479 A.2d 374 (N.J. 1984)
The plaintiffs in this action are Harold Feldman, a physician and pharmacist, and his daughter Carol Ann Feldman.1 Carol Ann Feldman was born on February 8, 1960.2 From September or October 1960 until the end of 1963, Dr. Feldman prescribed Declomycin, a brand of demethylchlortetracycline manufactured by Lederle Laboratories, a division of American Cyanamid Company, to his daughter approximately seven or more times to control upper respiratory and other secondary infections.3 The child's teeth became discolored, with baby teeth gray-brown and permanent teeth primarily gray.4
Lederle first marketed Declomycin in 1959.5 The 1959 Physicians’ Desk Reference entry for Declomycin did not mention tooth discoloration as a side effect, and this omission continued until the 1965 or 1966 edition.6 Scientific literature from 1956 onward, including articles published in the Journal of the National Cancer Institute, the Journal of Bone and Joint Surgery, and the Journal of Dental Research, described effects of tetracycline on bones and teeth in laboratory animals and staining in children receiving the drug.7 On November 16, 1962, the defendant's Director of Regulatory Agencies Relations proposed to the FDA that a warning about tooth discoloration be added to labels on all tetracycline products.8 The FDA directed that the warning be included, and the defendant began incorporating the warning in Declomycin literature in mid-December 1963 after receiving approval.9
The plaintiffs instituted suit against the defendant alleging that the failure to warn of the side effect caused the discoloration.10 The defendant maintained that the correlation between Declomycin and tooth discoloration was not known at the time the drug was administered to the plaintiff.11 The trial court submitted the case to the jury on strict liability and negligence counts after dismissing the breach of warranty claims.12 The jury returned a verdict for the defendant on the strict liability count and was unable to reach a verdict on the negligence count.13 The Appellate Division affirmed the judgment for the defendant.14 The Supreme Court granted certification following a remand to the Appellate Division for reconsideration in light of Beshada v. Johns-Manville Products Corp.15
Whether the doctrine of strict products liability applies to manufacturers of prescription drugs?16
Drug manufacturers are commercial profit-making enterprises that place products into the stream of commerce and therefore are subject to strict liability for defective products, including failure to warn, unless a specific public policy exception applies as it does for doctors, dentists, or nonprofit health care institutions providing services.17
Yes. Drug manufacturers like Lederle Laboratories produce prescription drugs such as Declomycin and place them into the stream of commerce for profit.18 The facts establish that the defendant is not a nonprofit institution or a provider of professional services akin to doctors or dentists.19 No public policy exception therefore applies to exempt the manufacturer from strict liability for a failure to warn.20
The doctrine of strict products liability applies to manufacturers of prescription drugs.21
Whether a drug manufacturer has a duty to warn of dangers of which it knows or should have known on the basis of reasonably obtainable or available knowledge at the time the drug is administered?22
In strict liability failure-to-warn cases involving prescription drugs, the manufacturer has a duty to warn of dangers that were knowable based on reasonably obtainable or available knowledge at the time the drug was administered to the plaintiff, and the manufacturer bears the burden of proving lack of such knowledge.23
Yes. Scientific literature from 1956 onward described effects of tetracycline on teeth.24 By November 16, 1962, the defendant proposed a warning to the FDA while the drug continued to be administered to Carol Ann Feldman until the end of 1963.25 The defendant is held to the standard of an expert in the field and must bear the burden of proving lack of knowledge.26
The drug manufacturer has such a duty.27
Whether the trial court erred in its jury charge regarding the timing of the manufacturer's knowledge of the danger in a strict liability failure-to-warn case involving a prescription drug?28
The jury must be instructed that the manufacturer's duty to warn is measured by the knowledge available at the time the drug was administered to the plaintiff, not at the time the drug was sold.29
The trial court erred in its jury charge.33
Whether evidence of a 1962 change in the package insert for the drug and a 1963 FDA regulation was admissible at trial?34
Evidence of subsequent remedial measures such as a 1962 package insert change is inadmissible, but evidence of a 1963 FDA regulation is admissible as proof of the standard of care.35
The 1962 evidence was inadmissible while the 1963 regulation was admissible.38