## Facts

- Carol Ann Feldman, as an infant and young child (1960–1963), was repeatedly given Declomycin, a tetracycline antibiotic first marketed in 1959.
- Feldman’s father, a physician and pharmacist, prescribed and administered the drug to treat respiratory and related infections.
- Feldman’s mother observed graying discoloration as Feldman’s teeth erupted; Feldman alleged permanent cosmetic injury (gray teeth).
- Feldman sued the manufacturer and marketer (Lederle Laboratories and American Cyanamid Company), alleging the drug was defective due to inadequate warnings that tetracycline use in infants could cause permanent tooth discoloration.
- The case focused on failure to warn; the drug’s therapeutic effectiveness was not contested.
- The parties disputed when scientific and medical information linking tetracyclines to tooth staining became sufficiently established that a warning was required.

## Issues

1. Whether prescription drug manufacturers are categorically exempt from strict products liability under Restatement (Second) of Torts § 402A comment k.
2. What knowledge standard governs strict-liability failure-to-warn claims for prescription drugs (actual knowledge versus risks knowable from reasonably obtainable scientific and medical information).
3. Which party bears the burden to prove (or disprove) that the risk was not reasonably discoverable at the relevant time.
4. Whether a drug manufacturer has a continuing post-sale duty to warn upon learning of risks after distribution.

## Decision

- The New Jersey Supreme Court reversed the judgment for defendants and remanded for a new trial.
- The court held that strict products liability applies to prescription drugs; comment k does not provide blanket immunity.
- The court adopted a duty-to-warn standard requiring warnings of risks the manufacturer knew or should have known based on reasonably obtainable or available knowledge at the time.
- The court placed on the manufacturer the burden to prove that the relevant risk information was not reasonably obtainable or available when the drug was marketed or distributed.
- The court recognized a continuing duty to warn of risks discovered after the product enters the market.

## Legal Principles

- Prescription drugs are not categorically exempt from strict products liability; comment k’s “unavoidably unsafe” concept is applied on a case-by-case basis.
- A prescription drug is defective for failure to warn if adequate warnings are not provided about dangers the manufacturer knew or should have known using reasonably obtainable scientific and medical knowledge.
- In strict-liability failure-to-warn claims involving pharmaceuticals, the manufacturer bears the burden to show that the risk information was not reasonably obtainable or available at the relevant time.
- Manufacturers have a continuing post-sale duty to warn when they become aware of product risks after distribution.
- Federal regulation of drug labeling does not, by itself, justify immunizing manufacturers from state strict-liability warning duties.

## Conclusion

The court required prescription drug manufacturers to provide adequate warnings of risks that were knowable from reasonably obtainable scientific and medical information, rejected a categorical comment k exemption, imposed on manufacturers the burden to show undiscoverability of the risk, and ordered a new trial under these standards.


Feldman v. Lederle Lab'ys, 97 N.J. 429, 479 A.2d 374 (1984)