26 Cal. 3d 588 (1980)
Judith Sindell and Maureen Rogers filed separate lawsuits in California against several pharmaceutical companies that manufactured diethylstilbestrol, commonly known as DES.1 The complaints stated that the plaintiffs' mothers had taken DES during pregnancy to prevent miscarriage, and that the plaintiffs later developed cancerous and precancerous conditions as a result.2 Sindell alleged exposure led to a malignant bladder tumor requiring surgery and ongoing adenosis necessitating frequent monitoring.3 Rogers' allegations were substantially similar.4
DES was first developed in 1938 and received FDA approval in 1941 for use in preventing miscarriages.5 Manufacturers produced the drug in multiple forms and strengths under many trade names, but all followed an identical formula set forth in the United States Pharmacopoeia.6 In 1971 the FDA ordered companies to stop marketing DES for miscarriage prevention after studies linked it to adenocarcinoma in the daughters of women who had used the drug.7 Hundreds of companies had manufactured DES between 1941 and 1971.8
Because of the long latency period between ingestion and the appearance of injuries, and because pharmacists often filled prescriptions with whatever brand was in stock, the plaintiffs could not determine which company had produced the particular DES their mothers received.9 The trial court sustained demurrers filed by the defendants, including Abbott Laboratories, Eli Lilly and Company, E.R. Squibb & Sons, the Upjohn Company, and Rexall Drug Company, on the basis that the plaintiffs had not identified the manufacturer of the injurious product.10 The actions were consolidated for appeal to the Supreme Court of California.11
Sindell sought compensatory damages of one million dollars and punitive damages of ten million dollars on her own behalf, along with class-wide equitable relief requiring the defendants to warn physicians and establish free clinics for screening.12 The complaints further alleged that the defendants had continued to market DES without adequate testing or warnings even after they knew or should have known of its carcinogenic properties.13
Whether a plaintiff injured by DES whose mother cannot identify the specific manufacturer of the drug may recover damages from manufacturers that produced a substantial share of the DES market?14
When a plaintiff cannot identify the specific manufacturer of a fungible product that caused her injury, she may still recover.15 If she establishes that the injury was caused by a defective product manufactured by one of a group of defendants, each of whom produced a substantial share of the market, the burden of proof shifts to each defendant to prove that it did not cause the injury.16 Each defendant is liable for its proportionate share of the plaintiff's damages based on its percentage of the relevant market.17
Yes. The established facts show that Judith Sindell and Maureen Rogers could not identify the specific manufacturer because of the long latency period and the fungible nature of DES.18 The drug was produced by hundreds of companies under an identical formula. The plaintiffs alleged that the named defendants produced a substantial percentage of the DES market.19 This satisfied the requirement that a substantial share of the market be joined. The defendants marketed DES without adequate testing or warnings despite knowing or having reason to know of its carcinogenic properties. The trial court sustained demurrers solely on the identification ground.
This factual pattern triggers the market share rule because the plaintiffs are innocent of any fault in failing to identify the manufacturer.20 The defendants are better positioned to bear the cost of injury from a defective product.21
Related opinions on this issue
Joined by Clark, J., And Manuel, J.
Justice Richardson dissented on the ground that the market share approach dispenses with the traditional requirement that a plaintiff prove by a preponderance of the evidence that a particular defendant caused her injury.24 He argued that this imposes liability on manufacturers who may not have produced the product that caused the harm and leads to arbitrary and disproportionate results.25 A manufacturer with a small market share may be held liable for a substantial judgment even though it is unlikely that its product caused the injury.26
He further contended that the Summers doctrine should not be extended to this situation. In Summers both potential tortfeasors were before the court and the injury was caused by one of them. Here the actual manufacturer may not be a party to the action at all. He would affirm the judgments sustaining the demurrers.27
Whether the alternative liability rule of Summers v. Tice applies when only five of approximately two hundred DES manufacturers are named as defendants?28
No. The established facts indicate that approximately two hundred companies manufactured DES between 1941 and 1971, yet the plaintiffs joined only five defendants representing a substantial but not complete share of the market.3132 In Summers the two hunters who fired in the plaintiff's direction were both before the court, creating a fifty percent chance that one of them caused the injury. Here the possibility that any particular named defendant supplied the injury-causing drug is remote when measured against the total number of manufacturers. The facts further show that one original defendant was dismissed upon proof that it did not manufacture DES until after the plaintiff was born.
