Smith v. Cutter Biological, Inc.

SMITH, v. CUTTER Plaintiff-Appellant, JOHN BIOLOGI Inc., INC., division Miles CAL, MILES LABORA TORIES, INC., TRAVENOL LABORATORIES, INC., AMOUR PHARMACEUTICAL CORPORATION, CORPORATION, ALPHA THERAPEUTICS AMERICA, UNITED STATES OF Defendants-Appellees NO. 14754 - (NO. CV-87-0891) D.C. 89-15839 NO. NOVEMBER LUM, C.J., PADGETT, HAYASHI,

WAKATSUKI, MOON, AND JJ. LUM, OPINION OF THE COURT BY C.J. This court has to address certified accepted request ques- Smith v. Cutter tions from the Circuit Ninth Court of Appeals. Inc., Biological, (9th 1990). 911 F.2d 374 Cir.

I. QUESTIONS CERTIFIED LAWOF Law, 1. Does Hawaii’s Blood Haw. Rev. Shield Stat. 327-51, Smith a from strict preclude § bringing claim? Law,

2. Blood Haw. Rev. Does Hawaii’s Shield Stat. 327-51, Smith from preclude bringing negligence § claim?

3. Would Hawaii allow in this case when recovery the of the actual tortfeasor be If identity cannot proven? (i.e. Hawaii would allow what burden- recovery, shifting, other) market enterprise liability, share or would the Hawaii Court Supreme adopt?

Id. at 376. In our considering responses to the questions, we note that the issue as to two and questions three concerns the causation in factor negligence. instant is that the can- problem plaintiff not identify defendant caused his particular injury.

Our consideration of the issues is limited to the facts as stated in this record. this case reached the Procedurally, Ninth Circuit Court on a motion. The order summary judgment granting summary did not rule judgment on and breach as to the duty manufacturers; was on summary judgment granted the basis that failed to plaintiff causation. prove i.e., The other elements of breach and negligence, duty, are not at issue damages, here. We note that at least two courts determined, action, have in cases similar to the instant that there Inc., was no breach of Laboratories, v.Miles duty. 887 F.2d Jones Inc., (11th 1989); Laboratories, McKee v. Cutter Cir. (6th However, 1989). F.2d 219 Cir. those cases are distinguishab le.1 We do not render an as to whether here opinion appellant cases; will overcome the obstacles met in those the plaintiffs decided, duty breach here have issues not not been they Therefore, are not before this court on the certified we questions. do not deal with the viability questions. those controlling here. The first distinction Second, Jones, jurisdictionally, the negligence those courts’ decisions are not was based on the failure of the “high defendant use questioning specifics risk” as to the of whether the donor Jones, was ahomosexual. solely 887 F.2d at 1580. The decision was based on the donor, identified, clearly fact that the who was would not and did not admit that he “high was a member of one of AIDS. Id. groups risk” McKee, In finding negligence of no was based on the fact that at the time being diagnosed industry decedent’s with AIDS October custom require processes did not developed later to inactivate the AIDS McKee, cases, virus. 866 F.2d at 224. A final that in distinction is both specific manufacturer was named.

421 — Our conclusions deal with this as it only case comes to us. Therefore, stands, of the reading on our record as it the relevant statutes, law, and the relevant case we answer to “yes” question one, and “no” to two. Our three is question answer question the alternative market-share “yes,” using theory recovery, defined herein.2

II. is a who tested Appellant hemophiliac has HIV-positive with the AIDS He virus.3 claims that his to the AIDS exposure virus occurred in 1983 or injections through (Factor AHF).4 Factor Concentrate VIII or Antihemophilic Factor hand, On approved application the other at least one court has of the market- Ray v. Cutter theory liability share Laborato- on facts similar to those herein. ries, (M.D. 1991). Ray Supp. 754 F. Fla. summary 193 was considered at also judgment stage, adopted theory but the federal court the market-share as that was only by approved supreme multi-tortfeasor then the state court. Id. at 195.

Travenol Corporation, ^[2] Defendants Laboratories, Cutter include not Biological, Inc. (now Inc., Baxter manufacturers Alpha Therapeutics Corporation, Laboratories) — Armour Pharmaceutical — but also the United (U.S.). allegations States of America against negligence are based on U.S. Although designated and failure appellee, to warn. as an the U.S. has not filed an answering against directly pertinent brief. are We note that claims the U.S. not questions the certified before this court. yellow AIDS is an fever, infectious hepatitis. R. disease Jarvis, caused M. Closen, Hermann, by a D. virus, as are A. herpes, smallpox, Leonard, AIDS 1990) (hereinafter (West The disease was Nutshell). AIDS Law in a Nutshell uniquely recognized July, 1981. Id. at5. There in June and are several modes intercourse, receipt infection: 1. sexual 3. sharing syringes, infected of human tissue, blood, etc., infected, Id. at 7. Once feeding. and 4. childbirth or breast a victim positive during period, will not test for HIV a which lasts “window” — although say between six weeks and months six some researchers the window Id. at 14. Although period may years. testing positive, be person may several Id. asymptomatic years. continue to be for seven to ten identified method of Although infection contracting blood transmission AIDS, July was not the earliest three hemophiliacs positively were VIII, III, as more discussed in Part is a fully blood which protein enables the blood to when properly coagulate a hemophiliac suffers a bleeding source of the VIII episode. original Factor blood donors. through

The United (U.S.) States Medical Tripler was Army Hospital for Factor VIII the appellant’s dispensary of time in during period claims to have been infected. to appellant According appel- lant, manufacturers5 furnished to the U.S. the Factor VIII appellee which was used by first appellant. Upon appellant’s tested being 1986, for HIV antibodies in were results positive. filed suit the four Appellant against manufacturers of appellee Factor VIII for negligence strict Defendants moved liability.6 for “that this is a case summary judgment. Despite acknowledging in which it be reasonable to of market might apply principles diagnosed pneumocystic pneumonia, pneumonia with carinii a form of which the (1981) early patients Kozup Georgetown University, developed. AIDS had 663 1048, (D.D.C. 1987), Supp. part part, F. 1051 in vacated other on aff'd 1982, (D.C. 1988). grounds, reported 851 In a F.2d 437 Cir. December there was possible transfusion-associated AIDS case. Id. 1982, meetings July

