Sheffield v. Eli Lilly & Co. (144 Cal. App. 3d 583, 1983)

Opinion

SIMS, J.

Plaintiffs, daughter and mother, have appealed from separate judgments entered in favor of five pharmaceutical manufacturers after the court granted the latter’s motions for summary judgment.

On October 20, 1975, plaintiffs filed their complaint seeking special, general and punitive damages for permanent disability suffered by plaintiff daughter, allegedly proximately resulting from injection with defective Salk vaccine in the fall of 1956 and spring of 1957 when she was a school girl in Indiana. The complaint, as amended November 20, 1975, set forth causes of action sounding in strict liability, negligence, fraudulent concealment and breach of express and implied warranties with regard to the manufacture, production, distribution, sale, testing, storing, inspecting and injecting of Salk antipolio vaccine. A supplemental complaint filed October 7, 1976, alleges that the defendants acted intentionally, wilfully and maliciously with conscious disregard for the safety, health and rights of the plaintiffs and the general public. The defendants represent all of the manufacturers authorized to and actually engaged in the manufacture, production and sale of the vaccine at the time of the daughter’s inoculation. Concededly despite exhaustive discovery it has been impossible to identify the manufacturer of the vaccine, defective or not, that was administered at the time and place that the plaintiff daughter allegedly was inoculated.

Each motion for summary judgment was made on the grounds that the plaintiffs had failed to produce competent evidence to establish the identity of the specific manufacturer of the injury-causing product, and that therefore the action had no merit, there was no credible issue of fact and the complaint failed to state a cause of action as a matter of law.

On appeal the plaintiffs contend that the trial court erred in granting the motions because there is a triable issue of fact under the market share basis of liability expounded in Sindell v. Abbott Laboratories (1980) 26 Cal.3d 588 [163 Cal.Rptr. 132, 607 P.2d 924, 2 A.L.R.4th 1061], certiorari denied 449 U.S. 912 [66 L.Ed.2d 140, 101 S.Ct. 286], and under an “enterprise,” or more accurately, “industry-wide” liability theory. (See Hall v. E. I. Du Pont De Nemours & Co., Inc. (E.D.N.Y. 1972) 345 F.Supp. 353, and Comment, DES and a Proposed Theory of Enterprise Liability (1978) 46 Fordham L.Rev. 963 (hereafter Fordham Comment).) They assert that under the foregoing precedents the burden was on each defendant to establish as a matter of law that it had no involvement in the manufacture or distribution of the vaccine causing plaintiff’s injury. When faced with the argument that the foregoing rules only applied to a market or enterprise in which all the participants were manufacturers or distributors of a defective product, the plaintiffs in their closing brief suggest that the defendants have failed to show that they did not act in concert so that all would be responsible if the vaccine was improperly prepared or marketed by one, and all would be responsible for failure to give a proper warning.

We conclude that the record in this case demonstrates that plaintiffs are not entitled to shift the burden of proof to manufacturers of nondefective vaccine, and that the trial court properly granted the defendants’ motions for summary judgment. The judgments must be affirmed.

Introduction

The facts are gleaned from the almost 2,000-page record of pleadings, admissions, interrogatories and answers thereto, extracts from depositions, declarations and motions as the same have been referred to in the parties’ presentations before this court. Those served and appearing as defendants and respondents are Eli Lilly and Company (hereafter Lilly), Parke Davis & Company (Parke Davis), Dow Chemical Company, as successor to Pit-man Moore Division of Allied Laboratories, Inc. (Dow), Wyeth Laboratories Division of American Home Products Corporation and American Home Products Corporation (collectively Wyeth), and Merck and Company, Inc., through its Sharpe and Dohme Division (Merck).

Following the establishment of issues by the pleadings and some discovery, defendant Lilly on June 8, 1979, filed its motion for summary judgment. The other defendants each joined in seeking similar relief. Plaintiffs filed their opposition to the motions in which they claimed that the motion was premature because they were making substantial progress in identifying the culpable manufacturer, needed time for further discovery, and sought delay pending determination of the Sindell case that had been granted a hearing in the Supreme Court. Following a hearing on June 25, 1979, the court ordered that the motion be denied without prejudice to renewal 120 days after the date of the order.

On October 25, 1979, Lilly again filed a second motion for summary judgment. Wyeth and Merck joined in this motion, and Merck also filed independently. The plaintiffs filed extensive opposition, opposing the motion on its merits, and again sought a delay for further discovery and because of pending undetermined litigation. The records filed in connection with the earlier motion were incorporated by reference. On November 9, 1979, the court continued the pending motions to January 11, 1980.

A month later, on December 14, 1979, the plaintiffs applied for a commission to take depositions in Indiana. Lilly filed opposition on the grounds that the plaintiffs had sought a delay in June to take depositions and had not promptly moved to do so. On December 20, 1979, the court denied plaintiffs’ application as to those employees of Lilly who had been mentioned as prospective deponents in the June proceedings, and granted the commission with respect to the other witnesses.

On December 26, 1979, Dow joined in the motion for summary judgment.

On December 27, 1979, the plaintiffs filed their notice of motion for leave to file an amendment to their complaint to assert additional causes of action against the defendants on theories of enterprise liability, concert of action and market share, similar to those set forth in the then pending Sindell case.

On January 11, 1980, after the plaintiffs, Lilly and Merck had filed other voluminous documents in support of their respective positions, the motions came on for hearing. The court granted the plaintiffs’ motions to file amendments to their complaint, and granted the pending motions for summary judgment. Subsequently, a similar motion for summary judgment was interposed by Parke Davis and was granted. It was stipulated that the appeals from the respective judgments entered for the defendants be consolidated in these proceedings.

The Facts

In March 1953, Dr. Jonas Salk announced the development of a vaccine for poliomyelitis. Thereafter, the National Foundation for Infantile Paralysis, a nonprofit organization which had funded extensive research culminating in Dr. Salk’s discovery, invited a number of manufacturers of biologicals to produce vaccine for a series of field trials designed to ascertain whether the vaccine was safe and effective. Six drug companies expressed a willingness to undertake production—Merck, through its Sharp and Dohme division, Lilly, Parke Davis and the Pitman Moore Division of Allied Laboratories, Inc., predecessor in interest to Dow, American Home Products Corporation, through its Wyeth Laboratories subsidiary, and Cutter Laboratories. Testing proceeded in 1954 and 1955 under the auspices of the foundation.

