A Critical Examination of the Key Legal Issues Raised by the Case of Henrietta Lacks and Johns Hopkins Hospital
30th March 2022
By Eli Baxter, Queen’s University Belfast
In 1951 an ordinary cancer biopsy led to a remarkable discovery. Researchers at Johns Hopkins observed that the cells harvested from a cervical tumour were immortal, dividing ad infinitum in culture. However, the unsuspecting donor – a young woman named Henrietta Lacks – did not consent to the procedure and unfortunately died before learning of her cell-line. Now infamous in the medical world, ‘HeLa Cells’ have been used indiscriminately for research and commercial gain, appearing in almost 11,000 patents. Plainly, there are severe ethical implications for the way scientists have treated – and continue to treat – human tissue, whether for research or profit. The following evaluation assesses the imminent need for reform in this research, whilst examining whether existing equitable frameworks could negate the plethora of issues arising from the commercialisation of human tissue.
Do Property Rights Exist in Human Tissue?
‘Biospecimens’ or ‘human tissue’ denotes cells, organs or blood removed from the human body. Biospecimens have played a ‘crucial’ role in scientific developments over human history, acting as a major catalyst for new discoveries, with few as significant as HeLa cells. The overarching question is whether the tissue’s source enjoys any ownership rights when their tissue is removed. Despite Locke’s assertion that ‘every man has a property in his own person’, it is unequivocally clear that individuals do not ‘own’ or otherwise ‘possess’ their whole bodies. However, as the following analysis demonstrates, there is profound legal uncertainty in the realm of excised human tissue.
Historically, body parts were regarded as inalienable, and as Kant recognised, one cannot ‘sell his limbs for money, even if he were offered ten thousand thalers for a single finger’. Kant’s assessment remains accurate per se. The law does not authorise agreements for the sale of personal body parts, nor does it afford individuals full property rights over their excised tissue. Yet, many jurisdictions have hesitantly started to recognise limited property rights in excised tissue, somewhat based on the concept of ‘separability’ in that an object must have a separate physical existence to be capable of ownership.
This concept was first iterated in the Australian case Doodeward v Spence, wherein the application of specialist work and skill to removed body parts could transform them into ordinary ‘property’ capable of ownership. Yet, this ‘ownership’ does not extend to the tissue’s source, and as Henrietta’s exploitation revealed, it overlooks the consequences of tissue samples removed without consent. Indeed, modern conceptions of bodily property have remained ‘ghosts of the past’ which largely appear to be unjustified in our modern, innovative world.Moore v Regents of the University of California illustrates how the US judicial system has preserved the disturbing precedent established by Henrietta’s legacy. In this case, a man sued under the tort of conversion (deliberate interference with another’s property rights) for the return of a lucrative patent derived from his spleen. Despite success at first instance, the Californian Supreme Court rejected his claim, regrettably using Henrietta’s case to support their decision, remarking how ‘the first human cell-line, which is still widely used in research, was isolated in 1951’. ￼ Consequently, the Court erased Henrietta’s identity even further (neglecting to mention her name in their deliberations), whilst reasoning that since the first isolated cell-line did not raise a proprietary interest, neither did the cell-line before them.
With respect to the court, their judgment is not entirely convincing. Principally, they did not contemplate meaningfully the important information contained in biospecimens, such as the unique mutation witnessed in the man’s spleen or HeLa cells. This information is deeply private as it can indicate, inter alia, hereditary illnesses and markers for genetic disorders, preventing certain individuals from obtaining life insurance. Yet, the court undermined this genetic privacy, instead relying on the backstop of public policy: scientific advancement. Indeed, it was only in 2008 when Congress introduced legislation to prevent discrimination based on this genetic information, regrettably long after the fact. Certainly, even beyond America’s borders, the callous disregard for genetic privacy has pervaded, with the HeLa genome being published non-consensually by a European Laboratory in 2013, a disregard arguably exacerbated by the laissez-faire approach to tissue ownership witnessed in Moore.
