Who Owns Your Body? A Patient's Perspective on Washington University v. Catalona

Scott R. , The Body as Property (New York: Viking Press, 1981): 185–86.

See Colavito v. New York Organ Donor Network, Inc. , 356 F.Supp.2d 237, 245 (E.D.N.Y. 2005) (“All fifty states have adopted either the 1968 or the 1987 Uniform Anatomical Gift Act in some form”). See, e.g., N.Y. Public Health Law Article 43; Cal.Health & Safety Code § 7100 et seq.

45 C.F.R. § 46.116(a)(8).

Washington University v. Catalona, Case No. 4-03-CV 010655NL. Quotes in this article are to documents filed in the case and the transcript of the hearing in the case.

For information about Catalona William Dr. , see <http://www.drcatalona.com/catalona_bio.asp> (last visited February 17, 2006); see also Scherzer A. , “Gala Honors Cancer Fight,” St. Petersburg Times, November 4, 2005 (“Catalona led national studies to win FDA approval for a blood test to screen for prostate cancer”); Thompson I. , “Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level less than 4.0 ng per Milliliter,” New Eng. J. Med. 350 (2004): 2239–46, at 2239.

Press Release, “Beckman Coulter, FDA Approves New ‘Free PSA’ Blood Test to Aid in Battle against Prostate Cancer” (March 1998), at <http://www.beckman.com/products/applications/diseasemgmt/pdf/FDAapproval.pdf> (last visited February 17, 2006).

Sirovich B. E. , “Screening Men for Prostate and Colorectal Cancer in the United States,” JAMA 289 (2003): 1414, 1417.

E-mail from Kratochvil Jon , Business Development Director, November 27, 2001 (read into the record, Tr. 3:33 (April 13, 2005)).

Washington Univ. v. Catalona , Tr 1:26 (April 11, 2005).

Complaint at 16–17 (on record with the author).

Complaint at para. 14 and para. 53 (on record with the author).

Technically, the plaintiffs are thus considered to be defendants, although Washington University is not asserting a claim against them per se.

Washington Univ. v. Catalona , Tr. 1:24 (April 11, 2005).

Washington Univ. v. Catalona , Tr. 1:24 (April 11, 2005).

Washington Univ. v. Catalona , Tr. 1:64 (April 11, 2005) (testimony of Dr. Catalona).

Washington Univ. v. Catalona , Tr. 1:64 (April 11, 2005) (testimony of Dr. Catalona).

Moore v. Regents of University of California , 793 P.2d 479 (Cal. 1990).

Oesterle D. A. , “The Sale of Human Body Parts,” Michigan Law Review 72 (1974): 1182–1243.

Dickens B. , “The Control of Living Body Materials,” University of Toronto Law Journal 27 (1977): 142–164.

Regina v. Kelly and Another , 3 All ER 741 (Court of Appeals, Criminal Division, 1998). For a discussion of the case, see Andrews L. and Nelkin D. , Body Bazaar: The Market for Human Tissue in the Biotechnology Age (New York: Crown Publishers, 2001).

Moore v. Regents of University of California , 793 P.2d 479 (Cal. 1990).

Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003).

See Moore , supra note 20; Greenberg , supra note 21.

See Moore , supra note 20, at 491.

Id., at 493.

Hecht v. Superior Court of Los Angeles County , 16 Cal. App. 4th 836, 846, (Cal. Ct. App. 1993).

York v. Jones , 717 F. Supp. 421, 426 (E.D. Va. 1989) (finding that a couple can have a property interest in their pre-zygote that limits a clinic's rights as bailee); Hecht v. Superior Court of Los Angeles County, 16 Cal. App. 4th 836, 850 (Cal. Ct. App. 1993) (holding that sperm is property to be distributed by decedent's estate); Whaley v. County of Tuscola, 58 F. 3d 1111 (6th Cir. 1991) (next of kin have a “constitutionally protected property interest” in the dead body of a relative).

Mansaw v. Midwest Organ Bank and Truman Medical Center West , No. 90-0271-CV-W-6, 1998 U.S. Dist. LEXIS 10307 (W.D. Mo. 1998).

998 U.S. Dist. LEXIS 10307, at *16. In contrast, the state law precedent in Florida which was applied in the Greenberg case was State v. Powell, 497 So. 2d 1188 (Fla. 1986) in which “the Florida Supreme Court refused to recognize a property right in the body of another after death.” Greenberg, 264 F. Supp. 2d. at 1075.

Washington University Pre-Hearing Brief at 8–9.

See Moore , supra note 20, at 492; Hecht, supra note 26, at 847.

