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RAYNOR v. RICHARDSON-MERRELL

August 8, 1986

DONALD RAYNOR, JR., et al., Plaintiffs
v.
RICHARDSON-MERRELL, INC., et al., Defendants



The opinion of the court was delivered by: HOGAN

MEMORANDUM OPINION

 This action is one of a number of similar products liability suits filed against the manufacturers and distributors of Bendectin, a drug marketed to combat nausea in pregnant women. Plaintiff Veronica Griffin ingested the drug during her pregnancy in 1979, and subsequently gave birth to the infant plaintiff Donald Raynor, Jr., who has severely malformed limbs. Plaintiffs allege that Bendectin caused Donald Raynor's birth defects, and have sued Richardson-Merrell, Inc. ("Merrell") for fraud and misrepresentation, breach of implied warranty, breach of express warranty, strict liability in tort, violation of food and drug disclosure laws, and negligence, seeking both compensatory and punitive damages.

 Plaintiffs also seek to recover compensatory damages from Standard Drug Co. ("Standard"), who filled Ms. Griffin's prescriptions, for breach of an alleged duty to warn of Bendectin's dangers. In addition, plaintiffs contend that Standard is strictly liable for selling a defective and unreasonably dangerous drug.

 The Court has before it three dispositive motions: (1) defendant Merrell's motion for summary judgment on the issues of fraud and punitive damages; (2) plaintiffs' motion for partial summary judgment on the issue of causation; and (3) Standard's motion to dismiss all claims against it. Upon review of the parties' memoranda and the voluminous supporting exhibits and appendices, the Court concludes that the motions of defendants Standard and Merrell should be granted, and that plaintiffs' motion should be denied.

 I. Findings of Fact1

 A. Testing and Marketing of Bendectin

 From 1953 to 1956, Merrell developed Bendectin as an anti-nauseant. Bendectin originally was composed of three drugs already marketed with FDA approval: pyridoxine (Vitamin B6); Doxylamine (an antihistamine Merrell had marketed as "Decaprin" since 1948); and Dicyclomine (an antispasmodic marketed as "Bentyl" since 1950). The drug was proposed by Dr. Raymond C. Pogge in 1953, who urged that clinical studies should be "expedited" to begin marketing by June, 1954, based on past studies of Bendectin's components. Pltf. Opp. App. 2. Merrell did not submit a New Drug Application to the Federal Drug Administration ("FDA") for Bendectin until July 1956. Pltf. App. 3. It was approved by the FDA the same month. The Bendectin tablet allegedly ingested by Ms. Griffin was approved for marketing in July, 1957. Def. Reply Exh. C. In keeping with the FDA's requirements, Merrell did not test Bendectin for possible teratogenicity until 1961, after the Thalidomide disaster became known.

 In 1963, Merrell tested Bendectin in rabbits and in rats. Dr. Robert E. Staples, the primary researcher on the rabbit study, concluded that the study did not show that Bendectin is teratogenic in the rabbit. Similarly, the rat study did not reveal teratogenicity. Dr. Staples recommended that further testing at higher dose levels should be done, and his successors at Merrell, Dr. James W. Newberne and Dr. John P. Gibson, conducted such tests in 1966 and 1967 of the individual components of Bendectin. The results of all these tests were published in 1968, in an article authored by Gibson and Staples. Nothing in the record supports plaintiffs' suggestion that the Staples study was improperly constructed, or that Merrell knew of any defects in the experimental design.

 Also in 1963, Dr. Carl A. Bunde, Merrell's medical director, published an epidemiological study comparing the pregnancy outcomes of over two thousand women who had ingested Bendectin with those of over two thousand women who bore children at the same time but had not taken Bendectin. This so-called "Bunde-Bowles" study showed no statistically significant difference between the two groups in terms of congenital defects. Merrell was not aware of any data-collection errors in this study, and relied on the results in responding to physicians' requests about the possible teratogenicity of Bendectin, and in advertising and marketing the drug. Although plaintiffs contend that the Bunde-Bowles study was severely discredited by the early 1970s, nothing in the record but their bare allegation supports this position. The position of the study in the academic field after 1979 is not relevant for the purposes of this case.

 In 1972, Merrell conducted a cumulative review of all reports received regarding birth defects among the children of Bendectin-using women ("Drug Experience Reports" or "DERs"). The review was done by Dr. Robert A. Stormont, a vice-president of Merrell, and Dr. Bunde. They found that although the total number of birth defects reported was lower than expected for the number of Bendectin users, the ratio of limb defects in this total was unusually high. They concluded, however, that the reports revealed no pattern of any specific type of limb defect, and attributed the high ratio to other factors: limb defects were more readily apparent at birth; and physicians were more likely to associate drug use with limb defects than with other defects.

 Following the receipt of the Stormont-Bunde report, Merrell requested two independent experts to consider whether the DERs gave any inference of Bendectin's possible teratogenicity. Both Dr. James Wilson, professor of Research Pediatrics and Anatomy at Children's Hospital Medical Center in Cincinnati, Ohio and Dr. Louis B. Salerno, Professor of Obstetrics and Gynecology of New York Medical College reviewed the DERs and the Bunde-Stormont report and agreed that there was no evidence that Bendectin was linked to any increased hazard of congenital defect.

 In 1974, at Merrell's request, a private consulting group, Bio-Basics International, Inc., convened a group of independent experts (the "Bendectin Peer Group") to consider the safety and efficacy of Bendectin. The Peer Group reviewed available animal and clinical data concerning Bendectin and concluded "that clinical experience, and a retrospective analysis of clinical data and animal evidence fails to reveal a teratogenic tendency of Bendectin." Def. App. VIII, Tab 12.

 In 1975 Merrell tested the two-component Bendectin formulation in rats and rabbits at over ninety times the human dose equivalent. The reports concluded that these tests showed no evidence of teratogenicity.

 Studies were also done of Bendectin outside of Merrell in the 1960s and revealed no unusual incidence of birth defects among offspring. There is no evidence that prior to November, 1979 Merrell knew or believed that Bendectin caused birth defects. There is no evidence that Merrell knew or believed that any of the tests it conducted were poorly structured. Further, there is no evidence in the record before the Court at this point that the tests had produced insufficient knowledge of Bendectin's safety to market the drug.

 B. Test Results: Reports to the FDA

 With one exception, all the data discussed above were reported to the FDA upon receipt. The 1963 Staples study was not reported to the FDA until 1966, when Project Report E-66-05 was submitted, and the original results (reflected in Project Report E-63-28) were not submitted to the FDA until 1979. The most significant omission this occasioned was the failure to report all observations of alterations such as fixed or clubbed limbs. See Def. Reply Ex. I. This data was reviewed by the FDA Fertility and Maternal Health Drugs Advisory Committee at hearings held on Bendectin in 1980. At that time, Dr. James L. Goddard, FDA Commissioner from 1966 to 1968, who would have had the responsibility to withdraw Bendectin from the market, testified that he would not have withdrawn Bendectin even had he been presented with all the data generated in the Staples study.

 The Staples study generated several hundred specimens, which were stored in Merrell's laboratory until 1970. Def. Reply Ex. F. At that time, no Bendectin litigation was pending, and specimens from several older studies - including Staples' - were discarded in the consolidation of Merrell's laboratories. Def. Reply Ex. G. The FDA reviewed all of Merrell's available Bendectin data after ...


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