May a plaintiff injured by DES, who cannot identify which manufacturer produced the drug her mother took, hold liable a group of DES manufacturers accounting for a substantial share of the relevant market, shifting to each defendant the burden to prove it did not make the injury-causing product?

Judith Sindell sued eleven drug companies and Does 1 through 100 on behalf of herself and a class of women similarly situated. Between 1941 and 1971, defendants manufactured and marketed diethylstilbesterol (DES), a synthetic estrogen compound, for preventing miscarriage. The FDA authorized DES for that purpose in 1947 only on an experimental basis with warning labels, but defendants allegedly marketed it without limitation, without adequate testing, and without warning of dangers, though they knew or should have known it was carcinogenic and ineffective. Sindell's mother took DES during pregnancy. After a latency period of ten to twelve years, daughters exposed in utero may develop adenocarcinoma, a deadly vaginal or cervical cancer, or adenosis, a precancerous condition requiring regular monitoring. Sindell developed a malignant bladder tumor that was removed surgically and suffers from adenosis. DES was produced from a common formula and prescribed generically, and pharmacists filled prescriptions with whatever brand was in stock. Roughly 200 companies made DES. Sindell could not identify the manufacturer of the drug her mother ingested, because decades had passed. She pleaded negligence, strict liability, warranty, fraud, conspiracy, and concert of action theories, seeking compensatory and punitive damages and equitable relief for the class. Maureen Rogers filed a similar complaint.

Defendants demurred to Sindell's complaint in the trial court. The court sustained the demurrers without leave to amend on the ground that plaintiff did not and could not identify which defendant manufactured the DES that injured her, and dismissed the action. The demurrer of Abbott Laboratories was sustained with leave to amend, and the action was dismissed as to Abbott when Sindell failed to amend. Eli Lilly and Company filed a motion for summary judgment or judgment on the pleadings, which the court treated as a demurrer. The appeal involves only five of the ten named defendants. In the separate Rogers action, the trial court sustained the demurrers of E.R. Squibb & Sons, the Upjohn Company, and Rexall Drug Company, and dismissed the action as to them. Rogers later amended her complaint to allege that Eli Lilly manufactured the DES her mother took. The cases were consolidated on appeal to the California Supreme Court, which reversed the judgments of dismissal.

(Mosk, J.)

Yes. A DES plaintiff who cannot identify the manufacturer of the specific drug may state a cause of action against manufacturers of a substantial share of the market, and each defendant bears liability in proportion to its market share unless it proves it did not make the injury-causing product.

The traditional theories fail as previously applied. Under Summers v. Tice, 33 Cal. 2d 80 (1948), the burden of proof on causation shifts to tortious defendants who each might have caused the harm. Defendants' lack of superior access to identifying information does not bar that rule. But Summers involved two defendants with a 50 percent chance each of being responsible, and all potential tortfeasors were before the court. Here, roughly 200 companies made DES and only five are defendants, so there is no rational basis to infer that any particular defendant caused the injury. Concert of action under Restatement (Second) of Torts § 876 fails because relying on each other's testing and marketing is common industry practice, not a tacit agreement to commit a tort. Industry-wide liability under Hall v. E.I. Du Pont de Nemours & Co., 345 F. Supp. 353 (E.D.N.Y. 1972), is inappropriate for a large number of producers in a pervasively FDA-regulated industry whose standards are government-influenced.

Nevertheless, policy supports adapting Summers. The plaintiff is innocent and not at fault for the absence of proof. Defendants' marketing of a drug with long-delayed effects contributed to the unavailability of evidence. Manufacturers are better able to bear and distribute the cost of injury and to guard against defects, as Justice Traynor explained in Escola v. Coca Cola Bottling Co., 24 Cal. 2d 453 (1944).

The likelihood that a defendant supplied the injury-causing product is therefore measured by its percentage of the entire DES market for miscarriage prevention. If plaintiff joins manufacturers of a substantial share of that market, the burden shifts to each defendant to prove it did not make the product. Defendants who fail to exculpate themselves are liable for the proportion of the judgment matching their market share, and they may cross-complain against other manufacturers. Exact market definition and share determinations are matters of proof, not pleading.

Dissent (Richardson, J.) The majority abandons the bedrock tort requirement of a causal connection between the defendant's act and the plaintiff's injury. Summers v. Tice applies only where harm was proved to be caused by one of the named defendants, whereas here it is speculative whether any of the five defendants caused the injury. A defendant may be held liable even though it is mathematically much more likely than not that it played no role. The use of market share data to allocate liability, rather than to prove that a particular defendant probably caused the harm, is irrelevant and inadmissible. Liability will fall unevenly on manufacturers amenable to suit in California, and the 'deep pocket' rationale ties liability to wealth rather than fault. Plaintiffs are treated more favorably than ordinary tort plaintiffs who must prove causation against a specific defendant. Imposing liability decades after use of an FDA-approved drug will chill pharmaceutical research and dissemination of new drugs, contrary to Restatement (Second) of Torts § 402A, comment k. A decision with such sweeping economic, medical, and social effects belongs to the Legislature, which was then considering DES legislation and product liability reform. The majority answered that such legislation does not address damages for injuries already suffered, and that it saw no justification for shifting that cost from drug manufacturers to California taxpayers. The judgments of dismissal should be affirmed.

Dissent (Clark, J. and Manuel, J.) Clark and Manuel joined Richardson's dissent and would have affirmed the dismissals.