Lacks v. Ultragenyx Pharm.

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RON L. LACKS, PERSONAL REPRESENTATIVE OF THE ESTATE OF HENRIETTA LACKS, Plaintiff, v. ULTRAGENYX PHARMACEUTICAL, INC., Defendant.

Civ. No. DLB-23-2171

United States District Court, D. Maryland

May 20, 2024

MEMORANDUM OPINION

DEBORAH L. BOARDMAN UNITED STATES DISTRICT JUDGE

Over 70 years ago, Henrietta Lacks, a Black woman from Baltimore County, Maryland, entrusted doctors at Johns Hopkins Hospital with the treatment of her cervical cancer. She was admitted to a segregated ward and placed under general anesthesia. Then, without her knowledge and without any medical basis doctors cut out samples of her cervical tissue and seized her cells. A few months later, her cancer ended her life. She was buried in an unmarked grave.

Yet the end of Henrietta Lacks' life was not the end of her story. As it turned out, her cells could replicate indefinitely under the right conditions. As a result, the “immortal” cells that now bear her name-HeLa cells-have enabled scientists around the world to conduct breakthrough medical research that has saved the lives of countless people Henrietta Lacks herself never knew.

The Estate of Henrietta Lacks, represented by her grandson Ron L Lacks (“Lacks”), claims these HeLa cells also have made some pharmaceutical companies a lot of money-money rightly due Henrietta Lacks' family. On August 10, 2023 Lacks sued one of those companies, Ultragenyx Pharmaceutical, Inc. (“Ultragenyx”), for unjust enrichment. Ultragenyx has moved to dismiss the one-count complaint for failure to state a claim. Ultragenyx's motion is denied. Lacks has stated a claim for unjust enrichment. His case may proceed.

I. Background

These are the facts as Lacks alleges them.

Henrietta Lacks was a Black woman, a mother, and a community leader in Baltimore County. ECF 1, ¶ 1. In January 1951, doctors at Johns Hopkins Hospital diagnosed her with cervical cancer. Id. ¶ 40. Her treating physician recommended radium treatment-an aggressive approach that would require surgery under general anesthesia. Id. ¶ 41. Her doctor did not tell her that radium treatment would render her infertile. Id. He also did not tell her that the surgeon would perform another procedure while she was anesthetized: cutting tissue from her cervix. Id. ¶ 42.

That seizure of Henrietta Lacks' tissue had nothing to do with treating her cervical cancer. Id. Its purpose was to advance the research agendas of two white doctors at Johns Hopkins: Dr. Richard Wesley TeLinde and Dr. George Gey. See id. ¶¶ 33-36, 41, 43-46. TeLinde, the hospital's chair of gynecology, wanted cervical cancer samples he could use to justify his notoriously aggressive treatment techniques by showing that the cancer he targeted was as deadly as other forms of cancer. Id. ¶¶ 33-34. Gey, the hospital's head of tissue research, wanted samples of human tissue he could use to cultivate a cell line-a culture of cells with a common lineage and uniform makeup-capable of reproducing indefinitely under laboratory conditions. Id. ¶¶ 34-35. Normally, cell samples die after they are removed from the human body. Id. ¶ 6. Cultivating a cell line that could survive would enable scientists to study them and conduct experiments that would otherwise be impossible. See id. ¶¶ 34-35, 47. Gey styled himself “the world's most famous vulture, feeding on human specimens almost constantly.” Id. ¶ 3.

Together, TeLinde and Gey devised a plan. Id. ¶¶ 34-36. Surgeons under TeLinde's supervision would take tissue samples from Black women with cervical cancer in the segregated wards at Johns Hopkins Hospital without the women's knowledge or consent. Id. ¶ 36. One of TeLinde's colleagues observed, “Hopkins, with its large indigent [B]lack population, had no dearth of clinical material.” Id.

TeLinde, Gey, and their collaborating colleagues were not unique in seeing Black patients more as “clinical material” than as human beings. See id. ¶¶ 37-39. In this same era, the U.S. Public Health Service, working with the Tuskegee Institute in Macon, Alabama, denied hundreds of Black men treatment for syphilis to study how the disease progressed. Id. ¶ 37. Over two dozen of them died of syphilis and over 100 more died from complications. Id. Doctors systematically sterilized poor Black women through a procedure known as the “Mississippi Appendectomy”: a hysterectomy under the pretense of an appendectomy. Id. ¶ 38. During the Second World War, the United States tested chemical agents on Black men and threatened to incarcerate any who objected. Id. ¶ 39.

On February 5, 1951, in a ward for Black women at Johns Hopkins Hospital in Baltimore, Maryland, a surgeon working for TeLinde cut two three-quarter inch samples of tissue from Henrietta Lacks' cervix-without her knowledge or consent-and gave them to Gey. Id. ¶ 43. As it happened, the radium treatment that she did consent to did her no good. Id. ¶ 5. On October 4, 1951, Henrietta Lacks died of cervical cancer. Id. ¶ 45.