On April 12, 1955, Dr. Thomas Francis of the University of Michigan reported that Salk vaccine had proved to be both safe and effective, and the Secretary of the United States Department of Health, Education and Welfare (HEW) immediately licensed the manufacturers to commence commercial production and distribution of the vaccine.

Between July 1955 and August 1956, the vaccine was allocated among the states under a voluntary system administered by the United States Public Health Service. Thereafter, vaccine could be purchased from the five manufacturers through each manufacturer’s independent sales and distribution system. Purchases of vaccine by state governmental entities were financed in part by the federal government through the Poliomyelitis Vaccination Assistance Act of 1955.

Salk vaccine was produced in accordance with the minimum requirements promulgated by HEW. Although live poliomyelitis virus was used in the production of vaccine, the infectivity potential of the virus was to be destroyed during the manufacturing process. If the vaccine were improperly processed so that the live poliomyelitis virus was not destroyed, the vaccine could actually result in the introduction of live virus thus causing the very disease against which the immunization was directed. (See Gottsdanker v. Cutter Laboratories (1960) 182 Cal.App.2d 602, 605 [6 Cal.Rptr. 320, 79 A.L.R.2d 290].) All vaccine lots produced were required to be tested in accordance with the minimum requirements. Additionally, sample and test protocols were submitted to the Division of Biologic Standards of the National Institute of Health, which authorized the release of each lot prior to distribution by the manufacturer.

In October 1956, plaintiff Kathryn Sheffield, who was born June 16, 1947, the daughter of plaintiff Mary Moorman, was a fourth grade student at Saint Andrews Parochial School in Richmond, Indiana. She participated in a voluntary polio inoculation program conducted by the Wayne County Health Department and received her first inoculation just prior to October 31. She received her second inoculation on or about February 14, 1957. Several months later, on May 14, 1957, Kathryn first began experiencing the symptoms of the physical disorder which is the basis of the lawsuit and she was seen by Dr. Sage. On May 23, 1957, she was hospitalized at St. Vincent’s Hospital, Indianapolis, Indiana with a neurological and muscular disorder which was diagnosed as encephalitis and which left her with a permanent disability. At the time of the commencement of this action plaintiffs had no information regarding the identity of the manufacturer of the vaccine that Kathryn received. During the course of this lawsuit, they have undertaken extensive efforts in an attempt to ascertain the identity of the manufacturer of that vaccine. In addition to the discovery that is reflected in the record, plaintiffs have contacted numerous individuals and entities at the local, state and federal level, as well as in the private sector, with respect to this issue. These efforts have proved fruitless. Kathryn’s school maintained no records of the inoculation program, nor did the Wayne County Board of Health maintain any records regarding the vaccine used in this program. Plaintiffs even attempted to contact by letter Kathryn’s qlassmates to ascertain if they had any information regarding the identity of the vaccine administered. Despite these efforts, plaintiffs were unable to obtain any information which indicated the manufacturer of the vaccine administered to Kathryn.

Salk polio vaccine was administered on a nationwide basis to school children during 1956 and 1957. Dr. Andrew C. Offutt was the State Health Commissioner for the Indiana State Board of Health from 1954 to 1973. The state board of health was responsible for the purchase and distribution of poliomyelitis vaccine which was utilized by the local Indiana County health officers in inoculating school children. Records from the Indiana State Board of Health indicate that during 1956 poliomyelitis vaccine was available through contracts negotiated by the United States Public Health Service with Cutter Laboratories, Lilly, Parke-Davis, Wyeth, Pitman-Moore, Inc. (predecessor in interest to Dow) and Sharp and Dohme, Inc. (a division of Merck).

The federal government maintained general records regarding the distribution of polio vaccine within the United States in 1956 and 1957. These records indicate that the five defendant manufacturers were given quotas of vaccine available for sale in Indiana during 1956 and 1957. They include releases from March 15, 1956, through July 26, 1956, and cover vaccines with a useful life through the date of the first inoculation of Kathryn. They reflect that of the total authorizations during that period Lilly had about 75 percent and Dow’s predecessor about 11 percent, with less than 2 percent in one authorization to Sharpe and Dohme, and the balance with Wyeth and Parke Davis.

The Indiana State Board of Health has furnished records of purchases for the public inoculation program with federal funds for the period from December 8, 1955, through April 30, 1957. These records were prepared at the request of the regional office of HEW and list each purchase and the manufacturer. They reflect that 79 percent of the vials of vaccine purchased by the board was manufactured by Lilly, and that none was purchased from Merck’s Sharpe and Dohme division during the period involved. Plaintiffs also secured some records of the distribution of polio vaccine by the state board of health to the respective counties in Indiana, but those records fail to indicate the manufacturer of the vaccine so distributed to Wayne and the other counties.

Microfilms of the records of Davis’ predecessor, Pitman-Moore, have been made available to plaintiffs. The records examined to the date of the hearing on the motions reflect that representatives of the manufacturers were meeting in 1955 to cooperatively solve technical problems in connection with the production of a safe polio vaccine; that there were other exchanges of information and products and processes in order to obtain that result; and that all manufacturers cooperated with the Pharmacy and Chemical Council of the American Medical Association in its evaluation of the Salk poliomyelitis vaccine.

On appeal plaintiffs contend that the trial court has deprived them of the right to produce further evidence regarding the activities of the defendants between and among one another with respect to the manufacture and distribution of polio vaccine in the relevant time period. The court did deny in December 1979 plaintiffs’ application for a commission to take the depositions of certain present and former employees of Lilly because in June and November plaintiffs had been granted continuances to take those depositions and had failed to do so in a timely manner. We cannot fault the discretion of the court in so ruling. The plaintiffs suffered no prejudice thereby. The record is replete with evidence that there was cooperation between the manufacturers themselves and HEW. It is obvious that “concert of action” was all directed toward producing a safe vaccine. (See part V below.)

I

The Market Share Liability Expounded in Sindell v. Abbott Laboratories Is Not Applicable to This Case.

