Dr. Catalona’s Views and Conclusions

Litigation Update

The legal battle lasting nearly 5 years between Washington University (WU) and Dr. William Catalona over ownership of blood and tissue samples has now come to an end at the U.S. Supreme Court when

Dr. Catalona, who joined the WU faculty in 1976, relocated to Northwestern in 2003. He had begun collecting the samples at WU in 1983. WU sued him after he sought to transfer samples from 6,000 men who had given him approval to transfer their samples to a biorepository at Northwestern.

Dr. Catalona explained, “These samples are important for my research into the causes of prostate cancer and our quest to develop better methods of detection, diagnosis, prognosis, treatment, and even prevention. The samples at WU were of particular value to me because I had solicited them from family members of men with prostate cancer, not from just the men themselves. I left WU hoping to take the samples with me. It is not unusual for researchers to take their research materials when

The Federal District Court in St. Louis ruled that, in the context of Missouri property law, WU owns the samples. The Court decided that the patients had gifted their samples to the WU. The opinion stated that once the patients had provided their samples, their ownership ended. Moreover, it considered their right to withdraw from research amounted to no more than the right not to provide more samples in the future.

“Not so.” said Dr. Catalona and the patients, who appealed the ruling, arguing that (1) the patients did not intend to gift their samples to WU, (2) federal regulations prohibit the language in WU’s consent forms that state they waived their rights, and (3) patients always retained their right to effectively withdraw from the research. Nevertheless, the Court of Appeals upheld the lower court’s ruling, although it acknowledged the patients’ right under federal regulations to request the destruction of their samples.

In fact, all patients who testified in court stated they wanted to have Dr. Catalona continue his research with their samples at Northwestern. Disregarding their testimony, the Courts relied on the language in WU’s consent forms to determine their intent. This language characterized the patient’s samples as a “donation” of bodily tissues and blood. Other language characterized the transfer of their tissue as a “free and voluntary gift.” But the presence of such language in research consent forms suggesting that the patients are giving up their property rights to their tissues is prohibited by federal regulations.

The Court of Appeals claimed it was not necessary for them to consider the argument about the federal government’s prohibition of so-called “exculpatory” waiver language in consent forms because the patients had already shown by the language in the same consent forms that the transfers of their samples were free and voluntary. Dr. Catalona and the patients viewed this as a “Catch 22,” i.e., the Courts had relied upon forbidden language in the consent forms to say they had waived their rights to their samples and to conclude that they had gifted their samples to WU.

In fact, the Office for Human Research Protections (OHRP), the federal regulatory enforcement body, provides research institutions with a guidance document about the interpretation of federal regulations. This document contains specific examples of “exculpatory language” that is not allowed in informed consent documents. One example is: “By consenting 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 research” – i.e., almost exactly the language that appeared in the WU consent forms.

Although 6,000 patients had sent written requests to transfer their samples to Dr. Catalona, the District Court held that the number who could testify at the hearing was limited. The three patients who testified were Richard N. Ward, Thomas A. McGurk, Jr., and James D. Ellis. Each testified that he provided his samples for Dr. Catalona’s research and that he wanted Dr. Catalona to continue using his samples. All testified specifically that they did not intend to make an irrevocable gift to WU and that they were never told that WU would own their samples. Representative excerpts of their testimony are illuminating:

Mr. Ward answered his attorney’s question: “Were you ever told that Washington University could do whatever it wanted with your sample?”

“Well, it is my understanding, and that's why I'm here today, that's pretty much their position, and that's why I got involved. That, frankly, I was offended by that. I entered into this research project; I consented to it with Doctor Catalona; and no time did I transfer ownership to Washington University or to anyone else – Doctor Catalona or Washington University – and when I found out that they took the position that they owned my body parts, my tissue, I wanted to get involved.”

Mr. Ellis answered his attorney’s question: “Was it your understanding that the research that was being done for which you would be a participant was being headed by Doctor Catalona?” by saying, “Absolutely. I understood at that time, and still do, that I was agreeing to participate in one of his [Dr. Catalona’s] research projects, it was personal to him and that it was part of the ongoing research that he had into finding a cure for prostate cancer.”

Mr. McGurk answered his attorney’s question, “Did you intend for Washington University to own the tissue sample that was taken from you by Doctor Catalona?” by saying, “No, my intent was for him [Dr. Catalona] to use it for research to – hopefully, along with his colleagues, find a cure for prostate cancer.”

