In 2021, Henrietta Lacks’ family sued Thermo Fisher Scientific, a Fortune 500 company with annual revenues of over $40 billion.Footnote 1 The family sued on the grounds that the company had been “unjustly enriched” by the sale of products developed with Henrietta’s cells.Footnote 2 The parties settled the case for an undisclosed sum in July 2023.Footnote 3 The family’s lawyers are now seeking compensation from other companies that are marketing Lacks’ cells or products based on them.Footnote 4
Given that hundreds of thousands of people have tissue on file in the United States, this essay will explore the legal disputes over body tissue that have occurred over the past forty years and how today’s patients might fare if they similarly sued professionals or companies that undertake research on and commercialize their tissue. As a lawyer who has brought pro bono lawsuits involving such disputes,Footnote 5 I will highlight some of the individual tissue sources behind these cases, adding their stories and the legal precedents they established to the story of Henrietta Lacks.
I have been involved academically with disputes over body tissue for nearly four decades. In 1986, I published “My Body, My Property” in the Hastings Center Report.Footnote 6 Throughout all my work in health law, I have analyzed each new technology, policy, medical practice, or other development for its impact on individuals, relationships, families, communities, social institutions, and legal principles. I undertook interviews with the people most affected,Footnote 7 went undercover at times to gather information,Footnote 8 and crunched dataFootnote 9 that my students, colleagues, and I collected about the benefits and risks of each development. From my interaction with colleagues George Annas, Wendy Mariner, and Fran Miller, I know how important it is to ensure that health care and research are undertaken ethically, and that patients’ needs and emotions are never left out of the equation. This viewpoint guided my pro bono work as well as my scholarly research.
Henrietta Lacks’ Immortal Cells
The Henrietta Lacks saga began in the 1950s, the same decade that Boston University initiated its celebrated health law program.Footnote 10 In 1951, Henrietta Lacks, a thirty-one-year-old African-American mother of five children, consulted Dr. Howard Jones at Johns Hopkins Hospital. Dr. Jones took a biopsy of her cervix, sent it to the lab, and diagnosed her with cervical cancer.Footnote 11 An experimental operation was undertaken to implant radioactive rods in her cervix to treat the cancer.Footnote 12 At the same time, Dr. Lawrence Wharton Jr., at the behest of a colleague and without Henrietta’s knowledge or consent, removed two pieces of cervical tissue in a procedure unrelated to her medical treatment.Footnote 13
The colleague, Dr. George Gey, had tried unsuccessfully for years to cultivate a cell line that would continue to reproduce indefinitely.Footnote 14 Cell lines typically die after a certain number of replications.Footnote 15 An immortal cell line was a Holy Grail, sought in order to enable cancer experiments and to foster research that could then be replicated by other scientists on an identical cell line.Footnote 16
Henrietta Lacks’ cells were unique and, as it turned out, extremely valuable..Footnote 17 They replicated indefinitely. HeLa cells, as they were called, were the first human cells to survive and thrive outside the body in a test tube.Footnote 18
Henrietta’s cells have formed the basis for much of the scientific enterprise across the world in the decades since her death. Virtually every high school biology student, every medical student, and every vaccine maker has manipulated her cells.Footnote 19 The Lacks family website notes that “[o]ver 50,000,000 metric tons of HeLa cells have been distributed around the world to become the subject of more than 75,000 studies.”Footnote 20 The cells formed the basis for the development of the polio vaccine, and for research on cancer, Covid, HIV/AIDS, Parkinson’s disease, as well as many other conditions.Footnote 21 They were even sent to space during the Space Race to uncover the impact of zero gravity on human cells.Footnote 22
