The opinions expressed here are those of the author, a columnist for Reuters.
By Jenna Greene
Feb 23 (Reuters) - In a little-noticed move, Novartis last week settled a lawsuit by the estate of Henrietta Lacks, resolving claims that it profited from using her "immortal" cells without permission.
The confidential deal doesn’t end the broader legal campaign by Lacks’ heirs. Litigation against other drugmakers that have relied on her cell lines to fuel biomedical research is heating up after a federal judge in Maryland last year refused to dismiss the claims as time-barred.
In each case, the family alleges unjust enrichment: that drugmakers wrongly used the “HeLa” cell line derived from tissue taken from Lacks without her knowledge or consent to develop new products.
Lacks, whose story became a best-selling book and as well as a movie, sought treatment for cervical cancer in 1951 in Baltimore. Doctors used a sample of her tumor to cultivate the first-of-its-kind cell line, unique in its ability to endlessly grow and divide in a laboratory setting. Lacks died of cancer later that year at age 31.
Since then, HeLa cells have been used by researchers working on everything from the polio vaccine to HIV treatments to sunscreen.
In a joint statement, Novartis and Lacks' family said they were "pleased they were able to find a way to resolve this matter filed by Henrietta Lacks' Estate outside of court" and declined further comment.
The agreement follows a 2023 settlement between Lacks' heirs and biotech company Thermo Fisher Scientific resolving similar claims for an undisclosed sum. Separate suits against Ultragenyx Pharmaceutical and Viatris (formed in 2020 by the merger of Mylan Pharmaceuticals and Pfizer's Upjohn business) remain pending.
Ultragenyx declined to comment and Viatris did not respond to a request for comment.
Plaintiffs' lawyer Christopher Ayers told me additional litigation against other pharmaceutical and biotech companies is likely to be forthcoming.
Along with co-counsel including Christopher Seeger and Ben Crump, he represents Lacks' grandson Ron Lacks, the personal representative of her estate, who sued Novartis in Baltimore federal court in 2024.
Lacks alleged the Swiss drugmaker owns hundreds of patents developed through use of the HeLa cell line, but has never compensated the estate for doing so.
The complaint also stressed themes of racial injustice, placing the "theft" of tissue from Lacks, who was Black, in the larger context of the "long, troubled racial history" of medical research.
Based on scant entries in the court docket, Novartis seemed to have little appetite to litigate the case. The company, which was represented by lawyers from Hogan Lovells, didn't file a response to the suit. Instead, it requested a series of continuances to submit its reply that stretched 18 months until the parties reached a settlement.
Viatris, which is also represented by lawyers from Hogan, was named as a defendant in the same complaint. To date, it has also not filed a substantive response to the allegations, and Hogan partner Rebecca Mandel did not respond to a request for comment. The litigation against the company remains pending.
Ultragenyx, by contrast has mounted a vigorous defense, only to hit two early roadblocks.
The California-based biopharma company, which is known for developing drugs to treat rare diseases, was sued by the Lacks' estate in 2023. In court papers, Ultragenyx says it has done nothing wrong and that Lacks has no viable claim against it.
While the company in acknowledges it has used HeLa cells in research, it says it has never sold a consumer product made from them, nor has it made "one cent of profit from HeLa cells, let alone 'tremendous profits.'"
Unswayed, U.S. District Judge Deborah Boardman in 2024 denied the company’s motion to dismiss the case. In a 76-page opinion, the Joe Biden appointee held that if the plaintiff’s allegations are true, it is plausible that Ultragenyx could be found liable for unjust enrichment.
Still, there’s the question of the statute of limitations, which in Maryland is three years for such claims.
Ultragenyx argues that the Lacks family knew about the alleged wrongs for decades but waited too long to take legal action. For example, they point to a 1997 documentary where Ron Lacks mentioned consulting lawyers about the use of his grandmother's cells, as well as the 2010 book by journalist Rebecca Skloot, "The Immortal Life of Henrietta Lacks."
The plaintiffs counter that a loophole in Maryland law prevents Ultragenyx from using the statute of limitations as a defense.
They argue that the Novato, California-based company has conducted intrastate business in Maryland, including hiring local sales representatives, doing research and entering partnerships with local entities, but failed to register with the state.
It’s a seemingly modest bureaucratic requirement, but under an obscure Maryland law enacted in 1938 (an era when common law only allowed state courts to exercise jurisdiction over defendants served within the state), the penalty for noncompliance can be huge.
If Lacks can prove that Ultragenyx conducted intrastate business in Maryland without registering to do so, Broadman held last year, "Ultragenyx may not benefit from the statute of limitations."
In an emergency petition to the 4th U.S. Circuit Court of Appeals, Ultragenyx protested the provision known as Section 5-204 is unconstitutional, violating the Commerce Clause's prohibition on laws that unjustifiably discriminate against or burden interstate commerce.
The appeals court in April 2025 declined without explanation to take up the case.
It's not just Utragenyx facing exposure. According to the plaintiffs, Novartis forfeited its registration in Maryland in 2018 for failure to file a property return, and Viatris has never been registered to do business in the state.
After the 4th Circuit declined the mandamus petition, Ultragenyx and the Lacks estate paused the proceedings for settlement talks, according to court filings. At the parties' request, the court lifted the stay last week and moved the case back into active litigation, setting a series of deadlines over the next year to ready the case for trial.
(Reporting by Jenna Greene)
((jenna.greene@thomsonreuters.com;))