Washington Univ. v. William J. Catalona

United States Court of Appeals
FOR THE EIGHTH CIRCUIT
___________
No. 06-2286
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Washington University, *
*
Appellee, *
*
v. *
*
William J. Catalona, M.D., *
*
Appellant. *
___________
Appeals from the United States
No. 06-2301 District Court for the
___________ Eastern District of Missouri.
Washington University, *
*
Appellee, *
*
v. *
*
Richard N. Ward; Thomas A. McGurk, *
Jr.; Luis Garcia; Antonio Castro; Philip *
Wilard; Ivan Parron; James D. Ellis; *
Mike Missios, *
*
Appellants. *
______________________
Us Too International; People’s *
Medical Society, *
*
Amici on Behalf of *
Appellants, *
*
American Cancer Society; Cornell *
University; Duke University; Emory *
University; The George Washington *
University; Johns Hopkins University; *
Mayo Clinic; The Board of Trustees of *
the Leland Stanford Junior University; *
The University of Michigan; University *
of Minnesota; The University of *
Pittsburgh; The University of *
Rochester; American Council on *
Education; Association of American *
Medical Colleges; Association of *
American Universities, *
*
Amici on Behalf of *
Appellee. *
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Submitted: December 13, 2006
Filed: June 20, 2007
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Before WOLLMAN, RILEY, and SHEPHERD, Circuit Judges.
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RILEY, Circuit Judge.
We are asked to determine the ownership of biological materials contributed by
individuals for the purpose of genetic cancer research and currently housed on the
campus of Washington University (WU). WU brought a declaratory judgment action
against Dr. William Catalona (Dr. Catalona), a former WU medical school faculty
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member, seeking to establish WU’s ownership of the research biological materials.
Dr. Catalona counterclaimed, seeking a declaration the contributing individuals could
direct the transfer of their biological materials to him. Dr. Catalona also moved for
an order prohibiting WU from utilizing, disseminating, transferring, or destroying the
biological materials at issue. The district court1 concluded WU owns the biological
materials and neither Dr. Catalona nor any contributing individual has any ownership
or proprietary interest in the disputed biological materials. These appeals followed.
We affirm.
I. BACKGROUND
WU, a prominent private research university located in St. Louis, Missouri,
houses its own medical school, including a Division of Urologic Surgery (Division).
Within the Division, WU physicians treat patients, teach students and residents, and
conduct medical research on urologic diseases such as prostate cancer. Dr. 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.
Dr. Catalona was instrumental in establishing the GU2 Biorepository
(Biorepository), the world’s largest storage facility for biological samples collected
by Dr. Catalona and other WU physicians for prostate cancer research. The
1
The Honorable Stephen N. Limbaugh, United States District Judge for the
Eastern District of Missouri.
2
“GU” is an abbreviation for genito-urinary.
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Biorepository is housed in one or more buildings owned by WU. WU provides the
majority of funding necessary to support the maintenance and operation of the
Biorepository. Additional funding is provided by public and private grants payable
to and administered by WU as the “grantee.” While employed by WU, Dr. Catalona
raised several million dollars in outside funding for the Biorepository. Other WU
employees, including Dr. Catalona’s successor as Division Chief, also have raised a
substantial amount of funds.
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,” a term designating the person “in charge
of conducting the research protocol.” Regardless of the physician designated as
principal investigator on a particular research study, the named principal investigator
generally collaborated with several other individuals in the research studies.
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.3 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.
The consent forms often used the term “donation” to describe the biological
sample’s transfer from the RP to a WU physician or medical technician. The forms
also noted biological samples “may be used for research with our collaborators at
[WU], other institutions, or companies.” The consent forms typically provided that
3
Fifteen versions of the consent forms, used for six different research studies,
were admitted into evidence before the district court.
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by participating in the study, the RP “agree[s] to waive any claim [he] might have to
the body tissues that [he] donate[s]” and also “waive[s] the right to any new material
or process developed through research involving [his] tissues.” RPs also were
informed by the consent forms, “Your participation is voluntary and you may choose
not to participate in this research study or withdraw your consent at any time.” Some
consent forms indicated RPs could request destruction of their biological materials if
they changed their minds about participating in the study, but noted it would not be
possible to destroy or recall any research results already obtained. Other consent
forms made no mention about an RP’s right to request destruction of materials
donated to research.4
In addition to the consent form, RPs received a genetic research information
brochure (brochure) to review and sign. The brochure provided RPs’ tissue samples
(1) will be used by “[WU] Medical Center researchers,” (2) “may be shared with other
authorized researchers doing research in similar fields at [WU] and other research
centers,” and (3) “may be used for studies currently in progress or studies conducted
10 or 20 years from now.” Similar to the consent forms, the brochure used the term
“donation” to describe the RP’s participation, noting, “By agreeing to participate, you
are making a free and generous gift of your tissue to research that may benefit
society.” The brochure advised RPs, “You will receive no monetary payment for your
tissue nor can you claim ownership rights to any medical or scientific product that
results from research with your tissue.” The brochure also informed RPs of their right
to have their biological materials destroyed upon request should they change their
minds about participating in the research study.