Various In Health addressed the issue. Public Hemophilia held Opportunistic Service Committee on Infections in Patients with (ARC) meeting, open representatives an at which Red Cross from the American banking organizations participated. and several other Id. The blood and health report meeting suggest from that stated ‘characteristics which an that “AIDS had etiology,’ ‘possible infectious and that a of transmission is via blood mode ” citing summary judgment. Exh. products.’ Id. E-l to ARC’S motion for January, Workgroup Identify Opportunities “In a for the Prevention were five meeting, AIDS was convened. . . . of the date of the there [A]s hemophiliacs.” The concensus that AIDS was reported among cases of AIDS Id. finally Id. at 1052. There were some recom- blood transmissible came develop screening Id. until did scientists mendations donors. Not seriologic testing at 17. to detect antibodies. AIDS Nutshell, See supra note regarding defendants. Appellant, at one point, attempted to convert this suit to class action but analysis of liabil through opportunity. to follow on the Our of the theories failed might ity differ were this a class action.

share district court liability,” granted summary judg- in favor of ment failed to appellees, holding appellant prove which manufacturer’s caused his infection. specifically product Circuit, took the case Ninth which certified the Appellant to this court. questions

III. The first asks whether the Hawaii question Blood Shield Law a strict claim. The blood shield statute reads as precludes follows: from strict

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

Hawaii Revised Statutes (1985) 327-51 (emphasis § added). The answer to this then on whether question depends Factor VIII can be as a “blood categorized component.” Appellant that the argues was or legislature to blood blood merely referring for the definition of blood The his- plasma legislative component. does not to us be that narrow. The states that: tory appear history bill... an to the doctrine provide[s] exception

Th[e] of strict on tort when transfer of of there is a part the human from to another. . . . one organism person [Tjhe of . . strict . imposition liability upon persons in scientific engaged procedures with dealing ... prepar- . . . human . . . ing or component thereof could blood[] inhibit, at the of the expense health welfare of the Hawaii, of people exercise of sound medical judg- ment in this area and restrict the of may availability scientific important and skills. knowledge Journal, Sen. Comm. Conf. No. in 1971 Senate Rep. humans, We do not believe that blood “preparing components” in the noted a history quoted, intends limitation to blood or blood plasma. legislature declined define that phrase. to the

Looking definition federal by the Food Drag Administration, a a single-donor “means component part unit blood separated by mechanical means.” physical 606.3(c) (1990).7 21 C.F.R. VIII Factor is a blood protein, § essential normal can be extracted from coagulation, which human blood. The extraction called involves process plas- blood, That called mapheresis. process separates part from whole blood.8 The factors cryoprecipitate, making clotting VIII are and then up Factor obtained from the cryoprecipitate, freeze-dried. Factor VIII’s than usefulness is substantially greater which, VIII, to the was cryoprecipitate, Factor prior refinement treatment for primary hemophilia. Therefore, we VIII believe that Factor is a component Inc., Laboratories, from blood. See also Roe v. Miles prepared (D. 1989). 740 F. 740 Alaska that we answer Supp. With finding, affirmative; the in first the Hawaii’s blood shield statute question a strict claim. precludes liability

[7] The part referenced in the federal regulations is titled “Current good manu- facturing practice components.” for blood and blood Standards obtaining cryoprecipitate process control for plasma are respectively. regulated. also C.F.R. 640 and 606.110 §§ IV. tied to the third It The second is question question. requires what the blood shield that this court decide Hawaii statute means the “its own is that phrase negligence.” Appellees’ argument bars a lawsuit where the tortfeasor cannot be phrase positively words, identified. In other is identical to the question virtually is, in first the third certified The distinction in the query question. instance, whether the first means of the blood shield legislature, by statute, tortfeasor, a claim an in against allows unidentified instance, second whether this court would allow such an action based on the Hawaii law. If tort “its own general development means the must be of that negligence” literally negligence particu- and have lar defendant caused the to the then damage plaintiff, there would be no room to consider multi- various any tortfeasor theories of liability. at the behind the blood shield stat-

Looking legislative history ute, we note that it states that strict does merely excluding theories, not “affect remedies based other such as legal upon negli- or willful gence misconduct.” Sen. Conf. Comm. No. in Rep. Journal, Senate at 1135. on which The wording appellees so “own absent from rely heavily, negligence,” conspicuously other history. Lacking wording, any wording giving indication, such an we believe that the has not legislature spoken exists, on this issue. We believe a lacuna free to and we are use our own in the determination words blood shield explain pertinent Therefore, the statute. second is answered question negative.

V. The final to this court comes in two question posed parts. whether first asks this court would allow part recovery negli- concluded, when the We actual tortfeasor cannot be gence proven. 426 IV,

in Part the Hawaii shield blood statute not mandate does identification of the specific tortfeasor. We now consider whether general Hawaii tort law allow the would action.

The reason this case is before this court is because legisla ture has not in the field of torts. the occasion fully legislated When arises for which there is no rule to “we are free to specific apply, Cione, fashion an Armstrong rule of law.” v. Haw. appropriate 69 176, 738 (1987). P.2d must 79 We consider what justification there is for from traditional in deviating proof negligence case, which, said, as this court the factor of has includes previously Inc., causation. See Hotel, Knodle v. Waikiki Gateway 69 Haw. 376, 385, 377, (1987). 742 P.2d 387 take issue were devel-

Appellees with theories which applying in a in oped, large for remedies the field of part, diethylstilbestrol (DES) with drug litigation and the inherent associated problems those actions.9 Their these theo- argument against using strongest Rptr. ^[9] 132, precursor 607 P.2d of the DES 924, cert. denied, cases is 449 U.S. Sindell v.Abbott 912, 101S. Ct. Laboratories, 285, 66 L. Ed. 2d 163 Cal. (1980). manufac 140 Sindell arose were sustained as to several when demurrers DES, product identify caused plaintiff turers of on the basis that could not whose 134, injury. considered the Id. at 607 P.2d at n.3. The Sindell court 926-27 four main theories. Michigan approved both the concert of action and alternate theories 311, Co., up summary Lilly judgment. in a DES case on Abel v.Eli & 418 Mich. 164, 833, 123, denied, L. Ed. 2d 65

