Henrietta Lacks

UP­DAT­ED: Fed­er­al judge weighs mo­tion to dis­miss HeLa law­suit against Ther­mo Fish­er

The sto­ry of Hen­ri­et­ta Lacks’ im­mor­tal cell line and her fam­i­ly’s fight for jus­tice caught the at­ten­tion of na­tion­al me­dia out­lets and Hol­ly­wood years ago. Now, the case faces an un­cer­tain fate as a Bal­ti­more fed­er­al judge con­sid­ers toss­ing the case.

Af­ter a hear­ing on Tues­day, Judge Deb­o­rah Board­man is weigh­ing Ther­mo Fish­er’s mo­tion to dis­miss the claims against it on the grounds that the statute of lim­i­ta­tions has passed, and the con­tin­u­ing harm doc­trine does not ap­ply. Board­man is grap­pling with the “ex­tra­or­di­nar­i­ly unique facts” of the case, ac­cord­ing to Mary­land Mat­ters, which first re­port­ed the news.

The case traces back to Lacks, a Black cer­vi­cal can­cer pa­tient who was ad­mit­ted to a racial­ly seg­re­gat­ed ward at Johns Hop­kins back in 1951. While un­der anes­the­sia — and with­out her in­formed con­sent — her tis­sue was har­vest­ed and cul­ti­vat­ed in­to a cell line that could sur­vive and re­pro­duce in­def­i­nite­ly in lab con­di­tions, un­like oth­er cell sam­ples which die short­ly af­ter be­ing re­moved from the body.

While Lacks died in 1951, her cells have been aid­ed ma­jor med­ical break­throughs, in­clud­ing in vit­ro fer­til­iza­tion and the po­lio vac­cine, among oth­ers.

The es­tate of Hen­ri­et­ta Lacks filed a com­plaint back in 2021, claim­ing that Ther­mo Fish­er con­tin­ues to prof­it from the cells, known as HeLa cells, with­out per­mis­sion. The case has since played out in the pub­lic eye, be­com­ing the sub­ject of the best­selling book “The Im­mor­tal Life of Hen­ri­et­ta Lacks” in 2010 and a movie star­ring Oprah Win­frey in 2017.

Ther­mo Fish­er mo­tioned for dis­missal in Feb­ru­ary, ar­gu­ing that the statute of lim­i­ta­tions is up and the es­tate can­not al­lege an un­der­ly­ing tort. The com­pa­ny al­so claimed it was not a bona fide pur­chas­er of the cells for val­ue.

The Lacks es­tate filed a mo­tion in re­sponse, ar­gu­ing that each in­stance in which Ther­mo Fish­er sells the prod­ucts con­sti­tutes a sep­a­rate act of un­just en­rich­ment.

“The statute of lim­i­ta­tions clock for an un­just en­rich­ment claim can­not start run­ning un­til the de­fen­dant is en­riched, even if the un­just con­duct that led to the de­fen­dant’s en­rich­ment oc­curred be­fore the statute of lim­i­ta­tions pe­ri­od,” the mo­tion states.

Sev­er­al am­i­ci cu­ri­ae, or “friend of the court” briefs have been filed against Ther­mo Fish­er’s mo­tion to dis­miss. One brief from the Lawyer’s Com­mit­tee for Civ­il Rights Un­der Law, the Na­tion­al Health Law Pro­gram and the Na­tion­al Women’s Law Cen­ter ar­gues that the un­eth­i­cal ori­gins of HeLa cells are well known by the com­pa­ny, yet the com­pa­ny con­tin­ues to com­mer­cial­ize them.

Caprice Roberts, a law pro­fes­sor at George Wash­ing­ton Uni­ver­si­ty who filed an am­i­ci cu­ri­ae brief in April, told End­points News that she ex­pects the Lacks’ com­plaint to sur­vive the mo­tion to dis­miss, adding that the de­fen­dants are mis­tak­en on the law of un­just en­rich­ment.

“De­fen­dants al­so main­tain that all of this oc­curred too long ago such that wit­ness­es may be dead and ev­i­dence sta­ble,” she said in an email. “Yet, rea­sons ex­ist for per­mit­ting this case to go for­ward to dis­cov­ery es­pe­cial­ly giv­en the po­ten­tial con­ceal­ment of in­for­ma­tion that is rel­e­vant to the plain­tiff’s abil­i­ty to show the con­nec­tion of un­just prof­its from the un­con­sent­ed pro­ce­dures to the de­fen­dant’s ill-got­ten gains. To de­ny plain­tiff the abil­i­ty to move for­ward at this ear­ly phase, would fore­close dis­cov­ery and send the wrong in­cen­tives to those in po­si­tions of pow­er.”

Should the plain­tiffs pre­vail, Roberts said it will be “a his­toric mo­ment for the fam­i­ly of Hen­ri­et­ta Lacks and the po­ten­tial force of the law of un­just en­rich­ment and the rem­e­dy of dis­gorge­ment.”

An at­tor­ney rep­re­sent­ing the Lacks es­tate de­clined to com­ment, and lawyers rep­re­sent­ing the Lacks es­tate were not im­me­di­ate­ly avail­able to End­points.

The sto­ry has been up­dat­ed to re­flect com­ments from Caprice Roberts. 

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.