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. The Biorepository contains:
(1) approximately 3,500 prostate tissue samples taken from patients of Dr. Catalona
4
Forms signed by seven of the eight defendant-patients fall within this category.
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and other WU physicians within the Division; (2) about 100,000 blood or serum
samples donated by over 28,000 men, 75% of whom were not patients of any WU
physician, but rather were volunteers recruited through the media; and (3) DNA
samples provided by approximately 4,400 men, which included patients of different
WU physicians and relatives of those patients.
Over the years, other research institutions requested and received biological
samples from the Biorepository to conduct genetic cancer research projects either in
partnership with or independent of WU. While at WU, Dr. Catalona repeatedly
transferred Biorepository materials to other research institutions pursuant to material
transfer agreements (MTAs). The MTAs typically were signed by an authorized WU
official as well as a providing investigator. Several MTAs personally signed by Dr.
Catalona, as the principal or providing investigator, acknowledge WU as the owner
of the biological samples.
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). In addition,
both the letter and release form were printed in a newsletter from the Urological
Research Foundation, for which Dr. Catalona served as the medical director. Dr.
Catalona estimated between 50,000 and 60,000 individuals received the letter and
release form. Although Dr. Catalona was still a WU employee at the time he sent the
letter and release form, Dr. Catalona was no longer the principal investigator on any
of the research protocols involving biological samples he sought to have transferred
to Northwestern University. Neither the letter nor the release form were approved by
any WU administrators or WU’s institutional review board. The letter discussed,
among other things, Dr. Catalona’s availability for treatment, his continuation of
prostate cancer research, and his need for the tissue and blood samples “contributed
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to [him] over the years.” In connection with Dr. Catalona’s stated necessity, the letter
requested the recipient sign and return to Dr. Catalona the attached release form,
which set forth the following language:
I have donated a tissue and/or blood sample for Dr. William J.
Catalona’s research studies. Please release all of my samples to Dr.
Catalona at Northwestern University upon his request. I have entrusted
these samples to Dr. Catalona to be used only at his direction and with
his express consent for research projects.
Approximately 6,000 RPs returned completed release forms to Dr. Catalona.
A. Procedural Background
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 following day–and before WU could
respond–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, converted Dr.
Catalona’s motion to a motion for a preliminary injunction, and set the motion for
hearing.
On February 11, 2005, in an effort to resolve continuing disputes between the
parties on the priority of the pending motions, the district court, sua sponte, ordered
a permanent injunction hearing for April 11, 2005. On February 22, 2005, eight of Dr.
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Catalona’s patients who served as RPs,5 sought to intervene in support of Dr.
Catalona. Upon finding the eight men were necessary parties to the litigation, the
district court ordered they be joined as defendants.
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.
Wash. Univ. v. Catalona, 437 F. Supp. 2d 985, 1002 (E.D. Mo. 2006). 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. This appeal followed.
II. DISCUSSION
A. Standards of Review
Because the district court’s finding that WU owns the biological samples
resolved all issues in the case, we have jurisdiction under 28 U.S.C. § 1291 to review
the defendants’ appeal from a final decision of the district court. We review de novo
the district court’s grant of summary judgment. See Burlington N. & Santa Fe Ry. Co.
v. State Tax Comm’n, 188 F.3d 1039, 1041 (8th Cir. 1999). We may affirm a grant
of summary judgment on any ground supported by the record. See P & O Nedlloyd,
Ltd. v. Sanderson Farms, Inc., 462 F.3d 1015, 1018 (8th Cir. 2006). We review the
district court’s denial of injunctive relief for an abuse of discretion. See Int’l Ass’n
of Machinists & Aerospace Workers, Dist. Lodge No. 19 v. Soo Line R. Co., 850 F.2d
368, 374 (8th Cir. 1988) (en banc). An abuse of discretion occurs if the district court
bases its decision on an erroneous application of the law or a clearly erroneous factual
5
The men included Richard N. Ward; Thomas A. McGurk, Jr.; Luis Garcia;
Antonio Castro; Phillip Wilard; Ivan Parron; James D. Ellis; and Michael Missios.
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finding. See Taylor Corp. v. Four Seasons Greetings, LLC, 403 F.3d 958, 967 (8th
Cir. 2005).
B. Ownership of the Biological Materials
We now turn our attention to the pivotal inquiry in this dispute: whether
individuals who make an informed decision to contribute their biological materials
voluntarily to a particular research institution for the purpose of medical research
retain an ownership interest allowing the individuals to direct or authorize the transfer
of such materials to a third party. Under the facts of this case, the answer is no.
In deeming WU the owner of the biological samples, the district court found all
RPs donated their biological materials to WU as inter vivos gifts.6 Wash. Univ., 437
F. Supp. 2d at 999. In addressing this issue, we look to the substantive law of
Missouri, which 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.” Pilkington v. Wheat, 51 S.W.2d 42, 44 (Mo. 1932); see,
e.g., Wills v. Whitlock, 139 S.W.3d 643, 653 (Mo. Ct. App. 2004). As the party
claiming the existence of an inter vivos gift, WU 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. See Clippard
v. Pfefferkorn, 168 S.W.3d 616, 618 (Mo. Ct. App. 2005). The RPs unquestionably
delivered their biological materials to WU at the time of their donation; thus, we focus
our inquiry on the first and third elements.
