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Feldman v. Lederle Laboratories

Decided: January 22, 1982.


On appeal from Superior Court of New Jersey, Law Division, Essex County.

Michels, McElroy and J. H. Coleman. The opinion of the court was delivered by McElroy, J.A.D.


Defendant Lederle Laboratories is the manufacturer and distributor of a tetracycline antibiotic, Declomycin, a drug first placed on the market in 1959. Plaintiff Carol Feldman was born February 8, 1960. Before she was eight or nine months of age her father, a medical doctor, who also has a degree in pharmacology, treated her with that drug whenever she had an infection. He administered it "eight or ten or twenty . . . a good many times" until the close of the year 1963. Suit was brought against defendant on strict liability and negligence grounds because the use of this drug caused discoloration of Carol's teeth. A graying of her teeth was noted by her mother when her child's teeth appeared at about the age of eight months.

Defendant's primary defense was a state-of-the-art approach demonstrating that between 1960 and late 1963 there was no scientific evidence that Declomycin would cause tooth discoloration and such knowledge did not come into existence until after Carol had already ingested enough of the antibiotic to cause her problem. The case was tried on that ground and the jury found in favor of defendant.

On appeal to this court the judgment was affirmed. The Supreme Court granted a petition for certification and summarily remanded the case to this court "for reconsideration in light of Beshada v. Johns-Manville Prod. Corp., 90 N.J. 191 (1982)," decided subsequent to our initial decision in this case. Feldman v. Lederle Laboratories, 91 N.J. 266 (1982). Beshada involved workers suffering from asbestosis and other asbestos-related illnesses due to exposure to asbestos. The Court held that in a

case of strict liability, culpability is irrelevant; that knowledge of the dangerous propensity of its product is imputed to a manufacturer, and in a failure to warn case a state-of-the art defense is not permitted. Thus, the Supreme Court on this remand requires that we consider their decision to prohibit such a defense in an "ordinary"*fn1 products case and to determine whether they intended that ruling to apply to drug product liability, an area of products liability law that in our view has heretofore been treated in this jurisdiction, and in most other jurisdictions, as an exception to the stringent rules applied in other types of products cases.

Although research reveals no case in the State directly dealing with the issue of whether a drug manufacturer is to be held strictly liable for a condition proximately caused by a factor inherent in its product but unknown when the drug was placed on the market and unknown until after the harm had occurred, New Jersey decisions demonstrate that our courts have followed Restatement, Torts 2d (1965), § 402A, comments j and k, as representing the principles applicable to drug and similar products liability cases. Brody v. Overlook Hosp., 127 N.J. Super. 331 (App.Div.1974), aff'd 66 N.J. 448 (1975) (approval and adoption of comment k of Restatement, Torts 2d, § 402A); Calabrese v. Trenton State College, 162 N.J. Super. 145 (App.Div.1978) (adoption of comment k), aff'd on other grounds, 82 N.J. 321 (1980); Torsiello v. Whitehall Laboratories, 165 N.J. Super. 311 (App.Div.1979), certif den. 81 N.J. 50 (1979) (adoption of comment j); Ferrigno v. Eli Lilly & Co., 175 N.J. Super. 551 (Law Div.1980) (adoption of comment k).

Comment k provides:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs.

An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. [Emphasis supplied]

In the same manner, comment j, which deals in part with over-the-counter drug products (Torsiello, supra, 165 N.J. Super. at 319-20), requires a warning to the consumer "if [the seller] has knowledge, or by the application of reasonable, developed human skill and foresight ...

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