U.S. health regulators on Thursday classified the recall of Dutch medical device maker Philips' respiratory machines as most serious, saying their use could lead to injuries or death.
The U.S. Food and Drug Administration said the silicon foam used in some of ventilator models, recalled in December, may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination.
The company's subsidiary, Philips Respironics, had recalled about 13,811 ventilators, used to provide breathing assistance to both pediatric and adult patients, distributed between March 1, 2022 and Sept. 6, 2022.
Philips Respironics did not immediately respond to Reuters request for comment on the impact from the recall.
There were 82 complaints till Jan. 4 and no reports of death or long-term injuries associated with the use of the product, the U.S. FDA said.
Pfizer Inc and its German partner BioNTech SE are gearing up for a 2024 trial with Moderna Inc at London's High Court in competing patent lawsuits over their rival COVID-19 vaccines.
The case reached London's High Court for the first time for a preliminary hearing on Thursday, ahead of a trial which is due to take place in April 2024.
Pfizer and BioNTech sued Moderna in London in September, seeking to revoke two of Moderna's patents in relation to its messenger RNA (mRNA) vaccines.
Moderna brought its own lawsuit that month over Pfizer and BioNTech’s Comirnaty vaccine, seeking damages for alleged infringement of its patents.
Pfizer, BioNTech and Moderna are also engaged in litigation in Germany, the Netherlands and the United States.
Moderna’s German and U.S lawsuits, which were filed on the same day in August, both seek monetary damages. Pfizer and BioNTech are countersuing in the United States.
All three companies are also embroiled in U.S. patent disputes with other companies over the vaccines.
CureVac, which develops mRNA technology, is involved in patent lawsuits with Pfizer and BioNTech in Germany and the United States, as well as at London's High Court, where a trial is expected to take place in July 2024.
Germany's CureVac and Britain's GlaxoSmithKline have been in an mRNA-focused partnership since 2020.
Doctors declared U.S. President Joe Biden, 80, healthy and "fit for duty" on Thursday after a physical examination that included removing a lesion from his chest and declaring him free of symptoms of long COVID after his bout last year with the virus.
"The president remains fit for duty, and fully executes all of his responsibilities without any exemptions or accommodations," White House physician Kevin O'Connor said in a summary of the health exam.
The exam was closely watched as Biden prepares for his expected run for a second term in 2024. The summary said Biden did not have any "long COVID" symptoms and that his stiff gait has not worsened since his last exam in November 2021.
Biden said his physical went well. "Everything really went well... Thank God for small favors," he told NBC News.
Biden's three-hour session with doctors at Walter Reed National Military Medical Center in the Washington suburb of Bethesda, Maryland, was his second extensive exam since taking office in January 2021.
Biden takes the statin Crestor to keep his cholesterol levels low, an anti-coagulant in response to atrial fibrillation that remains asymptomatic and medication to treaty seasonal allergies and acid reflux, the summary said.
Several small skin growths were moved from his face and head using liquid nitrogen and "one small lesion on the president's chest was excised today and sent for traditional biopsy," O'Connor said. Results are pending.
The summary found that Biden's weight had dropped six pounds, from 184 pounds in 2021 to 178. His body mass index was at 24.1 compared to 25.0 in 2021, and his blood pressure was at 126/78 compared to 120/70 in 2021.
The summary made no mention of whether Biden underwent any cognitive tests sometimes given to people of his age.
O'Connor said Biden's back stiffness is a result of significant spinal arthritis.
French duck farmer Herve Dupouy has culled his flock four times since 2015 to stop the spread of bird flu but as a wave of deadly outbreaks nears his farm once again, he says it's time to accept a solution once considered taboo: vaccination.
"The goal is that our animals don't fall ill and that they don't spread the virus," Dupouy said on his farm in Castelneu-Tursan in southwestern France. "Our job as farmers is not to gather dead animals."
Like Dupouy, more and more governments around the world are reconsidering their opposition to vaccines as culling birds or locking them inside has failed to prevent bird flu returning to decimate commercial flocks year after year.