Henrietta’s cells and the products made from them are sold and worth billions.Footnote 23 In an interview in 1994 with medical historian and ethicist Harriet Washington four decades after Henrietta’s death, her husband said, “As far as them selling my wife’s cells without my knowledge and making a profit — I don’t like that at all. They are exploiting both of us.”Footnote 24 While fortunes have been made on the foundation of the HeLa cells, Henrietta’s own children lacked access to education and basic health care.Footnote 25
In 2013, the Lacks family stumbled upon further troubling news. Researchers in Germany had sequenced Henrietta Lacks’ genome, compared it to the genomes of healthy cell lines, and made her genetic profile publicly available.Footnote 26 The family members were concerned about the invasion of their own privacy, because Henrietta’s genome might reveal their own disease risk.Footnote 27 Her grandson said, “It’s like, ‘Here we go again, being involved in research without our permission or our consent.’”Footnote 28
When the family complained, the German researchers removed Henrietta’s genome from public view.Footnote 29 The incident raised sufficient concern that, in 2013, the National Institutes of Health and the Lacks family entered into the HeLa Genome Data Use Agreement, which provided for advance scrutiny of NIH-funded research that would use genetic data from the HeLa cells.Footnote 30
The 2021 case of Henrietta Lacks might seem unique — a perfect storm where the appalling history of medical apartheid and the total absence of consent to the mining of her cells came to court in a post-George Floyd era where there had already been widespread coverage, through a best-selling bookFootnote 31 and a film starring Oprah,Footnote 32 of the harms to the Lacks family. But what about the hundreds of thousands of other individuals who have tissue on file in the United States? Might they also have legal claims when their tissue is used in ways that violate their personal wishes or religious beliefs?
The Widespread Use of Human Tissue Today
An astonishing amount of human tissue has been collected over the years as the potential uses for it have broadened. Over two decades ago, in 1999, the National Bioethics Advisory Commission estimated that more than 282 million archived and identifiable pathological specimens from more than 176 million individuals were stored in U.S. repositories.Footnote 33 Between public health screening, research studies, routine medical tests, and autopsies, virtually everyone has his or her tissue “on file.” If you were born in the United States since the early 1970s, a blood sample was taken at birth for newborn genetic screening, a public health program.Footnote 34 Some states save those samples indefinitely.Footnote 35
Even barbers and janitors have people’s DNA—and some try to exploit it. Astronaut Neil Armstrong’s barber sold his hair clippings to a collector, causing Armstrong to threaten suit.Footnote 36 Michael Jackson’s hair caught fire during a Pepsi commercial and charred pieces turned up on the biocollectibles market years later.Footnote 37
When Henrietta Lacks underwent surgery in 1951, uses for human tissue were limited to diagnosis and, in some cases, research.Footnote 38 That changed dramatically in subsequent decades. The 1960s brought successful organ transplants from cadavers,Footnote 39 and the 1980s biotech boom saw the commercialization of human tissue to create biotech products.Footnote 40 Expanding markets have increased the value of human tissue, and institutions — such as hospitals, research laboratories, museums, and the state and federal repositories that store tissue samples — find they possess a capital resource. As I wrote in 2005, “[a] single cadaver can be mined for medical and research uses — its skin worth $36,522, its bones $80,000, its tendons $21,400, and so forth.”Footnote 41 The value of a particularly interesting human gene can be over a billion dollars.Footnote 42 Conflicts can arise when tissue is used for research or commercialization in ways that have not been disclosed to the tissue source.