6
Whether the RPs made inter vivos gifts is a state law question of fact. See
Estate of Thompson v. Hicks, 148 S.W.3d 32, 36 (Mo. Ct. App. 2004). We review
de novo the district court’s interpretation of state law. See Protective Life Ins. Co. v.
Jim Orr & Assoc., Inc., 384 F.3d 949, 950 (8th Cir. 2004).
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With regard to the first element, we assess the donor’s intent by examining
whether a gift was intended at the time of the transaction. No specific language is
required to reflect the donor’s present intent to make a gift; in fact, the circumstances
surrounding the contribution may create an inference the donor intended to make a
valid inter vivos gift. See Duvall v. Henke, 749 S.W.2d 714, 716 (Mo. Ct. App.
1988). However, the donor must intend “to part with his right in and dominion over
the property immediately and irrevocably.” Ridenour v. Duncan, 246 S.W.2d 765,
769 (Mo. 1952). Here, the circumstances surrounding the RPs’ decisions to
participate in genetic cancer research demonstrate 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.”
Our conclusion the RPs intended to make gifts of their biological samples at the
time of their donation is 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
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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.
With regard to the third element–acceptance of the gift by the donee–the
defendants contend the RPs retained significant rights in the donated materials, and
thus the transfer of materials to WU could not have been absolute. We disagree. 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. See Clippard, 168 S.W.3d at 619;
see, e.g., Franklin v. Moss, 101 S.W.2d 711, 714 (Mo. 1937). The attachment of a
condition to a charitable donation of property does not negate or void an otherwise
valid inter vivos gift. See 14 C.J.S. Charities § 34 (2006) (recognizing “the
disposition of property for charitable purposes . . . can be in the form of an absolute
transfer subject to conditions”). Indeed, as WU points out, a contrary rule would
make many charitable donations wholly impossible or ineffectual. In this case, the
signed consent forms and the brochure delineate 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 includes 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
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research, the RP is 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 is 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.7
Dr. Catalona’s past conduct, as well as the practical consequences of the
research process itself, also refutes the defendants’ position. While at WU, Dr.
Catalona signed numerous 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, is at odds with his later
7
Because the specific language contained in the consent forms and brochures,
as well as the circumstances surrounding the RPs’ voluntary decision to donate their
biological materials, convinces us the RPs intended to make inter vivos gifts of their
materials, we find it unnecessary to address the effect or validity of the consent forms’
waiver language (“By agreeing to participate in this study, you agree to waive any
claim you might have to the body tissues that you donate.”).
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assertion the RPs own the biological materials.8 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 is 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.
Noticeably absent from the record is any mention the RPs ever were informed
they could physically withdraw or request the return of their biological samples.
Indeed, in no event could the samples physically be returned to their donors. Federal
and state regulations prohibit such a result by defining excised body tissue and blood
as hazardous substances or infectious waste, and by articulating the proper disposal
method. See 29 C.F.R. § 1910.1030; Mo. Rev. Stat. §§ 260.200.1(17), 260.203. Nor
could RPs who were surgical patients reasonably have anticipated they had any right
to have excised materials returned to them following surgery, because before
undergoing surgical procedures, patients were required to sign standard surgical
consent forms acknowledging that tissues removed during surgery and not used for
clinical purposes would be destroyed as hazardous medical waste. Also absent from
the record is any indication the RPs ever were informed they had the ability to direct
the transfer of their samples to another entity for research purposes. Based on the
record before us, we conclude WU’s acceptance of the donated biological materials
was absolute.
8
Dr. Catalona’s privileges to and treatment of biological samples while at WU
comports with the terms of WU’s Intellectual Property Policy, which provides “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.” (emphasis added).
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Thus, the district court properly concluded the RPs made informed and
voluntary decisions to participate in genetic cancer research, and thereby donated their
biological materials to WU as valid inter vivos gifts.9 This voluntary transfer of tissue
and blood samples to WU–without any consideration or compensation as an incentive
for doing so–demonstrates WU owns the biological samples currently housed in the
Biorepository. Whatever rights or interests the RPs retained following their donation
of biological materials, the right to direct or authorize the transfer of their biological
materials from WU to another entity was not one of them. Thus, the release forms
authored by Dr. Catalona and signed by approximately 6,000 RPs are ineffective to
transfer possession of biological samples housed in the Biorepository to another
entity. Given WU’s ownership of the biological materials, the district court neither
abused its discretion in denying Dr. Catalona’s motion for injunctive relief, nor erred
in granting summary judgment in WU’s favor.
III. CONCLUSION
For the foregoing reasons, we affirm the well-reasoned opinion and judgment
of the district court.
______________________________
9
Given our conclusion the RPs made inter vivos gifts to WU, it is unnecessary
for us to address, in detail, whether the RPs are entitled to control the disposition of
their biological materials under the law of implied bailments. However, in our view,
the district court correctly rejected this argument as unavailing.
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