Reuters spoke to senior officials in the world's largest poultry and egg producers, along with vaccine makers and poultry companies. They all said there had been a marked shift in the approach to vaccines globally due to the severity of this year's bird flu outbreak, though the biggest exporter of poultry meat, the United States, told Reuters it remains reluctant.
Besides the cost of culling millions of chickens, ducks, turkeys and geese there is also a growing fear among scientists and governments that if the virus becomes endemic, the chances of it mutating and spreading to humans will only increase.
"That's why every country in the world is worried about bird flu," French agriculture minister Marc Fesneau said.
"There's no reason to panic but we must learn from history on these subjects. This is why we are looking into vaccinations at the global level," he told Reuters.
Most of the world's biggest poultry producers have resisted vaccinations due to concerns they could mask the spread of bird flu and hit exports to countries that have banned vaccinated poultry on fears infected birds could slip through the net.
But since early last year, bird flu, or avian influenza, has ravaged farms around the world, leading to the deaths of more than 200 million birds because of the disease or mass culls, the World Organisation for Animal Health (WOAH) told Reuters.
U.S. drugs giant Pfizer and vaccine company Valneva have decided to end trials on a significant percentage of participants in the United States who had been used as the companies work on a vaccine product to tackle Lyme disease.
Pfizer and Valneva said in a joint statement on Friday that they were ending those trials due to "violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator."
"The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event," Pfizer and Valneva said in their statement
Soft-on-crime Manhattan District Attorney Alvin Bragg is under fire once again — this time for his apparent kid-gloves treatment of a violent attack on a nurse at a Harlem hospital, The Post has learned.
The vicious assault was among a spate of attacks on healthcare workers at the same Mount Sinai hospital in a matter of days, according to sources and police records.
Valentino Tablang, 55, a registered nurse at Mount Sinai Morningside, was so violently slugged by a deranged patient on Feb. 7 that he told The Post he feared he might be blinded.
Yet Bragg’s office filed only slap-on-the-wrist misdemeanor charges in the case — despite a state law that prescribes felony raps in on-the-job attacks on healthcare workers.
“The attack was bad enough, but then I became more upset when I saw that the district attorney only charged her with an assault in the third degree, a misdemeanor,” Tablang told The Post this week.
“That is crazy,” he added. “I’m very disappointed.”
Tablang, a nurse since 1988, was working a 9-6 shift in the emergency room when, during his last hour, an unhinged female patient got out of bed without clothing on, he recalled.
“I went to the room to see which patient it was so I could call her doctor,” he said. “When I tried to look at her ID bracelet, she swung and hit [me] in the head.
“I was in shock,” Tablang added. “It was so sudden — I started seeing lights.”
Mount Sinai Morningside nurse Valentino Tablang was slugged by a patient on Feb. 7 — and is ticked Manhattan DA Albin Bragg only charged his attacker with a misdemeanor.
The healthcare worker was left bloodied and said he was hit so hard in the eye, “I was afraid I would go blind, get double-vision.”
Police arrested Nikcia Martin, 28, and charged her with felony assault over the violent incident — but when the DA’s Office sent Tablang the criminal complaint to sign, the charges had been reduced.
Under New York State Penal Law, a suspect is guilty of felony assault if they attack a cop, peace officer, registered nurse, licensed practical nurse or a “public health sanitarian.”
The law was expanded in 2016 to include other healthcare workers — with the state Senate approving the amendment by an overwhelming 60-3 vote.
Tablang, a nurse at Mount Sinai Morningside, said he was outraged that Manhattan prosecutors only charged his attacker with a misdemeanor.
But the crazed patient who allegedly attacked Tablang was only charged with misdemeanor counts of assault and attempted assault, and harassment, a violation, according to the criminal complaint.
“When the district attorney sent me a copy of the complaint I said I wouldn’t sign it because she should have been charged with a felony,” Tablang said.
“What good is the law if it doesn’t have any teeth?” the veteran nurse added. “We are trying to help people and the law was written to protect us. The district attorney should be protecting health care workers.”
Nikcia Martin had charges had been reduced in the attack.
Prosecutors told him they were too backed up to bring a felony case, Tablang said.
