ABSTRACT
These are actions by eight female offspring for personal injuries they allegedly sustained because each of their mothers took a drug during pregnancy to prevent miscarriage. In the popular press, they have been denominated “the DES cases.”
The first legal complication arises because plaintiffs-mothers and daughters alike-are unable to link the pills used about a quarter of a century ago to a particular drug company. Plaintiff daughters were in utero when their mothers ingested the drug; a generation has passed, and because the need to identify was not and could not have been anticipated, no records have been maintained.
FERRIGNO v. ELI LILLY AND CO., Leagle, decision/1980726175NJSuper551_1669, July 2, 1980.
Although these are complex multi-party cases with forecasts of protracted trials involving novel legal issues of major import, the parties declined the court’s invitation to address some of the issues in advance of trial.
What I view as two of the most important issues shall be dealt with:
- the question of nonidentification
- and the legal principles that are to govern the trials.
Procedural History
Plaintiff Linda Ferrigno and her mother Marilyn instituted the first of the two actions involved here in June 1976. The complaint sought relief on their behalf and on behalf of a proposed class.
The would-be class was generally described as
… all those females born to mothers who consumed DES manufactured by the defendants, and were either born in this state or reside now in this state, and either:
- developed cancer of their genital organs;
- or developed structural changes of their genital organs not amounting to cancer;
- or who have been exposed, but are yet to manifest any change or disease.
The Ferrigno complaint alleged that Marilyn took the drugs in 1952 and 1953 during the gestation period of Linda who was born on July 1, 1953. As a consequence, plaintiffs contended Linda developed cancer in or about 1970.
In November 1976 the Ferrignos filed a motion, in what was then the only pending action, to file an amended complaint. The amendment sought to add 19 additional plaintiffs and several additional defendants.
A month later, before a ruling had been rendered on the motion to amend, the same plaintiffs named in the proposed amendment commenced a second suit against the same defendants named in the proposed amendment. Further, plaintiffs for the first time sought to name a defendant class consisting of all manufacturers, processors, packagers and distributors in the United States dealing in DES, prescribed by physicians to New Jersey women “to prevent so-called accidents of pregnancy.”
In May 1977 an order was entered permitting plaintiffs to file the amended complaint in the first action and consolidating it with the second for purposes of discovery. At the same time, another order was entered staying without date the assertion of crossclaims and third-party claims.
Plaintiff class certification was denied in March 1979 and defendant class certification was likewise denied in April 1980.
Because of their scope, the actions were assigned to one trial judge who handled all phases of the litigation until March 1980, when they were reassigned to me.
In the interim, the individual claims of Linda and Marilyn Ferrigno were settled for an undisclosed amount and a dismissal was filed in March 1980. All other claims remain.
The Pleadings
Eight of the plaintiffs, including Linda Ferrigno, named in the amended complaint in the first action and in the complaint in the second suit (hereafter “the complaint”), are daughters whose mothers when pregnant with each took a synthetic estrogen prescribed by their doctors to prevent miscarriage. The remaining plaintiffs are either parents or spouses of those daughters.
The complaint alleges that as a direct consequence of the mothers taking the drugs their daughters developed a variety of serious ailments, including cancer of the vagina and cervix, adenosis and certain structural changes.
From 1946 to 1972, the complaint says, the 22 defendants manufactured, distributed and sold large quantities of the kind of prescription drugs ingested by the mothers. Collectively denominated as DES by plaintiffs, the drugs are alleged to have been diethylstilbestrol, stilbestrol and dienestrol.
According to the complaint, 12 of the defendants, at an unspecified time, joined together to form an organization known as the American Drug Manufacturers Association and also formed a “Small Committee for Stilbestrol” to develop DES. These 12 companies, acting together, were responsible for getting the drug on the market.
The complaint sounds in strict liability, negligence, misrepresentation and breach of warranties.
Negligence is charged in the design, testing, investigation, experimenting with, manufacturing, packaging, marketing, distributing, inspecting, promoting and labeling of the drugs. As to misrepresentation, the complaint asserts that defendants misstated to plaintiffs and to the medical profession that the said products were adequately and fully tested, that they were safe for use as directed and that they would cause no serious or deadly long-range side effects, which was untrue, and that defendants marketed the drugs after knowing they were ineffective.
Plaintiffs also allege that defendants knew, or in the exercise of reasonable care should have known, that the drugs were capable of causing cancerous and precancerous growths and were nevertheless promoted by the defendants for prescription by doctors to pregnant women to prevent loss of the fetus by spontaneous abortion.
Plaintiffs further maintain that defendants prospered from the many sales of the DES before 1972 when the Federal Food and Drug Administration (hereafter the FDA) “banned” its further sale and use for the prevention of miscarriages.
Plaintiffs acknowledge in the complaint that they are unable to determine in any of the cases, except for the Ferrignos, which of the defendants manufactured, distributed and sold the DES involved.1 However, they allege that where the particular manufacturer of DES cannot be established, liability should be borne by members of the industry in proportion to the amount of DES each sold during the periods of time the product was marketed as an anti-miscarriage drug.
The answers of defendants generally deny the significant allegations of the complaint; they assert plaintiffs were negligent and invoke the statute of limitations as an affirmative defense. “
… continue reading FERRIGNO v. ELI LILLY AND CO. on Leagle.
More DES DiEthylStilbestrol Resources
- Other papers on DES cases and lawsuits.
- Diethylstilbestrol DES studies by topics.