On March 20, 1980, two days after the motion for summary judgment of Parke Davis had been granted after a hearing in open court, the Supreme Court filed its decision in Sindell v. Abbott Laboratories, supra, 26 Cal.3d 588. Plaintiffs’ expectations did not bear full flower. The court reiterated the general rule governing proof of causation as follows: “We begin with the proposition that, as a general rule, the imposition of liability depends upon a showing by the plaintiff that his or her injuries were caused by the act of the defendant or by an instrumentality under the defendant’s control. The rule applies whether the injury resulted from an accidental event (e.g., Shunk v. Bosworth (6th Cir. 1964) 334 F.2d 309) or from the use of a defective product. (E.g., Wetzel v. Eaton Corporation (D.Minn. 1973) 62 F.R.D. 22, 29-30; Garcia v. Joseph Vince Co. (1978) 84 Cal.App.3d 868, 873-875 . . . ; and see Annot. collection of cases in 51 A.L.R.3d 1344, 1351; 1 Hursh & Bailey, American Law of Products Liability (2d ed. 1974) p. 125.)” (Id., pp. 597-598; see, in addition to the authorities cited by the court, Rest.2d Torts, § 433 B(1), p. 441; Annot., Products Liability—Drug or Medicine (1961) 79 A.L.R.2d 301, 338; Namm v. Charles E. Frosst &. Co. (1981) 178 N.J.Super. 19, 27-28 [427 A.2d 1121, 1125].)

The majority decision also rejected the contention that the burden of proof should be shifted to the defendants under the theory enunciated in Summers v. Tice (1948) 33 Cal.2d 80 [199 P.2d 1, 5 A.L.R.2d 91], where the conduct of the actors was tortious with respect to the plaintiff and it was uncertain which one had caused the harm. (Id., at pp. 598-603; and see part IV below.) It further refused to apply the so-called “concept of action theory” (id., at pp. 603-606; and see part V below) or the concept of “industry-wide” liability (id., pp. 607-610, and see part II below).

The decision, however, did extend the principle of Summers v. Tice, supra, and created a “market share” theory of liability. It held that the likelihood that any one of several manufacturers of a generic drug, marketed and promoted for a use which proved to produce harmful effects in the yet unborn daughters of the women to whom it was administered, supplied the product that allegedly injured the plaintiff may be measured by the percentage which the product sold by each such manufacturer bears to the entire production of the drug sold by all for that purpose. (Id., at pp. 610-613.) For the reasons stated below, we decline to extend the theory behind the foregoing decision to the manufacturers of a product not intrinsically defective for the purpose for which it was used.

Plaintiffs assume that Sindell involved exactly the question raised by the defendants in their motion for summary judgment, namely, the necessity of establishing the identity of the actual manufacturers of the vaccine received by the plaintiff daughter. The cases are similar in one respect. The plaintiffs, allegedly through no fault of either, cannot establish the identity of the specific manufacturer of the vaccines that were administered in 1956 and 1957; nor, because of the passage of time, can any of the defendants determine that fact. They disregard the dissimilarities in the facts of the respective two cases and conclude on the basis of the foregoing deficiency of evidence that the burden of proof in this case should be shifted to each of the defendants to demonstrate that it could not have produced or distributed the defective vaccine that allegedly injured the plaintiff, and that on failure to do so each should be liable for the plaintiffs’ damages according to its share of the relevant market.

It is true that in each case the manufacturers were making a generic pharmaceutical product according to a uniform formula and a process approved by the federal government. Here, unlike Sindell, the injuries did not result from the use of a drug generally defective when used for the purpose it was marketed, but because some manufacturer made and distributed a defective product. The product that allegedly injured the plaintiffs was itself not a unit of a total generic pharmaceutical product but a deviant defective vaccine.

In each case the victim and the defendants were unable to trace the source of the product because of a delay in discovering the alleged source of the victim’s injury. In Sindell, the delay was occasioned because the potential for harm was latent and did not manifest itself for many years, whereas in this case the onset of the illness occurred shortly after the victim was inoculated with the vaccine. For purposes of these proceedings we must assume that plaintiffs’ allegations satisfy the defenses of limitations and laches. Nevertheless in formulating general policy we cannot overlook the fact that the delay in discovering the alleged causation was in no way related to the nature of the defective product or any other act or omission of the unknown tortfeasor. The record reflects that it was known to the medical profession that positive findings of live virus were found in certain lots of 1955 vaccine; that the vaccination program was suspended; and that Cutter ceased manufacturing the vaccine. More specifically, it appears that reports of untoward incidents were encouraged, and that defendant Merck, for example, received numerous reports of such incidents which were contemporaneously investigated. So far as the general necessity of allowing a “market share” approach because the passage of time has made identification impossible is concerned, there is little parallel between the scenario in Sindell and that in this case.

Nor does the rationale of Sindell apply to the facts established by this record. In support of the plunge into hypothetically charted but yet unauthenticated waters, Justice Mosk relied upon Justice Traynor’s landmark concurring opinion in Escola v. Coca Cola Bottling Co. (1944) 24 Cal.2d 453, 461-468 [150 P.2d 436], for the proposition that the courts should fashion remedies to meet the changing needs of our complex industrialized society. Justice Tray nor recognized that in an era of mass production and complex marketing methods the traditional standard of negligence was insufficient to govern the obligations of manufacturer to consumer, and that the manufacturer should guarantee the safety of his product even when there is no negligence. (Id., at p. 465.) In Sindell, the stated need was because “[i]n 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.” (26 Cal.3d at p. 610, italics added.) Neither suggests that the costs of injury should be assessed against a manufacturer whose product is not harmful.

To fashion the remedy the court resorted to Summers v. Tice, supra, 33 Cal.2d 80, where the court stated, “They are both wrongdoers—both negligent toward plaintiff. They brought about a situation where the negligence of one of them injured the plaintiff, hence it should rest with them each to absolve himself if he can. The injured party has been placed by defendants in the unfair position of pointing to which defendant caused the harm. If one can escape the other may also and plaintiff is remediless. Ordinarily defendants are in a far better position to offer evidence to determine which one caused the injury.” (33 Cal.2d at p. 86.) The Sindell opinion embraces the first part of that statement: “as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury.” (26 Cal.3d at pp. 610-611; see also Rest.2d Torts, § 433B (3), corns, f and h, p. 446.) The court observed that in both Sindell and Summers, the plaintiff was not at fault in failing to provide evidence of a causation, an assumption that we must make on the record before us. It added that in Sindell, as in the case here, as distinguished from Summers, the absence of such evidence is not attributable to the defendants, but it then went on to add, as is not the situation here, that the DES manufacturers’ conduct in marketing a drug, the effects of which are delayed for many years, played a significant role in creating the unavailability of proof. (Id., at p. 611.)