This illustrates that the actual manufacturer may not be a party. Because not all potential tortfeasors are joined, the Summers rule cannot be applied directly to shift the entire burden of proof.33
The Summers alternative liability rule does not apply on these facts because fewer than all possible manufacturers are before the court.34
Related opinions on this issue
Joined by Clark, J., And Manuel, J.
Justice Richardson dissented that the Summers doctrine should not be extended because in Summers both potential tortfeasors were before the court and the injury was caused by one of them. Here the actual manufacturer may not be a party to the action at all. He emphasized that the majority's approach guarantees plaintiffs will prevail on causation because defendants are no more capable of disproving factual causation than plaintiffs are of proving it.35 The rule applies only when it is proved that harm has been caused by one of the named defendants. Here it remains wholly speculative whether any of the five named defendants actually caused plaintiffs' injuries.
He would affirm the judgments of dismissal.36
Whether defendants may be held liable under a concert of action theory based on allegations that they relied on each other's testing and marketing methods for DES?37
No. The established facts reveal that the complaints alleged defendants relied upon each other's tests, promoted the drug in parallel fashion, and adhered to an industry-wide safety standard. These allegations describe only imitative conduct common in the pharmaceutical industry rather than a tacit understanding to commit a tortious act. The complaints further alleged that defendants produced DES from a common and mutually agreed upon formula set forth in the United States Pharmacopoeia. Yet this formula is a scientific constant required of any manufacturer and does not evidence a common plan to market an unsafe drug.
The facts show no allegation that each defendant knew the others' conduct was tortious toward the plaintiffs and substantially assisted or encouraged the inadequate testing and warnings.40 Because the allegations amount only to parallel conduct without a common design to cause injury, concert of action liability does not lie.41
The complaints fail to state a cause of action under the concert of action theory.42
Related opinions on this issue
Joined by Clark, J., And Manuel, J.
Justice Richardson dissented that the majority's new theory dispenses with the essential element of causation and that the Summers requirement of proof of actual causation by a named defendant cannot be satisfied when only five of two hundred manufacturers are joined.43 He stressed that an essential element of any tort cause of action is a reasonable connection between the defendant's act and the plaintiff's damage.44 The majority abandons this traditional requirement and creates a modified industry-wide tort that subsumes the necessity of a causal relationship.45
Recovery is permitted from defendants each of whom individually may account for only a small share of the market so long as the aggregate is deemed substantial.46 He would affirm the judgments of dismissal.
Whether industry-wide or enterprise liability applies to DES manufacturers when the industry is large and subject to extensive FDA regulation?47
Industry-wide or enterprise liability may shift the burden of proof when a small number of manufacturers adhere to an industry-wide standard of safety and delegate safety functions to a trade association.48 The theory does not apply to a large decentralized industry subject to pervasive government regulation.49
No. The established facts demonstrate that at least two hundred manufacturers produced DES, far exceeding the six manufacturers representing the entire blasting cap industry in Hall v. E.I. Du Pont de Nemours & Co.50 The complaints alleged joint enterprise and collaboration in testing and marketing but contained no allegation that defendants delegated safety functions to a trade association.5152 The facts further establish that the drug industry is closely regulated by the Food and Drug Administration, which controls testing, manufacture, and warning labels. Adherence to industry standards cannot fairly support liability for a product the defendant did not supply. Because the industry is large and government standards play a pervasive role, industry-wide liability does not apply.53
The theory of industry-wide liability does not apply to these facts.54
Related opinions on this issue
Joined by Clark, J., And Manuel, J.
Justice Richardson dissented that the majority's market share theory represents a radical departure from traditional tort principles that will inhibit research and dissemination of new pharmaceutical drugs, contrary to the social policy recognized in the Restatement Second of Torts section 402A comment k.55 He noted that the social and economic benefits from mobilizing the industry's resources in the war against disease are potentially enormous.56 Imposition of sweeping liability more than twenty years after ingestion of drugs that met every fair test and medical standard at the time requires the pharmaceutical industry to install a psychic's crystal ball.57
He would affirm the judgments of dismissal because the policy decision belongs with the Legislature.58