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.
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.
Intent on limiting the trials to the core controversy, however, the court has raised the issues considered here on its own motion. R. 4:25-1(b). See Leslie Blau Co. v. Alfieri , 157 N.J. Super. 173, 185 (App.Div.1978). They shall be treated as if brought on by cross-motions for summary judgment. R. 4:46-1.
What I view as two of the most important issues shall be dealt with: (1) the question of nonidentification and (2) the legal principles that are to govern the trials.
Plaintiff Linda Ferrigno and her mother Marilyn instituted the first (Docket L-41104-75) 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
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 (Docket L-15621-76) 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.
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.*fn1 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.
Stilbestrol and dienestrol, the two drugs named in the complaint, are the generic names for two synthetic estrogens.*fn3 Diethylstilbestrol is merely another name for stilbestrol and is the source of the term DES.
An estrogen is a hormone produced naturally in all women in varying levels, depending on the menstrual cycle, pregnancy, menopause and other factors. It is vital for sexual development and fertility, plays a significant role during pregnancy, and has other functions, some of which are still not fully understood by medical science.
In the late 1920s natural estrogens were available for human use and were prescribed to treat the symptoms of menopause. The natural estrogens, however, were not effective orally. They had to be administered by injection in an oil solution in the buttocks. This often resulted in painful abscesses and was much more expensive than the synthetic estrogens involved in this litigation. Accordingly, in the 1930s researchers started to seek ways to develop man-made estrogens.
The first breakthrough in the field of estrogen research occurred in 1937 when an English chemist, Dr. E. C. Dodds, and his coworkers first synthesized stilbestrol at Oxford and Middlesex Hospital, England. It was believed to be the first synthetic, nonsteroidal substance that duplicated the physiological action of natural estrogens in the human body. Dienestrol was also developed by a group headed by Dr. Dodds at about the same time.
Stilbestrol represented a marked scientific advance in that, unlike natural estrogens, it was effective by mouth, thus relieving the patient of the need for injections. It was significantly less expensive, costing approximately 1/300th as much as natural estrogens.
Dr. Dodds did not patent the drug, therefore anyone who cared to, could market it.
Eventually, hundreds of companies in the United States offered DES for sale through nationwide publications referred to by doctors, pharmacists and drug wholesalers. Before the marketing of DES in this country could occur, a new drug application had to be filed and become effective pursuant to the statutory requirements imposed by the since revised Federal Food, Drug and Cosmetic Act of 1938, 52 Stat. 1040 (1938).
In 1940 a number of pharmaceutical companies sought to market stilbestrol in up to five mg. doses for various female problems, but not including miscarriage prevention.
The "New Drug Application" (hereafter NDA) a pharmaceutical company had to submit to the FDA required data on the chemical identity of the drug, control data on methods of
manufacture and clinical studies. The information was needed to evaluate the safety of the drug and for proposed labeling.
When more than one company submitted an NDA to market a drug, the practice developed that the FDA would direct the companies to "pool" the clinical data into one consolidated "master file" in the "public interest."
By the end of 1940 ten firms had filed ten separate applications with the FDA seeking to market DES for uses in no way related to pregnancy. In December 1940 FDA officials decided to pool all the DES clinical studies in a single file and to refer to the pooled material as a "master file."
To comply with the single filing requirement, a committee was formed to collect the clinical data and submit it to the FDA which formed a master file. The FDA also required each company to agree to broad permission clauses which permitted any company to refer to the data in the master file, regardless of the company on whose behalf the clinical study had been performed.
To insure that the chemical characteristics of each company's active ingredient in the DES as marketed were identical, the FDA also instructed the companies to utilize the same United States Pharmacopoeia standard. See 21 U.S.C.A. §§ 321(j), 351(b). In addition, steps were taken to make all companies' labeling and product literature accompanying the drug substantially uniform. Only stilbestrol was involved in the single filing. Dienestrol was not.
In May 1941 the pooled master file was formally submitted to the FDA. Submission of the clinical studies, however, did not constitute an application by any company for permission to market stilbestrol. After the submission of the investigational material, each individual company was required to file a separate NDA to market stilbestrol and many did.
Thereafter, in 1941, the FDA began issuing approvals of the NDAs, thereby permitting the marketing of stilbestrol in the United States for treatment of menopausal symptoms, senile vaginitis, gonorrheal vaginitis and suppression of lactation.
Meanwhile, the clinical study of stilbestrol continued by independent physicians at major medical centers. There was increasing interest, notably at Harvard and at the Joslin Clinic in Boston, on whether it could be used to treat problems of pregnancy. Prior to the development of stilbestrol, estrogen therapy had been found to be highly effective in treating problem pregnancies.
Among the pioneers in estrogen research for use in pregnancy were a husband and wife team on the faculty of the Harvard Medical School, Dr. George Van Smith and Dr. Olive Watkins Smith. They discovered that hormonal deficiencies in pregnancy led to early miscarriage and that estrogen treatment could correct these deficiencies. At first they used the very expensive natural estrogens. Later, when stilbestrol became available, they used stilbestrol and found that it had the same physiologic effect.
Beginning in 1947 based on the reports of successful use of stilbestrol to treat problem pregnancies, several manufacturers filed NDA's with the FDA seeking permission to market stilbestrol as an aid in the prevention of certain problems of pregnancy. These new NDA's were prepared and filed independently. In the same year, various companies were permitted, for the first time, to market stilbestrol as a miscarriage preventative. Dienestrol was not approved for the same purpose until 1950.
At the time that those applications were made, the federal law provided that a new drug application became "effective" automatically if the Secretary of Health, Education and Welfare failed within a certain period of time to disapprove the application. If the agency had insufficient information to decide whether the drug was safe, or if it had information that it was unsafe, the application was denied. 52 Stat. 1052 (1938), § 505. Proof of efficacy was not required by the 1938 act.
Even though one company's application became "effective," the drug would however, continue to be regarded as "new" until that status was affirmatively terminated by a specific order of the FDA saying so. 52 Stat. 1040 (1938), § 201(p).
Sometime prior to 1952 the FDA declared that DES was no longer a "new drug," which meant that any company which wanted to enter the DES market was free to do so without prior testing and without submitting an NDA to the FDA. By 1954 there were 267 companies marketing DES in this country; ultimately there were more than 287.
In 1971 Dr. Arthur Herbst and other physicians on the faculty at the Harvard Medical School published a paper which disclosed a statistical association between the use of stilbestrol in pregnancy and a form of gynecological cancer in the daughters of the pregnancy. Subsequently other studies reported a higher than expected incidence of other conditions in daughters whose mothers were given stilbestrol to prevent miscarriage.
In 1972 the FDA banned the further sale and use of the synthetic estrogen drugs for the prevention of miscarriages and ordered the drug companies to warn physicians and the public that the drug should not be used by pregnant women because of the danger to their unborn children.
For other purposes, however, the drug is still prescribed today. It is presently approved for use as an estrogen replacement in cases of hormone deficiency, therapy for menopausal symptoms, treatment of some cases of cancer, and suppression of lactation. It is also the ...