Human Tissue Cases in the Courts
John Moore was one of the first targets of the emerging biotech industry’s quest for tissue.Footnote 43 A Seattle resident, John Moore sought treatment for his hairy cell leukemia at UCLA. Although his treatment was completed in 1976, his physician led him to believe he was still ill and kept asking him fly back to Los Angeles to provide tissue, including sperm, bone marrow, and blood.Footnote 44 When he told his doctor that he could no longer afford the trips, his doctor offered to fly him to Los Angeles and put him up at a Beverly Hills hotel.Footnote 45
That offer tipped Moore off that something strange was going on. That something strange: His doctor had patented Moore’s cell line and was negotiating with biotech companies for access to Moore’s tissue. When he learned that his doctor was commercializing his cell line, Moore felt “violated for dollars,” “invaded,” and “raped.”Footnote 46
Moore brought suit, alleging (1) conversion; (2) lack of informed consent; (3) breach of fiduciary duty; (4) fraud and deceit; (5) unjust enrichment; (6) quasi-contract; (7) bad faith breach of the implied covenant of good faith and fair dealing; (8) intentional infliction of emotional distress; (9) negligent misrepresentation; (10) intentional interference with prospective advantageous economic relationships; and (11) slander of title.Footnote 47
The trial court dismissed the case, but the California Court of Appeals analogized the situation to cases involving celebrities such as Bela Lugosi (who played Dracula), who had been held to have a legally-recognized interest in his own likeness which prevented other people from marketing photos of him.Footnote 48 The court wrote, “If the courts have found a sufficient proprietary interest in one’s persona, how could one not have a right in one’s own genetic material, something far more profoundly the essence of one’s human uniqueness than a name or a face?”Footnote 49
The court also pointed out that the Uniform Anatomical Gift Act gives patients control over what is done with their tissue after they die,Footnote 50 so it seems logical that they should have control before they die. On a practical note, the court wrote, “If this science has become science for profit, then we fail to see any justification for excluding the patient from participation in those profits.”Footnote 51
On appeal, though, the California Supreme Court refused to recognize Moore’s property right.Footnote 52 Marjorie Shultz, a Berkeley law professor, and I argued in an amicus brief that Moore had a valid cause of action for lack of informed consent and for breach of fiduciary duty — the physician’s responsibility to put the patient’s interest first.Footnote 53
The court agreed, holding that a physician must tell his patient if he has a personal interest unrelated to the patient’s health, whether research-related or economic, that might affect his judgment.Footnote 54 As a result, the American Medical Association’s Ethics Code § 7.3.9 now states that potential commercial applications must be disclosed to the patient.Footnote 55 And that physician “should… [s]hare profits from the commercial use of human biological materials with the tissue donor in accordance with lawful contractual agreements.”Footnote 56
The rationale of the Moore court’s duty to inform was that “[a] physician who adds his own research interest to this balance may be tempted to order a scientifically useful procedure or test that offers marginal, or no, benefits to the patient.”Footnote 57 This certainly seemed to be what happened to Moore, who was repeatedly called back to his doctor’s office to give blood, bone marrow, sperm, and other tissue.Footnote 58
Even though Moore had been wronged, the California Supreme Court declined to recognize Moore’s property rights in his tissue, in large measure because the justices did not want to hamper the fledgling biotechnology industry.Footnote 59 The majority stated, “The extension of conversion law into this area will hinder research by restricting access to the necessary raw materials.”Footnote 60
But failing to give Moore a property right in his tissue has led, as in Henrietta Lacks’ case, to the continued, problematic commercialization of peoples’ tissue. John Moore himself is still one of the many individuals whose cell lines you can order by perusing the catalogue of the American Type Culture Collection (ATCC).Footnote 61 John Moore’s cells are for sale as CRL-8066.Footnote 62 The entry about Moore’s cells on the ATCC website urges people to “Buy Now,” at a price of $708 per order, saying the cells have a rating of 99/100 Bioz Stars and are recommended for use in studies of “3D cell culture, Immune system disorder research, and Immunology.”Footnote 63 According to the entry, they have been referenced in 41 product citations and served as the basis for a 2022 patent, U.S. Patent No. 11,391,726, covering “MoT cells as a therapeutic screening tool for regulatory t-cell activity.”Footnote 64
The ATCC houses thousands of individuals’ cell lines in an over 100,000 square foot building in Manassas, Virginia — you can even buy HeLa cells — but it is doubtful that more than a handful of those individuals or their families realize that they are part of this elite market.Footnote 65
Unjust Enrichment Claims Enter the Debate
The Moore court’s refusal to rule that a person has a property interest in their tissue set the stage for other doctors and researchers to harvest their patients’ tissue. Dan Greenberg was the father of two children who suffered from Canavan disease. While Dan’s children were seemingly healthy at first, they failed to reach milestones such as raising their heads or crawling. Then came seizures and pain. With Canavan disease, children do not develop beyond the infant stage, even though they will live to age ten or older.
