REMEDYING THE IMMORTAL: THE DOCTRINE OF ACCESSION AND PATENTED HUMAN CELL LINES.

AuthorFissore-O'Leary, Julia E.

INTRODUCTION

Justice Cardozo once remarked, "[e]very human being of adult years and sound mind has a right to determine what shall be done with [their] own body." (1) Henrietta Lacks was not afforded this right. (2) In 1951, Lacks, a thirty-one-year-old black woman, underwent treatment for cervical cancer at Johns Hopkins. (3) Dr. Lawrence Wharton took a sample of Lacks's cervical tumor without her knowledge or consent. (4) Soon thereafter, Dr. George Gey, a prominent cancer researcher, discovered that Lacks's cells were far from ordinary: they were immortal, naturally replicating forever. (5) Today, Lacks's cells, or HeLa cells, are found in virtually every biomedical lab around the world. (6) More than 17,000 patents involve HeLa cells. (7) Indeed, Lacks's cells are behind some of the most important modern medical accomplishments--the polio vaccine, genetic mapping, and the COVID-19 vaccines. (8) Billions of people around the globe owe their lives, or at least their longevity, to Lacks's cells. (9) Accordingly, the profits reaped from the innovation borne of HeLa cells are so extensive the sum is effectively incalculable. (10) Despite this, Lacks died extremely poor, and she was buried in an unmarked grave." Today, her descendants are not even able to afford health insurance. (12)

Seventy years after Dr. Gey detected HeLa's novel capabilities, (13) the Estate of Henrietta Lacks is suing Thermo Fisher Scientific Inc. ("Thermo Fisher"). On October 4, 2021, Henrietta Lacks's descendantslevied a single cause of action against the biotechnology giant--unjust enrichment. (14) Plaintiff expounds a harrowing narrative of racial exploitation and injustice. (15) All efforts are made to emphasize the woman behind the cold, clinical cells. (16) Thermo Fisher, conversely, is cast as an opportunistic and unscrupulous adversary: "Thermo Fisher Scientific acknowledges 'the widespread but unsanctioned use of HeLa cells from Henrietta Lacks.'... [Its] business is to commercialize Henrietta Lacks' cells--her living bodily tissue--without the consent of or providing compensation to Ms. Lacks' Estate." (17) Plaintiff concludes with a colossal flourish, a prodigious ask: it requests that the Court order Thermo Fisher to "disgorge the full amount of its net profits obtained by commercializing the HeLa cell line to the Estate of Henrietta Lacks" and permanently enjoin the company from using the HeLa cell line without permission of the Estate. (18)

The case of Henrietta Lacks may appear at first blush to be an isolated circumstance--it is not. (19) The stories of John Moore, (20) Ted Slavin, (21) and Dorothy Garber (22) militate against construing Lacks as the rare story. And, while some may think that doctors taking tissues from patients without their knowledge or consent is a thing of the past, they are mistaken. Many Americans do not realize that "[w]hen you go to the doctor for a routine blood test or mole removal,... appendectomy, [or] tonsillectomy... the stuff you leave behind doesn't always get thrown out. Doctors, hospitals and laboratories keep them.... [Only] [s]ome get consent with admission forms...." (23) Perhaps more surprising, "[t]oday most Americans have their tissue on file somewhere." (24) Indeed, in 1999, the RAND Corporation circulated a report, which estimated that more than 307 million tissue samples from more than 178 million people are stored in the United States. (25) The report further assessed that each year the number of samples would increase by twenty million. (26) Thus, the issues confronting Henrietta Lacks's family do not appear to be going away any time soon. (27) The resolution of this case may have serious ramifications for past, present, and future patients. Research conducted using human cell lines could be seriously--and disastrously--curbed.

Interestingly, however, the Estate of Henrietta Lacks's unjust enrichment claim is crumbling. (28) Judge Boardman, who is presiding over the case, is overtly skeptical: she called the Lacks Estate's claim "complicated" and explained that "under [its] theory 'there's going to be claims of unjust enrichment forever.'" (29) Therefore, unjust enrichment might not be the perfect fit here. Consequently, this Note sets out to determine the proper measure of damages owed, if any, to the Lacks family. Indeed, this is a narrow, focused exercise in establishing recompense. Certainly, this is a problem that demands prompt attention--there will be future patients.

