Feldman by Feldman v. Lederle Laboratories

• Decision Date: 10 May 1983
• Citation: 189 N.J.Super. 424,460 A.2d 203
• Parties: Carol Ann FELDMAN, an infant By her parent and guardian ad litem Harold FELDMAN, Plaintiffs-Appellants, v. LEDERLE LABORATORIES, a corporation, and American Cyanamid Company, a corporation, Defendants-Respondents.
• Court: New Jersey Superior Court — Appellate Division

Page 424

189 N.J.Super. 424

460 A.2d 203

Carol Ann FELDMAN, an infant By her parent and guardian ad

litem Harold FELDMAN, Plaintiffs-Appellants, v. LEDERLE LABORATORIES, a corporation, and American Cyanamid

Company, a corporation, Defendants-Respondents.

Superior Court of New Jersey,

Appellate Division.

Argued Jan. 5, 1982.

Decided Jan. 22, 1982.

Reargued Following Remand

Oct. 27, 1982.

Decided May 10, 1983.

James I. Peck IV, West Orange, for plaintiffs-appellants.

James L. Melhuish, Livingston, for defendants-respondents (Morgan, Melhuish, Monaghan & Spielvogel, Livingston, attorneys; Bernard A. Leroe, Livingston, of counsel; Kevin E. Wolff, Livingston, on the brief).

John L. McGoldrick, Newark, for amici curiae (McCarter & English, Newark, attorneys for amicus curiae Eli Lilly & Co., John L. Goldrick of counsel and on brief; John F. Brenner, Gordon M. Chapman, Keith E. Lynott, Newark, on the brief; Porzio, Bromberg & Newman, Morristown, attorneys for amici curiae Pfizer, Inc. and Warner-Lambert Co.; Anita Hotchkiss and Moira L. Brophy, Morristown, on the brief; Lum, Biunno & Tompkins, Newark, attorneys for amicus curiae Abbott Laboratories; Sills, Beck, Cummis, Zuckerman, Radin & Tischman, Newark, attorneys for amicus curiae E.R. Squibb &amp Sons, Inc.; Lamb, Chappell, Hartung, Gallipoli & Coughlin, Jersey City, attorneys for amicus curiae The Upjohn Co.; Goldberg & Carlin, Newark, attorneys for amicus curiae Emons Industries, Inc.; Braff, Litvak, Ertag, Wortmann & Harris, East Orange, attorneys for amicus curiae Burroughs Wellcome Co.).

Before Judges 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, 447 A.2d 539 (1982)," decided subsequent to our initial decision in this case. Feldman v. Lederle Laboratories, 91 N.J. 266, 450 A.2d 579 (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" ¹ 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, 317 A.2d 392 (App.Div.1974), aff'd 66 N.J. 448, 332 A.2d 596 (1975) (approval and adoption of comment k of Restatement, Torts 2d, § 402A); Calabrese v. Trenton State College, 162 N.J.Super. 145, 392 A.2d 600 (App.Div.1978) (adoption of comment k), aff'd on other grounds, 82 N.J. 321, 413 A.2d 315 (1980); Torsiello v. Whitehall Laboratories, 165 N.J.Super. 311, 398 A.2d 132 (App.Div.1979), certif. den. 81 N.J. 50, 404 A.2d 1150 (1979) (adoption of comment j); Ferrigno v. Eli Lilly & Co., 175 N.J.Super. 551, 420 A.2d 1305 (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, 398 A.2d 132), requires a warning to the consumer "if [the seller] has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of the ingredient and the danger."

Comment k clearly does not employ strict liability principles as to prescription drug manufacturers. Their liability is gauged by what are essentially negligence principles, including the state-of-the-art concept, which are employed in recognition of the special benefits to society from new drugs and vaccines and an awareness that despite stringent federal regulation and independent testing by drug manufacturers, the "medically recognizable risk" of the unknown always exists, "but such experience as there is justifies the marketing and use of the drug" because the new or experimental drug does serve useful and intended purposes. The underlying reason for special exemption of prescription drugs is the public policy concern that imposition of the strict liability or, perhaps more accurately stated, the almost absolute liability, principle of the Beshada approach would chill if not smother the research, development production and marketing of new or experimental drugs necessary to alleviate or cure the ills to which we are all subject.

Beshada is a clear expression of another public policy, i.e., "that the manufacturers and distributors of defective products can best allocate the costs of the injuries resulting from those products." 90 N.J. at 205, 447 A.2d 539. Thus, Beshada, in the context of an ordinary products case, conceives no problem in spreading the risk of injury from a product, even one where the defect was undiscoverable, because "[b]y imposing on manufacturers the costs of failure to discover hazards, we create an incentive for them to invest more actively in safety research." Id. at 207, 447 A.2d 539. The problem, however, is not so readily addressed and resolved in cases involving a prescription drug which, as does Declomycin, serves a human need. We observe that although imposition of Beshada liability may indeed create incentive in ordinary products cases "to invest more actively in safety research," in new drug situations the imposition of strict liability can have an effect which does not serve the general public welfare. "It would cause drug companies to hesitate and prolong time before precious, beneficial and long-awaited drugs were put on the market." Leibowitz v. Ortho Pharmaceutical Corp., 224 Pa.Super. 418, 307 A.2d 449, 458 (Super.Ct.1973). Dean Prosser expressed the justification for the exception to the general rule as to such products in the following manner:

The argument that industries producing potentially dangerous products should make good the harm, distribute it by liability insurance, and add the cost to the price of the product, encounters reason for pause, when we consider that two of the greatest medical boons to the human race, penicillin and cortisone, both have their dangerous side effects,...