Brown v. Superior Court

California Supreme Court
751 P.2d 470, 44 Cal. 3d 1049, 245 Cal. Rptr. 412 (1988)

ELI5:

Rule of Law:

A manufacturer of a prescription drug is not strictly liable for injuries caused by a design defect. Instead, liability is determined by a negligence standard based on whether the manufacturer failed to warn of dangerous propensities that were known or scientifically knowable at the time of distribution.

Facts:

Numerous plaintiffs' mothers ingested Diethylstilbestrol (DES), a prescription drug, to prevent miscarriage during pregnancy.
DES was produced by many different pharmaceutical manufacturers, all using the same chemical formula.
Plaintiffs allege they were injured in utero as a result of their mothers' ingestion of DES.
Plaintiffs claim that DES was defective and unsafe for its intended use, and that manufacturers failed to warn users of its dangerous characteristics.
Plaintiffs are unable to identify the specific manufacturer of the DES that their mothers consumed.

Procedural Posture:

Numerous plaintiffs filed separate actions against over 170 drug manufacturers in the San Francisco Superior Court.
The presiding judge designated the actions as 'complex litigation,' consolidating pretrial rulings on common issues into a single proceeding.
The trial court made several pretrial rulings in favor of the defendants, holding that they could not be held strictly liable for design defects and that liability under the 'market share' theory would be several, not joint.
The plaintiffs sought a writ of mandate from the Court of Appeal to review the trial court's adverse rulings.
The Court of Appeal upheld the trial court's rulings and denied the writ.
The Supreme Court of California granted review to examine the conclusions of the Court of Appeal.

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Issue:

Is a manufacturer of a prescription drug strictly liable for injuries caused by a defect in the drug's design?

Opinions:

Majority - Mosk, J.

No. A manufacturer of a prescription drug is not strictly liable for a design defect. Public policy considerations surrounding the development, availability, and cost of beneficial drugs justify departing from the strict liability standard applied to other products. The court adopted the standard from comment k of the Restatement (Second) of Torts § 402A, which shields manufacturers from strict liability for 'unavoidably unsafe' products like prescription drugs. The court reasoned that imposing strict liability would deter research, delay the marketing of life-saving medications, and drive up costs, ultimately harming the public. Therefore, the appropriate standard is one of negligence: a drug manufacturer is liable only if it failed to provide adequate warnings of risks that were known or scientifically knowable at the time the drug was distributed. The court also held that under the 'market share' theory from Sindell, plaintiffs cannot bring claims for fraud or breach of warranty, and that defendants' liability is several, not joint and several, meaning each manufacturer is only liable for its own share of the market.

Analysis:

This decision solidifies the 'comment k' exemption in California, shielding prescription drug manufacturers from strict liability for design defects and establishing a negligence standard for failure-to-warn claims. By prioritizing the public interest in drug development and availability, the court created a significant protection for the pharmaceutical industry, making it more difficult for plaintiffs to recover for injuries caused by prescription drugs. The ruling also clarifies the application of the market share liability doctrine, limiting it to negligence and strict liability claims and ensuring that a defendant's liability is proportional to its market share, which prevents a single company from being held responsible for the entire judgment.

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