Nature of the Case
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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.
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