A suit against Novartis and Vitaris by Henrietta Lacks’ estate hinges on questions about the morality and legality of using the line for biopharmaceutical research.
Pharmaceutical companies Novartis and Viatris were hit in August with a federal lawsuit in Maryland that asserts they are unlawfully profiting from the use of the HeLa cell line. The line was created in the 1950s from cancerous cervical cells harvested from Henrietta Lacks, an African-American woman, without her consent.
The lawsuit filed by Lacks’ estate claims that despite being aware of the ethically troubled history around the origin of the cell line and the fact her cervical tissues were extracted without her knowledge, Novartis Pharmaceuticals Corporation, Novartis Gene Therapies and Viatris and its subsidiary Mylan Pharmaceuticals chose to use the HeLa cell line “as a biological factory to create and patent new drugs.”
This new legal action is a successor to lawsuits the Lacks estate filed against Thermo Fisher Scientific in 2021 for cultivating and selling HeLa cells in multiple product lines to a global market, and against Ultragenyx in 2023 for using HeLa cells to make its proprietary gene therapy products without permission from or payment to her estate. While Thermo Fisher and the estate reached a settlement, the Ultragenyx suit is ongoing.
BioSpace spoke with experts about the ethical questions at issue in the suits as well as the potential implications for companies’ bottom lines.
The Origin of HeLa Cells
Laboratory-grown human cell lines are valuable tools for studying biological processes and testing the efficacy of potential drugs. These cell lines are “immortal,” meaning that they can divide indefinitely under the right growth conditions.
For decades, scientists tried to cultivate human cell lines in the lab for study, but could not induce the cells to survive for longer periods. Then, in 1951 at Johns Hopkins Hospital in Maryland, doctor George Gey was performing a biopsy on Henrietta Lacks and put some of her cervical tissue aside for study. It turned out that the human papillomavirus (HPV) that infected her cervix had induced mutations in her cells that enabled them to keep propagating. This exceptionally durable and prolific line of cells was named “HeLa,” derived from the first two letters of Lacks’ first and last names.
Lacks succumbed to cervical cancer at the age of 31, a few months after she started her treatment at Johns Hopkins. Her immortalized cells remain an important tool in biomedical research 73 years after her passing. They played a crucial role in a number of medical and pharmaceutical milestones, including the development of a polio vaccine, IVF technology, understanding the effects of X-ray and zero gravity on cells and yielding important insights into how cells age.
Gey harvested Lacks’ cancer cells without her consent, as collecting samples from patients without their knowledge during their diagnosis and treatment was a common practice in the 1950s. It wasn’t until 1964 that the World Medical Association put forward the Declaration of Helsinki to ensure the safety of research participants, with informed consent as one of its core principles. Then, in the 1970s, Lacks’ descendants were made aware of the HeLa cell line and its origins.
The lack of consent around the HeLa cells’ extraction and use took place against a background of stark racial disparities in the U.S. healthcare system. In the 1950s, Johns Hopkins was one of the few institutions in Baltimore that would treat Black people. Johns Hopkins states that it does not own the right to the HeLa cell line and has never profited from it, instead offering the cells “freely and widely for scientific research.” But there are more than 11,000 patents involving the HeLa cell line and its derivatives that have generated large profits for life science companies—profits that were never shared with Lacks’ family.
In 2013 the National Institutes of Health and the Lacks family reached an agreement stating that NIH-funded researchers sequencing the HeLa cell lines have to submit their data to a controlled-access database. And going forward, a review board including members of the Lacks family would evaluate applications from scientists seeking to use Henrietta Lacks’s cells or genetic information.
Subsequent lawsuits brought against companies for profiting from the cells have so far had positive outcomes, with a settlement in the first case, explained Dorothee Caminiti, director of bioethics at Markkula Center for Applied Ethics at Santa Clara University, in an email to BioSpace.
“It should be kept in mind, however, that the use of HeLa cells is far from the only example of the unethical use of human genetic material for research purposes,” Caminiti added.
Nicole A. Fisher, a health equity and ethics consultant, pointed to the example of the Michigan Neonatal Biobank, which has faced legal challenges where the lawsuit alleged that its samples were collected without adequate consent from parents and then sold and commercialized for research.
She said that lawsuits against big companies, like the one filed by Lack’s estate, can create public awareness around the need for stricter regulations for safeguarding genetic information.
What Do Lawsuits Mean for the Use of HeLa Cells?
The Lacks estate, represented by Henrietta’s grandson Ron I. Lacks, filed the suit against Novartis and Vitaris under the theory of unjust enrichment, meaning that one party benefits at the expense of another under circumstances the law finds unjust.
The lawsuit outlines Novartis’ use of HeLa cells in the testing of its antiviral drug Famvir, which treats herpes infections. The lawsuit claims that the pharmaceutical giant generated billions of dollars in revenue from the drug before selling it to another pharmaceutical company, Atnahs Pharma UK Limited, in 2018. The complaint also highlights Viatris’ and Mylan Pharmaceuticals’ use of HeLa cells to test Denavir, an antiviral drug to treat cold sores caused by herpes simplex virus that generated $28 million in U.S. annual sales in 2021. It also mentions Mylan’s Mirtazapine, a treatment for major depressive disorder whose effects on DNA were tested using HeLa cells.
Novartis declined to comment on the case, and Viatris did not respond to BioSpace’s request for comment.
The lawsuit was filed in the U.S. District Court of Maryland. Should it survive an expected Motion to Dismiss, the defendants must file a response and present any affirmative defenses in response to the lawsuit. This is when a critical phase of litigation called discovery begins, as both parties seek and demand information relevant to the case.
“Big companies . . . are likely to want to avoid discovery as they can potentially have many of their internal records subject to review by the attorneys for the Estate of Henrietta Lacks,” Raul Gastesi, partner and co-founder of Florida-based Gastesi Lopez & Mestre, PLLC, wrote in an email to Biospace after analyzing the lawsuit.
Kirk Sigmon, an attorney at Banner & Witcoff Ltd., a Chicago-based law firm, wrote in an email to BioSpace that it is unlikely any company would want to be remotely associated with Henrietta Lacks’ exploitation. He noted that the case between Lacks’ family and Thermo Fisher Scientific was likely settled because it involved very uncomfortable and uncertain issues.
“The cases involving the Lacks estate are extremely complicated, in no small part because—while almost everyone would agree that what happened to Henrietta Lacks was an ethical injustice—the legal issues are uncertain,” Sigmon added. “It would not surprise me if other companies sued by the Lacks family will settle as well: sometimes it’s easier to settle than to gamble on an uncertain result in court, even if you think you have good arguments.”
He also pointed to the possibility of the Lacks family taking legal action against additional companies using HeLa cells. However, Sigman said it’s unlikely that companies will stop using the HeLa cell line, since its contributions to medical research are invaluable and finding alternatives might prove to be challenging.
Jay Patel, a senior pharma analyst at GlobalData, offered another possible explanation for why companies might be inclined to settle. “Most institutional investors include Environment, Social and Governance policies in their investment strategies. It is possible that investors will privately encourage companies to provide recourse in line with the ‘Social’ element of these policies,” he wrote in an email to BioSpace.
Potential Impact on Market Value
The extent to which civil litigation impacts a pharmaceutical company’s stock price and its market value is largely determined by the probability of the lawsuit succeeding, the market’s reaction to a negative ruling and any negative publicity generated from the case, Patel explained.
He also pointed out that the lawsuit filing had no significant effect on the market value of Novartis and Viatris. This, he said, can be attributed to uncertainty around its outcome alongside the companies’ large market size and investors’ belief that some negative press would not substantially harm their financials.