343 N.W.2d cert. 105 S. Ct. 83 469 U.S. (1984). year, Supreme In the issue on Washington the same Court addressed Laboratories, appeal summary judgment, 102Wash. 2d from in Martin Abbott 581, 689 (1984). reanalyzed enumerated P.2d The Martin court the theories 368 Sindell, liability. and then created the market-share alternate liability theory allowed the in a tentatively A federal court Illinois alternate case, yet had not acknowledging Supreme that the Illinois Court DES Therapeutic Corp., Supp. F. Alpha Poole v. addressed the issue. Later, case, (N.D. 1988). DES but Supreme Court did address a Ill. Illinois — adopt. theory liability which it Smith as to the market-share refused Co., (1990). Lilly v. Eli 137 Ill. 2d 560 N.E.2d 324 & York, Florida, theories as adopted In as in courts market-share New state Co., Lilly N.E.2d Hymowitz v. & 73 N.Y.2d viable in DES cases. Eli is the lack ries DES to Factor VIII as a comparison fungible DES was more than 200 different product. produced compa- nies, defunct, some of which are but the identical formula was used VIII, in a With universally highly regulated industry. Factor there manufacturers, are a handful of only and although product insofar can as it be used it not have fungible does interchangeably, — the constant of DES. The reason is obvious the donor quality Therefore, source of the is not a constant. Factor VIII is plasma infected; harmful if the donor was DES is harmful. inherently As we see that the lack of of donors and failure to warn screening are the breaches alleged, for not DES appellees’ argument using theories is not We find consideration convincing. of the theories discussed in the DES cases to be as we strive to find an helpful, and fair solution to the case at bar. equitable Our initial reference is to the Court reasoning Supreme Laboratories, California, in Sindell v. Abbott 163 Cal. Rptr. denied, 132, 924, 912, 285, cert. 607 P.2d U.S. 449 101 S. Ct. (1980). 66 L. Ed. 2d 140 We to the subscribe reasons policy Sindell, infra, and discussed propounded by-passing identification requirement. addition,

In we note that tort law is a continually expanding field. As discussed the American Law Institute Enterprise — (1991) for Personal Responsibility Injuries Reporter’s Study (ALI the field of torts has now Study), to include expanded actions personal described in three tiers of actions. I ALI injury first, These are defined as the traditional level Study loosely which includes accidents where an individual defendant causes harm to a The second level and stranger. includes defects product medical which include stakes cases with erratic mishaps high jury 1069, denied, (1989) (on cert. U.S. S. 2d 110 Ct. 107 L. Ed. market); Conley questions adopting certified national market as the base Co., Boyle (Fla. 1990) Drug 2d (adopting Washington’s 570 So. version of theories). liability, summarily market-share disposing of the other results. Finally, the third tier includes “mass” torts where toxic exposure many plaintiffs later, may, many years cause cancer or other illness. Id. at 9-10. It is this final tier with which this case deals. It necessitates how to considering deal with fairly the plight of plaintiffs unable to own, for no identify, fault of their the person who should entity bear the for their injury.

No can we longer traditional apply rules of such as negligence, those used in individual and low level negligence mass tort cases, here, especially where we are with a dealing pharmaceutical industry on a wide dispenses drugs scale that could cause mas sive to the injuries and where public, makes fungibility the strict difficult to requirements meet. The calls for problem new adopting causation, of rules for otherwise innocent would be left plaintiffs without a We remedy. concede that there is a difference of opinion instance, the need regarding for this For in change. to DES regard cases, the Illinois Supreme Court refused to the market- adopt share of theory liability, because part of market “[acceptance share and the concomitant burden on the courts and placed will parties imprudently down the in an bog almost judiciary Co., futile Smith v. Eli Lilly & endeavor.” 222, 253, 560 137Ill. 2d 324, (1990). addition, N.E.2d In that court criticized the fair of ness results in when reliable apportioning damage information on all manufacturers Id. not be might available. Part of that reason course, of ing, is based on the fact that the number of potential defendants in DES 254, 560 cases extends into the hundreds. Id. N.E.2d at 338. The numbers here are not so nearly and there large, fore, result, is, the harshness of the the innocent burdening without a plaintiff to us seems remedy, unfair and out totally with current efforts to step allow when the case is recovery proper brought. in Sindell

The and Hall convince us that it is appro- policies to consider a priate action where the negligence actual tortfeasor Therefore, cannot be proven. inherent although proof causation, is negligence we believe proof that this state is amenable to consideration of theories group of liability.

VI. The second of the third part certified asks what question or theory theories this court might where the adopt tortfeasor can not be There proven. are several theories which have evolved in the last several years. genesis these theories comes from Laboratories, Sindell v. Abbott 132, 607 924, 163 Cal. P.2d Rptr. denied, cert. U.S. 101 S. Ct. 66 L. Ed. 2d 140 (1980). The theories are described generally as: alternative action, concert of liability, enterprise industry-wide liability, cases, market-share In the evolution liability. of the DES market-share modifications, has theory various undergone to suit policies needs of the courts. particular

A. Alternative Liability This in the well-known case of Summers epitomized Tice, 80, 199 (1948). case, 33 Cal. 2d P.2d 1 In that two hunters in shot the negligently direction of the one of them plaintiff; him. injured that both were Upon deciding wrongdoers to the negligent the court felt that it plaintiff, was unfair to leave an burden impossible on the proof and shifted that burden plaintiff, to the defendants to absolve of Summers v. rule themselves. The Tice is (Second) (Restate included in the Restatement of Torts ment) as follows: tortious,

Where the conduct of two or more actors is and it is that harm proved has been caused to the plaintiff by them, one of but there is as to which uncertainty one it, has caused the burden is each such actor to upon prove that he has not caused the harm.

