Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. Nos. 83 C 1247, 83 C 1248 -- Prentice H. Marshall, Judge. 12: Robert M. Stephenson, Cotsirilos & Crowley, 33 N. Dearborn, Ste. 930, Chicago, Illinois 60602, for Plaintiff George M. Burditt, Burditt & Calkins, 135 S. LaSalle Street, Ste. 830, Chicago, Illinois 60603, for Defendant
Before WOOD and CUDAHY, Circuit Judges, and NICHOLS, Senior Circuit Judge.*fn*
NICHOLS, Senior Circuit Judge. Plaintiffs Paula Renfroe and Nancy Deitchman have brought pharmaceutical products liability actions in the United States District Court for the Eastern District of Missouri, Eastern Division, against E.R. Squibb & Sons, Inc. (Squibb) and other drug companies for injuries allegedly caused by in utero exposure to the drug diethystilbestrol (DES). Paula Renfroe, born in 1964, has an adenocarcinoma of the cervix; Nancy Dietchman, born in 1956, has an oat cell carcinoma in the endometrial lining of her uterus.
In connection with this litigation, Squibb in February 1983 asked the United States District Court for the Northern District of Illinois, Eastern Division, to issue subpoenas for deposition which required, in essence, the production of every document in the Registry for Hormonal Transplacental Carcinogenesis (the Registry) at the University of Chicago. The Registry monitors the clinical, pathological, and epidemiological aspects of clear cell adenocarcinoma of the genital tract and is the only centralized repository of data on that disease. On March 4, 1983, Dr. Arthur L. Herbst, custodian of the Registry's records and chairman of the University of Chicago's Department of Obstetrics and Gynecology, filed a motion to quash the deposition subpoenas, pursuant to Fed. R. Civ. P. 45(b), claiming that the Registry data were privileged and confidential. Squibb opposed Dr. Herbst's motion.
On March 23, 1983, a United States District Judge entered orders with an accompanying Memorandum Opinion, granting in major part Dr. Herbst's motion to quash. Insofar as Squibb's subpoena requested records relating to plaintiffs and their mothers, however, the court ordered Dr. Herbst to disclose any records or other information which pertained solely to them because, in their cases, the need for confidentiality was lost when this litigation began.
Squibb thereafter filed a Motion to Reopen for Reconsideration and for Relief, pursuant to Fed. R. Civ. P. 59(e), and a Motion to Vacate, To Reopen and for Relief, pursuant to Fed. R. Civ. P. 60(b)(2). The court entered orders denying these post-judgment motions.
Squibb appeals from the orders granting Dr. Herbst's motion to quash the deposition subpoena and from the orders denying its motion to reopen and reconsider. For the reasons set out below, we vacate each of the district court's orders and we remand for further proceedings.
Dr. Herbst, the appellee before us, is not a party to any case and will not testify at the trials. His connection with the cases will appear below. He was on the faculty of the Harvard Medical School and on the staff of Massachusetts General Hospital when he began in 1969 a study of clear cell adenocarcinoma of the vagina of young women. In 1971, he and his colleagues became the first medical researchers to suggest an association between exposure to DES in the womb and the development of clear cell adenocarcinoma of the vagina or cervix at an early age. See Herbst, Ulfelder & Poskanzer, Adenocarcinoma of the Vagina -- Association of Maternal Stilbestrol Therapy with Tumor Appearance in Young Women, 284 New Eng. J. Med. 871 (1971). All parties agree that the 1971 study is of enormous significance in this field of medicine and that Squibb will in all likelihood be confronted with it in one form or another at trial on the merits, even thought Dr. Herbst himself will not testify.
In order to monitor the clinical, pathological, and epidemiological aspects of clear cell adenocarcinoma of the genital tract (the disease), in 1972 Dr. Herbst set up the Registry. Among the Registry's initial goals were the determination of the incidence of the disease, the best means of treatment, the relationship between prenatal hormone treatment and the occurrence of the disease, the other factors which promoted the disease, and the other sites of the disease in the genital tract. Since the Registry's beginning, it has received over 500 case files, and Dr. Herbst and his colleagues have published more than a dozen articles which report all significant findings from the Registry on the subject of DES and clear cell adenocarcinoma.
