Feldman v. Lederle Laboratories, a Div. of American Cyanamid Co.

Citation561 A.2d 288,234 N.J.Super. 559
Parties, Prod.Liab.Rep. (CCH) P 12,232 Carol Ann FELDMAN, Plaintiff-Respondent and Cross-Appellant, v. LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID COMPANY, a Maine corporation doing business in the State of New Jersey, Defendant-Appellant and Cross-Respondent.
Decision Date13 July 1989
CourtNew Jersey Superior Court – Appellate Division

William C. Slattery, for defendant-appellant and cross-respondent Lederle Laboratories, a Div. of American Cyanamid Co. (Morgan, Melhuish, Monaghan, Arvidson, Abrutyn & Lisowski, Livingston, attorneys; and Norris, McLaughlin & Marcus, Somerville, of counsel; James L. Melhuish, Livingston, and William C. Slattery, of counsel and on the brief; Scott Friedman, Somerville, Michael K. Tuzzio, Kevin E. Wolff, Robert E. Corcoran, Livingston, on the brief).

James I. Peck, IV, West Orange, for plaintiff-respondent, cross-appellant.

Marc S. Klein, for amici curiae, Pharmaceutical Mfrs. Ass'n and E.R. Squibb & Sons, Inc. (Sills, Beck, Cummis, Zuckerman, Radin, Tischman & Epstein, attorneys; Charles J. Walsh, Marc S. Klein, Newark, Bruce J. Brennan, Geoffrey R.W. Smith, Howard L. Dorfman, of counsel and on the brief).

Before Judges MICHELS, MUIR, Jr. and KEEFE.

The opinion of the court was delivered by

KEEFE, J.S.C. (temporarily assigned).

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. 1 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. 2 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. 3

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. 4 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. 5 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...

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6 cases
  • Feldman v. Lederle Laboratories, a Div. of American Cyanamid Co.
    • United States
    • New Jersey Supreme Court
    • July 24, 1991
    ...concluding that "the theory of liability which undergirded the jury verdict against Lederle was preempted by federal law," 234 N.J.Super. 559, 564, 561 A.2d 288 (1989), reversed and remanded the case for entry of judgment in favor of defendant. We granted plaintiff's petition for certificat......
  • Feldman v. Lederle Laboratories
    • United States
    • New Jersey Supreme Court
    • June 10, 1993
    ...Appellate Division reversed and remanded for entry of judgment in favor of Lederle on the preemption issue. Feldman v. Lederle Lab., 234 N.J.Super. 559, 564, 561 A.2d 288 (1989). In doing so, the court Our failure to address the alternative issues should not be understood to mean that they ......
  • Lewis v. American Cyanamid Co.
    • United States
    • New Jersey Supreme Court
    • July 20, 1998
    ...(emphasis added), overruled on other grounds, Suter, supra, 81 N.J. at 158, 406 A.2d 140; Feldman v. Lederle Laboratories, 234 N.J.Super. 559, 595, 561 A.2d 288 (App.Div.1989) ("[O]nly regulations applicable at the time of marketing are relevant."), overruled on other grounds, 125 N.J. 117,......
  • Feldman v. Lederle Laboratories, a Div. of American Cyanamid Co.
    • United States
    • New Jersey Superior Court — Appellate Division
    • June 15, 1992
    ...by us in our prior opinion. Feldman v. Lederle Lab., 125 N.J. 117, 122, 592 A.2d 1176 (1991) (Feldman II ), rev'g, 234 N.J.Super. 559, 561 A.2d 288 (App.Div.1989), petition for cert. filed, 505 U.S. 1219, 112 S.Ct. 3027, 120 L.Ed.2d 898 (1991). The Distinction Between Preemption and Complia......
  • Request a trial to view additional results

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