Washington University v. Catalona

• Decision Date: 31 March 2006
• Docket Number: No. 4:03CV1065SNL.,4:03CV1065SNL.
• Citation: 437 F.Supp.2d 985
• Parties: THE WASHINGTON UNIVERSITY, Plaintiff, v. William J. CATALONA, et. al., Defendants.
• Court: U.S. District Court — Eastern District of Missouri

437 F.Supp.2d 985

THE WASHINGTON UNIVERSITY, Plaintiff, v. William J. CATALONA, et. al., Defendants.

No. 4:03CV1065SNL.

United States District Court, E.D. Missouri, Eastern Division.

March 31, 2006.

COPYRIGHT MATERIAL OMITTED

Allison G. Schnieders, Joseph Alexander Lawrence, Morrison and Foerster LLP, New York, NY, Elizabeth A. Teutenberg, Thomas E. Wack, Douglas W. King, Bryan Cave LLP, St. Louis, MO, H. Preston Moore, Matthew D'Amore, Morrison and Foerster LLP, San Francisco, CA, Sherman W. Kahn, Morrison and Foerster LLP, Los Angeles, CA, for Plaintiff.

Gene C. Schaerr, Winston & Strawn LLP, Washington, DC, Gregory R. Piche, Holland and Hart, Denver, CO, Jim J. Shoemake, Troy A. Doles, Guilfoil and Petzall, Burton H. Shostak, Moline and Shostak, St. Louis, MO, Janet F. Catalona, Patricia K. Susi, Catalona Law Firm, L.L.C., Clayton, MO, for Defendants.

MEMORANDUM OPINION

LIMBAUGH, Senior District Judge.

Plaintiff Washington University (hereinafter referred to as "WU") has filed this declaratory judgment action seeking to establish "ownership", and thereby, the destiny of certain research biological materials currently stored in the GU Biorepository. Central to the several pending summary judgment motions, and preliminary injunction motion(s) is the issue of "ownership"; thus, the Court determined that the most logical and efficient manner in which to address this issue was to hold a permanent injunction hearing in which all interested parties, including research participants who "donated" the subject biological materials, could coherently present their argument to the Court. On April 9 through 11, 2005, such a hearing took place before this Court. At the conclusion of the hearing, all parties were permitted to file post-hearing briefs, and this matter is now ripe for disposition.

After careful consideration of all objections to exhibits and testimony taken with the case, all said objections are hereby overruled, and all exhibits offered into evidence at the hearing are received into evidence. All testimony will be considered by the Court and given its due weight. This Court, having now considered the pleadings, the testimony of witnesses, documents in evidence, and any other evidentiary materials submitted for the Court's consideration, and being fully advised in the premises, hereby makes the following findings of fact and conclusions of law as required by Rule 52, Federal Rules of Civil Procedure.

FINDINGS OF FACT¹

Plaintiff Washington University (WU) is a Missouri not-for-profit corporation with its principal place of business in St. Louis, Missouri. WU is one of the leading private research universities in this country, if not in the world. As a research university, it has a medical school (Washington University School of Medicine) that includes a Department of Surgery and a Division of Urologic Surgery. The medical faculty regularly pursues and publishes significant original medical research. Within the Division of Urologic Surgery, WU physicians treat patients, teach students and residents, and conduct medical research.

Defendant William J. Catalona, M.D.² is a highly respected urologist and urologic surgeon, as well as a well-established medical researcher regarding prostate cancer. He was employed by WU from July 1, 1976 until February 23, 2003. Dr. Catalona was Chief of the Urology Division from 1984 to 1998. While at WU, Dr. Catalona performed thousands of surgeries, including prostate cancer surgeries. He was instrumental in establishing the GU³ Biorepository for the collection and storage of biological research materials. In 2003, Dr. Catalona left his position with WU to take a similar position with Northwestern University in Chicago, Illinois and to continue his prostate cancer research.

