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Keywords

plaintiffdefendantliabilityregulationstrict liability
plaintiffdefendantliabilityregulationstrict liability

Related Cases

Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374, 14 Envtl. L. Rep. 20,855, 39 UCC Rep.Serv. 866

Facts

Carol Ann Feldman experienced gray tooth discoloration as a result of taking Declomycin, a tetracycline drug prescribed by her father, a pharmacist and medical doctor, during her infancy. The plaintiff claimed that the manufacturer, Lederle Laboratories, failed to warn about the drug's side effect of tooth discoloration. The defendant contended that the plaintiff could not prove she specifically took Declomycin and argued that it complied with the state of the art in its warning literature, as the side effect was not known at the time.

Plaintiff, Carol Ann Feldman, has gray teeth as a result of taking a tetracyline drug, Declomycin. Plaintiff'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. Since Dr. Feldman claimed that he had administered Declomycin, suit was instituted against defendant, Lederle Laboratories, which manufactured and marketed Declomycin.

Issue

Whether drug manufacturers can be held strictly liable for failing to warn about side effects of their products, specifically in the case of prescription drugs like Declomycin.

Whether drug manufacturers can be held strictly liable for failing to warn about side effects of their products, specifically in the case of prescription drugs like Declomycin.

Rule

Drug manufacturers are not immune from strict liability; they can be held liable for failing to provide adequate warnings of known or constructively known dangers, and they are held to the standard of an expert in the field.

Drug manufacturers are not immune from strict liability; they can be held liable for failing to provide adequate warnings of known or constructively known dangers, and they are held to the standard of an expert in the field.

Analysis

The court analyzed the evidence presented, noting that the manufacturer had a duty to warn about the side effects of Declomycin, which included tooth discoloration. The court found that the manufacturer should have been aware of the potential risks based on existing scientific literature available at the time. The court emphasized that the reasonableness of the manufacturer's conduct is a factor in determining liability, and that reliance on FDA regulations does not absolve the manufacturer of its duty to warn.

The court analyzed the evidence presented, noting that the manufacturer had a duty to warn about the side effects of Declomycin, which included tooth discoloration. The court found that the manufacturer should have been aware of the potential risks based on existing scientific literature available at the time. The court emphasized that the reasonableness of the manufacturer's conduct is a factor in determining liability, and that reliance on FDA regulations does not absolve the manufacturer of its duty to warn.

Conclusion

The Supreme Court reversed the lower court's decision and remanded the case, establishing that drug manufacturers have a duty to warn about known side effects and are subject to strict liability.

The Supreme Court reversed the lower court's decision and remanded the case, establishing that drug manufacturers have a duty to warn about known side effects and are subject to strict liability.

Who won?

The plaintiff, Carol Ann Feldman, prevailed as the Supreme Court reversed the lower court's ruling, emphasizing the duty of drug manufacturers to warn about known side effects.

The plaintiff, Carol Ann Feldman, prevailed as the Supreme Court reversed the lower court's ruling, emphasizing the duty of drug manufacturers to warn about known side effects.

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