Then, Mr. Douglas King, an attorney for WU, who conducted their cross-examination, focused on the language in WU’s consent forms. He asked Mr. Ward and Mr. McGurk whether they signed a form that said: "By agreeing to participate in this study, you agree to waive any claim you might have to the body tissues you donate." They indicated that they had signed the form. Mr. King then brought out the fact that Mr. Ellis’s form contained the word “donate.” Thus, was the language that never should have been in the consent forms used to strip the patients of their ownership rights.

The official opinion of the District Court stated, “The forms spoke of “donation” and at least two (2) forms (Ward and McGurk) referenced a waiver of any claim to the excised body tissues. Since Ward, Ellis, and McGurk were presumably testifying on behalf of the eight (8) patients who joined the case, and reflect the opinion of all RPs (research participants) who signed Dr. Catalona’s “consent to transfer” form, the Court finds that all RPs who donated biological materials to the GU Repository, whether or not patients of Dr. Catalona, donated such materials with the present intent of making an inter vivos gift to WU. “

Dr. Catalona and the patients believe the lower courts erred. "The lower courts have not properly considered the federal issue. The district court incorrectly considered the patients’ guaranteed right to withdraw from research to be only the right not to provide any more samples in the future," Catalona said. "The appellate court ignored the federal issue except to state that patients had the right to withdraw their samples from research or order them destroyed, but they decided the case on the state property issue. Ignoring the fact that federal regulations prohibit patients from giving up any rights, the appellate court found that they gave up all their property rights in their tissues!"

Dr. Catalona added, "Given that the Constitution states that federal law and regulations trump state law, how would you reconcile these issues? And how would you explain that if a person wanted to provide a sample to be used for prostate cancer research only, as soon as the sample was obtained, the university owns it and can do whatever it wants with it. The patient's only way of ensuring that the sample would be used for the type of research desired would be not to provide the sample in the first place. How do you reconcile that intractable choice for research participants?"

This litigation has made the research compliance community jittery, particularly over the issues of informed consent, what the rights of research subjects really are, and how state laws mesh with federal regulations governing the rights of human research subjects.

On October 18, 2007, Dr.Catalona and the patients filed separate writs to the US Supreme Court, and US TOO International, the world’s largest prostate cancer patient support group, filed a "friend of the court brief" on his behalf on November 18, 2007.

Then, as the Supreme Court reviewed the legal briefs, on November 29, 2008, after reviewing the lower Courts’ decisions, the Office for Human Research Protection sent a letter to WU, instructing it to remove all exculpatory language from their consent forms. An excerpt from that letter follows:

“OHRP recognizes the possibility that individuals may have certain legal rights in their excised tissue or other human biological materials, even the absence of a specific recognition or an affirmative establishment of any such legal rights in these materials by the relevant legal body of a particular jurisdiction. Therefore, except in jurisdictions in which it has been conclusively determined that all research subjects have no legal rights in their excised human biological material, OHRP continues to find language that waives any such legal rights on the part of research subjects to be exculpatory. We believe that, to date, no jurisdictions have conclusively determined that all human subjects have no legal rights in their excised biological material that is used for research purposes.”

“Please ensure that any such language is removed from informed consent documents currently used at Washington University for human subjects research conducted under the University’s Federalwide Assurance with OHRP.”(The OHRP letter to WU can be viewed in its entirety on Dr. Catalona’s website.)

The ironic result of this case is that the OHRP weighed in too late. The basis of the lower Courts’ decision (i.e., prohibited language in consent forms) used against 6,000 patients to presume their donative intent must now be removed from all future WU consent forms. But, unfortunately, the decision that relied on the self-same consent forms stands! Thus is “The Law.”

Now, WU has attained outright ownership of the samples of 6000 patients – samples that contain highly personal information about them and their relatives that potentially could greatly benefit or harm them in the future. WU could now sell the samples, license them other institutions or companies, or use them for research that these men might find objectionable.

With advances in biomedical technology, the potential for research samples to benefit or harm patients has increased dramatically. And the availability of frozen tumor samples currently does affect, and in the future will increasingly affect, treatment choices. If the samples are sold off or consumed in other research, the 6,000 patients and their families could be compromised. And if their genetic information is published, they and their relatives could face discrimination for employment, insurance and in other ways.

“This case has turned the ethics of human research upside down,” Dr. Catalona said. “What was at stake in this case is that, as testified in court by medical ethicist, Dr. Ellen Wright Clayton, it eviscerates the rights of research participants guaranteed under federal regulations to effectively change their mind about participating in research involving their tissues and renders meaningless the federal regulations prohibiting the use of forbidden language that forces patients to give up their rights to participate in research.”