To establish the Registry, Dr. Herbst sent letters of inquiry to all departments of medical schools in the United States, to hospitals throughout the world that specialize in cancer treatment, and to the World Health Organization. He also placed announcements in various major medical journals. In his solicitations, Dr. Herbst requested records of all women born after 1940 who had contracted clear cell adenocarcinoma of the genital tract; he promised that the Registry would keep confidential all information submitted to it. After he received records for a particular case, Dr. Herbst attempted to contact the patient, and where possible, her mother's obstetrician, to obtain additional records and information about the mother's possible use of DES. He requested this information with an additional written promise of confidentiality.
Dr. Herbst continually updates and annually requests information from treating physicians on the status of their patients' diseases, the treatment being used, and any complications from the treatment. He also continues to solicit information on newly reported cases of clear cell adenocarcinoma of the female genital tract and on newly reported cancers in women exposed prenatally to other sex hormones. Because the FDA did not proscribe the use of DES for pregnant women until 1971, DES-associated cases of clear cell adenocarcinoma are expected to continue to appear until well into the 1990's. Continued monitoring through the Registry, therefore, will be vital in order to learn more about the disease and how to treat it.
When a discovery subpoena is issued against a party or person who objects to the disclosure of information called for, that party or person can move for either a protective order pursuant to Fed. R. Civ. P. 26(c), or an order quashing or modifying the subpoena, pursuant to Fed. R. Civ. P. 45(b). Fed. R. Civ. P. 45(d)(1).Dr. Herbst has moved for such protection, arguing not only that Squibb has no need to see Registry data, but also that the subpoena as issued is unreasonable and oppressive.
Generally, the Federal Rules of Civil Procedure allow for broad discovery: "Parties may obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action * * *." Fed. R. Civ. P. 26(b)(1) (emphasis added). When protection from a deposition subpoena is sought, the court "must apply a balancing test to determine whether the need of the party seeking disclosure outweighs the adverse effect such disclosure would have on the policies underlying the [claimed] privilege." Equal Employment Opportunity Commission v. University of Notre Dame du Lac, 715 F.2d 331, 338 (7th Cir. 1983). That is, the court must compare "the hardship to the party [or person] against whom discovery is sought, if discovery is allowed, with the hardship to the party seeking discovery if discovery is denied." Marrese v. American Academy of Orthopaedic Surgeons, 726 F.2d 1150, 1159 (7th Cir. 1984) (en banc). Thus, the nature and magnitude of Dr. Herbst's, the Registry's, and Squibb's competing hardships must be reviewed. We turn first to the hardship a subpoena will cause to Dr. Herbst and the Registry.
Dr. Herbst vigorously argues that a subpoena will literally destroy the Registry if it pierces the Registry's promised confidentiality. He buttresses his argument with affidavits from a number of experts in the field of medical science and epidemiology: Dr. Robert E. Scully, Professor of Pathology, Harvard Medical School, and a member of the Pathology Office of the Registry; Dr. Leonard T. Kurland, Chairman and Professor of Epidemiology, Mayo Medical School and Professor of Epidemiology, School of Public Health, University of Minnesota; Dr. William M. Halnzal, Professor of Epidemiology, University of Illinois School of Public Health and Senior Epidemiologist, Illinois Cancer Council; Dr. Philip Cole, Professor and Head of the Department of Epidemiology, University of Alabama School of Public Health and Associate Director of that university's Comprehensive Cancer Center; Dr. Kenneth Noller, Principal Investigator of the Mayo Clinic DES Examination Center; Dr. Raymond H. Kaufman, Professor and Chairman of the Department of Obstetrics and Gynecology and Professor of Pathology, Baylor College of Medicine, Houston; and Dr. Hugh R. Barber, a gynecologist in private practice in New York City. Drs. Scully, Noller, Kaufman and Barber specifically averred that they had in the past submitted information and other material to the Registry based on Dr. Herbst's representations of strict confidentiality and that this cooperation would cease should it become apparent that such material was amenable to subpoena.
Dr. Herbst and his affiants exhort us on the profound societal impact a subpoena here will have. They lecture us on the importance of confidentiality in epidemiological research, the significance of the Registry as a unique and valuable research project, the necessity for its continuation, and the harm that Squibb's discovery of the data in the Registry could cause, not only to the Registry, but to other epidemiological research projects as well.
Squibb, not surprisingly, makes absolutely no countershowing. It appears to concede that the loss of confidentiality here will adversely affect the Registry and that, as the district judge stated, "all society will be the poorer * * * [and] a unique and vital resource for learning ...