Feldman v. Lederle Laboratories
97 N.J. 429, 479 A.2d 374 (1984)
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Rule of Law:
A prescription drug manufacturer is subject to strict liability for failure to warn of a drug's dangerous side effects. This duty to warn is based on the actual or constructive knowledge of the manufacturer, meaning the manufacturer is responsible for dangers it knew or should have known about based on information that was reasonably available or obtainable at the time of distribution.
Facts:
- Carol Ann Feldman was born on February 8, 1960.
- Her father, Dr. Harold Feldman, a physician and pharmacist, prescribed and administered Declomycin, a tetracycline antibiotic manufactured by Lederle Laboratories, to her multiple times from late 1960 to the end of 1963.
- Dr. Feldman prescribed the drug to control upper respiratory and other secondary infections during Feldman's childhood illnesses.
- As a result of ingesting a tetracycline drug, Feldman's baby teeth and permanent teeth became permanently discolored gray.
- Lederle began marketing Declomycin in 1959, and its entries in the Physicians' Desk Reference (PDR) did not mention tooth discoloration as a side effect until 1965 or 1966.
- Scientific literature suggesting a link between tetracycline and tooth staining had existed since at least 1956.
- On November 16, 1962, Lederle wrote to the Food and Drug Administration (FDA) proposing to add a warning to all its tetracycline products about tooth discoloration.
- In May 1963, after receiving eight complaints from doctors, Lederle informed the FDA that Declomycin was also implicated in reports of tooth staining, and began including a warning in its literature in mid-December 1963.
Procedural Posture:
- Carol Ann Feldman sued Lederle Laboratories in the trial court on a theory of strict liability for failure to warn.
- The jury returned a verdict in favor of the defendant, Lederle.
- Feldman (appellant) appealed to the Appellate Division, which affirmed the trial court's judgment.
- Feldman petitioned for certification to the Supreme Court of New Jersey, which summarily remanded the case to the Appellate Division for reconsideration in light of Beshada v. Johns-Manville Prods. Corp.
- On remand, the Appellate Division again affirmed the judgment for Lederle (appellee).
- The Supreme Court of New Jersey granted Feldman's (appellant's) petition for certification.
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Issue:
Under a strict products liability theory for failure to warn, is a prescription drug manufacturer held to a duty to warn of dangers that were known or should have been known based on scientific, technological, and other information reasonably available at the time of distribution?
Opinions:
Majority - Schreiber, J.
Yes, a prescription drug manufacturer is held to a duty to warn of dangers that were known or should have been known based on reasonably available information. The doctrine of strict products liability applies to manufacturers of prescription drugs, as they are commercial profit-making enterprises that place products into the stream of commerce, unlike service providers such as doctors. The court rejected a blanket immunity for all prescription drugs under comment k of the Restatement (Second) of Torts § 402A, holding that whether a drug is 'unavoidably unsafe' must be determined on a case-by-case basis. Even if a drug is unavoidably unsafe, the manufacturer is not absolved of its duty to provide a proper warning. For warning defects, strict liability analysis focuses on reasonableness, imputing to the manufacturer knowledge that was reasonably obtainable at the time of distribution. This 'knew or should have known' standard includes keeping abreast of scientific literature, adverse reaction reports, and other available data. The court limited its prior holding in Beshada v. Johns-Manville, stating that a manufacturer cannot be held liable for failing to warn of dangers that were scientifically unknowable. Finally, the court shifted the burden of proof, requiring the defendant manufacturer to prove that information about the danger was not reasonably available or obtainable.
Analysis:
This decision solidifies the application of strict products liability to prescription drug manufacturers in New Jersey, rejecting blanket immunity under comment k. It significantly curtails the controversial 'unknowable risk' doctrine from Beshada, realigning warning-defect cases with a 'knew or should have known' standard that resembles negligence. By shifting the burden of proof to the manufacturer to prove a risk was not knowable, the court created a high evidentiary hurdle for defendants in failure-to-warn litigation. This ruling balances consumer protection with the realities of scientific discovery, holding manufacturers to an expert standard while stopping short of making them absolute insurers for scientifically undiscoverable risks.
