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The substantive law of Missouri defines an "inter vivos gift" as a voluntary transfer of property by the owner to another, without any consideration or compensation as an incentive or motive for the transaction. The party claiming the existence of an inter vivos gift bears the burden to prove by clear and convincing evidence there was: (1) present intent of the donor to make a gift, (2) delivery of the property by the donor to the donee, and (3) acceptance of the gift by the donee, whose ownership takes effect immediately and absolutely.
Dr. William Catalona, a highly respected urologist and urologic surgeon and researcher, was employed by WU from 1976 to 2003, and he served as Division Chief from 1984 to 1998. During Dr. Catalona's tenure at WU, he performed thousands of surgeries, many involving prostate cancer. As a leading medical researcher for WU, one of Dr. Catalona's principal areas of research was the genetic basis of prostate cancer. In 1983, Dr. Catalona began collecting samples of biological materials, such as blood and tissue removed during surgery, to be used later for prostate cancer research. Dr. Catalona encouraged his colleagues to do the same. He was instrumental in establishing the GU Biorepository (Biorepository), the world's largest storage facility for biological samples collected by Dr. Catalona and other WU physicians for prostate cancer research. During the relevant time period, Dr. Catalona and other Division physicians performed many genetic cancer research studies, with each study naming a particular WU physician as the "principal investigator." In order to conduct these studies, individuals were invited to participate in genetic research. Individuals who chose to donate excised prostate tissue or a blood sample to medical research and to become a research participant (RP) were required to complete an informed consent form. Although the language of the consent forms differs, depending upon the nature of the particular study or the study's principal investigator, generally all of the forms contain similar provisions, such as the WU Medical Center or WU School of Medicine logo, the principal investigator, the purpose of the research, and the nature of the RP's participation. In addition to the consent form, RPs received a genetic research information brochure (brochure) to review and sign. At the time of the district court's permanent injunction hearing in this case, more than 30,000 RPs were enrolled in WU prostate cancer research studies. About 2,500 to 3,000 RPs had been patients of Dr. Catalona. In early 2003, Dr. Catalona accepted a faculty position at Northwestern University in Chicago, Illinois. Given his plan to continue genetic research in the area of prostate cancer, Dr. Catalona sent a letter in February 2003 to his patients, their relatives, and other individuals who had served as RPs informing them of his departure from WU and requesting transfer of biological materials. Attached to the letter was a "Medical Consent & Authorization" form (release form). Approximately 6,000 RPs returned completed release forms to Dr. Catalona.
On August 4, 2003, WU filed a declaratory judgment action against Dr. Catalona, seeking to establish WU's ownership of the Biorepository and the biological materials contained therein. Dr. Catalona counterclaimed and sought a declaration that the RPs have the right to direct the transfer of their biological samples to him. In January 2004, WU moved for summary judgment. On June 8, 2004, after filing several extensions to respond to WU's summary judgment motion, Dr. Catalona moved for an order prohibiting WU from utilizing, disseminating, transferring, or destroying the genetic material at issue. The district court temporarily granted the motion. WU then moved to set aside the district court's order, arguing Dr. Catalona was truly seeking a preliminary injunction. The district court agreed, withdrew its June 9, 2004, order and converted Dr. Catalona's motion to a motion for a preliminary injunction. Following a three-day hearing on the permanent injunction, the district court found (1) WU was the owner of the biological samples housed in the Biorepository, (2) neither Dr. Catalona nor any RP in connection with any research protocols conducted under the auspices of WU had any ownership or proprietary interest in the biological samples in question, and (3) none of the release forms authored by Dr. Catalona and signed by any RP were effective to transfer ownership or possession of the biological samples to Dr. Catalona or to any other research facility or individual. Therefore, the district court granted WU's motion for summary judgment and denied Dr. Catalona's motion to enjoin WU's use of the biological samples.
Do the RPs retain an ownership interest in their biological samples which allow them to direct or authorize the transfer of such materials to a third party?