In 1987, Dan Greenberg contacted a geneticist to persuade him to search for the Canavan gene. He chose that particular doctor because the doctor had been active in screening for Tay-Sachs disease, a condition for which free genetic testing was undertaken in schools and synagogues, as well as in doctors’ offices, to alert Ashkenazi Jewish individuals to their risk of having a child with that disorder.
For over a decade, Dan’s family and other Ashkenazi Jewish families of children with Canavan disease, as well as non-profit foundations, provided tissue and money to the geneticist so that he could sequence the genetic mutation that caused this devastating neurological disease. They intended that the genetic sequence be used to develop a diagnostic test, so that couples could be tested to see if they were carriers of the disorder and prenatal testing could be done to see if a fetus was affected with the disorder.
For over a dozen years, Dan worked to make sure the research succeeded. He identified Canavan families from around the world, constructed their family trees, and convinced them to donate tissue from their children (including brain tissue when the children died, which in some cases conflicted with their religious beliefs). He also raised money for whatever equipment and services the doctor needed.
When the doctor identified the section of Dan’s and his son’s gene sequence that was correlated with Canavan disease, though, the doctor and his hospital patented that series of As, Ts, Cs, and Gs without Dan’s knowledge or consent. And when the families and non-profit foundations convinced medical providers to offer Canavan gene testing for free, the patent holders forced the free testing program to close. The families and foundations asked me if I would bring suit on their behalf.
I agreed to help and convinced a large law firm to join my pro bono efforts on Greenberg’s behalf. Then, shortly before the statute of limitations was to run, the law firm dropped out. It did not want to take the risk of scaring away biotech clients.
At the time, I was a law professor who did not even have a fax machine with a date stamp. I did not have the legions of big law firm associates that opposing counsel in the case had. The families and foundations had used their money to support the doctor’s work and had little money available for experts or other litigation-related costs. But I did have colleagues in the Law Offices of Chicago-Kent College of Law (Ed Kraus and Laurie Leader) who were willing to help. The law school dean, Hal Krent, and I offered a seminar for honors students to, in short order, draft a complaint for the case.
We asserted causes of action for conversion (to try to undo the faulty, in my opinion, Moore holding), lack of informed consent, breach of fiduciary duty, theft of trade secrets (the vast materials and international family tree that Dan had put together), and unjust enrichment.Footnote 66 We filed suit in federal court in Chicago, because the doctor had worked at the University of Illinois, Chicago and the Greenbergs lived in the Chicago area.
We were devastated when the federal court moved the case to Florida, where the doctor was now living.Footnote 67 But, seemingly unbeknownst to the defendant’s lawyers, a statute had been enacted in Florida that gave us a ray of hope. Florida Statute § 760.40(2)(a) said that the results of a genetic test were the “exclusive property” of the person tested.Footnote 68 We could argue that the mutation that Dr. Matalon patented was Dan Greenberg’s property.
Judge Moreno, federal district court for the Southern District of Florida, enmeshed us in a Catch-22 situation. He said that there had not been a previous case where the statute had been applied in a situation such as the Greenberg’s.Footnote 69 But the statute was so new at that point, there had not yet been a chance to apply it.
Relying on the Moore case, Judge Moreno held that the plaintiffs had no property right to the tissue.Footnote 70 However, the court ruled they could maintain a cause of action for unjust enrichment since “the facts paint a picture of a continuing research collaboration that involved Plaintiffs also investing time and significant resources in the race to isolate the Canavan gene.”Footnote 71
This decision led to an out-of-court settlement. Dan Greenberg and the other plaintiffs had not wanted money from the lawsuit, but access to the gene sequence for researchers and access to testing for people who, because of patent royalties, could not afford it. Decades later, unjust enrichment was used successfully on behalf of the Lacks family to receive a settlement with Thermo Fisher.Footnote 72
Can Reproductive Tissue be Property?
