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Feldman v. Lederle Laboratories, 479 A.2d 374 (N.J. 1984)
Guide to Feldman v. Lederle Laboratories, 479 A.2d 374 (N.J. 1984)

[footnotes have been moved into the text following the paragraph in which they are referenced]

[1] New Jersey Supreme Court

[2] A-70

[3] 479 A.2d 374, 97 N.J. 429, 1984.NJ.40564 <http://www.versuslaw.com>

[4] Decided: July 30, 1984.

[5] CAROL ANN FELDMAN, PLAINTIFF-APPELLANT,

v.

LEDERLE LABORATORIES, A CORPORATION, AND AMERICAN CYANAMID COMPANY, A CORPORATION, DEFENDANTS-RESPONDENTS

[6] On certification to the Superior Court, Appellate Division, whose opinion is reported at 189 N.J. Super. 424 (1983).

[7] James I. Peck, IV, argued the cause for appellant.

[8] James L. Melhuish argued the cause for respondents (Morgan, Melhuish, Monaghan, Arvidson, Abrutyn & Lisowki, attorneys; James L. Melhuish and Bernard A. Leroe, of counsel; James L. Melhuish and Kevin E. Wolff, on the briefs).

[9] Arthur Ian Miltz argued the cause for amicus curiae The New Jersey Affiliate of the Association of the Trial Lawyers of America (Kronisch & Schkeeper, attorneys).

[10] John L. McGoldrick argued the cause for amici curiae (McCarter & English, attorneys for Pharmaceutical Manufacturers Association and Eli Lilly and Company; Lum, Biunno & Tompkins, attorneys for Abbott Laboratories; Braff, Litvak, Ertag, Wortmann & Harris, attorneys for Burroughs Wellcome Co.; Shanley & Fisher, attorneys for Merck & Co., Inc.; Porzio, Bromberg & Newman, attorneys for Pfizer Inc. and Warner-Lambert Co.; Kuttner & Toner, attorneys for Schering-Plough Corp.; Sills, Beck, Cummis, Zuckerman, Radin & Tischman, attorneys for E.R. Squibb & Sons, Inc.; Lamb, Hutchinson, Chappell, Ryan and Hartung, attorneys for The Upjohn Company; John L. McGoldrick, Keith E. Lynott, David R. Kott, John F. Brenner and Gordon M. Chapman, on the brief).

[11] Barry M. Epstein submitted a separate brief on behalf of amicus curiae E.R. Squibb & Sons, Inc. (Sills, Beck, Cummis, Zuckerman, Radin & Tischman, attorneys; Marc S. Klein, on the brief).

[12] For reversal and remandment -- Chief Justice Wilentz and Justices Clifford, Schreiber, Handler, Pollock, O'Hern and Garibaldi. For affirmance -- None. The opinion of the Court was delivered by Schreiber, J.

[13] Schreiber

[14] In this case defendants and amici drug manufacturers argued that the doctrine of strict products liability should not apply to prescription drugs. We hold otherwise and conclude that drug manufacturers have a duty to warn of dangers of which they know or should have known on the basis of reasonably obtainable or available knowledge.

[15] 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,*fn1 which manufactured and marketed Declomycin.*fn2 The action was presented to the jury on the theory that the defendant was strictly liable, not because the drug was ineffective as an antibiotic, but because defendant had failed to warn physicians of the drug's side effect, tooth discoloration.

[87] *fn1 Lederle Laboratories is a division of the defendant, American Cyanamid Company. All references in this opinion to "defendant" are to Lederle Laboratories.

[88] *fn2 Declomycin is defendant's trade-mark name for demethylchlortetracycline, an antibiotic that falls within the tetracycline category.

[16] Defendant contended that the plaintiff had not proven that the drug she received was Declomycin. Rather, according to the defendant, the plaintiff could have ingested one of several other tetracycline drugs, any of which could have caused the discoloration. Further, defendant argued that it had complied with the state of the art in its warning literature. It had not warned of possible tooth discoloration because, the defendant claimed, the possibility of that side effect was not known at the time its literature was disseminated.

[17] The jury found for the defendant. The Appellate Division affirmed in an unreported opinion. Plaintiff petitioned for certification and we summarily remanded the cause to the Appellate Division to reconsider in light of Beshada v. Johns-Manville Prods. Corp., 90 N.J. 191 (1982), which was decided after the Appellate Division decision. 91 N.J. 266 (1982). The Appellate Division reaffirmed the judgment for the defendant, 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. 189 N.J. Super. 424 (1983). We granted plaintiff's petition for certification. 94 N.J. 594 (1983). We permitted the following amici to participate in the proceeding before us: ATLA-NJ, The New Jersey Affiliate of the Association of Trial Lawyers of America; the Pharmaceutical Manufacturers Association; and numerous drug manufacturers.

[18] I

[19] Most facts are undisputed, although there are some sharply disputed conclusions and opinions by the respective experts. Tetracyclines are a group of antibiotics that was first introduced in 1948. They were produced by different drug manufacturers that marketed the drugs under various trade names.

[20] Defendant first marketed Declomycin in 1959. The Physicians' Desk Reference (PDR), a book used by doctors to determine effects of drugs, contains data furnished by drug manufacturers about drugs, their compositions, usages, and reactions. The 1959 PDR entry for Declomycin stated that it had a greater antibiotic potency that made it possible to achieve therapeutic activity with less weight of antibiotic; it had a reduced renal clearance rate that produced a prolongation of the antibacterial levels in the body; and it was therapeutically equally effective as other tetracyclines in infections caused by organisms sensitive to the tetracyclines. The PDR is produced annually. Until the 1965 or 1966 edition, the PDR did not mention that tooth discoloration was a possible side effect of Declomycin. Since 1965 or 1966 the PDR has stated that the drug, when administered to infants and children, could cause tooth discoloration that would be permanent if the drug were given during the developmental stage of the permanent teeth.

[21] Plaintiff, Carol Ann Feldman, was born on February 8, 1960. Her father, Dr. Harold Feldman, asserted that he prescribed Declomycin for her approximately seven or more times from September or October, 1960, when she was eight or nine months old, until the end of 1963. She was given this drug to prevent secondary infections when she had different childhood diseases. In his words, "[i]t was a very effective drug for what I was using it for." He had been introduced to the drug by a medical representative employed by the defendant. The representative gave him a number of samples to be distributed to patients.

[22] Plaintiff's baby teeth were discolored gray-brown. Her permanent teeth were more deeply discolored, being primarily gray. The parties agreed that this discoloration had resulted from use of a tetracycline, although they disputed whether Declomycin was the particular tetracycline involved. In this respect defendant relied in large part upon plaintiff's testimony that her parents had told her the discoloration had been caused by "tetracycline" and on testimony that plaintiff's mother had stated to plaintiff's expert that her daughter had taken "tetracycline."

[23] The respective experts, Dr. Bonda for the plaintiff and Dr. Guggenheimer for the defendant, agreed that scientific literature existed by 1960 that referred to tooth staining being caused by tetracycline. Dr. Bonda specifically mentioned a 1956 article by Dr. Andre reciting that tetracycline accumulated in mineralized portions of growing bones and teeth of mice; an article by Dr. Milch July, 1957