1998 U.S. Dist. LEXIS 10307 at *16.

Moore , supra note 20, at 141; Hecht, supra note 26, at 847.

See Washington University Supplemental Memo, at 3.

Testimony of Ward Richard , Washington Univ. v. Catalona, Tr. 2:67–68 (April 12, 2005).

Dr. William Catalona's bio, Urological Research Foundation, available at <http://www.drcatalona.com/catalona_bio.asp> (last visited February 17, 2006).

Testimony of Ellis James , Washington Univ. v. Catalona, Tr. 1:168–69 (April 11, 2005) (on file with the author).

Plaintiff's Post-Trial Brief, at 13 (stating that “the consent forms they signed typically bore the WU Medical Center logo” as evidence of ownership).

Plaintiff's Proposed Findings of Fact and Conclusions of Law, at 16 (“The research participants intended to donate their prostate tissue and blood samples to Washington University for medical research”).

“Possession of property alone and without explanation is evidence of ownership; but it is the lowest species of evidence. It is merely presumptive, and liable to be overcome by any evidence showing the character of the possession, and that it is not necessarily as owner.” Rabinof v. United States , 329 F. Supp. 830, 840 (S.D. N.Y. 1971) (quoting Manning v. Anderson Galleries, Inc., 222 N.Y.S. 572 [N.Y. Sup. Ct.1927]). Moreover, under Missouri law, patients can maintain legal possession even if another entity has physical possession. See State of Missouri v. Hughes, 1985 Mo. App. LEXIS 4270, at * 7, 702 S.W.2d 864, 867 (1986).

Testimony of Ellis James , Washington Univ. v. Catalona, Tr. 1:158–59 (April 11, 2005); Testimony of Mr. Tom McGurk, Washington Univ. v. Catalona, Tr. 1:1211 (April 11, 2005); Testimony of Mr. Richard Ward, Washington Univ. v. Catalona, Tr. 2:71 (April 12, 2005) (on file with the author).

Testimony of Catalona William Dr. , Washington Univ. v. Catalona, Tr. 1:93 (April 11, 2005).

Dahl v. Hem Pharmaceuticals , 7 F.3d 1399, 1404–5 (9th Cir. 1993) (similar informed consent forms found to be contracts and defendant's argument against such characterization found “almost frivolous”); York v. Jones, 717 F. Supp. 421, 425 (E.D. Va. 1989) (finding that the research informed consent constituted a bailment contract governed by the same principles as apply to other contracts); Perna v. Pirozzi, 457 A.2d 431, 441 (N.J. 1983) (Supreme Court of New Jersey determined that informed consent includes the right to choose the surgeon and to refuse to accept a substitute, and the substitution of one surgeon for another without the consent of the patient could be framed as a breach of contract between the surgeon and the patient).

Forms used in at least two of the studies at issue provide that “If you choose to participate in a study that uses code numbers to link participants to tissue and later change your mind, the tissue can be destroyed upon request. To withdraw your consent, call Dr. Catalona at 314-362-4241. Any research results already obtained cannot be destroyed or recalled.” The studies in this case were “linked” studies.

Testimony of Ellis James , Washington Univ. v. Catalona, Tr. 1:158, 168 (April 11, 2005).

Testimony of Clayton Ellen Wright Dr. , Washington Univ. v. Catalona, Tr. 1:125–26 (April 11, 2005).

45 C.F.R. 46.116(a)(8).

Testimony of Clayton Ellen Wright Dr. , Washington Univ. v. Catalona, Tr. 1:121–23 (April 11, 2005) (“I think the reg[ulation]s by saying that patient/participants have a right to withdraw have to include within that, in a study like this, the right to withdraw their samples and the right to withdraw their information. If it doesn't mean that, then there is no right to withdraw”).

Post Hearing Brief of Patient/Defendants at 17. Franklin v. Moss , 1937 Mo. LEXIS 484, at *11, 101 S.W.2d 711, 714 (1937).

Bredell v. Kerr , 242 Mo. 317, 329, 147 S.W. 105, 108 (1912).

Frey v. Huffstutler , 1988 Mo. App. LEXIS 525, at *11, 748 S.W.2d 59, 63 (1988).

Davidson v. Lane , 566 S.W.2d 891, 892 (Tenn. Ct. App. 1978); Stock v. Augsburg College, C1-01-1673, 2002 Minn. App. LEXIS 421, at *15–17 (Minn. Ct. App. 2002) (donor had made a conditional gift for a building with his name, not a gift to a general building fund, and was entitled to a return of the money).

Plaintiff's Pre-Hearing Brief, at 6.

