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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 .

The pill Paxlovid, used to treat coronavirus disease (COVID-19), is seen in boxes at the Misericordia hospital in Grosseto, Italy, February 8, 2022.

Jennifer Lorenzini | Reuters

The Food and Drug Administration’s independent advisory panel on Thursday recommended full approval of Pfizer’s Covid-19 antiviral pill Paxlovid for high-risk 16-1 adults, but pointed to potentially harmful drug interactions.

Treatment is recommended for people over 50 or those suffering from a variety of conditions, such as high blood pressure or diabetes, that put them at higher risk of ending up in hospital or dying from Covid.

The FDA first made Paxlovid available for emergency use in high-risk individuals ages 12 and older in December 2021. Pfizer submitted an application for full approval of the drug in June 2022, but the FDA extended its review deadline for the application in December 2022.

The agency generally follows the advice of its advisory committees, but is not obliged to do so. A final decision will be made in May.

“I would say that along with oxygen, Paxlovid has probably been and continues to be the most important treatment tool during this epidemic,” said Richard Murphy, chief of infectious diseases at Veterans Affairs White River Junction Medical Center.

The panel relied on three of Pfizer’s mid- to late-stage clinical trials of Paxlovid, which enrolled more than 6,000 patients in 21 countries.

86% effective

A study called EPIC-HR looked at high-risk adults who were unvaccinated and had no prior Covid infection. The study found that Paxlovid reduced the risk of hospitalization or death by 86% in adults treated within five days of symptom onset and by 89% in those treated within three days of symptom onset, such a review of the company’s data by the FDA.

“I found the efficacy data clear and compelling,” said Dr. Sankar Swaminathan, chief of the Department of Infectious Diseases at the University of Utah School of Medicine.

However, the advisors agreed that serious side effects due to drug-drug interactions or DDIs are an important safety issue with Paxlovid.

Photo taken on July 31, 2022 shows a health worker taking a swab sample from a woman to test for the Covid-19 coronavirus at a swab collection center in Guangzhou, southern Guangdong province. About a third of people with Covid will experience recovery in their symptoms regardless of whether they have been treated with the antiviral Paxlovid, according to a study published online on Tuesday.

St. | AFP | Getty Images

“I just want to emphasize that we underscore the importance of risk reduction for the prescriber, primary care provider, physician and other prescribers in relation to drug-drug interactions,” said Dr. David Hardy, associate clinical professor of medicine at the University of Southern California.

“That’s where I think we could get in trouble, I should say where they would get in trouble if they prescribe this drug without knowing well what ritonavir does to other drugs,” he said. Paxlovid consists of two antiviral drugs, ritonavir and nirmatrelvir.

Interactions with other drugs

More than half of Paxlovid-eligible Medicare and Veterans Affairs patients take medications that have drug-drug interactions with Paxlovid, according to an FDA review of safety surveillance data. About 74% of Paxlovid prescriptions came from adult primary care physicians who may not have experience managing possible adverse drug interactions, the FDA review added.

The FDA said its Office of Surveillance and Epidemiology had recorded 271 reports of serious adverse events potentially related to drug-drug interactions with Paxlovid through the end of January, including 147 hospitalizations. The most common drugs causing problems are immunosuppressants, which are commonly used to treat HIV and organ transplant patients, according to the FDA.

But Swaminathan noted that drug interactions should be “responsive and minimized.” FDA officials said at the beginning of the meeting that they could potentially be addressed by adjusting the dose of certain drugs, increasing patient monitoring, and ensuring product labeling informs prescribers and patients about potential drug interactions.

Paxlovid consists of two separate medicines packaged together and is designed to reduce the risk of hospitalization or death from Covid. Nirmatrelvir blocks a key enzyme the Covid virus needs to replicate, while ritonavir boosts the first drug’s ability to fight infection.

Patients take Paxlovid within five days of onset of Covid symptoms to reduce the risk of hospitalization or death. To complete a full cycle of the drug, patients must take three Paxlovid pills twice a day for five days.

According to federal data, more than 12 million cycles of Paxlovid have been shipped to pharmacies in the United States, and 1.3 million doses are available nationwide. About 10 million patients in the US and 14 million worldwide have been treated with the drug, according to Jim Rusnak, Pfizer’s chief development officer for internal medicine.

