On certification to the Superior Court, Appellate Division, whose opinion is reported at 189 N.J. Super. 424 (1983).
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.
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.
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.
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.
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.
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.
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.
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.
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."
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 in the July, 1957 Journal of the National Cancer Institute reporting that laboratory animals had yellow fluorescents in bones, including teeth, following dosages of tetracycline; a second article by Dr. Milch in the July, 1958 issue of the Journal of Bone and Joint Surgery again describing fluorescents in the bones and incisor teeth of rodents that had been fed tetracycline; a 1959 article by Dr. Swackman noting that of 50 children with cystic fibrosis who had received massive doses of tetracycline, 40 had dark tooth staining; a 1960 letter from Dr. Sigrelli, a Columbia University professor, to the Pediatric Journal observing that patients with cystic fibrosis of the pancreas who had received tetracyclines as an antibiotic suffered severe discoloration of their teeth, possibly as a result of their tetracycline use; a May, 1961 article by Dr. Sigrelli in the New Jersey/New York State Dental Journal containing the same information; and an essay by Dr. Bevlander
on "The Effect of the Administration of Tetracycline on the Development of Teeth" in the October, 1961 issue of the Journal of Dental Research reflecting the adverse effect of tetracycline on developing teeth in young laboratory animals. Dr. Bonda concluded the defendant should have begun to investigate the possible effects of all forms of tetracycline on teeth no later than 1956, when the Andre article appeared.
Defendant's expert, Dr. Guggenheimer, on the other hand, noted that before 1962 the literature on tooth discoloration concerned only patients with cystic fibrosis who had been receiving massive doses of tetracyclines. He pointed out that Dr. Milch's papers described only fluorescents, not tooth staining. He testified that Declomycin did not become available until 1959 and that it would take 2 1/2 years for permanent teeth developing in 1959 to erupt. The completion of accurate controlled studies of multiple well-documented cases would have been the only way one could really know whether Declomycin caused tooth discoloration in permanent teeth. Dr. Guggenheimer's testimony is unclear as to whether a correlation between tetracycline and tooth discoloration had been established in 1962. One reading of his testimony indicates that such a correlation was not known to exist and that only by hindsight could that conclusion be drawn. It is also possible to interpret his opinion to be that such correlation had been established in 1962. In any event it is significant that Dr. Guggenheimer gave no opinion as to 1963.
On November 16, 1962, Dr. Swanzey, defendant's Director of Regulatory Agencies Relations, wrote to the Federal Food and Drug Administration (FDA) that the defendant proposed to add to the labels on all its tetracycline products the following warning: "During therapy tetracyclines may form a stable calcium complex in bone-forming tissue with no known harmful effects. Use of any tetracycline during teeth development in the neonatal period or early childhood may cause discoloration of the teeth." Dr. Swanzey explained that it was not necessary to obtain FDA approval before placing a warning on a label, but
it was the practice to do so. On cross-examination, however, he indicated that although no FDA approval was needed to write letters to doctors informing them of this correlation, labeling the product without FDA approval could be considered a misbranding.
The FDA acknowledged receipt of Dr. Swanzey's letter on December 3, 1962, and advised him that the FDA "has been acutely interested by the increasing number of new and/or undesirable effects accompanying or following the use of these products," and would notify the defendant "as soon as any conclusion is reached." Dr. Swanzey telephoned Dr. Barzilai of the FDA, who advised against putting any statement in a circular proposed to be distributed by the defendant and that the FDA had the matter under study. On January 15, 1963, Dr. Swanzey sent to the FDA two articles on bone effects, including a copy of the Bevlander article. Dr. Swanzey also spoke with Dr. Sigrelli, who advised that staining would occur with some tetracyclines, but he had not observed that it occurred with Declomycin.
The FDA, in a letter dated February 4, 1963, proposed that the defendant insert the following warning statement in "all" its tetracycline products:
Tetracyclines may form a stable calcium complex in any bone forming tissue with no serious harmful effects reported thus far in humans. However, use of any tetracycline drug during tooth development ( = last trimester of pregnancy, neonatal period and early childhood) may cause discoloration of the teeth ( = yellow-grey-brownish). This effect occurs mostly during long-term use of the drug but it has also been observed in usual short treatment courses.
Dr. Swanzey responded that the suggested statement was satisfactory and would be incorporated in its literature. He added that he assumed that the directive was applicable to Declomycin as well as other tetracycline drugs. The FDA replied that "[t]here is practically no specific clinical evidence to substantiate such a labeling requirement" for Declomycin and the warning would have to appear only on labeling of other tetracycline drugs. On April 12, 1963, the FDA made it clear that the warning statement was to refer not to tetracyclines
generally but only to the specific brand names of the implicated products.
In 1963, the defendant received complaints from eight doctors that Declomycin was causing tooth staining. In May, 1963 the defendant referred the FDA again to the side effect of Declomycin. Commencing in mid-December, 1963, after receipt of FDA approval, it included the same warning in the Declomycin literature as in other tetracyclines.
In 1975, Dr. Feldman questioned defendant's medical representative regarding dental discoloration related to the use of tetracycline. Lloyd Carr, defendant's Product Service Manager, wrote to Dr. Feldman in response to that inquiry:
When the causal relationship between tooth staining and tetracycline became unquestionably demonstrated by our Company, we notified the Food and Drug Administration by letter of November 16, 1962 and requested of the Food and Drug Administration that appropriate warnings be included in the labeling of our tetracycline products.
During April 1963, apparently after conducting their own investigation, the Food and Drug Administration concurred and at that time the Federal Agency directed all manufacturers of tetracycline to include appropriate warnings in their labeling.
In April 1963 Lederle's labeling for ACHROMYCIN (registered) tetracycline HCl was amended accordingly. DECLOMYCIN (registered) demeclocycline HCl crystalline was specifically excluded as the Food and Drug Administration had no evidence that this analogue caused tooth staining. However, on or about May 1963 we informed the Food and Drug Administration that DECLOMYCIN was also implicated in reports of tooth staining and during December of 1963 this warning was approved for the DECLOMYCIN labeling.
The trial court's charge to the jury was directed to two substantive issues. One was whether Declomycin was ingested by the plaintiff. The second was whether the defendant 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 the defendant 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 defendant
to the danger, then there would have to be a finding for the defendant. The trial court also charged that the defendant's reliance on the FDA would not serve to relieve defendant of its duty to insert a warning if it knew or should have known of the ...