Medicine and the Law : First DES third-generation injury claim, 1991

On Feb 19, 1991, the New York Court of Appeals rejected the right to claim for a third-generation injury resulting from ingestion of diethylstilboestrol (DES) during pregnancy. The plaintiff was a 9-year-old girl with cerebral palsy. Her grandmother had taken DES during pregnancy in 1959, and her mother (born in 1960) had deformities in her reproductive system which, it was claimed, led to premature birth and neurological injuries in the third generation.

Medicine and the Law Diethylstilboestrol: third-generation injury claims, sciencedirect, Feb 19,1991.

DES was marketed for about 30 years in the belief that it reduced the risk of miscarriage. Over two hundred firms manufactured it, and it was widely prescribed in the Netherlands and USA. In 1971 it was “banned” by the US Food and Drug Administration (FDA) because of evidence of an abnormal incidence of vaginal and cervical cancer in the daughters of women who had taken DES during pregnancy. There were also adverse effects in male children.

… the daughters reached puberty at the earliest. Another problem has been to identify which manufacturer produced the brand of DES that each woman took. Furthermore, records have been destroyed or lost, manufacturers have closed down, prescribers have retired or died, and memories have faded. Early claims named the FDA as co-defendants but all claims against the Administration were dismissed.

One approach was the “concerted action petition”, which aimed to identify all distributors who participated in the “common purpose” of supplying DES to a particular area in which the plaintiffs mother had lived at the time of ingestion. This ploy was seldom successful, but in Michigan and New York courts ruled that the manufacturer’s marketing strategy showed evidence of conscious parallel strategies, and two cases did succeed. An attempt to shift the burden of proof on to a defendant, so that a manufacturer would have to establish his innocence, failed. The courts ruled that it would be unjust to find a firm guilty of dispensing an unsafe product when that individual manufacturer was merely one of a group whose identity was doubted. In California in 1980 plaintiffs were allowed to sue, on the basis of market share, all DES manufacturers who had supplied the drug to a particular area. This approach, though much criticised, has been the model for the later cases in which the plaintiff has been able to prove the manufacturer’s failure to test the safety of the drug or to warn the users of potential harm.

The claims for third-generation injuries by about 100 “DES granddaughters” marks a new stage in the battle for compensation. They allege that maternal uterine hypoplasia, cervical stenosis, and/or endometriosis caused by their mothers’ exposure to DES ingestion while in utero are responsible for their own congenital deformities. They also claim for large sums to compensate for anxiety over the increased risk of clear-cell adenocarcinomas. In most cases, thirty years or more have elapsed since the original DES ingestion, and such cases would normally be well outside time limits for bringing a suit. Even under the Consumer Protection Act 1987, which is not retrospective and which came into force in Britain on March 1, 1988, there is a maximum time limit of ten years in which claims may be brought. Beyond that, the plaintiff must pursue a claim in negligence in the normal way, if not time barred.

By a majority of 6 to 1, the New York Court of Appeals rejected in principle the right to pursue a third-generation DES injury claim.

Giving the judgment of the majority, Chief Judge Sol Wachtler said:

“For all we know, the rippling effects of DES exposure may extend for generations. It is our duty to confine liability within manageable limits. Limiting liability to those who ingested the drug or who were exposed to it in utero serves this purpose.”

Judge Stewart F. Hancock Jr, dissenting, argued that the girl

“should have the same right to sue the drug makers for her injuries as her mother… she is one of a class of thousands of persons who have allegedly suffered devastating abnormalities and injuries resulting from defendants’ marketing of DES … Is there any basis in the law or social policy or any principled reason in justice and fairness for holding that she-unlike other members of the class–should not be permitted to prove her case?”

The New York decision is likely to be persuasive in other states, though it is not binding outside New York, and with so much at stake the large numbers of would-be plaintiffs are unlikely to give up the struggle just yet.

Diana Brahams, 1991.

Click to download the full paper.

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