Testimony of Andriole Dr. , Washington Univ. v. Catalona, Tr. 2:126 (April 12, 2005). See also Testimony of Dr. Catalona, Washington Univ. v. Catalona, Tr. 1:40–41 (April 11, 2005) (stating, “some [patients] are destined to have a recurrence…we could possibly develop [a] new treatment to delay, control or prevent the recurrence in these patients”).

Testimony of Andriole Dr. , Washington Univ. v. Catalona, Tr. 2:126 (April 12, 2005).

York , 717 F. Supp. at 425. “A ‘bailment’…imports the delivery of personal property by the bailor to the bailee who keeps the property in trust for a specific purpose, with a contract, express or implied, that the trust shall be faithfully executed, and the property returned or duly accounted for when the special purpose is accomplished or that the property shall be kept until the bailor reclaims it”(emphasis added).

Id., at 424.

Id., at 425.

Id., (citation omitted).

Id., at 426–27.

Plaintiff's Pre-Hearing Brief, at 16. However, Washington University appears to misrepresent the law of bailment in its Pre-Hearing Brief at 9–10. The cases it cites for the premise that there must be an anticipation of return for a bailment to have occurred themselves say that there can be an expectation of return or an expectation of the bailee dealing with the goods according to the bailor's direction. See Scope Enters., Ltd. V. United States , 18 Cl. Ct. 875, 884 (1989); Welding Metals, Inc. v. Foothill Capital Corp., No. 3:92CV00607, 1997 WL 289671, at *7 (D. Conn. 1997).

See, e.g., Weinberg, 1966 Mo. App. LEXIS 657, at *4–5, 402 S.W.2d at 599; D&R Distrubutors, Inc. v. Caryl, Civil Action Nos. 89-C-46, 89-C-47, and 89-C-48 (Cir. Ct. W. Va. 1992) (finding a bailment where Union Oil transferred possession of oil to D & R for delivery to the State of West Virginia with no expectation that the oil would be returned); Home Indem. Co. v. Harleysville Mut. Ins. Co., 166 S.E.2d 819, 824 (S.C. 1969) (“Bailment has been defined as the delivery of a chattel for some express or particular purpose upon a contract, express or implied, that, after the purpose has been fulfilled, then the chattel shall be redelivered to the bailor, or otherwise dealt with according to his directions”) (emphasis added).

717 F. Supp. at 425.

Id., at 426.

Plaintiff's Post-Trial Brief at 9 (“WU could choose to anonymize the samples and continue to use them in research”). However, WU's expert, Dr. Prentice, admitted that the regulations do not contemplate anonymization. Washington Univ. v. Catalona , Tr. 2: 224 (April 12, 2005) (when asked whether the regulations contemplate anonymization, Dr. Prentice answered, “No, not specifically”).

WU Post-Trial Brief, at 10 (“Currently, the samples are still linked to the participants' identities”).

See Opening Statement of Washington University Counsel, Wack , Washington Univ. v. Catalona, Tr. 1: 28 (April 11, 2005).

1998 U.S. Dist. LEXIS 10307, at *26–27.

AMA Code of Ethics 2.08, Code of Medical Ethics: Current Opinions with Annotations (Chicago: AMA, 2000).

Committee on Human Genome Diversity, Commission on Life Sciences, National Research Council, Evaluating Human Genetic Diversity 65 (Washington, DC: National Academy Press, 1997).

The guidance in its entirety reads: “No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.” 45 CFR 46.116. Examples of exculpatory language: By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances; I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items; By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research; I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. Examples of acceptable language: Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur; By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above; This hospital is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research; This hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge.” Office for Protection from Research Risks (OPRR), Cooperative Oncology Group Chairpersons Meeting, November 15, 1996, “Exculpatory Language” in Informed Consent.

Testimony of Clayton Ellen Wright Dr. , Washington Univ. v. Catalona, Tr. 1:122 (April 11, 2005) (“If [patients] understand that when or if it becomes the law that when you provide samples for research that you in fact lose all control, that you have no right to withdraw at all…it will radically undermine the research enterprise”).

Washington University v. Catalona, Tr. 1:77 (April 11, 2005).

Andrews L. and Nelkin D. , Body Bazaar: The Market For Human Tissue In The Biotechnology Age (New York: Crown Publishers, 2001) (some universities and hospitals sell access to patient's tissue to biotech companies).

Dalton R. , “When Two Tribes Go To War,” Nature 430 (2004): 500–02; Tilousi v. Arizona State Univ. Bd. of Regents, No. 04-CV-1290-PCT-FJM (March 3, 2005).