The Court similarly overlooked the implications of unfettered tissue-research, forgetting that the way we treat human tissue is an ethical question about ‘how we treat people’. Legal systems largely avoid this question, with only the European Union appearing to contemplate the ethical bedrock for tissue research. The Court in Moore, however, exhibited great reticence regarding a change in the law which might reflect the innate value of biospecimens, choosing instead to uphold the anachronistic legal principles gleaned from Henrietta’s case in the 1950s. Such judicial reticence is troubling in that it demonstrates that little has changed from Henrietta’s era. Ominously, it appears as though the rights of patients continue to acquiesce to the chalice of scientific discovery.
Conversely, the United Kingdom has proved more willing to recognise property rights in biospecimens. The Human Fertilisation and Embryology Act (HFEA) 1990 was central to the finding of property rights in Yearworth and Others v North Bristol NHS Trust. In this case, six men undergoing chemotherapy committed sperm samples to a health-trust. Subsequently, the Trust negligently destroyed the sperm, but the men could not claim for personal injury as the tissue (sperm) no longer formed part of their bodies. Nonetheless, the court allowed a bailment claim against the Trust as the sperm was stored for the men’s subsequent use with no transfer of ownership. Accordingly, Yearworth read in conjunction with the HFEA facilitates, albeit rather loosely, a central tenet of property law over human reproductive tissues – the right to physical possession. This ‘fundamental feature of ownership’ allowed the men to order the destruction of the sperm at any time, because only they had rights over it. The Trust merely possessed a duty of care regarding the sperm, not personal rights of ownership. Subsequently, Australia has similarly endowed property rights over a deceased’s sperm, denoting the nascent willingness of many jurisdictions to recognise ‘property’ in excised tissue to protect the producer’s interests, whilst simultaneously deviating from their own Doodeward exception.
As such, the legal significance of Yearworth stems from its tacit recognition that human tissue does not fit comfortably within pre-existing legal categories, but rather within its own facet of ‘quasi-property’,in that only physical possession is permitted. Nevertheless, this right is paramount, and as Honoré recognised, the right to physical possession is the ‘superstructure’ for genuine ownership. However, more comprehensive property rights are evidently needed over biospecimens. With growing trends of intense scientific research (exemplified excellently by Covid-19 studies with thousands of participants), the legitimate interests of the tissue’s producer must be balanced with valuable scientific research.
It is submitted that an infrastructure akin to the UK’s relaxed-yet-effective approach to the ownership of reproductivetissue(s) might balance these scales. This approach may have afforded Ms Lacks some legal protection. Given that HeLa cells originated from Henrietta’s cervix, a key part of the reproductive system, much like the sperm in Yearworth, the court could have perhaps formed a legal analogy (based on the importance of reproductive rights). Notwithstanding, this comparison is problematic as Henrietta’s cells originated from a tumour, something which must be removed, and in distinction to reproductive tissue, does not have personal value to the producer. Nevertheless, the inherent danger is that the tissue’s source could then hold science hostage in a quest for financial dividends if the biospecimen is valuable. This fact influenced the decision inMoore, as did the ‘capriciousness’ of the ‘owner’ of two kidneys in Colavito v New York Organ Donor Network who refused to donate them, despite the kidneys being incompatible with his blood type for a transplant. Plainly, the issue is a balancing act between legitimate scientific research and the interests of anyone with a genuine claim to the tissue in question, and it is an immensely difficult line to draw, especially in the current scientific climate which has placed immense pressure upon scientists to undertake research to ascertain the efficacy of vaccines, coupled with unearthing supplementary treatments for SARS-Cov-2.
Consequently, the future utility of Yearworth remains somewhat ambiguous,whether as an English precedent, or persuasive authority in America, unfortunately leaving the broader question of non-reproductive tissue ownership unanswered.Nonetheless, Yearworth does signify a nascent judicial recognition of ‘property’ in excised tissue, a deviation from Doodeward, and is demonstrative of a mounting willingness to rule against scientific professionals in an area where the judiciary typically defer to their judgment. Accordingly, in the UK, the gates are open to the recognition of property rights over all forms of human tissue in the near future, endowing the tissue’s source with legal protection, precluding the reoccurrence of exploitation akin to that faced by Henrietta Lacks.
