Hawkinson v. AH Robins Co., Inc., Civ. A. No. 75-M-714

• Decision Date: 18 September 1984
• Docket Number: 80-M-1677,Civ. A. No. 75-M-714,80-M-603,80-M-10,80-M-605,81-M-639 and 81-M-659.,81-M-210,80-M-766,80-M-389,80-M-442,81-M-209
• Citation: 595 F. Supp. 1290
• Parties: Janette Allyn HAWKINSON, Ruth A. Winchester, Jo Susan Verspohl, Ella Lee Ford, Linda A. Parks, Mary Jayne Catto, Xenia D. Graves, Diane Whitney, Merrilyn Dickens, Stefanie M. Selden, Donna Cornelisse, and Bonnie Alexander-Frisk, Plaintiffs, v. A.H. ROBINS COMPANY, INC., a Virginia corporation, Defendant.
• Court: U.S. District Court — District of Colorado

595 F. Supp. 1290

Janette Allyn HAWKINSON, Ruth A. Winchester, Jo Susan Verspohl, Ella Lee Ford, Linda A. Parks, Mary Jayne Catto, Xenia D. Graves, Diane Whitney, Merrilyn Dickens, Stefanie M. Selden, Donna Cornelisse, and Bonnie Alexander-Frisk, Plaintiffs, v. A.H. ROBINS COMPANY, INC., a Virginia corporation, Defendant.

Civ. A. Nos. 75-M-714, 80-M-10, 80-M-389, 80-M-442, 80-M-603, 80-M-605, 80-M-766, 80-M-1677, 81-M-209, 81-M-210, 81-M-639 and 81-M-659.

United States District Court, D. Colorado.

September 18, 1984.

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Douglas Bragg, John T. Baker, Bragg & Dubofsky, Denver, Colo., Joe Gordon McPhee, Telluride, Colo., for plaintiffs.

Harmon Graves, Charles Socha, Tilly & Graves, Denver, Colo., Deborah M. Russell, McGuire, Woods & Battle, Richmond, Va., for defendant.

FINDINGS OF FACT, CONCLUSIONS OF LAW AND ORDER

MATSCH, District Judge.

These twelve civil actions were consolidated for trial to the court because all of the plaintiffs claim that they suffered injuries from the use of the same product, manufactured and marketed by the defendant, the Dalkon Shield intrauterine contraceptive device. These claims are brought within the jurisdiction provided by 28 U.S.C. § 1332, and the law of Colorado is applicable in all of these cases.

EARLY PRODUCT HISTORY

The Dalkon Shield device was designed by the joint efforts of Dr. Hugh James Davis and Mr. Irwin S. Lerner. Dr. Davis is a physician who, at all relevant times, was an associate professor at Johns Hopkins University School of Medicine, serving as director of its family planning clinic since 1963. Dr. Davis practiced obstetrics and gynecology ("OB/GYN") in the clinic at Johns Hopkins and also served some private patients there, although he was never board certified in that specialty. He did experimental work with intrauterine devices at Johns Hopkins Hospital from about 1963 to 1967 under various grant programs. He began discussions with Mr. Lerner in 1967, and, on June 10, 1968, they entered into an agreement by which Dr. Davis would be compensated for his help in the development and testing by Lerner Laboratories of an experimental intrauterine device which became the Dalkon Shield, and would undertake a program of testing the device to determine its safety and reliability. Essentially, Dr. Davis was to receive 5% of sales.

The Dalkon Shield is an oval shaped plastic device, slightly larger than a dime, with fin-type projections on each side. It was designed to conform to the shape of the uterine cavity and the projections were added to improve resistance to expulsion and to cause the device to be fundal seeking with normal uterine movements. A tailstring was tied to the bottom of the Shield by a knotted loop as an indicator of proper placement of the device and as a means for removal of the Shield. When this IUD was placed properly in the uterus, the tailstring projected through the cervix and into the vagina. A locator knot was tied at a point where it could be seen by the physician and felt by the patient as an assurance that placement was proper. Because the removal of the Dalkon Shield required greater force than other IUDs, the string had to be stronger, and this was accomplished by the use of multiple strands of suture material encased by a nylon sheath open at both ends.

Dr. Davis began inserting Dalkon Shields into women at the Johns Hopkins clinic beginning in August, 1968, and he collected data concerning 640 women for a one-year period up to September, 1969. Dr. Davis authored two publications reporting the experience of those women. One appeared in Excerpta Medica and another was a two-page article appearing in the American Journal of Obstetrics and Gynecology in February, 1970. In those articles, Dr. Davis reported a pregnancy rate of 1.1%, and he was very enthusiastic about the Shield device.