Both John Moore and Dan Greenberg were denied property rights in their tissue, but it seemed to me that such an approach would lead to abuses by doctors and researchers who viewed their patients as gold mines. Plus, as I had argued as far back as my 1986 article, legal protections were needed for people who stored their tissue (such as an embryo for in vitro fertilization or their blood before an operation to avoid transfusion-related HIV) and expected to get it back or have a say in its future uses.Footnote 73 Even in Moore, the court stated that “we do not purport to hold that excised cells can never be property for any purposes whatsoever[.]”Footnote 74
Soon after “My Body, My Property” was published, I was approached by a couple for another pro bono case.Footnote 75 Risa York had been trying to conceive a child for the previous four years. She and her husband Steven sought care at what was, at the time, the only in vitro fertilization clinic in the country. The clinic was run by Howard Jones — one of the doctors involved in the Henrietta Lacks case.Footnote 76 Risa’s eggs were fertilized in a petri dish with her husband Steven’s sperm. On their fourth unsuccessful attempt at in vitro fertilization, they were offered the opportunity to have one of their embryos frozen for later use.
Before freezing the embryo, the Yorks were asked to sign a consent form. It said that the Yorks had “the principle [sic] responsibility to decide the disposition” of their embryo.Footnote 77 And it said that, if they no longer wished to seek a pregnancy, they had three choices—terminate the embryo, donate the embryo to another couple, or allow research on the embryo.Footnote 78
During the course of their treatment, the Yorks moved to Los Angeles and decided to change clinics to obtain in vitro fertilization from Dr. Richard Marrs there. Marrs had achieved the United States’ first birth from a frozen embryo.Footnote 79
Steven and Risa researched how to safely move the embryo from the East Coast to the West Coast. They learned that it could be transported — like other human tissue or organs — in a liquid nitrogen tank known as a biological dry shipper. Steve was a physician who had transported human tissue, such as corneas, while a medical resident, so he felt completely comfortable about picking up the embryo and flying it back in the biological dry shipper in the seat alongside him in the airplane.
But Dr. Howard Jones would not allow it.Footnote 80 He said Risa was limited to the three choices in the form. Risa was devastated that he would not allow her to move the embryo to achieve a pregnancy, but was willing to throw it out, do research on it, or donate it to another woman.
There had been one previous case in which a couple (the Del Zios) argued that their embryo was property. In that case, a doctor at Columbia Presbyterian attempted to perform in vitro fertilization in 1973, but his department chair removed the embryo from the laboratory, thus thwarting the couple’s attempt to be parents, because of his opposition to the procedure.Footnote 81 The couple sued, but the jury rejected the property claimFootnote 82 and instead granted Mrs. Del Zio $50,000 for emotional distress and Mr. Del Zio $3.00 in nominal damages (substantially less than he would have received if he had sold the sperm to a sperm bank).Footnote 83
My co-counsel in the York case, Virginia lawyer Jerry Denton, tried to persuade me to give Yorks’ embryo a name in our legal documents, giving the impression that refusal to release the embryo was akin to kidnapping. But I protested: “Turning the embryo into a person with legal rights of its own would set a dangerous precedent. Women’s abortion rights would be in jeopardy — abortion would be murder. Other areas of law would be turned topsy-turvy.”Footnote 84 We chose instead to assert claims based on property law, contract law, and constitutional law.
Months after denying our motion for summary judgment, the court finally ruled that the Yorks had a valid cause of action under property law.Footnote 85 Their act of depositing their embryo at the clinic created a bailment, ruled the judge, just like dropping one’s car off at a parking garage would.Footnote 86 The court also held that the informed consent form gave them contract rights to control the disposition of the embryo.Footnote 87 Three months later, the clinic finally agreed to give the embryo back. We proceeded to the airport and the Yorks put the three-foot cylindrical dry shipper holding the embryo into the window seat, put a pillow around it, and clicked its seatbelt.