Human Tissue: A Mere Commodity?
Our world has seen human tissue consistently commercialised, with the global tissue market being valued at 65 billion dollars in 2020. ‘Commercialisation’ simply denotes the process of transferring patented human tissue specimens from the laboratory into the market for sale, as witnessed with HeLa cells. Yet, the perennial question is whether such commercialisation is morally permissible. Ethical considerations aside, economic transactions can only occur if an individual is capable of owning the product they later exchange for remuneration, whether monetary or otherwise. Despite this, there are no ironclad precedents which allow a producer (the person from which the tissue is excised) to own their tissue, or partake in profits derived from it, thereby annexing ownership to the researcher alone, corresponding with the ruling in Doodeward.
Dr George Gey undeniably commercialised HeLa cells, distributing various samples among his research colleagues and announcing on national television how they would eradicate cancer, thereby firing the starting pistol for the race to the cure. While his prediction was premature, his colleagues nevertheless gained major profits through their research, resulting in the global circulation of the cell-line. Meanwhile, the impoverished Lacks family did not receive any compensation, partially due to negligible personal property rights in tissue, but also because of the pervasive racist attitudes in the segregated America of the 1950s, which categorised the African-American Lacks family as ‘lower-class’ and underserving of legal protection. Indeed, the hospital did not disclose to the Lacks family any information regarding HeLa cells or the profits they generated for 20 years, showcasing just how cutthroat and mercenary the tissue market truly is, reinforcing the idea that ethical considerations are subservient to the pursuit of profits.
The practice of Umbilical Cord Banking illustrates the many uses our modern world has found for human tissue. Umbilical Cord Banking denotes the process of extracting post-natal umbilical-cord blood for the purposes of life saving stem-cell research. This contemporary procedure usefully demonstrates how most forms of human tissue can now be employed to advance science and create a profit, despite their historical categorisation as a ‘waste product’, recalling that HeLa cells themselves originated from a tumour. Evidently, with the growing trend of using almost all forms of human tissue for research, the law needs to formulate a bespoke answer to this prevalent issue which reflects the growing ‘psychological significance’ of human tissue, notwithstanding the genuine benefits of research.
It is undeniable that certain facets of this commodification are problematic, and there are many difficult questions to be answered concerning its ethical foundations. Certainly, individuals with no knowledge of the law would likely be shocked to discover that they cannot control their removed tissue. For instance, one must only discern the widespread public indignation after the Adler Hey Scandal, (essentially the British counterpart to Henrietta’s case) where the Royal Liverpool Hospital secretly retained organs for research, including the hearts of 2000 deceased children. Naturally, the parents of these children were distraught and outraged. The practice of retaining a deceased’s organs was not public knowledge until the subsequent inquiry which duly unearthed the ‘gross malfeasance’ in the hospital’s research process. Subsequently, the European Court of Human Rights found that the retention of tissue samples without explicit consent (from the individual themselves or their legal representatives) infringes the right to privacy under Article 8 ECHR. Resultingly, the problem necessitates a balancing act between legitimate and ethical research and the interests of anyone with a genuine claim to the tissue.
An equitable approach may provide a proportionate solution to these competing interests. This model would emulate the structure of a trust, seeing researchers maintain their pre-existing legal ownership of the tissue, acting as de facto trustees. Meanwhile, the tissue’s producers (or donors) receive an equitable interest, becoming the beneficiaries. Resultingly, a trust is created, opening the door to a principled framework which adequately regulates the widespread use of human tissue by treating it as ‘normal’ property under a trust. Such an approach offers several fundamental benefits over the insufficiency of the current situation. Principally, the dual interest in the tissue precludes a power disparity between researcher and donor, evading the exploitation of vulnerable individuals like Henrietta. In the event a donor is exploited, the court may use their discretionary powers to grant equitable remedies, remembering that ‘equity will not suffer a wrong to be without a remedy.￼ Therefore, donors could be entitled to compensation for exploitation, and may also be able to terminate the use of their property (human tissue in this case) through an injunction if it is deemed equitable. Such an approach could have allowed the indigent Lacks family to attain profits from the HeLa industry, or at least curb the use of these cells, which the Lacks family viewed as the remnants of their mother’s soul.
