Payton v. Abbott Labs

• Decision Date: 23 April 1981
• Docket Number: Civ. A. No. 76-1514-S.
• Citation: 512 F. Supp. 1031
• Parties: Brenda PAYTON et al., Plaintiffs, v. ABBOTT LABS et al., Defendants.
• Court: U.S. District Court — District of Massachusetts

512 F. Supp. 1031

Brenda PAYTON et al., Plaintiffs, v. ABBOTT LABS et al., Defendants.

Civ. A. No. 76-1514-S.

United States District Court, D. Massachusetts.

April 23, 1981.

Jeanne Baker and David J. Fine, Baker & Fine, Cambridge, Mass., for plaintiffs.

Marshall Simonds, Goodwin, Procter & Hoar, Boston, Mass., for defendants.

MEMORANDUM AND ORDER ON DEFENDANTS' MOTION FOR PARTIAL SUMMARY JUDGMENT ON ISSUES 9 AND 10 CERTIFIED FOR CLASS TREATMENT

SKINNER, District Judge.

In a memorandum and order dated July 30, 1979, I conditionally certified thirteen issues for class resolution. See 83 F.R.D. 382, 386-87. The case is presently before me on defendants' motion for partial summary judgment on class issues 9 and 10. These issues are defined as follows:

9. whether and when, in producing, marketing, and promoting DES Diethylstilbestrol as a miscarriage preventative, the defendants engaged in a joint enterprise;

10. whether and when the defendants combined and conspired in their acts and omissions relating to DES.

See 83 F.R.D. at 386.¹

I. SUMMARY JUDGMENT STANDARD

Fed.R.Civ.Pro. 56(c) provides that summary judgment shall be rendered

if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.

This standard requires the party opposing the motion to "establish the existence of an issue of fact which is both `genuine' and `material'". Hahn v. Sargent, 523 F.2d 461, 464 (1st Cir. 1975), cert. denied, 425 U.S. 904, 96 S.Ct. 1495, 47 L.Ed.2d 54 (1976). In determining whether summary judgment is appropriate the court must look at the record in the light most favorable to the party opposing the motion and must indulge all inferences favorable to that party. Id.

II. FACTS

Viewed in the light most favorable to plaintiffs, the affidavits submitted by the parties reveal the following facts.

Estrogen is a female sex hormone present in varying amounts in the body of every woman. This hormone is crucial to female sexual development and fertility.

Natural estrogens were first isolated outside the human body in the 1920's. Doctors initially used the hormone to treat menopausal symptoms in women. Natural estrogen therapy had several drawbacks, however. The process of isolating the hormone was very costly. Furthermore, natural estrogens could only be administered through injections into the buttocks, often resulting in painful abscesses.

In the late 1930's, a group of British scientists discovered Diethylstilbestrol ("DES"), a synthetic compound which shares some of the characteristics of estrogen. DES could be produced at only a fraction of the cost of isolating natural estrogens and could be administered orally. It was never patented.

Approval of the Food and Drug Administration ("FDA") was required before DES could be marketed in the United States. Pursuant to § 505 of the Federal Food, Drug, and Cosmetic Act, each company wishing to market DES had to file a New Drug Application ("NDA") detailing the proposed uses of the drug, clinical data establishing its safety and efficacy, the drug's chemical composition, methods of manufacturing it and proposed labeling.

The first NDA for DES was filed in 1939. By the end of 1940, ten firms had applied. The NDAs sought authorization to market and distribute DES for four purposes: the treatment of post-menopausal symptoms, senile vaginitis, gonorrheal vaginitis, and suppression of lactation. None of the proposed uses relate to problems of pregnancy.

All indications from the FDA in 1939 suggested that the FDA would review each manufacturer's NDA separately. This meant that each firm had to stand on the clinical data it submitted in its own NDA, and could not rely on other companies' data. Some companies expressed hope that the FDA would change its policy to permit the use of pooled clinical data.² Carson Frailey, then Executive Vice President and Secretary of the American Drug Manufacturers Association ("ADMA") decided to monitor the situation for possible changes in FDA policy. In December 1939, several firms held an informal meeting to compare their clinical experience with DES.

In late 1940, Dr. Theodore G. Klumpp, then Chief of the Drug Division of the FDA, communicated to Carson Frailey that the FDA was considering requesting the drug companies to pool their clinical data on DES. Several drug companies objected on the ground that it would be unfair to those firms that had done the most testing and expended the most resources.