Paxlovid’s sales rose to $18.9 billion in 2022, the first year it was available, but Pfizer expects sales to fall 58% this year to $8 billion.

rebound cases

The only vote against Paxlovid came from Terry Gillespie, a patient advocate from Plainfield, Illinois. Gillespie expressed concern that doctors didn’t know when to prescribe the drug, noting they had had Covid infection four to five times, “but never once” Paxlovid was offered.

“I don’t feel like doctors really know how to use it,” Gillespie said.

After the vote, Swaminathan also noted that he has a “worryingly large number of patients” whose doctors are advising them not to take Paxlovid for fear of renewed Covid cases. Then patients see their Covid symptoms or a positive test after initially recovering.

“I am concerned that there is not a good understanding in the medical community and patients are actually being discouraged from taking an effective drug that could save their lives,” he said

Reports of these cases surfaced shortly after Paxlovid launched in 2021, with President Joe Biden and his former chief medical adviser Dr. Anthony Fauci appeared to have recovered from Covid after taking the antiviral cocktail before testing positive again.

Swaminathan said there is “dramatic acceptance” in the media that Paxlovid causes rebound cases and is “potentially worse” than what you had before taking the drug, although there is a lack of data to support this belief.

dr Lindsey Baden, the panel chair and director of Brigham and Women’s Hospital, added that new data suggests the rebound cases caused by Paxlovid “are not the biology of what’s going on.”

“Until recently, even some of the data shared today helped me understand what that means. So we’re seeing real-time data that’s systematic and informative,” Baden said.

An FDA review of Pfizer’s clinical trials found that overall rebound rates ranged from 10% to 16%, “with no evidence of a higher rate of symptom rebound or moderate symptom rebound” in patients taking Paxlovid compared were given a placebo. This is also independent of the patient’s risk of serious illness or whether the Omicron variant or an earlier strain is dominant, according to the agency’s staff.

Nathan Frei, a former active-duty infantry officer who served from 2011 to 2015, first noticed problems with his hearing in 2013, shortly after returning from training with the US Army. Nate was identified with tinnitus and is now one of more than 200,000 plaintiffs suing 3M over its Combat Arms earplugs.

Nathan Frei

Former active-duty US Army infantry officer Nathan Frei said from 2011 to 2015 he underwent some of the most intensive training the US Army had to offer. There were also loud noises – everything from guns to helicopters to explosions.

To protect his hearing, Frei wore commercially available earplugs 3M.

Today, he is one of more than 200,000 military members and veterans suing the conglomerate. 3M stock, which hit a fresh 52-week low on Wednesday, is one of the worst-performing industrial stocks this year, shedding more than 16% against the stock in 2023 XLI Industrials ETFwhich is down 1.5% year-to-date.

Plaintiffs allege that 3M earplugs are “defective” and did not protect against hearing loss and tinnitus.

“We used [the earplugs] Every time we were near loud noises,” Frei, who lives in Seattle, told CNBC. “And I have relied on this hearing protection during that time.”

From 2003 to 2015, Aearo Technologies and its parent company 3M manufactured and supplied Combat Arms’ CAEv2 eartips to the US military. The earplugs were standard equipment for soldiers in Afghanistan and Iraq and were designed to protect military personnel’s hearing during military training and combat.

3M Combat Arms CAEv2 Ear Tips

CNBC

Each earbud had two ends: The green end was designed to block all noise. The yellow end, signaling ‘whisper mode’, was designed to block loud noises – but allowed the user to hear quieter sounds like conversations.

I don’t look like someone who at my age should probably have as severe a hearing loss as I do.

Nathan Frei

Former US Army active duty infantry officer

“We were told we could still protect our hearing by wearing ‘whisper mode,'” said Frei, who claims to have first noticed problems with his hearing in 2013.

“I heard the doorbell ringing,” Frei recalls. “At first I thought it was a TV that was on. So I searched and searched the house trying to figure out where the noise was coming from before realizing it was just in my head.”

Over the years, the 35-year-old said his hearing problems had gotten worse. Department of Veterans Affairs records that Frei shared with CNBC show he was later diagnosed with tinnitus.

