Author: Justine Deitz

Before viewing HBO’s recent release of The Immortal Life of Henrietta Lacks, it is appropriate to gain an understanding of the true story that give rise to the film. The story begins with Henrietta Lacks, a poor black tobacco farmer from Virginia who reported to Johns Hopkins Hospital in 1951 with complaints of a “knot in her womb” and abnormal bleeding following the birth of her fifth child. After shuffling her to the segregated colored ward for treatment, Lacks’ physician gave her a devastating diagnosis: advanced cervical cancer. Less than a year later, just months after her 31st birthday, the malignant cells coursing throughout Lacks’ body caused her early death.

Yet unbeknownst to Henrietta or her family, she would continue to live on for decades following her death. During the course of her treatment, Henrietta’s physician, Dr. George Gey, received a sample of her cells. Dr. Gey incorporated the cells into his research, which involved an ongoing search for “immortal” cells, or cells that would continuously divide and grow after removal from a patient. Dubbed HeLa cells, Henrietta’s cells turned out to be the miraculous cells Dr. Gey sought; they would go on to revolutionize modern medical research. The cells played an integral role in the development of the polio vaccine, and their use was included in cancer, AIDS, radiation, and gene mapping research over the decades following Henrietta’s death. HeLa cells were also the first human cells to survive the cloning process in 1955.

Despite the widespread use of Henrietta’s cells, her family possessed no knowledge of their circulation until more than 20 years after her death. The Lacks’ family first learned about HeLa cells in the 1970s, when a scientist contacted the family to request their blood samples and other genetic materials. The family followed up on these requests with multiple inquiries about the status of HeLa cells and further information about their uses and distribution, but their questions remained unanswered until the late 1990s and early 2000s. During that period, the release of an award-winning documentary by the BBC and a bestselling book by Rebecca Skloot started to peel back the layers of the HeLa cell story.

Throughout their long and controversial history, HeLa cells raised a number of legal questions relating to the notions of informed consent and property rights. First, researchers all over the world used Lacks’ cells for medical research without her knowledge or consent (or her family’s). A landmark decision in the Supreme Court of California addressed a similar issue in the 1990 case Moore v. Regents of the University of California. In that case, John Moore argued that personal ownership of his cells continued after their removal from his body during a course of leukemia treatment. But the court disagreed, and denied Moore’s claim for conversion. The court’s weariness of Moore’s argument stemmed from fears that including bodily tissues under the umbrella of property rights would have a chilling effect on medical research. Based on this case, it appears there is little chance that a tort liability suit over the use of Lacks’ cells would have much success.

Yet other violations of Lacks’ personal information occurred as well. In 1976, Science Magazine published the article Genetic Characteristics of the HeLa Cell. Without seeking consent from the Lacks family, the article contained private information about the genetic markers contained in the DNA of Henrietta and her family members. Because DNA reveals the most fundamental makeup of a person’s body, and reveals private information about abnormalities and/or predispositions to disease, this publication constituted another circumstance where the Lacks’ family’s private information was put on public display without their consent. In a similar vein, Johns Hopkins released Henrietta’s private medical records to journalist Michael Gold in 1985 for use in his book A Conspiracy of Cells: One Woman’s Immortal Legacy and the Medical Scandal It Caused.

Some might call Henrietta’s story and its legacy a perfect storm of privacy violations. It is important to remember that the concept of informed consent barely existed in the 1950s, and statutory privacy protections such as HIPAA were still decades away from existence when her cells were first taken and used for research. Though it is now an extensive field providing comprehensive protections, the topic of medical privacy still faces some significant obstacles. One of the most difficult issues for researchers in the medical field to overcome is their inability to prospectively determine biospecimen uses and research. As HeLa cells displayed, sometimes the range of possibility connected to a specific cell or tissue sample is not determined until after scientists conduct further research on the sample. Patients are understandably weary of signing over samples for any and all uses, creating strict limitations on researchers and the ways they may use human samples. Other significant obstacles to informed consent include lack of understanding on behalf of the patient, questions surrounding the life of the consent, and ethical considerations regarding the proper time and scenario to ask patients for consent.

As the fabric of American healthcare continues to grow and change on a regular basis, these obstacles pose concrete challenges to healthcare professionals and legal practitioners in the healthcare field. Henrietta Lacks’ contentious cells may continue to teach us new lessons about privacy and informed consent for decades to come.

In September, 2015, the New York City Board of Health approved a new sodium warning measure. The law requires chain New York City restaurants with 15 or more locations nationwide to display a salt shaker symbol next to menu offerings that contain more than 2,300 mg of sodium. Shortly following the regulation’s announcement, the National Restaurant Association sued NYC, arguing that the law was arbitrary and capricious because the science regarding sodium’s health effects remains unsettled. On February 10, a New York appeals court allowed the rule to remain in force by affirming the trial court’s rejection of the National Restaurant Association’s arguments.

A stay was initially placed on the regulation shortly following its creation, preventing its enforcement until May, 2016. At that time, the Appellate Division of the New York State Supreme Court lifted the stay, and allowed enforcement of the rule throughout New York City. Health Commissioner Dr. Mary T. Bassett publicly applauded the decision, stating that the ruling “allows New Yorkers to make informed and better decisions about their diets and their health.” The Manhattan Appellate Division of the State Supreme Court then affirmed the 2016 decision in last month’s holding.

In the court’s opinion, Justice Ellen Gesmer pointed out the health risks of high-sodium foods and dishes: “Excess consumption of sodium, the primary ingredient of salt, can cause high blood pressure, which is in turn correlated with a higher risk of cardiovascular disease, congestive heart failure and kidney disease, according to the overwhelming consensus among scientists and the federal agencies charged with protecting the nation’s health.” Justice Gesmer continued by clarifying the reasoning behind the court’s decision, and pointing out that this mandate differed from other NYC dietary restrictions that came before it because it did not interfere with citizens’ personal autonomy when making individual food choices. Bloomberg’s big-soda ban, for example, entirely prohibited consumers from purchasing large sodas. The salt warnings, on the other hand, merely inform the consumer about the levels of salt rather then restricting them from purchasing such dishes altogether.

The mandate was opposed by the New York State Restaurant Association, an ardent advocate against governmental regulation of dietary information and regulation. The association fought a similar law in 2009. In that case, New York State Restaurant Association v. New York City Board of Health, the association asserted that a city law requiring chain restaurants with 15 or more locations nationwide to post calorie content information on menus and menu boards was both preempted by federal law and unconstitutional. Meeting a similar demise to the argument in the recent salt warning case, the NYC calorie warning regulation was upheld in the Second Circuit Court of Appeals on the grounds that the city law was reasonably related to its goal of reducing obesity.

The regulation (and the NY Court’s decision to uphold it) is increasingly relevant as local, state, and federal legislatures consider similar dietary warnings and regulations, and courts at all levels grapple with what constitutes an appropriate amount of government involvement (if any) in private citizens’ dietary decisions. What remains to be seen is how these and other regulations actually influence consumer decisions. American University Washington College of Law Professor Lindsay Wiley wrestles with these important questions in her 2014 research about the impact of product configuration bans. Wiley suggests that, despite the fact that such regulations are subject to a great deal of public discourse, their high visibility might lead to long-term decreases in portion size and increases in the availability of balanced meals. Despite such research, this field continues to be largely unchartered territory as the United States attempts to mitigate the nation’s growing obesity and health care epidemic.