawaii’s blood shield statute and the public policy which prompted its enactment, but such a broad imposition of liability is wholly unjustified, unfair, and likely to discourage the future development and sale of blood therapies. The decision of whether such an expansive theory *458of liability should apply as against manufacturers of blood products is best left to the legislature, which is equipped to address the “Pandora’s box” of questions that the majority acknowledges results by today’s decision.

I submit that the majority is mistaken if its characterization of the record as a “virtual factual vacuum” means that the facts are insufficient, and thus a trial is necessary to develop additional facts in this case. Additional facts will not change the inevitable —that is, Smith’s inability to establish when and how he was infected by the HIV virus, and the fact that information regarding AIDS and the techniques to detect the HIV virus were just being developed during the pertinent period, make it impossible for Smith to prove a standard of care. The majority’s decision now allows all of the parties to proceed to trial, which undoubtedly will result in substantial costs and attorneys’ fees being incurred. However, the expenditure of time and money will be for naught.

For these reasons, I would answer the certified questions as follows:

1. Hawaii’s blood shield law, HRS § 327-51, precludes Smith [plaintiff] from bringing a strict liability claim.
2. Hawaii’s blood shield law does not preclude Smith from bringing a negligence claim as to any defendant against whom Smith is able to establish 1) a duty owed to him; 2) breach of that duty; 3) causation; and 4) injury. The statute requires Smith to prove that his HIV infection was caused by one of the defendant’s own negligence.
3. Hawaii does not recognize the applicability of any nonidentification theory of causation to this case. The circumstances of this action do not provide a sufficient or appropriate basis to depart from the *459well-established principles of negligence liability under Hawaii law.

See United States Department of Justice, Report of the Tort Policy Working Group on the Causes, Extent and Policy Implication of the Current Crisis in Insurance Availability and Affordability 33-35 (Washington, D.C. Government Printing Office, Feb. 1986).

The answering brief of defendant Baxter Healthcare Corporation explains that “[t]his action is one of four related cases filed in the United States District *450Court of Hawaii. The first, John Doe v. Cutter Biological, et. al. (No. 87-0232), was instituted as a class action suit on behalf of all hemophiliacs in Hawaii (including Smith). However, class certification was denied on December 8,1977 by Judge Fong. Doe and the other plaintiffs therefore proceeded with individual actions against the same defendants, under the pseudonyms ‘Richard Roe’ (No. 87-0893-HMF), ‘James Jones’ (No. 87-892-ACK), and his brother, the appellant in this action, ‘John Smith’ (No. 87-0891-ACK). All alleged negligence by the defendant processors and by treating physicians at Tripler Army Medical Center. Both Jones and Roe have since been dismissed with no appeal. The Doe action presently remains pending before the Ninth Circuit Court of Appeals (No. 89-15274), on appeal of the District Court’s Order which granted summary judgment to defendants.” (Footnote omitted.)