October 13, 2021
Henrietta Lacks was a young black woman who in 1951 was diagnosed with a particularly aggressive form of cervical cancer. His attending physicians at Johns Hopkins Hospital took a sample of the tumor and it was the birth of “HeLa” – an “immortal” line of rapidly replicating cells that have since been reproduced, used in scientific and medical innovations, including polio vaccine development, infertility research, and even early research on a Covid19 vaccine. The HeLa cell line was essentially the first time human cells could be successfully cloned, and it has been used continuously for research that has touched almost every area of medicine.
In October 2021, his estate filed a lawsuit against Thermo Fisher, the pharmaceutical company that bought the cells from the hospital. His family, represented by Ben Crump, the lawyer who represented George Floyd’s family in 2020, is asking the company to reimburse all of the profits made over 70 years of using his cells without consent. This is the American remedy for “profit drain”, which essentially involves the transfer of all of the company’s patents and profits from the HeLa line to the Lacks estate. Essentially, disgorgement removes the incentive to get rich unjustly at the expense of others.
The problem with this remedy is that it depends on whether the enrichment is based on the property of the other person. In American law, as in the United Kingdom, there is no property in the body. In fact, US law is silent on the ownership of bodily resources. The only law governing this matter is the National Organ Transplantation Act 1984 which prohibits the sale of all organs, including kidneys. The ban extends only to the sale of kidneys for transplantation; the sale of kidneys for research and experimentation is not prohibited.
In this country, the Human Tissue Act 2004 was introduced following the scandal of the Bristol Royal Infirmary and the Alder Hey Hospital in Liverpool withholding the organs of babies who died without parental consent. Preservation of body parts and organs of children who died without parental consent was in fact very common in the UK at the time. As the Chief Medical Officer pointed out, there have been many occasions when the study of tissues after death has led to discoveries in medical science that have resulted in saving lives and alleviating suffering, especially in the field of cancer research.
The British Commission on Human Genetics stated in 2006 that
the need to restore public confidence in genetic research and the collection of human biological samples must not be bought at the cost of seriously hampering research into deadly diseases
Even the Human Tissue Act, which covers cells, does not cover cell lines, since it does not extend to any human created material. outside the body. Or more specifically, the Act does not directly address the issue of whether a person possesses bodily objects once they have been removed. In fact, in law, the person does not have any bodily material that was taken from him during the medical procedure. Article 39 of the law refers to human material acquired through the application of human skills – presumably those of the hospital whose specialists have worked on the cells to make them a productive lineage.
Additionally, the law does not require consent if bodily material is retained for intended purposes such as “education, training and auditing”. Whether this exclusion includes research is a delicate question. But it is clear that the use of human raw materials for these purposes is seen as intrinsic to the health of the nation. The 2004 law provides that a High Court judge can order that appropriate consent may be considered “for the purposes of research relating to disorders or the functioning of the body”. This pretty much covers everything that is involved in medical research.
Coming back to the United States, the case of Moore vs. Regents of the University of California (Cal 1990) would appear to be on all fours with the Lacks Estate v Thermo Fisher case.
John Moore, who has hairy cell leukemia, had his spleen removed. Her attending physician discovered that the white blood cells in this spleen produced proteins with potentially beneficial properties. Dr. Golde developed a cell line from the spleen, which he ultimately sold for $ 15 million. The resulting products are said to be worth several billion dollars.
Moore brought an action based on conversion, breach of fiduciary duty and informed consent. The California Supreme Court dismissed the conversion request. There was no ownership interest in the body, the court said; this would hamper medical research by restricting access to raw materials and lead to a “contentious lottery”. For the court, the key value was the promotion of scientific innovation. They weren’t that concerned with Moore’s personality. Allowing patients full control over the excised tissue would, the court feared, confuse doctors in long and costly negotiations. The prospect of seeing patients shopping around for the best price for body parts or products was unappealing.
There are technical difficulties in considering bodies as goods. Bodies are neither transferable nor divisible. It is wrong to think that just because no one else owns our body, we have to. Either way, we don’t want any control rights or liability over the vast majority of our waste or bodily material that is deposited. The doctrine of surrender deals with these issues.
If the California court had ruled that Moore owned his cell line, that would mean he was entitled to all the money produced by his property. Valuable research on stem cell lines and DNA will be hampered if there is a risk that patients will claim an interest in the products.
On the other hand, as technology develops and it becomes easier to add, extract and modify the genetic basis of our bodies, not just organs, this question of ownership will only do increase in complexity.