It is obvious from the foregoing that neither Summers itself, nor Summers as exposited in Sindell, can furnish a key to unlock a treasure chest of a shared liability indiscriminately imposed on manufacturers of safe and defective products of the same nature. The rule of Summers only applies where it is proved that each of two or more actors has acted tortiously. The plaintiff has the burden of proving that each of the actors so conducted itself. “The rule stated has no application to cases of alternative liability, where there is no proof that the conduct of more than one actor has been tortious at all. In such a case the plaintiff has the burden of proof both as to the tortious conduct and as to the causal relation.” (Rest.2d Torts, § 433 B(3), com. g., p. 446; see also Shunk v. Bosworth (6th Cir. 1964) 334 F.2d 309, 312, as cited with approval in Sindell, 26 Cal.2d at p. 598.)

As a further cornerstone for the remedy he created Justice Mosk again relied upon Justice Tray nor. The Sindell opinion recites: “From a broader policy standpoint, defendants are better able to bear the cost of injury resulting from the manufacture of a defective product. As was said by Justice Tray nor in Escola, ‘ [t]he cost of an injury and the loss of time or health may be an overwhelming misfortune to the person injured, and a needless one, for the risk of injury can be insured by the manufacturer and distributed among the public as a cost of doing business.’ (24 Cal.2d p. 462; see also Rest.2d Torts, § 402 A, com. c, pp. 349-350.) The manufacturer is in the best position to discover and guard against defects in its products and to warn of harmful effects; thus, holding it liable for defects and failure to warn of harmful effects will provide an incentive to product safety. (Cronin v. J.B.E. Olson Corp. (1972) 8 Cal.3d 121, 129 . . . ; Beech Aircraft Corp. v. Superior Court (1976) 61 Cal.App.3d 501, 522-523 . . . .) These considerations are particularly significant where medication is involved, for the consumer is virtually helpless to protect himself from serious, sometimes permanent, sometimes fatal, injuries caused by deleterious drugs.” (26 Cal.3d at p. 611.)

Here again one seeks in vain for a shift of responsibility to innocent manufacturers. Section 402 A of the Restatement, as cited provides: “(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer ... is subject to liability for physical harm thereby caused to the ultimate user or consumer, ...” (Rest.2d Torts, at pp. 347-348, italics added.) In Cronin v. J.B.E. Olson Corp. (1972) 8 Cal.3d 121 [104 Cal.Rptr. 433, 501 P.2d 1153], the court deleted the requirement of showing that the defective product was “unreasonably dangerous to the user or consumer” (8 Cal.3d at pp. 127-135; see also Beech Aircraft Corp. v. Superior Court (1976) 61 Cal.App.3d 501, 522-523 [123 Cal.Rptr. 541]), but it reiterated that the injured plaintiff was required to prove that the product contained a defect. (8 Cal.3d at p. 134.)

The “deep pocket” theory may be socially desirable as a vehicle to insure that all victims of a defective product will be compensated from an industry-wide fund; but if applied indiscriminately to penalize the careful and careless producer alike it fails to act as a deterrent to the latter or provide an incentive to product safety industry-wide, and it may result in keeping beneficial but potentially dangerous products off the market. It may not be solely sufficient merely to say that it would be legally and morally irresponsible to hold manufacturers, who never produced a defective vaccine, to be liable on a market share basis for the damage caused by one manufacturer who did. It is clear, however, that one manufacturer cannot force its competitors to discover or guard against defects in its products. The imposition of such a liability over that portion of the pharmaceutical industry producing the beneficial safe product would inhibit drug research and development, unreasonably raise the cost of health care, and punish drug manufacturers who have done no wrong. (See Note, Sindell v. Abbott Laboratories: A Market Share Approach to DES Causation (1981) 69 Cal.L.Rev. 1179, 1200-1202; Franklin and Mais, Tort Law and Mass Immunization Programs: Lessons from the Polio and Flu Episodes (1977) 65 Cal.L.Rev. 754, passim; Fischer, Products Liability—An Analysis of Market Share Liability (1981) 34 Vand.L.Rev. 1623, 1652-1653; Comment, Refining Market Share Liability: Sindell v. Abbott Laboratories (1981) 33 Stan.L.Rev. 937, 944; Note, Market Share Liability for DES (Diethystilbestrol) Injury: A New High Water Mark in Tort Law (1981) 60 Neb.L.Rev. 432, 444-446.)

There is a recognized public policy in encouraging the swift production and marketing of new pharmaceutical products which prevent disease and save human life. In the case of Salk vaccine the record reflects that there was an enormous decrease in the incidence of poliomyelitis following the nationwide inoculation program. The results of that program reflected that the vaccine, when properly manufactured and tested, was safe. Nevertheless when Sabin oral vaccine, involving the use of live, but attenuated, polio virus, was substituted because it gave quicker protection from a threatened polio outbreak, and the disease was suffered after ingesting the vaccine, a liability was imposed on the manufacturer for failure to warn of that possibility. (Grinnell v. Charles Pfizer & Co. (1969) 274 Cal.App.2d 424, 434-442 [79 Cal.Rptr. 369]; Reyes v. Wyeth Laboratories, supra, 498 F.2d 1264, 1273-1275, cert. den. 419 U.S. 1096 [42 L.Ed.2d 688, 95 S.Ct. 687]; and see Franklin and Mais, supra, 65 Cal.L.Rev. 754, 755-768.) As a result when the public interest indicated a national program for swine flu should be undertaken there was a reluctance on the part of the insurance companies to insure the risks, and the federal government undertook to underwrite liability so that the pharmaceutical companies would participate. (Franklin and Mais, supra, 65 Cal.L.Rev. at pp. 769-775; Appel, Liability in Mass Immunization Programs (1980) B.Y.U. L.Rev. 69, 69-75, 90-91; and see In re Swine Flu Immunization Prod. Liability Lit. (D.Utah 1982) 533 F.Supp. 703, 714, 716-727; Sindell v. Abbott Laboratories, supra, 26 Cal.3d 588, 619, 621-622, Richardson, J., dis.; Rest.2d Torts, § 402 A, com. k, pp. 353-354, note also, Henderson, The Boundary Problems of Enterprise Liability (1982) 41 Md. L.Rev. 659, 674, fn. 62, 675-676; Note, Market Share Liability for DES (Diethystilbestrol) Injury: A New High Water Mark in Tort Law, supra, 60 Neb. L.Rev. 432, 446-449; and Note, Strict Liability for Drug Manufacturers: Public Policy Misconceived (1961) 13 Stan.L.Rev. 645, 651-652.)