Yet Henrietta Lacks' cells lived on after her death. Id. ¶¶ 44-46. For reasons unknown to Gey, her cells had the very quality Gey sought. Id. Unlike the other cells Gey had tested before, Henrietta Lacks' cells could reproduce indefinitely under laboratory conditions. Id. Eventually, her immortal cells came to be known as “HeLa cells.” Id. ¶ 6.

In the years that followed, HeLa cells were distributed for free to scientists across the globe. Id. ¶ 47. The HeLa cell line became the foundation for countless medical research projects. Id. HeLa cells enabled-and still enable-transformative breakthroughs, from the polio vaccine to in vitro fertilization to treatment for sickle cell anemia. Id. ¶¶ 8, 47. Henrietta Lacks' contributions to medicine are incalculable. See id. ¶ 8.

Even as Gey promoted the HeLa cell line, he and Johns Hopkins endeavored to keep its real origins secret. Id. ¶¶ 46, 48. Gey claimed the cells came from a woman named Helen Lane. Id. ¶ 48. Despite these efforts to obscure the HeLa cell line's origins, the scientific community knew that the cell line originated in nonconsensual, non-therapeutic medical experimentation on Black patients. Id. ¶ 49. In more recent years, the story of Henrietta Lacks has become widely known to the scientific community and to the public. Id. ¶¶ 50, 61.

Ultragenyx is a pharmaceutical company that develops drugs to treat “orphan diseases.” Id. ¶ 19. An orphan disease is a disease impacting so few people that developing treatments typically is not profitable. Id. ¶ 9. Much of Ultragenyx's drug development is focused on gene therapy. Id. ¶ 10. Gene therapy depends on the manufacture of adeno-associated virus (“AAV”) vectors, which deliver into cells genetic material that enables them to produce therapeutic proteins. Id. AAV vectors are very difficult to produce at scale. Id.

To grow AAV vectors at scale, Ultragenyx relies on HeLa cells. Id. ¶¶ 11-12, 14, 53-61. The company has developed a proprietary HeLa cell platform for that purpose. Id. ¶¶ 12, 54, 56. In the words of Sam Wadsworth, Ultragenyx's Chief Scientific Officer:

The HeLa platform is the most advanced platform that we have. It is a highly engineered system for manufacturing AAV gene therapy vectors using HeLa cells. The elements of the platform are finely tuned to work in concert to produce AAV vectors at the scale and quality required for our products.... We like to think of this as letting biology do the work.

Id. ¶ 12. By working with HeLa cells, Ultragenyx has been able to research, develop, and manufacture a range of gene therapies. Id. ¶¶ 64-68. Ultragenyx also has monetized its HeLa cell platform through partnerships with other pharmaceutical companies, including a $200 million licensing deal with Daiichi Sankyo Company. Id. ¶ 58. And Ultragenyx has secured millions of dollars of federal funding for AAV vector development. Id. ¶ 67. In these ways, Ultragenyx “reap[s] huge profits that would never have been possible without Henrietta Lacks's cells.” Id. ¶ 14; see also id. ¶¶ 53-55, 61, 64. In 2022, Ultragenyx reported total revenues of $363 million and a year-end cash balance of $896.7 million. Id. ¶ 23.

On Lacks' account, Ultragenyx has known the story behind the HeLa cell line “since the development of its manufacturing platform.” Id. ¶ 51; see also id. ¶ 13. Ultragenyx even acknowledges that the HeLa cell line originated with the wrongful seizure of tissue from Henrietta Lacks. Id. ¶ 13. When Henrietta Lacks “received treatment at then-segregated Johns Hopkins Hospital . . . tissue samples were collected and replicated without her knowledge,” a page on Ultragenyx's website explains, “help[ing] scientists achieve numerous medical breakthroughs.” Id. ¶ 51. Lacks also alleges Ultragenyx never paid the real value of the HeLa cells it acquired, id. ¶ 78; never compensated the Lacks Estate for their possession or use; Id. ¶ 70; and never sought or received the permission of the Estate to use them, Id. ¶ 14.

Ultragenyx is incorporated in Delaware and headquartered in California. Id. ¶ 18. Nevertheless, some of Ultragenyx's work takes place in Maryland. Id. ¶¶ 26-29. The company has employees based in Maryland, such as marketing personnel who promote the company's work to Maryland physicians. Id. ¶ 29. The company conducts research and drug development in Maryland as well. Id. ¶¶ 26-28. Ultragenyx has recruited patients for and conducted clinical trials at the National Institutes of Health Clinical Center in Bethesda. Id. ¶ 26. Since 2018, Ultragenyx has paid doctors at Johns Hopkins Hospital over $1.1 million for research and consulting. Id. ¶ 28. In November 2021, Ultragenyx paid Johns Hopkins University $116,382.39 for a study. Id. Ultragenyx's Maryland research and development expenditures include payments for work to commercialize HeLa cells. ...