430 (1965). 433B(3) Restatement comments the Restate- § ment suggest also that this theory may be appropriately subject Id. at modification a later h. time. comment First, Two follow this the presumptions must theory. plaintiff that “all prove defendants acted harm that the tortiously Sindell, from resulted of one of conduct them.” 163 Cal. Rptr. 139, n.16, at 607 P.2d at 931 citing Restatement 433B § comment g. This has been to mean that the tortious interpreted Starling Seaboard Coast actions must occur simultaneously. Line R.R., 183, 191 (S.D. 1982) (court 533 F. consider Ga. Supp. However, court, ing theories in asbestos related another injury). case, Poole v. See in Factor VIII a applying theory disagreed. 351, Alpha Therapeutic (N.D. 1988). Corp., 696 F. 356 Ill. Supp. Sindell, Second, all be must responsible parties joined. 139, 607 163 Cal. P.2d at is Rptr. theory 930-31. this Typically, cases, useful in several car crash cases multiple pollution by defendants, and medical where the injury during operations plain tiff is sedated. In re Liab. Agent Orange Litig., Prod. F. 597 Supp. 740, cert. (E.D.N.Y. 1984), (1987), 822-23 F.2d aff'd, denied, (1988). L. U.S. 108 S. Ct. Ed. 2d 648 however, in the Additionally, and several is inherent joint application alternative liability.

We choose not to alter the to the that it would be point useful on facts Several arise which us to here. lead problems First, this decision. we look at the various theories negligence One is there was appellant duty suggested. argument donors; select and other follow properly arguments screen — same line of that the manufacturers should have reasoning tests, verified or that implemented surrogate laboratory they have donor should ceased from centers where using plasma It had numbers of AIDS incidents. groups population significant times, so that each acted at various different obvious manufacturer the simultaneous of a strict application theory requirement Also, fails. has that manufacturers are appellant alleged although tortfeasors, have “most” of the and the manufacturers not possible it to factual rebutted that is still clearly argument, subject proof we do not believe and several findings. Finally, joint Therefore, is case. under circumstances of this this appropriate here, modified, cannot be and we not theory unless choose applied facts, theories, to do so based on these other discussed infra, have been modified. already appropriately

B. Concert of Action This derives from the law criminal theory concept aiding Starling, 533 F. See abetting. at 187. Supp. Restatement Concert of action with a small usually § number applied defendants, a and a time single plaintiff, short between period the tort and its discovery. defendants’ is the basis of plan joint action, the cause of and most often the is able to plaintiff identify which defendant caused the Abel v. Eli & actually Lilly injury. Co., 338, 164, 176, 311, denied, 418 Mich. 343 N.W.2d cert. 833, 105 123, (1984).10 469 U.S. Ct. S. 83 L. 2d Ed. The court stated that the identification did not use of the Id. preclude theory. court, the to the burden According withstand a plaintiffs motion, action, summary judgment failure to state cause of was to that the defendants were “allege engaged tortious jointly as a activity result of which harmed.” Id. Inherent was plaintiff in this theory is the and several As the application joint liability. stated, court Michigan also can establish that all plaintiffs “[i]f defendants acted to a common will tortiously pursuant design, they all be held liable for the entire result.” Id. case, Michigan

10 The in a applied court allowed this to be DES had summary judgment, appeared plaintiff reached the court on where it could 311, 343 Co., 164, Lilly v. Eli identify Abel & the tortfeasor. N.W.2d 418 Mich. denied, cert (1984). 469 U.S. 105 S. Ct. L. 2d 65 Ed. 432

Even if we this thought theory in a Factor appropriate VIII case, we do again, not wish to burden defendants with joint Therefore, several we liability. choose not to allow this to theory be to applied this case.

C. or Enterprise Industry-Wide Liability The essence of the is that enterprise theory there is con- joint trol of the risk throughout The particular industry. theory origi- case, nated in the blasting Hall v.E.I. Du Pont de Nemours & caps Co., (E.D. 345 F. 1972). N.Y. Supp. The basis of the case was that there was an industry-wide standard concerning safety; the safety was planning to a central delegated and there was co- group; in the operation manufacture and dictates that when design. Policy occur, all of those facts Therefore, the entire is liable. enterprise the industry-wide standard became the cause of the plaintiff’s injury.

The main premise this is in one against stated theory DES cases:

The rationale in all of underlying the decisions rejecting enterprise is that the law of liability torts does not include a which would allow an entire to be industry held liable an strictly injury caused aby defective product. Enterprise liability described in Hall is predicated upon industry-wide of a cooperation much greater than that degree alleged by the plaintiff. Laboratories,

Martin v. Abbott 581, 600, 102 Wash. 2d P.2d (1984). That is premise directly disputable by reading Hall, as the court states:

There is thus no for defendants’ support argument risk, that to establish control of must joint plaintiffs demonstrate that the was explosives industry “rigidly the trade association with to controlled” through regard and that blasting object such control cap design,... breach of particularly reprehensible was some duty. business variety property relationships control has of risk been found demonstrates the joint the doctrine. not limited flexibility par- Liability ticular formal modes of nor illegal cooperation, activities. negligent grossly at F. Supp.

However, another court has stated the burden aptly plaintiff’s with proof showing: (1) the by that was manufactured one of a small product (2) in number of defendants an the defendants industry; of the had a to reduce the risks joint capacity product; (3) each of them to take to reduce the risk at a failed steps concurrent time their substantially delegating respon- by to an association. sibility Co., 600,

Conley Boyle Drug (Fla. v. 1985), 477 So. 2d App. rev’d grounds, on other (Fla. 1990) 570 So. 2d 275 (specifically alternative, of the lower court as to approving analysis action, and Sindell market-share theories of concert of enterprise, liability). on the set Conley,

Based as forth in steps theory enterprise be a appears to somewhat persuasive method of this approaching case. We note that the do not raise that the pleadings allegation had the defendants to reduce the joint capacity risk. Appellant however, brief; does not even this in argue theory his opening facts in the brief lend to this alleged credibility argument. type Were it not that we are faced with the inherent again application joint liability, the fact addition we find one aspect Hall scenario we this distinguishable, endorse convincingly might to the theory answer certified question. Hall,

First, we mention the characteristic of distinguishable which is out to us by and the court convincingly pointed appellees Laboratories, in Sindell 132, Abbott 163 Cal. Rptr. 607 P.2d denied, 912, cert 449 U.S. 101 S. Ct. 66 L. Ed. 2d 140 (1980). The court there noted that “the drug industry is closely regulated Administration,... the Food and by Drug a consider [t]o therefore, able degree, the standards followed manufactur by drug ers are suggested 143, 607 Id. compelled by government.” P.2d at 935. With the actions, government in control of the parties’ it is unfair to hold them liable for the standards. following Appel lees’ arguments convince us that such reasoning appropriate here, too, to eliminate this on these facts.