When asked about the Supreme Court’s denial of reviewing the case, Dr. Catalona remarked, “It’s a shame that that the Supreme Court did not weigh in on this case and even more shameful that the courts have failed to enforced the federal regulations promulgated to protect research participants. It makes a travesty of the federal regulations, if Washington University can flout them, and the courts will not enforce them. Hopefully, neither Washington University, nor any other university, will be able to get away with anything like this again.”

Dr. Catalona continued, “Not only is it an injustice to the patients, but also it defies logic. The federal regulations are completely clear that, in agreeing to participate in research, patients cannot waive their property rights to their tissues.  The regulations are crystal clear that a university cannot accept a sample for research without a signed consent form. The regulations further require, and the OHRP now strongly re-affirms, that informed consents cannot contain language suggesting that patients are waiving any rights. The consents also must assure patients control of their samples to the extent that, if they change their mind, they can effectively withdraw from research. WU claimed in court that if the patients want to withdraw from research, the University could, at its sole discretion, destroy their samples, put them on the shelf and not use them, or de-identify them and use them for any research purpose they deemed appropriate. That’s too much discretion, in my view.”

Dr. Catalona pointed out that, although WU is regulated by the OHRP and by its own Institutional Review Board, he believes that that both fell short on their oversight by allowing forbidden language in their consent forms and brochures. “If the federal regulations would have been enforced, Washington University would not have been able to acquire ownership. Even under the present circumstances, the courts should have acknowledged that the federal regulations are at odds with the finding that the patients had gifted their samples.”

Dr. Catalona continued, “I think it should have been properly within the domain of the Supreme Court to review this important issue, since both the OHRP and Washington University’s Institutional Review Board let the University get by with exculpatory language in their research documents. If the research participants cannot rely on OHRP, IRB, or the courts for protection, where can they turn?”

“All human subject researchers are required to take courses and pass examinations about protecting patients' rights before they are allowed to conduct research.  One of the key fundamental ethical issues that they address is that patients should have the autonomy to make decisions about whether or not they want to participate in research. Researchers and their institutions must respect these rights and honor the patients’ wishes. Researchers cannot perform research upon patients without the patient’s consent, and the patients should decide how their tissues can be used in research and by whom. How will the outcome of this case be reconciled with those ethical teachings?”

When asked about the other institutions that supported WU in this case, Dr. Catalona remarked, “All of these institutions, including the American Cancer Society, have a financial stake in large research sample repositories, or represent institutions that have them; therefore, they all have a conflict of interest. It doesn’t surprise me that they would all want to be declared “owner’ of the samples. However, the National Institutes of Health guidelines consider biorepositories the “custodians” of the samples, not the “owners.”

“It is telling,” Dr. Catalona concluded, “that WU attorneys and attorneys for some institutions that supported them are now publicly advising other universities to consider drafting their informed consent documents in such a way that their respective state laws also might find a research sample a gift. This speaks volumes about where patient’s rights stand in relation to their own financial interests.”

In an Author’s Note to his book, Next, Michael Crichton (M.D. from Harvard Medical School) states,

“Human tissue collections are increasingly important to medical research and increasingly valuable. Appropriate federal regulations to manage tissue banks already exist, but courts have ignored federal rules. Historically, the courts have decided questions about human tissues based on existing property law. In general, they have ruled that once your tissue leaves your body, you no longer maintain any rights to it…” “But people have a strong feeling of ownership about their bodies, and that feeling will never be abrogated by a mere legal technicality. Therefore we need new clear, emphatic legislation.”

“Why do we need legislation? Consider a recent court ruling on the case of Dr. William Catalona. This eminent prostate cancer physician assembled a collection of tissue samples from his patients so he could work on the disease. When Dr. Catalona moved to another university, he tried to take the tissues with him. Washington University refused, saying that it owned the tissues; the judge upheld the university, citing such trivial facts as some of the releases’ being printed on Washington University stationery. Patients are now understandably outraged. They believed they were giving their tissues to a beloved doctor, not a shadowy university lurking in the background; they thought they were giving tissues specifically for prostate cancer research, not for any use, which the university now claims the right to do.”

“The notion that once you part with your tissue you no longer have any rights is absurd…”

“The required legislation should ensure that patients have control over their tissues. I donate my tissues for a purpose and that purpose only. If, later, someone wants to use them for another purpose, they need my permission again. If they can’t get my permission, they can’t use my tissues….”

“We should not fear that such regulations will inhibit research. After all, the National Institutes of Health seems to be able to conduct research while following the guidelines…”