On appeal from the Superior Court, Law Division, Essex County.
Michels, Muir, Jr. and Keefe. The opinion of the court was delivered by Keefe, J.s.c. (temporarily assigned).
[116 NJ Page 563] In this failure to warn product liability case, defendant Lederle Laboratories (Lederle), a division of American Cyanamid Company, appeals from an adverse jury verdict in favor of plaintiff, Carol Ann Feldman.*fn1 The general theory of liability
presented by plaintiff at trial was that Lederle's product, Declomycin, was defective in the years 1960 through 1963 because it lacked a warning that its ingestion by young children might result in tooth staining. Lederle argues on appeal that plaintiff's failure to warn claim is preempted by federal law. Alternatively, Lederle argues that certain trial errors regarding evidence matters and jury instructions require a new trial.*fn2 By leave of court, Pharmaceutical Manufacturer's Association and E.R. Squibb & Sons, Inc. filed a brief as amici curiae, joining in Lederle's preemption argument. Amici also argue that imposing liability on Lederle under the facts of this case conflicts with the public policy considerations underlying New Jersey's product liability law.
We conclude that the Food and Drug Administration's (FDA) regulation of the drug industry does not warrant a finding of implied federal preemption of all State tort claims grounded in strict liability failure to warn. However, under certain circumstances, such as presented here, federal law may preempt a discrete issue upon which liability is predicated because compliance with State decisional law would require federal law to be violated. Thus, plaintiff's entire cause of action was not preempted. However, the theory of liability not preempted was decided adversely to plaintiff by the jury and is not challenged on appeal, while the theory of liability which undergirded the jury verdict against Lederle was preempted by federal law. Thus, Lederle's motion for judgment notwithstanding the verdict should have been granted. Because the preemption issue resolves this appeal we do not address the other issues raised by Lederle.*fn3
Plaintiff was born in February, 1960 and alleges that she was treated with Declomycin produced by Lederle during the period from her infancy into her fourth year. Declomycin is one of a group of tetracycline containing drugs which are broad spectrum antibiotic analogues used to combat bacterial infections.*fn4 Plaintiff's father, Dr. Harold Feldman, prescribed the medication for plaintiff in order to treat various illnesses. He was introduced to Declomycin by a Lederle medical representative in approximately 1959 when it was first marketed. Lederle had recommended the drug for pediatric use in its product labeling during the years 1960 through 1963 inclusive.
No medical records were kept by Dr. Feldman of plaintiff's treatment. However, he testified that he first gave the drug to his daughter approximately two to three months after her birth and continued to administer it until 1963, or possibly 1965.*fn5 Regardless of the time period, the doctor stated that he administered Declomycin only a total of eight to ten times over this period because the plaintiff was generally healthy. In 1965, Dr. Feldman noticed that his daughter's teeth were stained a shade of grey. He took her to Dr. Sachs, the family dentist, to learn the cause and was then informed of the correlation between tetracycline and tooth staining.
Dr. Milton Houpt testified as an expert in pediatric dentistry for the plaintiff. He examined her in January, 1985 and concluded that her teeth had been stained by tetracycline. The doctor testified that the staining on plaintiff's teeth was possibly consistent with tetracycline administration until the age of six or seven.
Dr. Feldman testified that in the 1960's, in addition to relying on the Lederle detailmen and package inserts, he relied on the Physician's Desk Reference (PDR) for information about Declomycin. The PDR did not contain a warning concerning tooth staining until 1965, although package inserts and other literature were changed in December, 1963.
In 1975, Dr. Feldman wrote a letter of inquiry to Lederle Laboratories concerning the staining problem. He received a reply from Lloyd S. Carr, Lederle's product's service manager. The letter, dated November 6, 1975, stated that, after "the causal relationship between tooth staining and tetracycline became unquestionably demonstrated," Lederle notified the FDA in November, 1962 requesting permission to place a warning on the drug. The letter noted that Declomycin was specifically excluded by the FDA in April, 1963 from the requirement imposed on other tetracyclines to contain a warning concerning tooth staining. It further stated that in or about May, 1963, Lederle informed the FDA that Declomycin was also implicated in reports of tooth staining. Lastly, it said that a warning for Declomycin was approved by the FDA in December, 1963 and appeared in the PDR in 1965.