We further digress on our reluctance to expound adopt joint First, in the liability Factor VIII a new cases. we are writing Hawaii, in tort law in chapter the State of we endeavor to set princi- which we think ples would be our We note adopted by legislature. statute, that by and several in tort was abolished to joint 1990). some extent as of October 1991. HRS 663-10.9 (Supp. § allowed, As to what is still are still limited the doctrine damages (1985). of modified HRS 663-31 comparative negligence. § Therefore, we believe to the the has seen a need balance legislature in this field. equities evolving addition, cases,

In as noted of the in DES by many opinions there is an inherent unfairness in one or two holding parties respon- in sible full for the who actions tortfeasors may escape liability trade-off, for some reason. It at fair where the seems least a plain- tiff cannot to at caused his identify party actually injuries, allow least the defendants to limit their share of to their Therefore, relative of the market. we move on to dis- proportion cuss, endorse, market-share with modifications. liability,

D. Market-Share and Its Progeny Liability This has been most to variations and susceptible refinements, the DES but also in line with especially litigation, law of the state in which it has been It was applied. first defined Sindell, 132, denied, 924, cert. 163 Cal. 607 P.2d Rptr. U.S. 912, 285, (1980). S. Ct. 66 L. Ed. 2d 140 there policies Tice, stated included: 1. the of Summers reasoning 33 Cal. 2d 80, (1948), 199 P.2d 1 that between innocent plaintiffs negli defendants, liable; gent the negligent should be held parties 2. advances in science and the creation of whose fungible goods traced; source cannot be 3. the financial of defendants ability to costs; bear the and 4. the fact that manufacturers are in a better to position defective from prevent products the consumer reaching Sindell, market. 163 Cal. at Rptr. 607 P.2d at 936. We on expand those policies that defendants acknowledge may bear the loss by that cost of passing business on to doing consum addition, ers. In we feel that and fairness call equity using market-share Another approach. is that where justification many lethal, can drugs be and it is difficult for the consumer to identify the source of the product, burden should shift. The concept law, itself meets the of tort objectives both by providing plaintiffs but remedy, also by defendants from deterring acts. negligent After Sindell court stated: its stating policies, hold it to be reasonable in the context present

[W]e measure the likelihood that any defendants sup- plied product which allegedly injured plaintiff by which the DES percentage sold each of by them for the purpose preventing bears to the entire miscarriage pro- duction of the sold all for that drug purpose.

Id. 607 P.2d at Included in the definition was a that a substantial requirement of the market must be percentage defendants, joined and that an clause be included. exculpatory Id. We feel that this basic with and theory, modifications distinc- state, tions to suit the of this discussed an infra, provides policies modem for appropriate case. The appellant’s relevant considera- 436 market, and joint 2. identification

tions are: 1. defining 3. allowances. finally several liability, exculpatory 1. Defining the Market Criticisms of Sindell include the definition of need for a market, “substantial share” of the the share of order not to distort Laboratories, 581, Martin v. Abbott 602, liability. Wash. 2d 102 368, (1984). P.2d 381 The Martin court adopted 689 a narrow market, definition of the that particular geo- being plaintiff’s 605, market. Id. at at 382. The graphic justification 689 P.2d the narrow defen- that market share make a purports “particular that it dant’s . . . to the potential liability probability proportional Id. reaffirmed by caused was later This plaintiff’s injury.” policy court, evidence lacking the same with acknowledgement market, within the . . such as then “other . figures, specific state, circumstances in certain or even in the county, country may Parke-Davis, 584, 592, v. Wash. 2d George introduced.” 107 be Court, Conley 507, (1987). P.2d The Florida Supreme Co., 1990), with the (Fla. Boyle Drug agreed 570 So. 2d 275 “as narrowly the relevant market should be court that Washington Id. as the evidence in a case allows.” given defined with the to be consistent this manner of definition court found show- itself by Martin a defendant to allowing exculpate does meet goal in that market. It no ing participation on those companies market-share liability only impose who could have manufactured the injurious product. national market as adopted

Another court has specifically Co., N.Y.2d 487, 511, v. Eli & Hymowitz Lilly the best option. 1077, cert. denied, 944, 110 S. Ct. N.E.2d 493 U.S. this hold (1989). supported 107 L. Ed. 2d 338 Several premises market smaller any 1. it was difficult to determine reliably ing: one, need to establish separate 2. it avoided the than the national share, as 3. it an matrices to market avoided unfair burden on 511, 539 Id. N.E.2d at The national market was at 1077. litigants. intended to so as to to the over-all correspond “apportion liability defendant, of measured the risk of each amount of culpability Id. each the defendant created to injury public-at-large.” N.E.2d at This relief for 1078. provides equitable plaintiffs, and a rational distribution of defendants. It responsibility among the also avoids a windfall to who to sell escape producer happens therefore, certain to distributors. The mar is for culpability, keting product.

As we are here with a minimal of faced number manufacturers we believe that product, culpability prod- marketing uct is a better Should the issue arise under circum- policy. different stances at some we find it to narrow the point, may appropriate case, however, definition. For this we believe the market national is the more consideration. equitable Identification and Several Liability Joint

Courts differ their on of an assertive on the requirements effort of to the actual part plaintiffs identify manufacturer of the specific which We product caused harm. take another to this approach concern. Whereas manufacturers here should argue appellant have which of manufacturer’s he was we kept log using, product fail how to see such failure affects the suit viability appellant’s in view of our market-share adoption liability. manufacturers,

Plaintiffs use due all should to diligence join but failure to do is not a do so defense. Failure to so affect may However, percentage recovery, discussed manufacturers infra. case, But, are to other all permitted manufacturers. this implead However, manufacturers are so the issue is not us. joined, before court, that the conditions of the Martin we note in passing defendant, would allow to initiate suit plaintiffs against only one Sindell, which would a “substan- require plaintiffs join and of defendants, are tial” number of immaterial as as long plaintiffs will realize their on recovery depend manufactur- joining many can; ers as will they plaintiffs endeavor to all join manufacturers.