To be clear, Thermo Fisher has filed a motion to dismiss, arguing that the statute of limitations has run--essentially that the Lacks family is too late in bringing this suit. (30) This Note does not assess the merits of that claim. Nor does this Note attempt to address the myriad of ancillary intricacies. Its focal point--its central query--is what is the Lacks family owed?

This is not necessarily a new question. Prior lawsuits seeking compensation for cellular contributions to patented cell lines have failed. (31) To be sure, courts have displayed caution in this context, betraying significant apprehension as to the potential adverse implications for scientific research:

[T]he theory of liability... threatens to destroy the economic incentive to conduct important medical research.... [W]ith every cell sample a researcher purchases a ticket in a litigation lottery. Because liability for conversion is predicated on a continuing ownership interest, "companies are unlikely to invest heavily in developing, manufacturing, or marketing a product when uncertainty about clear title exists."... "[I]t is not unreasonable to conclude in these circumstances that the imposition of a harsher test for liability would not further the public interest in the development and availability of these important products." (32) Therefore, this Note propounds the application of a yet untried theory of damages in this context: the property concept of accession. Accession is a uniquely fitting remedy here and in future cell line lawsuits because it aptly weighs the patient's desire to be remedied with the substantial, countervailing need for robust clinical research. This is a complex equilibrium--made more difficult by the convolutions and realities of cell biology.

Crucially, accession's remedy is retroactive rather than prospective: restitution is calculated based on the one-off, original trespass. Accession's retrospective nature is particularly advantageous in the immortal-human-cell-line context. Otherwise, determining damages for future iterations of these eternally replicating, regenerative, and possibly mutating cells is at best an extreme administrative burden, and at worst, infeasible. (33) With the application of accession, biotech companies do not have to fear continuous and crippling monetary penalties. Accordingly, researchers' curiosity and innovative experiments are safeguarded. Further, as explained below, accession appropriately acknowledges the intellectual contributions of the scientists, doctors, and researchers involved in the Thermo Fisher patents while simultaneously recognizing the initial trespass to Henrietta Lacks and crediting her unique cellular contribution.

Importantly, though this Note employs Henrietta Lacks as the illustrative, paradigmatic case for the theory of accession it proposes, accession can be, and should be, broadly construed to apply to all like-situated patients. Part I of this Note briefly explains the timeless human-body-as-property debate. Next, Part II addresses the concept of accession--its theoretical underpinnings, definitions, and amenability to this and other lawsuits. Part III applies accession to HeLa and develops a methodology for calculating damages in this unique setting. This Note does not pretend to present a perfectly wrought formula. Instead, it offers several possibilities for determining compensation. Finally, Part IV concludes this Note by addressing lingering qualms, future action, and persistent issues that require resolution.

  1. A BRIEF OVERVIEW OF THE COMMERCIALIZATION OF HUMAN TISSUE DEBATE

    This Note first contends that human tissue should be construed as property. Consequently, it first addresses the longstanding debate surrounding the human body as property.

    The majority, concurring, and dissenting opinions expressed in Moore v. Regents of the University of California (34) aptly characterize the public policy, moral, and autonomous personhood arguments consistently present in the abiding commercialization-of-the-human-body dispute. While the Lacks lawsuit stemmed from a cervical tumor biopsy, John Moore's lawsuit was borne from a splenectomy. (35) Moore, who suffered from hairy-cell leukemia, (36) was advised by Dr. Golde to undergo surgery to remove his spleen to slow the progression of the disease." After the operation, Dr. Golde and his team extracted tissue from the excised organ, recognizing the cells' potential value for research in cancer therapies. (38) Moore was not informed of Dr. Golde's research interest in, nor the potential cell line derived from, his spleen. (39) But, in 1984, Dr. Golde as inventor and the Regents as assignee were granted U.S. Patent No. 4,438,032 on the technology developed from Moore's spleen cells. (4)" This patent generated substantial revenue through commercial arrangements with two biotech firms. (41) The patented technology using Moore's cells, generally known today as Mo or Mo T, is still sold for experimental use. (42)

    Moore eventually filed an action against Dr. Golde and his research team alleging, among other causes of action, breach of physician disclosure obligations and conversion. (43) The Supreme Court of California found for Moore with regard to the former claim, but not for conversion. (44) The majority opinion, penned by Justice Brandeis, decriesMoore's conversion theory mainly on public policy grounds--"we have... considered the impact that expanded liability would have on activities that...

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