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Abortion rights supporters gather in front of the J Marvin Jones Federal Building and Courthouse on March 15, 2023 in Amarillo, Texas.

Moises Avila | AFP | Getty Images

A federal judge in Texas this week heard arguments for the first time in a closely watched case challenging the Food and Drug Administration’s approval of mifepristone.

Wednesday’s hearing in Amarillo was open to the public but was not broadcast live.

Judge Matthew Kacsmaryk of the US Northern District of Texas in Amarillo heard arguments for four hours. The anti-abortion group that filed the lawsuit, the Alliance Defending Freedom, first presented its case against the FDA. They were followed by Justice Department attorneys who defended the FDA, and then abortion pill maker Danco Laboratories.

The Alliance Defending Freedom argued that mifepristone was unsafe and the FDA did not properly follow its approval process when clearing mifepristone for use in 2000. The Justice Department strongly denied these claims, arguing that the FDA used its Congressional-approved powers to approve a drug it determined is safe and effective.

Download a full copy of the hearing transcript here.

“This court will issue a decision and an opinion as soon as possible,” Kacsmaryk said at the end of the hearing.

Erik Baptist, Alliance Defending Freedom’s top attorney, told the judge he had the authority to order the FDA to begin its internal process to withdraw a drug from the market, but argued that such action would be inappropriate in this case because it the case could last “many years”.

Instead, Baptist argued that the court could “of its own accord” order the FDA to withdraw the drug, rather than relying on the agency to initiate its internal procedures to do so.

“Any relief you grant, Your Honor, must be complete. The plaintiffs’ scope of this relief must be universal and nationwide,” Baptist told the judge.

Kacsmaryk asked Baptist to explain why the court had such “broad authority.” Baptist said the court has the authority to “take all measures necessary to prevent harm.” The judge also asked Baptist if he could point to another case where a court had withdrawn a drug that has been on the market for more than 20 years.

“My answer to your question is no, I can’t,” Baptist said, although he argued that this was because the FDA had denied previous requests to withdraw mifepristone and impose tighter restrictions.

Julie Straus Harris, a Justice Department attorney, said the statute of limitations prevented plaintiffs from challenging the FDA’s 2000 approval of mifepristone. Harris argued that the public interest would be “irreparably harmed” by an order to take mifepristone off the market.

“An injunction would cause significant harm to the public and deprive patients and physicians of a safe and effective drug that has been on the market for more than two decades,” Harris said. She argued such an order would upend the status quo and harm patients, physicians and the pharmaceutical industry’s reliance on FDA approvals.

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Kacsmaryk sparked controversy ahead of oral arguments after the Washington Post reported that he had tried to keep news about the hearing’s timing private. Citing death threats and harassment, Kacsmaryk told lawyers involved in the case that “less publicity is better” during a conference call last week, according to a court transcript.

The court finally relented and announced the date Monday after media outlets, including NBCUniversal News Group, which owns CNBC, filed a letter criticizing the move as “unconstitutional.”

“The court’s attempt to delay notification and thereby the ability of the public, including the press, to attend Wednesday’s hearing is unconstitutional and undermines the important values ​​served by public access to court proceedings and court records,” he wrote to Peter Steffensen of Southern Methodist University’s Dedman School of Law on behalf of the media.

Former Theranos CEO Elizabeth Holmes (C) arrives in federal court with her mother Noel Holmes (L) and father Christian Holmes in San Jose, California, September 01, 2022.

Justin Sullivan | Getty Images

Elizabeth Holmes failed to pay back more than $25 million to creditors at her former company Theranos as she tries to extend her 11-year sentence, according to a lawsuit.

Theranos ABC, a corporation formed on behalf of its creditors, alleges in a lawsuit filed in the Superior Court of California in Santa Clara County that “Holmes failed to make payment on any of the promissory notes.”

The lawsuit was filed in December 2022 but only came to light on Friday when Holmes appeared in court.

According to the breach of contract lawsuit, Holmes executed three promissory notes while she was CEO of the failed blood testing company. According to the lawsuit, the promissory notes read as follows:

August 2011 in the amount of $9,159,333.65.

December 2011 in the amount of $7,578,575.52.

December 2013 of $9,129,991.10.

According to the complaint, “Theranos ABC demanded payment of Promissory Note #1 and Promissory Note #2 from Holmes, but Holmes failed to pay any amounts pursuant to the Promissory Note.”

Theranos ABC’s attorneys did not immediately respond to a request for comment.

Two of the promissory note payments were due for the first time in 2016 and the third in 2018. In July 2016, the board of directors of Theranos, which then included Holmes, former Secretary of Defense James Mattis, attorney David Boies, and former Bechtel Group CEO Riley, amended terms to include Bechtel and former Wells Fargo CEO Richard Kovacevich to extend the bonds by five years. The first two notes are overdue and the third is due in December, the lawsuit said.