We have already discussed our that this action should feeling not be subject joint We reiterate what other liability. simply “ courts have said on this that cornerstone of market point, ‘[t]he share alternate is that if a defendant can establish its actual liability share, market will it not be liable under circumstances for more any ” Conley, than that of the total percentage plaintiff’s injuries.’ Parke-Davis, quoting George 2d 570 So. at 107 Wash. 2d Therefore, 733 P.2d at 513. we advocate several liability. We define the to rules distribution as market share for this Martin, case as was done in that is: The defendants that to them- are unable exculpate selves from are members of potential liability designated the . . . .... These defendants are plaintiffs’ market[] have of the market and initially to shares presumed equal are liable for the only judgment percentage plaintiff’s that share of the market. their represents presumptive this These defendants are entitled to rebut presumption reduce their thereby potential liability establishing their market in the . . . share of respective [Factor VIII] market.

Martin, 605, 689 102 Wash. 2d at P.2d at 383. As several liabil we the that a defendant is ity, adopt particular to establish their liable for its market share. Defendants failing will difference in share of the market be liable proportionate However, to 100 of the market. should plain judgment percent market, tiff fail to name all members of the will not plaintiff if defendants recover 100 the named judgment prove percent an share of less than 100 aggregate percent. Allowances Exculpatory

As a result our determination that a market is national as defendant one of the appropriate, long actually producers VIII, Factor there is little to of defendant. How justify exculpation ever, the would occur where that defendant could exception prove it on had no at the market time of the As far as product injury. concerned, in this defendants suit are it that none of appears them able would be on that basis.11 escape

VII. conclusion, In we will recognize the basic market-share theory of multi-tortfeasor as defined herein. Acknowl- liability, could this a Pandora’s edging box of we open questions, believe that we have defined at least a as to starting point appropri- However, to the as we ately certified are responding questions. vacuum, in issues a virtual we that our deciding recognize factual us, to opinion is limited the facts to and we reserve the presented or amend our answers to these right modify questions.

John Charles Kozak and for Rapp plaintiff-appellant. Berkman, L. (Dechert Rhoads, Richard Pro Hac Vice Price & Roeca, counsel, F. Louie, of Pennsylvania; Arthur of Roeca & of counsel, Honolulu, brief) with on of him for defendant- Healthcare appellee Baxter fka Travenol Laborato- Corporation, ries, Inc. have, acknowledge

11 Oneof difficulties will we appellant and earlier, that problem injury the district court noted the is when his pinpointing necessary duty period occurred. be That will must be defined that of time. Smith, Geoffrey R. W. Pro Hac Vice (McDermott, Will & Smith, counsel, D.C.; of of Washington, H. Burnham Greeley and Futa, Janice T. Greeley, Kowen, counsel, Walker & of of Honolulu; Duncan Barr Leibman, Vice, Deborah H. Pro Hac O’Connor, Cohn, Barr, Dillon counsel, & California, of with brief) him on the for Cutter defendant-appellee Laboratories. CONCURRING AND DISSENTING OPINION MOON,

BY J. I concur in the majority’s decision that Hawaii’s blood shield statute claim precludes plaintiff’s for strict I also concur liability. in the to the extent majority’s opinion that it the alternative rejects action, concert of liability, theories of liability cau- enterprise However, sation. as to the decision to majority’s the market- adopt share I theory dissent. liability, respectfully endorsement of majority’s the market-share liability contrary established rules of construction statutory and contravenes the intent of the Hawaii legislature enacting Hawaii’s blood shield statute. The considerations which policy underlie our blood shield law of a preclude adoption negligence theory abandons the fundamental principle causation and shifts the burden to defendants to exonerate them- Moreover, selves. the case law which the relies upon majority that Factor VIII requires be and untraceable to fungible specific manufacturers order for market-share to be appropriate. However, Factor VIII is not and it is fungible not impossible or other Factor VIII hemophiliacs users to identify manufac- turers of Factor VIII concentrates used. they Furthermore, the from majority’s well-established departure tort law in Hawaii is based on a factual record that prevents plain- tiff from the existence of establishing a and breach of legal duty

441 care, essential which is on a standard provable that based duty, to the of the market-share of liability. application

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

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

Hawaii’s blood shield statute provides sur- liability. from strict No Exemption physician, bank, bank, or blood tissue or other geon, hospital, person donates, obtains, who entity prepares, injects, transplants, transfers, transfuses, or or or otherwise who assists par- injecting, ticipates obtaining, preparing, transplanting, tissue, transferring organ, otherwise transfusing, any thereof, blood or from one or component more persons, dead, or to another living person, shall be liable as a result such any activity, save and that except each such per- son or shall entity remain liable for the or its own person’s negligence wilful misconduct. or

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

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

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

[t]he “own heavily, is negligence,” absent from the conspicuously history. other Lacking wording, such any wording giving indication, an we believe that the has not legislature spo- exists, ken on this issue. We believe a lacuna and weare to use our own determination explain pertinent free words in the blood shield statute. added.) This

(Emphasis construction approach statutory novel because it allows the inappropriate to attain desired majority result without to the established rules of regard construc- statutory Scalia, tion. Justice Recently, criticizing Court’s Supreme construction of the Act of stated: Voting Rights however, the Today, Court a method adopts [for in a interpreting meaning language quite statute] out of accord with that usual It begins not with practice. what but with says, the statute an about what expectation the statute must mean absent . . . particular phenomena and the Court then the words the statute to interprets fulfill its expectation.... backwards, this is method,

As and however just much we attracted it may produces be the result in a particular case, we should in resist it. every case Our job that begins with a text has and the Presi- Congress passed dent We has are to read the words of that text signed. of Member would have read them any ordinary Congress ... and so determined. apply meaning Roemer, J., 2354, (1991) (Scalia, Chisom v. S. 111 Ct. 2369 added). dissenting) (emphasis statute,

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

A BILL FOR AN ACT PROVIDING THAT PERSONS ENGAGED THE IN TRANSPLANTATION OR OF TRANSFUSION HUMAN TISSUES AND RELATED PURPOSES LIABLE SHALL NOT BE FOR DAMAGES EXCEPT FOR THEIR OWN NEGLI- GENCE OR WILLFUL MISCONDUCT. “ added.) The that

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

[t]his on tort when liability strict there is a transfer part human from one It organism to another. is felt person of strict imposition organiza- upon persons tions with engaged scientific dealing procedures donating, injection, obtaining, preparing, transplanting, tissue, or otherwise of human transfusing, transferring inhibit, at the organ, blood or thereof could component Hawaii, of the health and welfare of the expense people the exercise of medical in this area sound judgment scientific restrict the may availability important and skills. knowledge Journal, at 1135 Senate Stand. Comm. No.