Property Disputes Over Tissue Take Many Forms
In the years since the decision in the York case, other courts have recognized property rights in human tissue. In some instances, a state entity has directly or implicitly authorized the removal of tissue from a deceased individual without the explicit consent of relatives,Footnote 88 or a statute or ordinance has condoned the removal.Footnote 89 In cases where the tissue has been removed pursuant to such a governmental policy, family members of the deceased have an additional legal weapon: the Fourteenth Amendment, which prohibits states from depriving a person of life, liberty, or property without due process of law.Footnote 90
At Saginaw Community Hospital in Michigan, Armando Herrera was an assistant to the pathologist who conducted autopsies.Footnote 91 Herrera’s job was to open up the bodies and then, after the pathologist had finished work, sew them back up.Footnote 92 But Herrera had another job: he owned and operated the Central Michigan Eye Bank and Tissue Center.Footnote 93 So when the autopsies were over, and without informing the next of kin, he would remove the deceased’s eyes and sell them.Footnote 94
Relatives of Herrera’s deceased victims claimed Fourteenth Amendment violations on the grounds that state entities, namely the counties of Saginaw and Tuscola, had been paid by Herrera for access to the eyes,Footnote 95 but the trial court dismissed their claims on the grounds that a relative’s interest in a next of kin’s body was not a “property interest” under the Fourteenth Amendment’s Due Process Clause.Footnote 96 The Sixth Circuit Court of Appeals, however, was clearly troubled that people might not be protected if their next of kin’s bodies could not be considered property. If a woman’s husband died in a neighbor’s yard, one judge asked, should the neighbor simply be able to keep the body?Footnote 97 To the appellate court, the answer was clear. The court ruled unanimously that next of kin have “a constitutionally protected property interest in the dead body of a relative.”Footnote 98
In some body-as-property cases, the patients are third parties in the dispute between conflicting researchers or between researchers and their institutions, where both sides claim a property interest in the tissue. When 30,000 patients gave tissue to Dr. Catalona for prostate cancer research, he developed important and widely-used tests. But his university saw the tissue samples as a capital resourceFootnote 99 and filed suit, arguing that it owned the tissue samples and had the right to use them as it wished “in its sole discretion.”Footnote 100
No informed consent document expressly provided that a patient could not require Washington University to transfer his tissue to another institution.Footnote 101 No form stated that Washington University “owned” the patient tissue.Footnote 102 The federal research regulations, which applied to Washington University, said that research subjects could withdraw at any time without penalty or loss of benefitsFootnote 103 and that research participants cannot be asked to waive their legal rights.Footnote 104
James Ellis, one of the patients, testified that he had donated his tissue for research on prostate cancer done by Dr. Catalona.Footnote 105 He wanted to benefit his son and other descendants who might be predisposed to the disease.Footnote 106 If Washington University exercised control, it might sell the samples to the highest bidder for research on, say, baldness, since a cure for baldness had a bigger market than prostate cancer.
James Ellis was the opposite of Henrietta Lacks. He was white, male, and powerful.Footnote 107 Ellis was the Vice-President and General Counsel of a Fortune 500 Company.Footnote 108 His appearance in the case underscored for me that lack of control over one’s tissue can affect anyone.
The Eighth Circuit Court of Appeals ruled against the patients, saying that they had made an inter vivos gift of the tissue to Washington University.Footnote 109 The court ignored the fact that the patients had a continuing interest in and control over the samples since, under the federal research regulations, they could terminate the use of their material in research.Footnote 110 But, much like Risa York did not want her embryo terminated (which Dr. Jones offered to do in lieu of giving her embryo back to her),Footnote 111 the prostate cancer patients did not want their samples thrown out. They wanted these irreplaceable resources — such as tumor tissue removed during surgery — used for prostate cancer research by Dr. Catalona.