It is not unreasonable to assume that if the theory advocated by plaintiff had been generally prevalent in the mid-1950’s there would have been a reluctance to proceed with the dispatch that intercepted projected incidents of poliomyelitis in 1956 and 1957 and there would have been thousands of sufferers who, in fact, were saved by the Salk vaccine program.

The difficulties of the apportionment mandated by Sindell are not all present in this case because, admittedly, all of the manufacturers have been joined. Defendants Wyeth and Merck suggest that insofar as Sindell imposes market share liability to relieve the injured party from joining less than a substantial share, it is unnecessary in a case where all are joined. We are not of the opinion that the presence of all manufacturers would defeat the application of Sindell in a proper case. Consideration of apportionment, however, does highlight the difference between this case and Sindell.

“Each defendant will be held liable for the proportion of the judgment represented by its share of that market unless it demonstrates that it could not have made the product which caused plaintiff’s injuries. . . . [f] Under this approach, each manufacturer’s liability would approximate its responsibility for the injuries caused by its own products. ...” (26 Cal.3d at p. 612.) It is obvious that if four innocent manufacturers are required to share in paying plaintiffs’ damages because none can prove that plaintiff daughter was not inoculated with its vaccine, the liability of each is in no way commensurate with its responsibility for an injury caused by its own product. By the same token the tortfeasor who manufactured the defective vaccine is receiving an undeserved contribution.

For the foregoing reasons we hold that the market share liability expounded in Sindell is not applicable in this case.

II

Plaintiffs Are Not Entitled to Assert a Cause of Action Against Respondents on the Basis of “Enterprise Liability. ”

The second of the two grounds for reversal originally urged by plaintiffs on their appeal rests upon the decision in Hall v. E. I. Du Pont De Nemours & Co., Inc., supra, 345 F.Supp. 353. A similar attempt to predicate liability on that case was analyzed and rejected in Sindell as follows: “A third theory upon which plaintiff relies is the concept of industry-wide liability, or according to the terminology of the parties, ‘enterprise liability. ’ This theory was suggested in Hall v. E. I. Du Pont De Nemours & Co., Inc. (E.D.N.Y. 1972) 345 F.Supp. 353. In that case, plaintiffs were 13 children injured by the explosion of blasting caps in 12 separate incidents which occurred in 10 different states between 1955 and 1959. The defendants were six blasting cap manufacturers, comprising virtually the entire blasting cap industry in the United States, and their trade association. There were, however, a number of Canadian blasting cap manufacturers which could have supplied the caps. The gravamen of the complaint was that the practice of the industry of omitting a warning on individual blasting caps and of failing to take other safety measures created an unreasonable risk of harm, resulting in the plaintiffs’ injuries. The complaint did not identify a particular manufacturer of a cap which caused a particular injury. [Fn. omitted, which pointed out that the Hall decision, predicated on an assumption that there existed a national body of state tort law, was undermined by the same court’s later decision that the plaintiffs’ claims should be severed and tried in the respective federal districts where each injury occurred.]

“The court reasoned as follows: there was evidence that defendants, acting independently, had adhered to an industry-wide standard with regard to the safety features of blasting caps, that they had in effect delegated some functions of safety investigation and design, such as labelling, to their trade association, and that there was industry-wide cooperation in the manufacture and design of blasting caps. In these circumstances, the evidence supported a conclusion that all the defendants jointly controlled the risk. Thus, if plaintiffs could establish by a preponderance of the evidence that the caps were manufactured by one of the defendants, the burden of proof as to causation would shift to all the defendants. The court noted that this theory of liability applied to industries composed of a small number of units, and that what would be fair and reasonable with regard to an industry of five or ten producers might be manifestly unreasonable if applied to a decentralized industry composed of countless small producers. [Fn. quoting Hall omitted.]

“Plaintiff attempts to state a cause of action under the rationale of Hall. She alleges joint enterprise and collaboration among defendants in the production, marketing, promotion and testing of DES, and ‘concerted promulgation and adherence to industry-wide testing, safety, warning and efficacy standards’ for the drug. We have concluded above that allegations that defendants relied upon one another’s testing and promotion methods do not state a cause of action for concerted conduct to commit a tortious act. [See part V below.] Under the theory of industry-wide liability, however, each manufacturer could be liable for all injuries caused by DES by virtue of adherence to an industry-wide standard of safety.

“In the Fordham Comment [see text, p. 587 above], the industry-wide theory of liability is discussed and refined in the context of its applicability to actions alleging injuries resulting from DES. The author explains causation under that theory as follows, ‘. . . [T]he industry wide standard becomes itself the cause of plaintiff’s injury, just as defendants’ joint plan is the cause of injury in the traditional concert of action plea. Each defendant’s adherence perpetuates this standard, which results in the manufacture of the particular, unidentifiable injury-producing product. Therefore, each industry member has contributed to plaintiff’s injury.’ (Fordham Comment, supra, at p. 997.)

“The comment proposes seven requirements for a cause of action based upon industry-wide liability,[] and suggests that if a plaintiff proves these elements, the burden of proof of causation should be shifted to the defendants, who may exonerate themselves only by showing that their product could not have caused the injury. (Fn. omitted.)

“We decline to apply this theory in the present case. At least 200 manufacturers produced DES; Hall, which involved 6 manufacturers representing the entire blasting cap industry in the United States, cautioned against application of the doctrine espoused therein to a large number of producers. (345 F.Supp. at p. 378.) Moreover, in Hall, the conclusion that the defendants jointly controlled the risk was based upon allegations that they had delegated some functions relating to safety to a trade association. There are no such allegations here, and we have concluded above that plaintiff has failed to allege liability on a concert of action theory.