Re: first element — The circumstances surrounding the RPs' decisions to participate in genetic cancer research demonstrated the status of the RPs as donors and their intent to make gifts of their biological materials to WU's medical research activities. Before participating in WU's research activities, each RP was required to read and sign the consent form, which bore WU's logo and characterized the RP's participation as a "donation" of bodily tissues or blood. The consent form emphasized the voluntariness of the RP's participation and discussed the RP's right to decline participation in the study or to withdraw consent at any time. Although some RPs were Dr. Catalona's patients, many other RPs were patients of different WU doctors and participated in research studies designating someone other than Dr. Catalona as the principal investigator. Even the consent forms designating Dr. Catalona as the study's principal investigator invited RPs "to participate in a research study conducted by Dr. William J. Catalona and/or colleagues." (emphasis added). The consent forms also advised RPs their biological samples "may be used for research with our collaborators at [WU], other institutions, or companies." The court’s conclusion the RPs intended to make gifts of their biological samples at the time of their donation was bolstered further by the language of the brochure, which characterized the RPs' donations as "a free and generous gift of [biological materials] to research that may benefit society." The brochure's acknowledgment that donated materials may be shared with non-WU researchers, without any further authorization needed from the RPs, informed the RPs they would relinquish or abandon the right to designate the particular destination of their biological materials upon agreeing to participate in a medical research study. Such language, considered together with the consent form, cannot reasonably be characterized as reflecting the RPs' intention either to entrust their samples solely to Dr. Catalona or to transfer the samples in some legal form other than a gift.
Re: third element —WU accepted and retained absolute possession of the biological materials immediately upon donation. Although Missouri law generally prohibits a donor from revoking a completed inter vivos gift once the gift is delivered to and accepted by the donee, an inter vivos gift nevertheless may be subject to a condition allowing the donor to exercise a particular revocation right in the future. The attachment of a condition to a charitable donation of property does not negate or void an otherwise valid inter vivos gift. Indeed, as WU pointed out, a contrary rule would make many charitable donations wholly impossible or ineffectual. In this case, the signed consent forms and the brochure delineated the specific and limited recourse placed upon each RP's donation of biological materials should an RP change his mind about participating in the medical research: namely, the right to revoke voluntary participation in or consent to the research study, and, in some of the consent forms, the right to request destruction of the donated biological materials. Under the terms of the consent forms and brochures, the RP's participation in genetic cancer research included answering questions about the RP's family history of cancer, having blood drawn, and allowing excised tissue and blood samples to be sent to a laboratory and used for research at WU or other institutions. Additionally, should an RP experience a change of heart about participating in genetic cancer research, the RP was entitled to request his biological materials no longer be used, and under the terms of the brochures (and some of the consent forms as well), the materials would be identified and destroyed upon request. Viewing these provisions in their entirety, it was evident the RPs did not retain the right to revoke and physically repossess the donated biological materials. Nor did the RPs retain the right to direct or authorize the use, transfer, or destination of the biological materials after their donation. The RPs' subsequent rights to their biological materials were expressly limited to the option to discontinue participation in the study to avoid answering additional questions, donating more biological materials, or allowing their biological materials to be used for further research. Beyond these particular and limited rights, the RPs retained no greater interest with regard to their biological materials. Such rights cannot be equated with or interpreted to include the broad privileges or proprietary interests advocated by the defendants.
Dr. Catalona's past conduct, as well as the practical consequences of the research process itself, also refuted the defendants' position. While at WU, Dr. Catalona signed numerous material transfer agreements (MTAs) and research agreements acknowledging WU's ownership of the biological materials. Moreover, during Dr. Catalona's tenure, he routinely ordered the destruction or "purging" of Biorepository samples in order to create more storage space, and did so without obtaining any additional consent from RPs. Dr. Catalona's habitual destruction of samples, in a manner consistent with apparent indifference to any proprietary interest of the donors, was at odds with his later assertion the RPs own the biological materials. Furthermore, during research involving the use of prostate tissue and blood samples, the research process might consume an entire particular biological specimen, leaving behind no tangible material in which a donor could assert a potential proprietary interest. It was difficult to reconcile the use, consumption, and destruction of biological materials by Dr. Catalona and the events that occurred during the research process with the assertion the RPs retained an ownership interest in the donated materials.