If Washington University’s logic were followed, the tissue could, in contravention of a patient’s wishes, be used in research to create a human clone. It could be used for a type of research that violated a patient’s religious beliefs, such as embryonic stem cell research. Or it could be sold to a biotech company for sheer commercial gain.Footnote 112
Not Recognizing a Person’s Property Interest in Tissue Can Lead to Abuses and Lack of Trust in the Research Enterprise
The specter of using people’s tissue in contravention of their explicit desires and religious beliefs can chill potential research subjects’ willingness to participate in research. This is exactly what happened when tissue from members of a Native American tribe, the Havasupai, was used in ways that the tribe members had not authorized.
The Havasupai have one of the highest incidences of type 2 diabetes anywhere in the world, with over half of Havasupai women and over one-third of Havasupai men being affected.Footnote 113 Members of the tribe alleged in a lawsuit that researchers at Arizona State University collected 400 blood samples from them for diabetes research, but that the university also performed unauthorized research on those samples related to schizophrenia, inbreeding, and population migration.Footnote 114 They asserted that the research on schizophrenia and inbreeding was stigmatizing to them, and that they would not have authorized the migration research because it conflicted with their religious origin story.Footnote 115 Once other Native American groups learned about how the Havasupai samples were being used, they severed ties with researchers and passed resolutions not to participate in research.Footnote 116
A federal district court found that the Havasupai had asserted valid claims for intentional infliction of emotional distress, negligent infliction of emotional distress, civil rights violations, negligence, and gross negligence.Footnote 117 In April 2010, the researchers’ university settled with the Havasupai, paying $700,000 to forty-one members of the tribe.Footnote 118 Tribe members undertook a ceremony marking the return of the samples to the tribe.Footnote 119
Sadly, some health care institutions have not learned the lessons of these cases. On my last visit to Northwestern University’s Medical Center for health care, I was asked for my signature in the small slit of a digital device. The clinic receptionist assured me that “this is just so that we can bill your insurer.” When I asked to see the form that I was being asked to sign, a supervisor begrudgingly printed out the four-page, single-spaced form, which contained provisions that would force me to agree to research on my tissue.Footnote 120 When I wanted to delete that provision, they told me I had to agree to it or I could not be seen by my doctor.
Despite long-standing ethical guidelines (from the time of the Nuremberg Code to the current federal research regulations) guaranteeing that research is not a matter of conscription, patients at Northwestern and many other health care institutions today are treated like Henrietta Lacks in terms of unconsented-to research on their tissue.
Health care professionals and institutions that are still using people’s tissue without informing them or providing an opportunity to consent or refuse need to think about how they will be judged by society in the future. In many instances, patients and research subjects would be able to allege a property claim, an unjust enrichment claim, or, if the defendant is a state actor, a Fourteenth Amendment claim,Footnote 121 but people may not realize their tissue has been taken or used without their consent. Even if institutions that use tissue without consent feel their actions are supported by current law, will they be in the position of the doctors and researchers in the Henrietta Lacks case, where, decades later, their actions will be considered unethical, reprehensible, and maybe even legally problematic?
What is the emotional impact on patients (and the practical impacts on the medical and research enterprises) when you tell someone their precious tumor tissue cannot be used for the type of research they agreed to because the university can find a higher price for it elsewhere? What is the impact of telling an in vitro fertilization patient that her physician is willing to destroy her embryo, do research on it, or give it to someone else, but not give it to her? What happens when you do un-consented-to research on people’s tissue that violates their religious beliefs? Should a hospital, medical center, or coroner’s office escape liability when they fail to even notice that employees are selling patients’ body parts? With the success of unjust enrichment, property, and Constitutional claims, patients and other tissue sources may now be able to address some of these abuses.
Thinking about medicine’s “future history” is particularly important because we are not dealing with widgets here. The “bio” in biotechnology is generally pieces of people like you and me, whether they are poor and disenfranchised like Henrietta Lacks and the Havasupai or rich like James Ellis. We all have, literally, skin in this game.