Plaintiff's theory was that Lederle knew or should have known of the side effects before 1962. Her proofs on that issue were substantially based on two articles co-authored by Dr. Harry Shwachman. The articles were entitled "The Tetracyclines, Applied Pharmacology" and "The Effect of Long Term Antibiotic Therapy in Patients With Cystic Fibrosis of the Pancreas." Dr. Shwachman, a specialist in cystic fibrosis, testified on behalf of plaintiff by way of a de bene esse deposition. He related conversations he had with Dr. Carey, the deceased former medical director of Lederle, in which Dr. Shwachman told Dr. Carey about the "problem of staining of the teeth" he had encountered in using tetracyclines to treat children with cystic fibrosis. However, Dr. Shwachman admitted that both articles, published in 1956 and 1958, were inconclusive as to the cause of the observed tooth staining and were
based solely on work with cystic fibrosis patients who were treated with the tetracycline drugs on a daily basis over a long period of time. Further, none of this work involved Declomycin, which was introduced in 1959.
In a letter dated January 10, 1963, addressed to Roy Schaefer at Lederle, Dr. Shwachman detailed his findings, at Schaefer's request, concerning tooth staining in cystic fibrosis patients up to that point in terms of age versus dosage. The letter revealed an apparent correlation between tetracyclines and tooth staining without drawing any real conclusion. As stated in the letter by Dr. Shwachman, "[t]he study is still being continued and I think that the specific answer to your questions will become obvious in due course of time."
Dr. Swanzey, who had been employed by Lederle in the 1960's, was called as plaintiff's witness and examined concerning the Shwachman articles. He testified that both of the articles were in the possession of the defendant in 1960. Each article contained a notation to the effect that tooth staining had been observed in cystic fibrosis patients who were treated with tetracyclines. He noted that both articles had been written in the 1950's, before Declomycin was marketed. Thus, Declomycin was not the tetracycline containing product referred to in either article. Dr. Swanzey stated that, even after the publication of the second study, it was not clear whether the tooth staining was due to the drug or the disease of cystic fibrosis. To Dr. Swanzey's knowledge, no comparative study was done on the teeth of cystic fibrosis patients who had received tetracycline versus those who had not to determine if the discoloration was due to the antibiotics or the disease itself.
Defendant presented Doctors Guggenheimer, Sweeney, and Wasserman to testify concerning the state of scientific knowledge in the relevant time period. Dr. Guggenheimer, a dentist and professor of dentistry, opined that there was no information available suggesting a relationship between the administration
of tetracyclines and tooth discoloration in 1960 and 1961. He testified that reports began to appear in 1962 which raised questions as to whether there was a relationship between tooth discoloration, cystic fibrosis and the tetracyclines, but the medical investigators "could not come to any conclusion as to what exactly was going on." The doctor cited an editorial in The New England Journal of Medicine in 1963 which "indicated that more evidence was needed as to what exactly the mechanism [for discoloration] was and why this was occurring." The apparent reason for the confusion was that all children with stained teeth were also cystic fibrosis patients. Dr. Guggenheimer said it was impossible to separate the two phenomena. The doctor had participated in animal studies at Columbia University in the early 1960's to attempt to answer this question but could not do so because no significant effect could be found at that time on the teeth of animals. When asked his opinion regarding Declomycin, Dr. Guggenheimer said:
Since that particular antibiotic was, I believe, introduced in 1959, by 1963 there would -- it would not be possible to identify it as a cause of tooth discoloration because any person receiving the antibiotic in 1959, their permanent teeth would not have yet appeared in 1963. The earliest that would be come evident would be approximately 1965.
He concluded that, with regard to Declomycin, Lederle could not have known of the correlation until after 1963.
Dr. Sweeney, a dentist educator, testified that prior to 1962 Lederle could not have known "in any way, shape or form" that the use of tetracyclines resulted in stained teeth. The doctor noted that only three or four papers had been written on the subject in that time frame and they were inconclusive. In his opinion, 1962 was a critical year because evidence began to indicate that the teeth of children other than cystic fibrosis patients might be affected by tetracyclines. Dr. Sweeney felt that Lederle should have known there was a problem with Auromoycin and Acromycin in 1963, but not Declomycin, because there were no reports in 1963, or earlier, pertaining to
Declomycin.*fn6 Dr. Wasserman, a pediatrician and professor of medicine, also testified that there was insufficient information about the possibility of tooth discoloration from the use of tetracyclines through 1963.
Plaintiff offered a three page Lederle Laboratories District Manager Weekly Report, dated August 18, 1962, as further proof of Lederle's knowledge. The report read in part:
We are beginning to hear comments about the yellowing discoloration of teeth in children following tetracycline therapy. One physician, already reported to Pearl River, [Lederle's home base] also states his own children's second teeth are soft following tetracycline therapy. This physician states he will discontinue using tetracyclines until this phenomenon is proved or disproven.