Dr. Thad Earl, M.D., was a physician with a general practice in Defiance, Ohio, with approximately 70% of his practice in obstetrics and gynecology. He was not board certified in that medical specialty. He read a newspaper article about the Dalkon Shield and went to Baltimore to consult with Dr. Davis about it. As a result, Dr. Earl became very enthusiastic about using this device and purchased some 48 of them from Mr. Lerner at his business in Greenwich, Connecticut. Dr. Earl took the Shields to his office in Defiance and inserted them in his patients, including his wife. Dr. Earl was very careful with follow-up on his patients and took endometrial biopsies. The biopsy tissue was then examined by a pathologist. These studies were understood by Dr. Earl as confirming his view that the Dalkon Shield was effective because it evoked an inflammatory response in the endometrial tissue.

By the Spring of 1970, Mr. Lerner, Dr. Davis, and a lawyer, named Robert Cohn, formed the Dalkon Corporation as a Connecticut corporation for the purpose of manufacturing and marketing the Dalkon Shield. In April, 1970, Dr. Earl purchased a 7?% interest in the Dalkon Corporation for $50,000, and with that purchase, Dr. Earl became the company's medical director.

A.H. Robins Company, Inc. ("Robins") is a well-established pharmaceutical company which had no experience in the contraceptive products market before June, 1970. There was no OB/GYN on the defendant's staff in any department. Dr. Frederick Clark, Jr. is a physician who was Medical Director of A.H. Robins Company, appointed in 1964, although he did not always function in that capacity. He was made Assistant Vice-President in September, 1971, and Vice-President on September 1, 1973.

In May, 1970, Dr. Earl had contact with a representative from Robins, and discussion of a sale of the Dalkon Shield to Robins followed. Robins did very little to investigate this device before proceeding with the purchase negotiations. Dr. Clark read the Dr. Davis article in the February, 1970 issue of American Journal of Obstetrics and Gynecology. Dr. Clark, Roy Smith and Ed Davis from Robins went to see Dr. Thad Earl in Defiance, Ohio, and looked at six to ten case records provided by Dr. Earl. Dr. Clark then made a trip to see Dr. Hugh Davis on June 8, 1970, and wrote a memorandum in which he reported that Dr. Davis had data for the first 14 months, from September, 1968 through November, 1969, covering 832 insertions with 26 pregnancies. That apparent difference from the reported pregnancy rate of 1.1% did not generate any concern at Robins.

The sale to Robins took place on June 12, 1970 for a purchase price of $750,000 plus a 10% royalty. Additionally, Dr. Davis was given a consulting contract by Robins for three years at $20,000 per year, which contract was later extended for another two years, to 1975.

Dr. Earl suggested that Robins finance an endometrial biopsy study, but that was not done because of a reluctance to incur the costs and the lack of a definite methodology. Dr. Earl became a consultant for Robins by an agreement dated June 20, 1970, for three years at a retainer of $30,000 per year. In that role, Dr. Earl attended many meetings of medical groups as a spokesman for the Dalkon Shield. He exhibited a film and talked with doctors in a Robins booth set up at such meetings. Dr. Earl used the Dr. Davis paper from the American Journal of Obstetrics and Gynecology at these meetings, and distributed many reprints of that article.

Dr. Clark developed a project plan for the use of doctors as clinical investigators of the Shield and, after Robins' purchase, Dr. Chremos was Robins' employee charged with supervising these clinical investigations because he had experience with such work with other Robins products. Dr. Chremos made a visit to Dr. Hugh Davis on February 3, 1971, at his office at Johns Hopkins Hospital. After their talk, Dr. Chremos recommended that Dr. Davis not be used as a clinical investigator because of the possible bias resulting from his being a participant in the invention and development of the device. He did not make a recommendation that the company discontinue the use of Dr. Davis' article. Robins made plans for other testing of the Dalkon Shield in anticipation of the need for it if IUDs became subject to government regulation. That possibility was then being considered by the Food and Drug Administration and some members of Congress.

In January, 1971, Robins began dual campaigns, both testing and marketing a modified Shield. Although the parties dispute the matter, it is this court's view that the modifications made to the Dalkon Shield by Robins are not changes of significance to the issues in these cases. Robins made the Dalkon Shield in two sizes. The standard size was for use in multiparous patients and a smaller size was recommended for use in nulliparous women.

The Earl consultation agreement with Robins ended in June, 1972. Dr. Earl left Defiance, Ohio and moved to Lordsburg, New Mexico at the end of June, 1972, because of personal medical problems. After a few months there, he moved to Sierra Vista, Arizona. On June 23, 1972, shortly before leaving Defiance, and after his consultation agreement had expired, Dr. Earl wrote a letter which is in evidence as Plaintiffs' Exhibit 530. That letter was addressed to John Burke at Robins, and refers to the last two meetings Dr. Earl attended: the American Academy of Obstetricians and Gynecologists at Chicago, and the AMA meeting in San Francisco. Dr. Earl reported several discussions with physicians who reported problems with the use of the Dalkon Shield, including higher pregnancy rates in certain areas, difficulty with removal, difficulty with insertions and an increase of infections in nulligravida women. Dr. Earl outlined how he responded to those problems by emphasizing the importance of the proper technique for insertion, assuring high fundal placement. It was not until the third paragraph of page three of the letter that Dr. Earl...