The FDA then convened a meeting with the drug companies on December 20, 1940, at which it formally requested that the companies submit their clinical data jointly in a "master file". According to Dr. Klumpp, this decision was taken in the "public interest". The FDA believed that the individual NDAs did not contain sufficient clinical data to properly evaluate the safety and efficacy of DES. Pooling of the data, in the FDA's view, would eliminate this problem as well as expedite its evaluation of DES. The FDA did not have authority to compel the drug companies to submit a "master file". Nevertheless, Dr. Klumpp impressed upon the companies that if the FDA had to consider each manufacturer's NDA separately, the process of approval would be seriously delayed.

On January 21, 1941, the "small committee" was formed, composed of representatives of the firms that had filed NDAs for DES. Its purpose was to coordinate the pooling of clinical data into the "master file".

The FDA made three other requests of the drug companies at this time. The first was that each company use the same United States Pharmacopeia standard to establish the chemical identity of the drug. The second was that they develop uniform labeling regarding the indications for use of the drug and recommended dosage. The third was that they place a provision in their NDAs authorizing the FDA to use the materials gathered by each firm in considering any other NDAs that might be filed.

The companies, for the most part, complied with these additional requests. Each company's DES compound tracked the United States Pharmacopeia standard. Their proposed labeling and warnings for the drug were similar. With respect to the FDA's request for a permissions clause, though several companies did not agree to it, at least six did include such a clause in their NDAs.³

The ADMA coordinated all communications between the FDA and the individual drug companies throughout this period. On behalf of the drug companies, the ADMA also filed the final versions of the 1941 NDAs with the FDA.

In May 1941, the small committee submitted the "master file" of clinical data to the FDA. The FDA approved the marketing of DES for uses unrelated to problems of pregnancy in late 1941. Thereafter, the small committee was disbanded, never again to reconvene. The ADMA continued to file NDAs up through 1943 on behalf of other companies seeking to market DES for the uses previously sanctioned.

Experimental use of DES as a miscarriage preventative began in the early 1940's. Several drug companies supplied DES to independent researchers for such experimentation. The drug companies also sent representatives to medical conferences on this topic.

The first supplemental NDAs for the use of DES as a miscarriage preventative were filed in 1947. Only a few companies conducted their own experiments to establish the safety and efficacy of DES for this purpose. Among these, none tested DES on pregnant laboratory animals. The applicants relied instead upon published studies done by independent researchers to support their applications, in particular, the work of Dr. Karl John Karnaky of Houston and Drs. O. Watkins Smith and George Van S. Smith of Boston. The supplemental NDAs did not refer to the "master file" of clinical data that had been submitted with the 1941 NDAs. The FDA's policy in reviewing supplemental NDAs, however, was to take into consideration all of the material that it had in support of the original NDAs.

The FDA began approving the supplemental NDAs in July 1947. Soon thereafter, DES was marketed as a miscarriage preventative. Some companies marketed the drug under a trade name; others marketed it generically. Several companies supplied DES to competitors. Because the DES compounds produced by the drug companies were chemically identical, pharmacists often filled prescriptions for DES with whatever company's drug was in stock, a practice that the firms were aware of. None of the companies warned physicians about the possibility of carcinogenic or other risks to the offspring of women who took DES. Several, however, had warned against the use of DES in women having a history of cancer.

The number of firms marketing DES has fluctuated considerably over the years. In 1941, ten firms filed NDAs for DES. By 1947, 71 companies were producing or distributing the drug. In 1957, this had increased to 151 firms. And by 1967, the number of firms marketing DES had dropped back to 91. Additionally, companies have entered and left the DES market at different times.

In 1952, the FDA decided that DES was no longer a "new drug" within the meaning of § 505 of the Food, Drug, and Cosmetic Act. This meant that companies wishing to market DES for the first time would not have to file NDAs.

In 1971, Dr. Arthur Herbst and several other physicians published a study linking the outbreak in young women of clear cell adenocarcinoma, a form of cancer, with the ingestion of DES by their mothers during pregnancy. In November of that same year, the FDA required the drug companies to include a statement on all labels that "DES is contraindicated for use in the prevention of miscarriages." Today, the FDA continues to permit the use of DES in treatments unrelated to problems of pregnancy.

III. THEORIES OF CONCERT OF ACTION AND JOINT VENTURE

As with most...