He said the district attorney’s office reached out to him on Thursday “just to follow up” on the case — several hours after The Post asked prosecutors for a comment on the case.
“I believe we spoke a couple of weeks ago [regarding] client documents that I sent you over for you to review and sign regarding the assault incident that you were a victim of,” the message said. “I just re sent me [sic] those documents.
“Please give us a call back if you have any concerns or issues.”
Peggy Desiderio, co-president of the bargaining unit at the New York State Nurses Association, called out Bragg’s office, saying, “he was elected to do a job [and] enforce the law.
“Nurses are a powerful voting block. He better start protecting us,” Desiderio said Thursday. “During COVID, everybody was banging pots and pans for us, now healthcare workers have to worry about getting hit with pots and pans while DA Bragg does nothing.”
Police records show there were two other attacks on Mount Sinai Morningside healthcare workers this month, including on a 61-year-old employee who was slugged in the face by a patient he was escorting out of the medical facility on Feb. 4.
In that case, cops only charged the suspect with misdemeanor assault.
As many as three nurses at Mount Sinai Morningside Hospital were violently attacked by patients this month, and the attackers got off with a slap on the wrist, union reps say.Stephen Yang
On Feb. 9, a rookie nurse was injured when a patient slammed a door on her arm — but the victim did not pursue criminal charges against her assailant, according to sources and the NYPD.
In another incident in October, sources said a technician was assaulted but informed there was no crime because cops responding to the hospital told him there was no visible bruising. It is unclear what the assault was or if charges were filed in that case.
A spokesperson for Bragg’s office said in an email Thursday that the DA’s office has “used this felony statute on multiple occasions” in the past year alone “in incidents where hospital workers were attacked,” citing four specific cases.
“The safety of nurses and healthcare workers, who save the lives of New Yorkers every day, is of the utmost importance to us,” the spokesperson said.
“Our initial charging decision and the full order of protection [in the case against Martin] take into account the individual’s underlying mental health needs that brought her to the hospital while balancing the seriousness of her conduct and the safety of hospital staff.”
At least one state lawmaker said the DA’s Office should know better.
“Of all our government officials, the district attorney above all should enforce the law,” state Sen. Andrew Lanza, a former Manhattan prosecutor from Staten Island said Thursday.
The state nurses union says the Manhattan DA’s office ignored a state law that mandates felony charges for attacks on healthcare workers in recent assaults at Mount Siani.Stephen Yang
“We need to protect healthcare workers providing direct care to those in need,” Lanza said. “Not enforcing this law, when applicable, dangerously ignores that important principle.”
Desiderio, of the state Nurses Association, added that: “These nurses are literally putting their lives on the line … they don’t need to look over their shoulder while they are working and fear for their life.
“They need to be protected,” she said. “That is why the law was changed and the district attorney was elected to enforce the law and protect victims.”
he top Republicans on U.S. congressional foreign affairs and armed services committees pressed Democratic President Joe Biden on Thursday to include $2 billion in military assistance grants for Taiwan in his upcoming budget request.
Representatives Michael McCaul and Mike Rogers, chairmen of the House of Representatives Foreign Affairs and Armed Services committees, and Senators Jim Risch and Roger Wicker, ranking Republicans on the Senate Foreign Relations and Armed Services committees, asked Biden to include up to $2 billion in Foreign Military Financing (FMF) grants for Taiwan in his proposed budget for the fiscal year ending in September 2024.
Congressional aides said they expect Biden to release the budget on March 9.
In a letter to Biden, the four lawmakers called China's build-up of its military capabilities and the recent incursion into U.S. airspace of a high-altitude surveillance balloon "a grave threat" to U.S. interests.
They stressed the need to support Taiwan, an independently ruled island that China views as a breakaway province.
"To stop these trends, the United States must act with urgency to defend itself and ensure our allies and partners have the capabilities they need to defend against the (Chinese Communist Party)," the letter said.
Congress late last year overwhelmingly approved legislation authorizing $10 billion - or $2 billion per year for five years - of annual FMF grants for Taiwan. However, a spending bill passed at the end of the year did not include the money to fund the program.
The White House did not immediately respond to a request for comment on the letter.