“Equally important, the drug industry is closely regulated by the Food and Drug Administration, which actively controls the testing and manufacture of drugs and the method by which they are marketed, including the contents of warning labels.[] To a considerable degree, therefore, the standards followed by drug manufacturers are suggested or compelled by the government. Adherence to those standards cannot, of course, absolve a manufacturer of liability to which it would otherwise be subject. (Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65 ... .) But since the government plays such a pervasive role in formulating the criteria for the testing and marketing of drugs, it would be unfair to impose upon a manufacturer liability for injuries resulting from the use of a drug which it did not supply simply because it followed the standards of the industry.” [Fn. omitted.] (26 Cal.3d at pp. 607-610.)

Plaintiffs rely upon the allegations of their ultimate amendment to their amended complaint that are set forth in the margin. They further allege that those activities were carried on by the defendants for their mutual and collective benefit and profit and to facilitate the sale and marketing of Salk vaccine. In order to show some wrongful industry-wide standard of safety they further allege the defendants were negligent and careless in that they knew or should have known that the activities set forth in the margin and the information received therefrom could and did lead to the production, manufacture, sale and distribution of defective Salk vaccine, particularly that furnished plaintiff daughter. The record, even if confined to that produced by plaintiffs, is to the contrary. Plaintiffs’ proof shows that the activities related were all designed to insure that a nondefective Salk vaccine was produced through mutual cooperation, and promoted, not by the manufacturers, but by the federal government, through HEW and the National Foundation for Infantile Paralysis.

Since there was no joint or collective action which would result in the production of defective vaccine, as distinguished from any individual failure to follow the standards developed, there was no duty to warn the general public of the existence of hazards and dangers from defective Salk vaccine (a contradiction in terms), and plaintiffs’ allegations predicating liability on a collective failure to warn must be disregarded as inconsistent with the proof in the record.

Plaintiffs failed to show that there was an inadequate industry-wide standard of safety. Their proof has established a case showing the lack of the industry-wide negligence which was present in Sindell where the court nevertheless refused to impose industry-wide liability for a drug that was generally defective for the purpose for which it was prescribed. It would certainly be unfair to impose upon the manufacturer of a safe drug liability for a defectively manufactured specimen of the same drug which it did not supply simply because it, as distinguished from the tortfeasor, followed the standards of the industry. (See 26 Cal.3d at p. 610.)

Plaintiffs urge that in this case, as in Hall but unlike Sindell, all of the potential tortfeasors are before the court. The defendants therefore may not be able to argue that it would be manifestly unreasonable to apply the Hall theory to a decentralized industry composed of countless small producers. (26 Cal.3d at p. 608.) This thread, however, cannot support the conclusion that industry-wide liability should be applied in this case. The weight of the countervailing factors is too great to enable the plaintiffs to bind the defendants to the liability imposed in Hall.

The Sindell court noted the seven factors that the Fordham Comment suggested should be present to impose such liability. (See fn. 12 above.) Here the record reflects that there existed a sufficient, rather than an insufficient industry-wide standard of safety as to the manufacture of the product. Here it is still an open question whether the plaintiffs were at fault for the absence of evidence identifying the causative agent, and it is clear that the defendants’ conduct in no way contributed to the delay in such alleged identification. The record fails to show that a genetically defective product was manufactured by all the defendants; it is clearly alleged, and shown by the record that only one, if any, of the defendants manufactured such a product. It is true that it must be assumed at this stage of the proceedings that plaintiffs’ injuries were caused by a defective vaccine. Defendants did owe a duty to the class of which plaintiffs were members to produce a safe vaccine, but it is not shown that the joined defendants accounted for a high percentage of any defective products on the market at the time of plaintiffs’ injury. In fact, the record fails to show that there was any defective Salk vaccine on the market at the time of plaintiffs’ injury, other than that dose with which she was vaccinated. Finally, it is clear from the record that only one of the defendants could be the alleged tortfeasor.

We therefore uphold the action of the trial court in refusing to apply the industry-wide theory of liability to the facts of plaintiffs’ case as alleged and as shown by the uncontradicted facts adduced on the motion for summary judgment.

Ill

Liability May Not Be Predicated on Breach of a Duty to Warn.

The foregoing disposes of the theories urged by plaintiffs in their opening brief. Over the objection of defendant Parke Davis (denied without prejudice) plaintiffs further contend in their closing brief that the record fails to rebut their right to recover on any of the theories of negligent failure to warn, concert of action and enterprise liability.

In their amended complaint each plaintiff set forth five causes of action. The first charged the defendants jointly and severally with negligence in compounding, manufacturing, testing, inspecting, packaging, storing, selling, distributing and injecting Salk vaccine so as to cause it to be defective and unsafe for the use for which it was intended in that it was contaminated, adulterated, impure and deleterious, causing the person inoculated with the said vaccine to contract polio, encephalitis and/or other serious paralytic disease. The second charges the defendants jointly and severally with breach of an express warranty of merchantable quality that the drug was fit and safe for the use for which it was intended, and the third alleges breach of an implied warranty of the same tenor. The fourth cause of action charges that at the time the Salk vaccine administered to plaintiff daughter was manufactured, compounded, tested, inspected, packaged, stored, sold and distributed and injected into plaintiff it was defective, and that the defendants are jointly and severally strictly liable in tort.

The fifth cause of action charges that the defendants, jointly and severally, intentionally, wilfully and maliciously with conscious disregard of the rights of plaintiff and the general public compounded, etc. the vaccine administered to plaintiff daughter knowing it was defective, dangerous, and unsafe for the use for which it was intended in that it was contaminated, adulterated, impure, deleterious and likely to cause harm to plaintiff as well as other persons engendering in them polio, encephalitis and other serious disease. Further allegations charge that the defendants with such knowledge failed to warn the plaintiff and the public at large of the deleterious nature of the vaccine, failed to recall it, and continued to compound, etc. said defective vaccine for business profit.

By their amendments to its first amended complaint the plaintiffs allege first that from the joint and concerted enterprise of defendants (see fn. 14 above) they should have known that it would lead to the production, manufacture, sale and distribution of defective Salk vaccine, including its vaccine administered to plaintiff in 1957, and defendants negligently and carelessly failed to warn the general public of the hazards and dangers from defective Salk vaccine. Secondly, that from those activities the defendants in fact knew of the hazards and damages from defective Salk vaccine and wilfully and intentionally failed to warn and thirdly, that the defendants were strictly liable for failure to warn.