Sen. Rep. Thus, added). the history clearly review of legislative (emphasis view, that, the legislature the majority’s contrary demonstrates issue.” has on this “spoken in shield law enacted Hawaii’s blood

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

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

Our conclusion is also consistent with behind policy enactment blood shield statute. Although of legislative history 19a-280 blood § [Connecticut’s nonexistent, shield one of the virtually driving statute] forces behind the of “blood shield” stat- promulgation utes, 19a-280, such as is to ensure that certain medical § services, tissue, namely, of blood and provision remain available to citizens in need of such As services. stated, one court aptly public policy represented “[t]he these statutes is not difficult to discern: blood transfu- area____” sions are essential in the medical These statutes a legislative judgment that to require providers to reflect serve as insurers the safety these might materials of of impose such an overwhelming burden as to discourage the gathering and distribution blood. of Zichichi, 409, 204 Conn. at 528 A.2d at 810 Garvey (quoting 756, St. 248, Hosp., 103 Wash. 2d Elizabeth 697 P.2d (1985)) added). (emphasis

In the American Medical Association reported “in the pharmaceutical industry, meaningful product liability A.M.A., insurance has all but Report the Board disappeared.” Trustees on Impact Liability Product on the Development New Medical (1988). Technologies This lack of insurance is due to the largely of nonidentification theories of development liability.1 Justice, 1 SeeUnited Department Report Policy Working States of the Tort of Group Causes, Policy on Implication the Extent and the Current Crisis in of Availability Affordability

Insurance (Washington, and 33-35 D.C. Government Office, 1986). Printing Feb. of the The market-share application liability theory may on being placed result defendants liability no bearing responsi- product for the defective bility create costs may unpredictable innocent In 327-51, parties. HRS the enacting Hawaii legisla- § ture sought to unquestionably the risk guard of against adversely However, the affecting blood supply and blood components. the majority’s decision that risk and imposes not very may jeopardize the of blood supply the products protect “health Hawaii,” ... of the but “restrict the people also may availability of important scientific I submit that knowledge skills.” had the legislature intended to sanction such an of liabil- expansive as that ity advocated the it would not have by used the majority, restrictive “own in the statute nor would phrase negligence” we find the so with the statute’s legislative history consistent language.

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

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

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

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

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

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

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

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

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

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

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

Based on the I that majority’s submit foregoing reliance on DES cases its decision to the market- support adopt share liability misplaced. first, Biological, (No. 87-0232), Doe Cutter et. al.

Court of Hawaii. The John was on hemophiliacs instituted as a class action suit behalf of all Hawaii Smith). However, 8,1977 (including class certification was denied on December by Judge Fong. plaintiffs proceeded Doe and the other therefore with individual defendants, (No. against pseudonyms Roe’ actions same under the ‘Richard 87-0893-HMF), brother, (No. 87-892-ACK), appel- ‘James Jones’ and his action, (No. 87-0891-ACK). alleged negligence by lant in this ‘John Smith’ All processors treating by physicians Tripler Army defendant and Medical Cen- and Roe have since been dismissed with no The Doe appeal. ter. Both Jones presently pending action remains before the Ninth Court of Circuit 89-15274), (No. Appeals granted on of the District Court’s Order which appeal (Footnote omitted.) summary judgment to defendants.” III. Standard of Care The caveat that “we majority’s that our recognize opinion us,” limited to the facts is ironic because the facts presented before us do not allow for the of a market-share application theory. The market-share eliminates the element of causation but still the first two elements requires plaintiff prove — fundamental ato cause of action negligence existence and breach of that legal duty duty. states, we see that the lack of majority screening “[a]s

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

Smith was as a in 1964 and diagnosed hemophiliac began Factor VIII concentrates in using 1972 from unidentified sources. He moved to Hawaii in late 1982 and received Factor VIII concen- trates from between 1982 and 1985. For the first Tripler Hospital time in Smith’s blood was tested HIV for the virus. The test was Smith positive. claims that his to the virus occurred exposure However, in 1983 or there is no evidence that Smith did not sources, contract the HIV from virus other activities or including blood manufactured products other than the defen- by companies (citations omitted): dants. As noted majority 452

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

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

The evidence shows that VIII who Factor began using in have received infected Factor VIII may concentrates before the HIVof transmission blood possibility through products Moreover, was ever known. in no tested having positive demonstrates that Smith was infected with virus the HIV way after to Hawaii. nature coming The of AIDS indicates history Smith that was as to have the virus contracted months likely even before to Hawaii. years coming cites a Florida United States District Court case majority of the market-share approved application liability theory in a Factor VIII Ray case In v. stage. summary judgment Laboratories, Cutter (M.D. 1991), 754 F. Fla. the court Supp. Co., 1990), Conley Boyle Drug (Fla. relied 2d 570 So. upon decision, a Florida Court which had the market- Supreme adopted However, share in a DES case. the district court’s liability theory Ray market-share premise applying faulty it because distorts the and fails to fungibility requirement recog- nize would not have been able to establish a standard that plaintiffs of care. the of Ray,

In the court noted that DES met prerequisite the same of harm users liability by market-share risk to all creating it then because was the same formula. The court produced using Factor that VIH differ from one batch to the acknowledged may next, However, on the of it depending pool donors. then plasma concluded one erroneously that “while Factor VHI may product have been infected with the AIDS virus while another may not been, have the that was risk infection was the present same from to during the product product period time to prior initiation of of donors at risk screeningfor having AIDS.” 754 F. at 196 Supp. added). The court state: Ray on to (emphasis goes infected, At the time the Ray boys allege were not they exist, did no test AIDS virus AIDS itself had Thus, even not been identified. it will never be possible for the Plaintiffs to or batch identify particular batches of Factor VIII caused their AIDS respective infections.”