Furthermore, the tissue can be used in a mutually advantageous manner which benefits the entire public. For instance, as the beneficiaries have equitable rights concerning the tissue’s use, researchers possessing the legal title could be constrained from unduly abusing rare tissue samples (such as blood types), whilst patients who require the tissue for genuine reasons such as transplants may avail of it. This approach could have the welcome effect of undercutting the UK’s much-publicised tissue shortages, whilst endowing the historically unenforceable private field with transparency, particularly if the equitable model was applied broadly in public and private research. Researchers seeking to patent valuable biospecimens would no longer be able to ‘enrich’ themselves at the expense of individuals who did not consent to the use of their tissue, nor would such individuals fall victim to medical exploitation.
The equitable model also ensures that profit is no longer the primary motivation for undertaking research, despite its inherent value to pharmaceutical companies and scientists alike. Instead, this model fosters patient-researcher trust by balancing the interests of the donor and the researcher, preventing the tissue from being used unilaterally by researchers. The consent of each party would be a prerequisite. Such an approach could cultivate trust in communities that typically revile medical professionals. For example, one can note the initial hesitancy of ethnic minority groups to receive the Covid-19 vaccine, indicating that the pervasive history of mistrust fostered by unscrupulous physicians has pervaded. This model would actually increase confidence in the profession by endowing those cautious, hesitant individuals with legally protected interests in their own tissue samples and a route to remedy.
Nevertheless, this model is not a panacea. Despite the flexibility of a trust, this solution would likely require a sui generis equitable framework specifically for human tissue. While this proposition could serve as a ‘halfway house’ per se on the road to a principled regulatory framework, a ‘copy and paste’ trust model would struggle to reflect the significance of human tissue as a unique form of ‘property’. Meanwhile, scientists continue to enjoy their historical hegemony in tissue research, and the law governing tissue research remains predominantly on their side, perhaps in acknowledgment of the fact that tissue is the ‘canvas’ upon which scientists ‘undertake their artistry’ to improve the world.
Although, it remains irrefutable that the prevention of exploitative tissue research requires a ‘continuing control’ over the excised material. From my estimation, this represents the producer maintaining a legal stake or interest in their tissue, allowing them better- but not flawless- protection from medical exploitation. Even today, HeLa cells remain a considerable source of revenue, with a current retail price of 250 dollars a vial. If beneficial equitable rights were extended to excised biospecimens, there would be protection against unethical commercialisation, and perhaps incidental dividends from any profits. This method is the most feasible due to the need for a legal stake in the tissue, but it remains presupposed on the existence of an applicable equitable framework, meaning this question, for the time being, remains in the hands of the legislator.
Informed Consent: Quick Fix or Magic Bullet?
Informed consent represents a voluntary and cognisant choice to allow the invasion of one’s bodily integrity whilst knowing of, and consciously consenting to, all the benefits and risks arising from the invasion. It is the ultimate protection for bodily integrity. Typically, ‘consent’ is governed by contemporary societal attitudes, and the pre-Civil Rights era of America dictated that an impoverished black woman like Henrietta deserved no legal protection, despite the doctors following common procedure (notwithstanding the procedure’s racist ancestry stemming from research into enslaved women in 1845). In 1951, ‘consent’ was judicially defined, holding that ‘Every human being of adult years and sound mind shall determine what shall be done with his own body’. Yet, this was inconsequential to Henrietta; she was not informed of what would be done with her excised cells, and the hospital’s questionable ethics went unnoticed due to societal indifference regarding Henrietta’s race and gender. Unfortunately, she was just ‘one in a sea of black women violated’ by the medical world, and her subjugation was therefore immaterial to the wider population. Similarly, because the cell-line came from a black woman, society viewed it as a ‘contaminant’ of other cell-lines,￼ perhaps truly explaining why ‘Henrietta Lacks’ was anonymised to ‘HeLa’, despite the universal utility of her cell-line to all races and cultures.