Holmes returned to federal court in San Jose, Calif., on Friday, asking that her report date next month in prison be postponed while she appeals her conviction. A man leading the lawsuit approached Holmes at her lawyers’ table in the courtroom. The man, who was becoming increasingly upset, was taken away by marshals. It could not be immediately confirmed if he was a bailiff trying to serve Holmes with the lawsuit.

In January 2022, a jury found Holmes guilty on four counts of wire fraud and conspiracy. Holmes was ordered to turn herself in to begin her sentence on April 27, 2023. Her attorneys have signaled their intention to appeal Holmes’ case to the Ninth Circuit Court of Appeals.

Following her guilty verdict last year, Holmes became pregnant and gave birth to a second child.

A lawyer for Holmes gave several reasons why she poses no risk of escaping, including her young children, and that she has been out on bail without escaping for more than a year.

However, the government pointed to a one-way ticket that Holmes and her partner Billy Evans booked to Puerto Vallarta, Mexico days after their conviction.

Holmes is also at odds with prosecutors over how much compensation she should pay. Prosecutors want her to pay nearly $900 million, while Holmes argues the government failed to prove investors relied on her allegations.

US District Court Judge Edward Davila plans to rule on both applications in early April.

Holmes founded Theranos in 2003 after dropping out of Stanford with a promise to revolutionize the healthcare industry. The company shut down in 2016 after a series of failed regulatory inspections and articles by then-Wall Street Journal reporter John Carreyrou.

A man wearing a face mask as a preventive measure against Covid-19 walks past a Communist Party flag in Wuhan, China, March 31, 2020.

Noël Celis | AFP | Getty Images

The World Health Organization on Friday urged China to release new data linking the origins of the Covid pandemic to animal samples in the Wuhan market, after the country recently halted research.

The agency said China’s Center for Disease Control and Prevention uploaded data to the public virus tracking database GISAID in late January relating to samples taken at Wuhan’s Huanan Market in 2020.

Researchers from several countries downloaded and analyzed the data before removing it, presenting their findings to the WHO last weekend. The researchers found molecular evidence that raccoon dogs and other animals susceptible to Covid were being sold at the market, consistent with hypotheses about the virus spilling over from a wild animal to humans.

The new data doesn’t provide a conclusive answer as to how the pandemic began, “but it does provide more clues” to a potential host of the virus that transmitted it to humans, said Maria Van Kerkhove, the WHO’s technical lead for Covid-19 . She urged China to release the data publicly so the WHO and other researchers can further analyze it and get closer to understanding the origins of a pandemic that has killed millions of people worldwide.

“The big problem right now is that this data exists and is not readily available to the international community,” said Van Kerkhove. “First and foremost, this is absolutely critical, not to mention that it should have been available years earlier, but that data needs to be made available for people to access, analyze and discuss with one another. “

The WHO call comes as the debate over the origin of Covid intensifies. Researchers bicker over competing theories and governments stake out positions on what to do next.

The New York Times reported the new data earlier Thursday. Researchers told the Times that starting in January 2020, the molecular data was collected from swabs taken from walls, floors, metal cages and carts in and around the market. At that point, the Chinese government had already closed the market on suspicion of a link to the Covid outbreak.

The researchers added that large amounts of the data were no match for raccoon dogs.

Van Kerkhove stressed that the data does not necessarily prove that a raccoon dog or other animal was infected with the virus and transmitted it to humans. But she said it is found that animals capable of transmitting Covid have been sold at the market which is ‘new information’.

It is not known where the animals came from and whether they were wild or domesticated, she added. According to Van Kerkhove, the WHO is pushing for studies to be conducted in other markets in Wuhan and across China. It also looks for serological tests, which measure antibodies, for people who have worked in the markets.

Van Kerkhove also noted that “all the hypotheses” about how Covid entered the human population are still on the table. She said further investigation is needed into possible biosecurity breaches by a lab or whether the virus originated in a bat before spreading to humans.

“We don’t have all the information in front of us and we need to be able to look at all these different hypotheses. We have to look at all the data that is needed to evaluate each and every one of them so we can say that this may have happened, this may not have happened,” she said.

She added that the WHO “will not be able to remove various hypotheses” until China uploads its data again.

FBI Director Christopher Wray said earlier this month that the FBI believes Covid most likely originated in a Chinese government-controlled laboratory.

In February, the Department of Energy assessed “with low confidence” that Covid had leaked from a lab.

About 44% of US adults believe the virus leaked from a virology lab in Wuhan, China, according to a Morning Consult poll released last month, while 26% say it passed naturally from animals to humans .