Id.

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

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

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

I, too, with Smith’s situation. sympathize tragic and this court has been faced with similar situations has applied of restraint to established principles judicial by declining expand Recently, the common law to a remedial merely measure. provide Bar, 524, 797 (1990), we P.2d 51 in Winters v. Silver Fox 71 Haw. the United States were with a certified from presented question an Court for the of Hawaii that us gave oppor District District death our law to allow a wrongful dram tunity expand shop minor. In cause of action for the of a deceased family declining that the our dram law we stated question expand shop can be found in further whether some remedial measure the burden and shifting common law modifying from their to minors injuries resulting responsibility the commercial of alcohol to voluntary consumption seller of is best left to the wisdom of Legislature liquor and its process. and within the to weigh

It is legislature’s province social, economic and legal balance the far reaching

455 the common law as consequences modifying Appel- lant urges. 535,

Id. at P.2d 797 I submit that this court is confronted with an which again issue it is to rule There too are unanswered ill-equipped upon. many social, economic, and questions legal import, only with its can legislature, investigative powers procedures, determine. Deference to the legislature especially appropriate due to the enactment of the blood shield legislature’s statute that impact nonidentification such as market share any have may on the blood products industry.

Furthermore, I with the statement that disagree majority’s Hawaii would be “out of with current efforts to allow step recovery when the case is As defendant Cutter proper brought.” Biological brief, (1984) (DES case); 105 S. Ct. 107 581, (1984) (DES case). 102 Wash. 2d P.2d 368 In 689 no state was that in the face of a statute similar to theory applied contrary Hawaii’s blood shield law.

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

456 of federal courts have also rejected

A number doctrine: Co., (D.C. 1988) (DES Lilly Eli & F.2d 418 Tidler v. 851 Cir. Laboratories, v. Abbott Morton case); (M.D. 538 F. 593 Fla. Supp. Co., case); Lilly & Eli 1982) (DES v. Mizell 526 F. 589 Supp. (DES Co., 1981) v. (D.S.C. case); Ryan Eli Lilly & 514 F. Supp. (D.S.C. 1981) (DES case). An of this issue empirical study concluded that the last several “[i]n a years decisions in number clearly jurisdictions indicate that courts are in to no mood extend that doctrine expansionary further.” any liability] [market-share & Henderson Quiet Revolution in Products Eisenberg, Liability: An Empirical Legal Study Change, 37 U.C.L.A. L. (1990) added). Rev. (emphasis Co., Lilly & Mulcahy Eli The Iowa Court in Supreme (Iowa 1986), reasons N.W.2d states some of the basic aptly theories, nonidentification which eliminate causation as an why element be the courts: should not proof, adopted plaintiff’s by with an

We that a DES case acknowledge plaintiff an unidentified manufacturer product presents appealing relief, courts claim for relief. to Endeavoring provide in one or another have theories which developed way court- of loss a kind of provided plaintiffs recovery The result is that manufac- constructed insurance plan. contribute to turers are or required pay payment not their have caused. injuries may product We not be a desirable result. may This may however, believe, an awarding that admitted damages device means of court-constructed innocent party by not on manufacturers who were places liability to have involves social engi- caused the injury proved domain. legislative more within neering appropriately determination, three to reach such a broad policy In order burden One is whether the must be answered. questions of for these damages injuries should be transferred in a constitutional manner to the of an industry irrespective individual manufacturer’s connection with the particular so, If the second injury. relates to the question principles and which the burden would be trans- procedures by ferred. how do we ascertain the extent of dam- Finally, to be assessed each ... ages against manufacturer?

Plaintiffs we a that make substantial request depar- ture from our fundamental of negligence requirement causation, without proving previous warning guide- lines. The a manufacturer for imposition liability upon harm that it not have caused is the may very legal legerde- main, standards, at least our held traditional long we believe the courts should avoid unless warnings prior remain unheeded. It is an act more identified as closely function to the under its assigned legislature power enact laws.

Id. at 75-77.

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

I mistaken characterization majority submit are as a “virtual factual vacuum” means that the facts the record insufficient, additional facts and thus a trial is to necessary develop —that in this case. the inevitable Additional facts will not change is, he was infected by Smith’s to when and how establish inability virus, AIDS and regarding the HIV and the fact that information being developed virus were just to detect the HIV techniques a to for Smith prove make it impossible during pertinent period, all of the par- now allows decision standard of care. majority’s trial, in substantial will result which undoubtedly to to ties proceed However, the expendi- fees incurred. attorneys’ being costs and will be for naught. time and money ture of reasons, the certified questions I would answer For these follows: 327-51, law, pre- HRS blood shield §

1. Hawaii’s a liabil- strict from bringing cludes Smith [plaintiff] claim. ity Smith law does not preclude

2. Hawaii’s blood shield defend- claim as to any a negligence from bringing 1) a duty to establish ant whom Smith is able against causation; him; 3) 2) that duty; breach of owed Smith 4) prove The statute requires injury. one was caused that his HIV infection defendant’s own negligence. of any Hawaii does not recognize applicability to this case. of causation

nonidentification theory not action do provide of this The circumstances from basis to depart sufficient appropriate well-established principles negligence liability under Hawaii law. notes its since the initial of market- answering adoption Sindell, share courts of four other states highest Co., have Conley Boyle Drug 570 So. 2d adopted theory. Co., (Fla. (DES 1990) case); Hymowitz v. Eli & Lilly 487, denied, 941, 1069, N.Y.2d 541 N.Y.S.2d cert. N.E.2d 944, Collins v. Eli Lilly 350 (1989) (DES case); 493 U.S. 1 110 S.Ct. Co., denied, 166, 342 cert. 116 Wis. 2d N.W.2d U.S. Laboratories, Martin v.Abbott

Case Details

Case Name: Smith v. Cutter Biological, Inc.

Court Name: Hawaii Supreme Court

Date Published: Nov 29, 1991

Citation: 823 P.2d 717

Docket Number: NO. 14754

Court Abbreviation: Haw.