Although the amended complaint is unverified and the amendments are alleged on information and belief, the plaintiffs assert that we may disregard the allegations that their case rests on the vaccination with a deféctive vaccine (which could only be the product of one manufacturer) and apply the theory of enterprise liability (see part II above), or the alleged theories of negligent failure to warn or concert of action. As we have pointed out above, the failure to warn approach founders in a record which not only fails to show that Salk vaccine as properly manufactured, compounded, tested, inspected, packaged, stored, sold, distributed and injected in accordance with prescribed federal standards—albeit that the defendants participated in the preparation of those standards—was dangerous, but also affirmatively shows it was safe when those standards were observed. There is nothing in this record to indicate that each manufacturer should be his brother’s keeper, or owed it to the public to publish unnecessary warnings that would be contraproductive to the national program to reduce and abolish the toll of poliomyelitis.

This is not a case where there are known risks in taking a drug and the product is distributed without a proper warning of such risks. (See Grinnell v. Charles Pfizer & Co., supra, 274 Cal.App.2d 424, 436-441; Toole v. Richardson-Merrell Inc. (1967) 251 Cal.App.2d 689, 710-711 [60 Cal.Rptr. 398, 29 A.L.R.3d 988]; and Davis v. Wyeth Laboratories, Inc. (9th Cir. 1968) 399 F.2d 121, 127-131; Rest.2d Torts, §402 A, corns, j and 1.) Unlike the Sabin polio vaccine that allegedly injured the plaintiff in Davis, there is nothing in the record to reflect that Salk polio vaccine, if properly manufactured, would cause the disease itself. In those cases, the record reflected that before the plaintiff took the live but attenuated vaccine, the Surgeon General had issued a report on Sabin vaccine warning of the small but definite risk that polio could possibly ensue from taking that type vaccine. (See 274 Cal.App.2d at pp. 436-441; 399 F.2d at pp. 123-125, 131, fn. 20.) There is no comparable data in our record.

IV

Liability May Not Be Predicated on Res Ipsa Loquitur and Alternative Liability.

In Garcia v. Joseph Vince Co. (1978) 84 Cal.App.3d 868 [148 Cal.Rptr. 843], the court affirmed a judgment of nonsuit in an action against the manufacturers of sabres, where the plaintiff was unable to identify the manufacturer of a dueling sabre with an alleged and proved defectively narrow blade. The court distinguished Summers v. Tice, supra, where both defendants were negligent toward plaintiff and in affirming the judgment concluded, “Here, the appellant has not shown that either respondent has violated a duty to him (i.e., produced the defective product) and seeks wrongly to place on them the burden of proving his case which he himself has found too heavy to bear.” (84 Cal.App.3d at p. 875; and see Sindell, as quoted above at p. 18.)

In an effort to avoid a similar result in this case the plaintiffs resort to the doctrine of res ipsa loquitur. In Sindell, the court in discussing the theory of “alternative liability” expounded in Summers v. Tice, supra, remarked: “In Summers, we relied upon Ybarra v. Spangard (1944) 25 Cal.2d 486 .... There, the plaintiff was injured while he was unconscious during the course of surgery. He sought damages against several doctors and a nurse who attended him while he was unconscious. We held that it would be unreasonable to require him to identify the particular defendant who had performed the alleged negligent act because he was unconscious at the time of the injury and the defendants exercised control over the instrumentalities which caused the harm. Therefore, under the doctrine of res ipsa loquitur, an inference of negligence arose that defendants were required to meet by explaining their conduct.” (26 Cal.3d at p. 599, fn. omitted.)

Plaintiffs refer to Anderson v. Somberg (1975) 67 N.J. 291 [338 A.2d 1], certiorari denied 423 U.S. 929 [46 L.Ed.2d 258, 96 S.Ct. 279], in which case the plaintiff was injured because a surgical instrument broke. In addition to the doctor and the hospital, he joined the distributor and manufacturer of the instrument. The court concluded, “We hold that in a situation like this, the burden of proof in fact does shift to defendants. All those in custody of that patient or who owed him a duty, as here, the manufacturer and the distributor, should be called forward and should be made to prove their freedom from liability.” (67 N.J. at p. 302 [338 A.2d at p. 7] fn. omitted.)

In a subsequent DES case against 22 manufacturers the law division of a New Jersey superior court found Anderson v. Somberg deals with both the inability to identify the precise causative agent and the possibility that the precise causative agent is not among the defendants before the court and holds seemingly without dissent on both issues that a plaintiff’s cause of action survives either event. (Ferrigno v. Eli Lilly and Co. (1980) 175 N.J.Super. 551, 567-568 [420 A.2d 1305, 1313].) The burden was therefore placed on each of the wrongdoing defendants to exculpate itself. The court noted that all of the defendants in the case before it were wrongdoers, and that the only problem was whether there was a likelihood that other than a joined defendant produced the DES actually taken by the plaintiffs. It concluded that under New Jersey law the theory of “alternative liability” could be applied despite such likelihood. It therefore refused to follow rejection of the alternative theory as had been done in Sindell (26 Cal.3d at pp. 598-603); and, having so concluded, it found it unnecessary to consider “enterprise liability,” {Hall), “fair share of the market” (Sindell) or “concert of action”; the last of those theories had already been rejected in New Jersey. (175 N.J.Super. at pp. 569-571 [420 A.2d at pp. 1314-1315].) The burden was therefore placed on each of the wrongdoing defendants to exculpate itself.

In Namm v. Charles E. Frosst & Co., supra, 178 N.J.Super. 19 [427 A.2d 1121], another DES case against 44 drug manufacturers and distributing companies, the appellate court upheld a summary judgment as to all the defendants, granted primarily on the grounds that plaintiff had failed to identify the manufacturer or to produce any evidence linking any individual defendant with the drugs which allegedly caused plaintiffs’ injuries. The court applied the general rule as to the burden of proof. (See p. 593 above.) The court distinguished Anderson v. Somberg, supra, another earlier New Jersey case, and Summers v. Tice, supra, on two grounds; first because of all the persons who could have been responsible for the injury were not joined, and second because the defendants were in no better position than the plaintiff to identify the culpable person before them. (178 N.J.Super, at pp. 28, 38 [427 A.2d 1121, 1125, 1128]. It expressly disagreed with the interpretation of Anderson v. Somberg, supra, in Ferrigno v. Eli Lilly and Co., supra, and declined to follow that case. (Id., at p. 32, fn. 3 [id., at p. 1127, fn. 3].) The Namm court noted that Sindell had rejected the alternative liability theory and had allowed recovery on a market share theory but declined to apply the principle of alternative liability as it was modified in Sindell because the application “would impose liability without fault upon any one who manufactured a product manufactured by others as well. It would result in the taking of the property of all the named defendants in order to pay for harm which may have been caused by only one of the defendants, or even by one who is not a party to the lawsuit, who is unknown to the defendants, over whom they have no control or even any meaningful contact.” (Id., at p. 33 [id., at p. 1128].) That indictment is overly strong as applied to Sindell because it fails to recognize that all the manufacturers were tortfeasors. It does, however, apply to this case, where the record establishes only one manufacturer was at fault.

