Birth Defects Lawsuit

Birth Defects Attorneys
Metanalysis of the appropriate cohort and case control studies has been conducted and the results indicated that Bendectin is not related to teratogenic outcomes in humans (Einarson et al., 198S; Lamm et al., 1993; McKeigue et al., 1994; Brent, 1995). The estimates of relative risk for the cohort studies had an odds ratio (OR) of 1.01 (95% CI, 0.66-1.55) and 1.27 for the case control studies (95% CI, 0.83-1.94) (Einarson et al, 19SS). A similar value of 0.95 (95% CI, 0.88-1.04) was obtained by other investigators for the risk of any malformation at birth in association with
Bendectin treatment in the first trimester (McKeigue et al., 1994). For limb-reduction defects alone, the OR was 1.17 (Khoury et al., 1994). Clearly, the results of the study evaluations and statistical analyses performed on the cumulative studies do not demonstrate that Bendectin exposure in pregnancy presented a measurable risk to the human. Johnson (1989) corroborated these data with a margin of safety (MOS) estimate of 555, a value clearly demonstrating a large margin of safety. Brent (1981, 1983, 1985, 19SS, 1995) pointed out the litany of misconceptions concerning the alleged teratogenicity of Bendectin. The large number of negative epidemiological studies indicating that pregnant women exposed to the drug do not have an increased risk of having a malformed child; absence of a true clinical syndrome in humans; animal studies indicating the drug is not teratogenic when administered at several orders of magnitude above the therapeutic range; and that
the malformed child in the publicized trial had features that made it extremely unlikely that anydrug (or chemical) caused the malformations.

Brent pointed out too, using estimates of the number of past exposures to the drug (some 30 million) and with a normal background malformation rate(3%), there have been 900,000 malformed children associated with Bendectin pregnancies just by chance alone. Furthermore, sales plotted over time (1970-1983) and secular trend analysis (Fig.
16-1) do not support an association with malformations. In Brent’s and many other scientists view, the initial trial could never have been undertaken without the ignorance of the plaintiffs lawyers about malformation etiology and without the willing cooperation of partisan scientists. The real tragedy of the episode was the unwarranted fear instilled in many pregnant women who had taken
the drug during pregnancy and the energy, in terms of money and time that was devoted to the matter. It has been estimated that the drug accounted for 5% of all Federal Court filings in the
1974-1985 period involving product liability litigation, according to the U.S. Government Accounting Office (GAO).

The situation for Bendectin became clear on June 9, 1983, when the manufacturer, Merrell-Dow, acting on some 300 potential lawsuits and the first judgment ruled against them in the courts,
ceased producing the drug altogether. The costs of liability insurance and litigation outweighed the profitability of the drug. They estimated that the drug had been used in 33 million pregnancies, an
sample population for judging cause and effect. The cessation of production of the drug signaled a resounding victory for mass media sensationalism, lobbying groups, and malpractice litigation over
medical science (Lceder et al., 1983). The real losers are pregnant patients, now “therapeutic orphans” (Sheffield and Batagol, 1985). Interestingly, following removal there was no concomitant drop in birth defect rates for any specific malformation in either the United States or Canada, and hospitalizations for nausea and vomiting of pregnancy increased in almost mirror fashion (Lamm
el al, 1993; Neutcl and Johansen, 1995). Unfortunately, costs in excess of 89 million dollars were incurred in the 1983-1987 period for increase in hospital admissions following its withdrawal (Neutel and Johansen, 1995).

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