Henrietta’s case therefore remains the white whale of any analysis of the modern American consent model: ‘The Common Rule’ (TCR). Herein, doctors must obtain explicit written consent before surgery, which is then ratified by the Institutional Review Board (IRB), thus providing two layers of patient protection. Yet particular elements of TCR lack practical coherence, and in some respects, it is the antithesis of patient protection. For instance, if the donor’s identity cannot be ascertained, IRB oversight is unnecessary. Additionally, the TCR applies solely to novel cell-lines and not previously isolated cell-lines, meaning HeLa cells can still be used without further consent, signifying a lack of substantive change. Indeed, even under the revised 2018 version of the TCR, the only consent required for the use of human tissue is broad consent for ‘future unspecified purposes.’ Furthermore, empirical research has indicated that US consent forms are overly complex and beyond patients’ understanding, with the only successful approach being a prolonged discussion between doctor and patient. But this approach is plainly impractical, exemplified by the pressure on hospitals during the ongoing pandemic, meaning doctors lack the time to explain the minutiae of each surgery. However, the advancement of medical science is contingent on an effective yet expedient consent process, and if ‘consent’ becomes too difficult to obtain, does anyone benefit? The answer to this endemic issue can be found in the British consent model, the Human Tissue Act 2004 (HTA).
The HTA covers all the issues for which consent is required, whilst providing a statutory definition of ‘consent’, all of which is regulated by an independent body, the Human Tissue Authority. Moreover, the HTA is predicated on the words ‘appropriate’ and ‘capacity’ in that the person from whom the tissue is drawn must consent to its use, storage or removal, all-the-while possessing the mental capacity to consent. Equally, if the person concerned is dead, their consent must be contained in their will with a corroborating witness present. The ramifications of the HTA cannot therefore be understated. If a tissue-sample includes even a single cell of DNA, it is ‘relevant material’ covered by the HTA, making it an offence to use, or re-use it without the requisite consent, even if the cell line has been isolated before. This goes even further than the TCR, in that the HTA would protect HeLa cells from further use without further consent. This is significant. The HTA is then capable of protecting the interests of patients who may not support their tissue being used for certain purposes for which they did not specifically consent, highlighting the major inadequacies of the TCR.
There are many lessons regarding consent arising from Henrietta’s case, but principally, it demonstrates that ‘consent’ should symbolise the protection of the vulnerable. Therefore, research methods which present a prima facie risk of exploitation should be terminated. Equally, consent forms should be tailored subjectively according to each patient’s need (with vocabulary befitting their education) whilst incorporating their consent for a specific useof their tissue, allowing ‘true’ consent, as patients know exactly what their tissue will be used for. This solution would curtail the ‘excessive latitude’ researchers enjoy in their study of human tissue, without stymieing scientific progress, as research can still occur, but alongside greater safeguards for patients.
Henrietta Lacks and HeLa cells have altered science and law to an immeasurable extent, acting as a catalyst for the polio vaccine and numerous ground-breaking cancer studies. While modern legislation has clarified the issues of tissue ownership and consent arising from Henrietta’s story, in some respects, it has not gone far enough, particularly in regards to sharing the profits of profitable tissue-based patents. The global framework concerning human tissue is no longer adequate, and as one judge opined, ‘the law marche[s] with science, but in the rear and limping a little’. Accordingly, legal conceptions of bodily property must be modernised and restructured. Many of the problems stemming from Henrietta’s case could be solved by a property-based approach, and for the sake of avoiding patient exploitation, excised tissue should be capable of the quasi-proprietary status observed in Yearworth, but extended further beyond the sphere of reproductive tissues. Alternatively, the proposed equitable model should be adopted because it can curtail the excessive autonomy researchers enjoy in their study of tissue, bestow patients with legal remedies, and has the potential to prevent Henrietta’s tragedy from ever happening again. This model would therefore provide a proportionate solution within which research can still proceed, but simply in the presence of greater patient protection.