Namm accepted Sindell’s analysis of the “enterprise”—“industry-wide”—theory of liability and rejected it also. (Id., at p. 35 [id., at p. 1129].)

In Abel v. Eli Lilly and Co. (1979) 94 Mich.App. 59 [289 N.W.2d 20], another DES case, the court reversed a summary judgment that had been entered on pleadings which stated a cause of action for concert of action in negligently failing to perform adequate tests and in failing to warn, and for alternative liability because all who produced and distributed the drug in Michigan were joint tortfeasors. The court sustained both theories. Since the record here fails to reflect the facts assumed to be true by the Michigan court and since Sindell rejected both of the theories relied upon, we find the Michigan case is not persuasive. (See Morton v. Abbott Laboratories, supra, 538 F.Supp. 593, 597, fn. 6.)

In seeking to combine res ipsa loquitur with an alternative theory of liability, plaintiffs have failed to establish that any one of the defendants had such a contact with plaintiff daughter that it should be required to come forward and exculpate itself because it alone, or with others who treated or dealt with plaintiff, was in a better position to identify the culpable party. Nor have plaintiffs shown that all of the defendants are tortfeasors.

In Sindell, the court held that the rule of alternative liability enunciated in Summers v. Tice, supra, and section 433 B (3) of the Restatement 2d of Torts as previously applied could not relieve plaintiff of the burden of proving the identity of the manufacturer which made the drug causing his injuries. It so ruled on the grounds that the possibility that any of the five defendants, out of a potential of two hundred manufacturers, supplied the DES to the plaintiff’s mother was so remote that it would be unfair to require each defendant to exonerate itself and that there was a substantial likelihood that none of the five defendants joined in the action made the DES which caused the injury and so the offending producer not named would escape liability altogether. (26 Cal.3d at p. 603.)

This rationale is not present in this case where acknowledgedly all manufacturers are joined. The court, however, did note that in order for the alternative theory to apply it was necessary to show that, as in Sindell, where the DES manufactured by each manufacturer was allegedly defective for the purpose it was used, each defendant was a tortfeasor. (Id., at p. 603, fn. 18; and see text above pp. 595 and 596.)

V

Liability May Not Be Predicated on the “Concert of Action” Theory.

In Bichler v. Eli Lilly and Co. (1982) 55 N.Y.2d 571 [450 N.Y.S.2d 776, 436 N.E.2d 182, 22 A.L.R.4th 171], the court of appeals affirmed a judgment for the plaintiff in a DES case in which the defendant manufacturer had been held liable for all of the plaintiff’s damages on the concert of action theory. (See also Bichler v. Eli Lilly and Co. (1981) 79 App.Div.2d 317 [436 N.Y.S.2d 625].) The court of appeals refused to review the defendant’s contention that the instructions were erroneous because it had failed to preserve the objections it urged on appeal by appropriate request or exception in the trial court. (55 N.Y.2d at p. 583 [450 N.Y.S.2d at p. 781, 436 N.E.2d at p. 187].) The reviewing court concluded that in the light of instructions which became the governing law of the case, the jury’s verdict had sufficient factual foundation to show concerted action to market DES without adequate testing, by both agreement and by substantial assistance. (Id., at p. 585.) Here any concert of action was designed to and did effect the production of a safe vaccine.

The “concert of action” theory was explored in depth in Sindell and rejected. (26 Cal.3d at pp. 603-606.) We find no substantial difference between the allegations contained in the amendments to plaintiffs’ amended complaint (fn. 14 above) and those discussed in Sindell. In any event the record in this case reflects a situation clearly falling within the principles which led that court to reject the plaintiffs’ reliance on that doctrine.

In Sindell, the court reviewed section 876 of the Restatement Second of Torts, Professor Prosser’s comments on the doctrine and several cases in which the principle had been applied, including hunting and drag race accidents. The following comment governs here: “What the complaint appears to charge is defendants’ parallel or imitative conduct in that they relied upon each others’ testing and promotion methods. But such conduct describes a common practice in industry: a producer avails himself of the experience and methods of others making the same or similar products. Application of the concept of concert of action to this situation would expand the doctrine far beyond its intended scope and would render virtually any manufacturer liable for the defective products of an entire industry, even if it could be demonstrated that the product which caused the injury was not made by the defendant.” (Id., at p. 605; see also text above pp. 596, 599-600, 608-609.)

Furthermore in this case, as distinguished from Sindell, the record shows that such concert of action as did take place was designed to produce a safe vaccine, not a drug unfit for the purpose for which it was sold, distributed and used.

Conclusion

Having examined the facts and the legal principles pertinent to the decision in this case, we turn now to the principles governing the granting of a summary judgment as codified in section 437c of the Code of Civil Procedure and enunciated by the courts. In Stationers Corp. v. Dun & Bradstreet, Inc. (1965) 62 Cal.2d 412 [42 Cal.Rptr. 449, 398 P.2d 785], the well settled rules of the law of summary judgment were succinctly summarized as follows: “The matter to be determined by the trial court in considering such a motion is whether the defendant (or the plaintiff) has presented any facts which give rise to a triable issue. The court may not pass upon the issue itself. Summary judgment is proper only if the affidavits in support of the moving party would be sufficient to sustain a judgment in his favor and his opponent does not by affidavit show such facts as may be deemed by the judge hearing the motion sufficient to present a triable issue. The aim of the procedure is to discover, through the media of affidavits, whether the parties possess evidence requiring the weighing procedures of a trial. In examining the sufficiency of affidav