“It’s constant,” he said. “It’s a loud ringing in my ears — very much like a buzzing.”

He said the ringing was so annoying that it occasionally kept him awake.

“I don’t look like someone who at my age should probably have as severe a hearing loss as I do,” he said.

Answer from 3M

Eric Rucker, an attorney for 3M, told CNBC the company has great respect for the men and women in the military and that their safety has always been a priority.

Maplewood, Minnesota, global headquarters of the 3M company.

Michael Siluk Getty Images

“The purpose of creating [the Combat Arms earplugs] was to work with the military to solve one of the longest-standing problems of soldiers not wearing their hearing protection in loud noise and in combat,” Rucker said.

According to Rucker, the connectors were developed in conjunction with the U.S. military and have been tested by the Air Force, Army, the National Institute for Occupational Safety and Health, and others.

“All of this testing shows that when properly fitted and used as directed, Combat Arms earplugs protect people’s hearing,” he said.

Rucker acknowledged that military audiologists are “well trained in how to train people and get people fit to use earplugs,” but claimed “it should have worked and protected their hearing in environments where those earplugs were appropriate.” to use.”

After a 2016 whistleblower lawsuit was filed accusing 3M of selling “dangerously defective” earbuds, the company agreed to pay the Justice Department $9.1 million to resolve the allegations, without admit liability.

Soon after, there was a flood of new suits from hundreds of thousands of other service members.

Where things are today

Today, lawsuits were consolidated in a Florida federal court, resulting in what some are calling the largest mass tort act in US history, even surpassing litigation in several districts Johnson & Johnson’s talc products.

3M has lost 10 of the 16 cases brought to trial to date, with 13 plaintiffs awarded a total of $265 million to date.

“There were several landmark processes. And unfortunately, Aearo and 3M have not been able to provide all the evidence regarding the original design of the product, the involvement of the military in the design of the product, and any issues regarding the instructions, and how to use the product and how well that product worked, including some test information that was excluded from certain studies,” Rucker said.

“All of this is on appeal. And we hope the appeal decisions will result in more of that information coming out,” he added.

Combat Arms earplugs, when properly fitted and used as directed, protect people’s hearing.

3M recently released new data showing that 90% of a cohort of 175,000 plaintiffs do not have a hearing impairment by medically accepted standards, according to US Department of Defense records. Lead attorneys for the plaintiffs call the data a “misrepresentation.”

“3M intentionally distorted this data by relying on hearing standards that do not measure the frequencies most affected by noise, in order to hide the hearing damage suffered by veterans,” said Bryan Aylstock and Chris Seeger, co-lead counsel for the Service Members and Veterans, in a joint statement.

3M contradicted these claims, telling CNBC, “The data supports what 3M claimed during this litigation: The second version of the Combat Arms eartips were safe and effective to use.” This has been verified by every independent third-party organization that has tested the product, including the Army Research Lab, Air Force Research Lab, NIOSH, and others.”

liability risk

Brett Linzey, Mizuho’s executive director, wrote in a note to customers that “Even the low end of the previously settled lawsuits against Combat Arms (or even half that amount) equates to some pretty healthy liabilities that 3M may be facing.” is.”

According to a Wall Street analyst, 3M’s liability risk could potentially run into the billions.

“Calculate the number of plaintiffs, which is over 200,000, and take the average comparison — the simple math gets you well past $10 billion to $20 billion,” JPMorgan analyst Stephen Tusa told CNBC. 3M told CNBC that the estimate was “entirely speculative.”

“We will continue to defend the cases. But the vast majority of these claims do not contain complete information,” Rucker said.

In a legal maneuver that would indemnify 3M, the company’s lawyers sought to place its subsidiary Aearo Technologies in bankruptcy protection and set aside a $1 billion trust fund to settle the lawsuits. The service workers suing 3M accuse the company of using bankruptcy to shield itself and have asked a judge to dismiss it.

A decision on this possible dismissal is planned for April. Oral hearings for the appeal of the first Bellwetter trials are scheduled for May 1st.

As for Frei, he expects his case to go to court by the end of the year.

“It makes me angry,” Frei told CNBC, accusing 3M of “trying to escape responsibility for what they did, either through bankruptcy or through these arguments.”