LEDERLE's KNOWLEDGE OF DECLOMYCIN (TETRACYCLINE) SIDE EFFECTS

LEDERLE's KNOWLEDGE OF DECLOMYCIN (TETRACYCLINE) SIDE EFFECTS prior to 1963 makes the firm accountable for the absence of a label warning at that time, the N.J. Supreme Court ruled July 30 in its review of Carol Ann Feldman v. Lederle. "The evidence is overwhelming that at least by mid-November 1962, [Lederle] had sufficient information to warrant that it warn doctors of the possible tooth discoloration effects of Declomycin [demeclocycline HC1] when administered to infants," Justice Schreiber wrote for the court's decision. Nonetheless Lederle "continued to market the drug in 1963 [without a label warning] and plaintiff continued to ingest the drug that year." The lawsuit against Lederle, filed on behalf of Carol Feldman in 1978, argues that Lederle is liable for failure to include in labeling warnings prior to 1963 a statement that tetracycline use in infants could result in irreversible graying of teeth. In its defense, Lederle has argued that the "state of the art" at that time precluded scientific evidence supporting the need for such warnings. A ruling in favor of Lederle by a jury in county court in 1982 has been upheld on appeal on two separate occasions. After a reaffirmation of the jury ruling in an unreported opinion, the case went back to the Appellate Division of New Jersey Superior Court following the Beshada v. Johns-Manville ruling that a "state of the art" defense should generally not be available in a strict liability case. The Appellate Division again found in Lederle's favor "holding that Rx drugs are a special category of products and that drug mfrs. would not be strictly liable for failing to warn of a side effect that was unknown when the drug was sold." The state Supreme Court's unanimous ruling overturns the decision of the appellate court and remands the case for a new trial. Noting that Lederle and amicus groups including the Pharmaceutical Mfrs. Assn., argued that strict product liability should not apply to Rx drugs, the court asserted: "We hold otherwise and conclude that drug mfrs. have a duty to warn of dangers of which they know or should have known on the basis of reasonably obtainable or available knowledge." Responding to the contention that all Rx drugs are "unavoidably unsafe" and their mfrs. are protected under tort law, the court noted that the law immunizes mfrs. of some products from strict liability, "including certain drugs, that are unavoidably unsafe." However, the court added: "We see no reason to hold as a matter of law and policy that all Rx drugs that are unsafe are unavoidably so." The court stated that "whether a drug is unavoidably unsafe should be decided on a case-by-case basis; we perceive no justification for giving all the Rx drug mfrs. a blanket immunity from strict liability manufacturing and design defect claims." Moreover, the court said, "even if an Rx drug were unavoidably unsafe, the [tort] immunity would not eliminate strict liability for failure to provide a proper warning." In remanding the case for retrial, the court said the burden was on Lederle to prove the company did not have knowledge of the discoloration side effects of Declomycin in the 1960-1963 time period that the plaintiff was taking Declomycin.