The GU Biorepository houses biological specimens of prostate tissue, blood, and DNA samples for prostate cancer research. Patients of Dr. Catalona, as well as several other WU physicians, contributed biomaterials for prostate cancer research. As of the date of the hearing, there were more than 30,000 research participants enrolled in prostate cancer research studies; of these, 2500-3000 had been patients of Dr. Catalona. There are approximately 3500 prostate tissue samples in the GU Biorepository taken from patients of Dr. Catalona and other WU physicians within the Urologic Surgery Division. There are approximately 100,000 serum samples in the GU Biorepository; 75% of these contributions were made from research participants who were not patients of Dr. Catalona or any other WU physician. Approximately 4400 men contributed DNA samples to the GU Biorepository; again, some were patients of Dr. Catalona, while others were not. The GU Biorepository is not used for clinical care or follow-up care; it is strictly used for research purposes. At times, other research institutions have requested and received samples from the GU Biorepository for research projects outside of WU (or in partnership with WU). The transfer of such material is made pursuant to a Material Transfer Agreement (MTA). At least seven (7) of these MTAs personally signed by Dr. Catalona acknowledge WU as the owner of the biological samples at issue in this case. Plaintiff's Exhibits 7-10, 12-14.

At all relevant times, the GU Biorepository has been housed in one or more buildings owned by WU. At all relevant times, WU employees have administered the GU Biorepository. WU has provided the majority of funding necessary to operate and maintain the GU Biorepository. External funding for the GU Biorepository is in the form of public and private grants made to and administered by WU as the grantee. Dr. Catalona, as a WU employee and physician, has raised several million dollars in outside funding for the GU Biorepository. Other WU employees, most notably Dr. Gerald Andriole (Dr. Catalona's successor as Urology Division Chief), have raised substantial funds for the GU Biorepository.

WU's Intellectual Property Policy states that "all intellectual property (including . . . tangible research property) shall be owned by the University if significant University resources were used or if it is created pursuant to a research project funded through corporate, federal, or other external sponsors administered by the University." Plaintiff's Exhibit 17, § I . .3(a). It further states "[G]enerally, creators and research investigators will retain custody of tangible research property while at the University." Plaintiff's Exhibit 17, § 1.3(a).

Defendants Richard Ward, Thomas McGurk, Luis Garcia, Antonio Castro, Phillip Wilard, Ivan Parsons, James Ellis, and Michael Missios⁴ are/were patients of Dr. Catalona and participants in one or more research projects at WU in which Dr. Catalona was involved.⁵

During the relevant time-period, several prostate cancer studies have been undertaken by Dr. Catalona and other doctors in the Urology Division. Dr. Catalona, as well as other WU physicians, were named "Principal Investigators" on these studies. Dr. Catalona testified that the principal investigator "is in charge of conducting [a] research protocol." Tr. 1:46.⁶ The testimony at the hearing established that regardless of who was listed as the "Principal Investigator", the research studies were a collaborative effort involving substantial work by many individuals, all of whom were/are employees of WU.

In order to carry out the subject prostate cancer research studies⁷, surgical and non-surgical research participants (hereinafter referred to as "RPs") were invited to participate in genetic cancer research. If they agreed to participate, they had to sign "informed consent" forms. Although the informed consent forms differed slightly due to variances in the protocol and the particulars of each Principal Investigator, generally they all contained the similar language. The informed consent forms typically bore the WU Medical Center logo. Plaintiff's Exhibits 27, 58, 59, 60, 61, and 98; Catalona Exhibit UUU; RP Exhibit 1. The informed consent forms state that the collection of samples is for medical research and not for patient care. They typically stated that the RP could not "claim ownership rights" to any medical or scientific product that results from research with the sample. They typically use the word "donate" to characterize the delivery of the sample (blood, tissue and/or DNA) from the RP to the WU physician or another WU medical technician. They typically state that by participating, the RP "make[s] a free and generous gift of your [blood, tissue and/or DNA] to research that may benefit others." Furthermore, the typical WU informed consent form states that "[y]our participation is voluntary and you may choose not to participate in this research study or withdraw your consent at any time." Some forms use the phrase "withdraw my consent and discontinue participation." None of the submitted WU informed consent forms address the issue of the RP withdrawing samples from the GU Biorepository or the RP requesting samples be sent to another institution.

Along with the informed consent forms, RPs are given a WU Genetic Research Brochure (to also sign) which generally addresses the issues of primary importance to the RP. Catalona Exhibit X. Under the section: What if you change your mind?, the brochure states the following: "To request that your tissue no longer be used for research, you should call the investigator listed on the consent form. Your tissue will be identified and destroyed upon request. Any research results already obtained cannot be destroyed or recalled." Nowhere in the brochure does it state anything about a RP withdrawing his/her sample or a RP requesting that his/her sample be transferred to another facility.

WU is a federally approved and regulated institution for the human-subject research involving the GU Biorepository. The Department of Health and Human Services (HHS) office known as the Office for Human Research Protection (OHRP) is...