Case Law, Regulations Don’t Support Individual’s Biospecimen Ownership

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By John T. Aquino

Recent legislative and regulatory activity and a possible lawsuit concerning ownership of famous “immortal cells” used in medical research raise the question: Can an individual have an ownership right in biological material taken from his or her body?

The importance of the question was reinforced when the son of Henrietta Lacks announced he would file litigation asserting a property right and a share of the revenues obtained from research in the HeLa cell line from his late mother’s cells. A local news story on that was picked up throughout the world. The issue was also discussed in comments on the revision of the federal Common Rule for protection of human research subjects.

“I think it’s fair to say that there is not much support in existing case law for individuals retaining rights in materials that are voluntarily donated for research or otherwise abandoned in the course of medical practice per normal hospital policies and practices,” Kate Gallin Heffernan, a partner at Verrill Dana LLP, Boston, told Bloomberg BNA in a June 2 email. She added that, arguably, establishing an individual property right in DNA, as some state laws do, may leave open the possibility for gifting or abandoning that property.

Mark Barnes, a partner at Ropes & Gray LLP, Boston, told Bloomberg BNA that for four centuries, common law has held that a body part severed from an individual isn’t the property of the person from whom it was taken. As to the state laws, he said, “Whether an individual has a right to biospecimens is one thing, and whether he or she has a right to DNA with its genetic information is something else.”

Little Case Law Support

ln February 2017, newspapers in Washington and Baltimore reported the attorney for Henrietta Lacks’ son Lawrence Lacks said he would file litigation within the next few weeks against Johns Hopkins University, arguing his client’s family is entitled to ownership and a share of revenues derived from use of the HeLa cell line.

The line was cultured from cells taken from Henrietta Lacks without her permission or her family’s knowledge when she died at the JHU hospital of cervical cancer on Aug. 8, 1951. The cells didn’t die after a set number of cell divisions, were deemed “immortal,” and are used today in medical research throughout the world.

As of June 6, the lawsuit hadn’t been filed, and Lacks’ attorney declined Bloomberg BNA’s request for comment on the litigation’s status.

Court decisions about the ownership of biological material have so far not been favorable for plaintiffs: Moore v. Regents of the University of California, Greenberg v. Miami Children’s Hospital Research Institute, Inc. , and Washington University v. Catalona .

Barnes said, “Raw material from anyone’s body has no value unless a great deal of effort has been put into developing something from it. It’s like a piece of wood in the forest that is made into a bannister after it is shaped and designed. The person from whom a body part or bodily material was removed in the regular course of medical diagnosis or treatment has no right to that material in any ethical or legal sense.”

He said the Moore case never went to trial and the lower court’s dismissal was appealed. “While the court found he had no ownership right in the body part, it concluded that his argument that the body part wasn’t taken in the course of medical treatment allowed him to sue for breach of fiduciary duty and lack of informed consent.” Barnes is a Bloomberg BNA advisory board member and former executive vice president at St. Jude Children’s Research Hospital.

Heffernan said, “I don’t think Moore, Greenberg, and Catalona necessarily suggest that at no point does an individual have a property right in his/her own body. But they do suggest that once you voluntarily gift or abandon your property, including your excised body parts and tissue, to research, you no longer have residual rights in that property, or at least, the individuals in these cases were not found to have residual rights once the specimens had been donated.”

She said the court in Greenberg found the plaintiff didn’t have a right to claim conversion because the property interest had ended upon voluntary donation. Similarly, in Moore, the court found no cognizable claim of conversion of property related to excised specimens, even though in this case there was arguably no informed consent to research participation.

“Furthermore, Catalona was a case decided almost entirely on Missouri gift law principles; once a voluntary gift was established, which was found to be a gift by the plaintiffs to Washington University and not to Dr. Catalona, the individuals did not have a right to re-direct the gift to Dr. Catalona, even though under principles of research ethics and law, they may have had a right to withdraw from participation in further research,” Heffernan said.

She added, “I think what is interesting, and it’s a tension found in the Catalona case as well, is that in the context of biospecimen research, the informed consent document for research participation also usually serves as the document of gift for any tissue donation, so there is a blending of two different legal frameworks within the same document: informed consent to research participation—which is prescriptive, required by statute, and premised on providing material information to the participant—and a document of gift, the adequacy of which would be dictated by applicable state gift law.” Heffernan also is a Bloomberg BNA advisory board member.

No Support in Federal Regs

Federal regulations don’t provide individuals who seek ownership of biological material taken from them for medical research purposes much support either, although the Department of Health and Human Services had the opportunity to address the issue.

In its Jan. 19 Federal Register notice on the final revision of the Common Rule, the HHS cited comments submitted on the proposed version of the rule: “Still others supported the expansion of the definition of ‘human subject’ to include all biospecimens because of a desire to receive research results or to financially profit from discoveries, implying that retaining identifying information with biospecimens would enable both of these possibilities. Some who felt there is an entitlement to financially profit from discoveries described biospecimens as personal property. For example, one commenter compared the use of an individual’s biospecimens without consent to one party illegally taking another’s property such as land, a house, or an arm.”

But the final revised Common Rule doesn’t define biospecimens as property. It does provide an additional element of consent that will require, as appropriate, a statement that the subject’s biospecimens may be used for commercial profit and whether the subject will or won’t share in this commercial profit.

Heffernan said the fact the HHS declined to address biospecimens as property may not be significant because if there is any authority over biospecimens under the Common Rule, it would be through a redefinition of “human subject.” “So it is unclear to me whether HHS would really have authority—at least through the Common Rule—to assign property value to biospecimens. That said, it is certainly the case that the Final Rule declined to include non-identified biospecimens in the scope of the rule, so they are not protected as human subjects in the Final Rule—identifiability is still key to the applicability of the regulations.”

Heffernan said the new element of informed consent in the final rule related to the possible use of specimens for commercial profit suggests that the HHS is taking the position that research participants don’t necessarily have residual rights in specimens. “This type of element, which essentially allows for an agreement between the researchers and the participants as to whether the participants will see any benefit from future commercialization, might be considered in tension with a conclusion that participants have legally effective residual rights in specimens once they have been provided for research purposes.”

DNA Ownership Rights

A number of states, however, have passed or introduced legislation providing a property interest in an individual’s DNA.

“It will be interesting to see how these laws impact the apportionment of intellectual property rights out of research, if at all,” Heffernan said. “Arguably giving an individual a property right in DNA may still leave open the possibility for gifting or abandoning that property.”

Some of the existing case law supports the idea that the value of most commercialized biospecimens comes from the intellectual contributions of the researchers, Heffernan said. “It is arguably rare that donated tissues are inherently unique in a way that would lead to patentable intellectual property. The Moore case is one example where there was something sort of unique about the cell line, and arguably the HeLa cell line that is at issue in the Lacks case may similarly be characterized as having unique properties, but even in Moore the court found no cognizable conversion claim in the developed cell line.”

Barnes said, “The state laws amount to an abrogation of common law, and in Florida, at least, courts have questioned the interpretation of the state law.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

Request Health Care on Bloomberg Law