In October, 1962, Dr. Swanzey and his associates began to compose a warning concerning tooth staining caused by tetracycline drugs for submission to the FDA. On November 16, 1962, Dr. Swanzey wrote a letter to the FDA concerning the possibility of a correlation between tooth discoloration and Lederle's tetracycline drugs. In the letter, Lederle proposed to warn of the phenomenon in terms of all its tetracycline products. Lederle submitted its proposed warning language and asked for the FDA's "opinion and consideration" so that this statement could "be added at the earliest possible time." On December 3, 1962, Dr. Barzilai, medical officer, Division of Antibiotic Drugs, Bureau of Medicine of the FDA, replied to Dr. Swanzey's letter. Dr. Barzilai stated that the FDA had "not yet reached any form of final opinion (= medical, scientific, regulatory, etc.), . . ." He concluded by informing Dr. Swanzey that the FDA was currently "devoting a great deal of active attention to the matter and [would] . . . notify as soon as any conclusion is reached."
In February, 1963, Dr. Barzilai wrote to Dr. Swanzey advising him that the FDA had approved the warning to be asserted in the printed material of "all [Lederle's] tetracycline products.
. . ." On February 14, 1963, Dr. Swanzey, in acknowledging receipt of the FDA's letter with the approved warning language for all tetracycline drugs, wrote to the FDA, stating, "I assume that this statement is being proposed for chlortetracycline, oxytetracycline*fn7 and demethylchlortetracycline [Declomycin] as well."*fn8
On February 18, 1963, Dr. Barzilai replied to Dr. Swanzey's inquiry and stated that the warning had to appear in the labeling of only tetracycline, chlortetracycline, and oxytetracycline. Dr. Barzilai further stated, "[t]here is practically no specific clinical evidence to substantiate such a labeling requirement for demethylchlortetracycline [Declomycin] at present, but we intend to remain alert for such a future possibility."
On April 18, 1963, the FDA issued a press release to all medical and dental journals, and to the general media, with respect to tooth discoloration and tetracyclines. The release stated in pertinent part:
Children's teeth can be seriously discolored by three types of tetracycline antibiotics, the Food and Drug Administration said in a message to physicians and dentists.
The three drugs are: tetracycline, chlortetracycline and oxytetracycline. There is no evidence to date that a fourth drug, [declomycin], causes the discoloration, FDA said.
On April 23, 1963, Lederle issued an "Action" memorandum to all Lederle sales personnel. The purpose of the memo was to advise the sales people of the latest information concerning FDA requirements for antibiotic literature, and its specific subject was tooth staining. The memo told the salesmen that inserts would be sent to them shortly for inclusion with all of the tetracycline based drugs except Declomycin. Further, the memo told the salesmen not to capitalize on the fact that
Declomycin had been excluded from FDA warnings because Declomycin would probably soon be implicated in staining and require warnings as well.
On May 8, 1963, Dr. Swanzey wrote to Dr. Barzilai to bring the FDA up to date on additional information concerning the subject of tooth discoloration that had come into Lederle's possession since Swanzey's last correspondence. Enclosed with that letter was an article printed in the June, 1962 issue of the Canadian Medical Association Journal, together with another document which quoted from the first, suggesting that Declomycin was associated with tooth discoloration and looseness of finger nails.
On May 31, 1963, Commissioner Larrick of the FDA wrote to Dr. Swanzey and explained why the warning approved by the FDA for tetracycline products specifically exclude Declomycin. He said:
Actually, the original statement was revised to require the inclusion of the name of the drug in lieu of the word "tetracyclines" because to date we have no evidence that your drug [Declomycin] will stain teeth. If the warning statement as originally proposed is used, it automatically incriminates [Declomycin].
On July 1, 1963, Dr. Barzilai replied to the May 8, 1963 letter from Dr. Swanzey and said that the FDA had reviewed all of the Declomycin adverse incident reports and other information supplied by Lederle but that it could not "as yet justify any change in our current formal position on this matter."
On November 8, 1963, in a telephone conversation between Kevin Rooney of Lederle and Dr. Barzilai that was later confirmed in a letter from Rooney to Barzilai on November 11, 1963, it was finally decided that Lederle would incorporate the tooth staining statement in all of the labeling for Declomycin tooth staining warning was made by letter to the FDA dated December 12, 1963.
The plaintiff's position, as stated earlier, is that Declomycin was defective in the years 1960 through 1963 because it lacked a warning concerning tooth staining during those years. It
was in the context of the foregoing facts and plaintiff's theory of liability that the trial judge asked the jury to answer the following special interrogatory.
Was there a defect in defendant Lederle's product, Declomycin, because it failed to warn ...