FELDMAN V. LEDERLE LABORATORIES
479 A.2d 374 (1984)
NATURE OF THE CASE: Feldman (P) appealed a judgment which held that Lederle (D) was
immune from a strict liability claim for failing to warn that an antibiotic drug it produced
would cause teeth to discolor if taken by infants and young children.
FACTS: P's teeth turned gray as a result of taking a tetracyline drug, Declomycin. P's
father, a pharmacist and a medical doctor, prescribed and administered the drug to her when
she was an infant to control upper respiratory and other secondary types of infections. P
sued D who manufactured and marketed Declomycin. P claims that D was strictly liable, not
because the drug was ineffective as an antibiotic, but because D had failed to warn
physicians of the drug's side effect, tooth discoloration. D claimed that it had not warned
of possible tooth discoloration because the possibility of that side effect was not known at
the time its literature was disseminated. The trial court's charge to the jury was directed
to two substantive issues. One was whether Declomycin was ingested by P. The second was
whether D knew or should have known of the need to place a warning on its literature
accompanying the sale of Declomycin and in the literature distributed to the medical
profession. The trial court also stated that if D did not know of the danger of tooth
discoloration, and if the application of reasonably developed human skill and foresight
consistent with the state of the art and the knowledge of the scientific community existing
during the periods in question would not have alerted D to the danger, then there would have
to be a finding for D. The trial court also charged that D's reliance on the FDA would not
serve to relieve D of its duty to insert a warning if it knew or should have known of the
need for such a warning. No exceptions were taken to the charge. D got the verdict. The
Appellate Division affirmed. P petitioned for certification and the case was summarily
remanded to the Appellate Division to reconsider in light of Beshada v. Johns-Manville
Prods. Corp. The Appellate Division reaffirmed holding that prescription drugs are a special
category of products and that drug manufacturers would not be strictly liable for failing to
warn of a side effect that was unknown when the drug was sold. P appealed. D contends strict
liability should not be applied to drug manufacturers under any circumstances.
ISSUE:
RULE OF LAW:
HOLDING AND DECISION:
LEGAL ANALYSIS:
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