Sindell v. Abbott Laboratories

Under Summers v. Tice, when multiple defendants have each acted tortiously and one of them caused the plaintiff's injury, the burden may shift to each defendant to show that it did not cause the harm. The rule protects an innocent plaintiff from losing a remedy merely because it is impossible to determine which of a small group of proven wrongdoers inflicted the injury.

Sindell's inability to identify the manufacturer was not her fault. Her exposure occurred in utero many years before the disease appeared, and the passage of time made identification difficult or impossible. The court also rejected the argument that burden shifting requires defendants to have better access than the plaintiff to information identifying the responsible producer; Summers itself did not make superior access an absolute prerequisite.

But the traditional rule could not impose full, joint and several liability on the few defendants Sindell sued. About 200 companies manufactured DES, so there was a substantial possibility that none of the five respondents made the product taken by Sindell's mother. Unlike Summers, where all possible tortfeasors were before the court, the ordinary alternative-liability rule supplied no rational basis for treating every named defendant as a possible actual cause of Sindell's injury.

Concert-of-action liability requires a common design to commit a tort, substantial assistance or encouragement of another's tortious conduct, or substantial assistance in accomplishing a tortious result combined with an independent breach of duty. A tacit agreement can suffice, but the complaint must allege facts showing more than parallel behavior.

Sindell alleged that manufacturers relied on one another's tests and marketing methods, adopted common practices, and used a common formula. Those allegations described ordinary imitation and reliance within an industry, not a shared plan to perform inadequate testing or to withhold necessary warnings.

The common DES formula did not establish a wrongful agreement because the formula was a scientific constant prescribed in the United States Pharmacopoeia. Extending concert liability to manufacturers simply because they make the same regulated product would make a producer liable for defects in the entire industry's products even when its own product was not the one that caused the injury.

The industry-wide theory discussed in Hall v. E. I. Du Pont de Nemours & Co. rested on a small, concentrated industry whose manufacturers had jointly controlled safety risks, in part through delegation of safety functions to a trade association. In that setting, an industry standard itself could be treated as a causal source of the injury.

DES was made by at least 200 manufacturers, rather than a small group comprising virtually the entire industry. Sindell also did not allege the kind of collective control over safety decisions that supported the Hall theory.

The pharmaceutical industry was extensively regulated by the Food and Drug Administration, including in matters of testing, manufacture, marketing, and warnings. Although regulatory compliance does not eliminate ordinary product liability, the court found it unfair to hold a manufacturer liable for injuries caused by another company's product merely because it followed industry standards heavily shaped by the government.

The court concluded that traditional causation rules required adaptation for fungible, mass-produced products whose delayed effects make specific identification impossible. Requiring Sindell either to identify the manufacturer or to join every possible DES producer would, as a practical matter, deny any remedy to an innocent plaintiff injured by an allegedly defective drug.

The central policy of Summers favored placing the cost of the injury on negligent manufacturers rather than on an innocent victim who could not prove product identity through no fault of her own. Manufacturers can insure against product risks, distribute costs as part of doing business, and have stronger incentives and better practical capacity to test products, discover defects, and provide warnings.

The court therefore measured the likelihood of causation not by the number of all possible DES producers, but by each defendant's percentage of DES sold for pregnancy use in the relevant market. If Sindell joined manufacturers accounting for a substantial share of that market, there would be a correspondingly substantial likelihood that one of them made the drug that injured her.

Each defendant would be responsible only for the portion of damages corresponding to its market share, unless it established that it could not have made the DES taken by Sindell's mother. Defendants could also seek contribution from unjoined manufacturers. Exact market-share calculations might be difficult, but those evidentiary problems did not justify dismissing the claim at the pleading stage.