WASHINGTON (AP) — The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a long-awaited settlement announced Tuesday by federal officials.
Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or provide refunds to all U.S. customers who got the defective devices, the department said.
The action is a major step toward resolving one of the biggest medical device recalls in history, which has dragged on for nearly three years.
Most of the devices recalled are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep mouth and nasal passageways open during sleep. Left untreated, sleep apnea can lead to dangerous drowsiness and increased risk of heart attack.
Philips has recalled more than 5 million of the machines since 2021 because their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep. Efforts to repair or replace the machines have been plagued by delays that have frustrated regulators and patients in the U.S. and other countries.
Lawyers for the federal government alleged that the company failed to comply with good manufacturing practices needed to ensure device safety. The company did not admit to the allegations, according to the court filing.
“This office, the FDA and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk," U.S. Attorney Eric Olshan said in a statement.
Under the legal agreement, Philips must hire independent auditors to create a plan for fixing its manufacturing problems and for monitoring problems with the sleep devices. The plan must then be approved by the Food and Drug Administration. The experts must also certify that new foam selected by the company meets FDA safety standards.
Jeffrey Reed, of Marysville, Ohio, experienced persistent sinus infections and two bouts of pneumonia during the seven years he used a Philips machine.
“I worry about my long-term health,” Reed said. “I used this machine for years and no matter what money I might get out of this, what’s going to happen?”
Reed received a newer Philips device after returning his old machine, but he doesn't like to use it, preferring a competitor's device.
“I don’t trust the company,” Reed said. “I don't want to use it.”
Reed is one of more than 750 people who have filed personal injury lawsuits against the company over the devices. Those cases have been consolidated in a federal court in Pennsylvania.
Similar lawsuits are pending in Canada, Australia, Israel and Chile, according to the company.
The Dutch manufacturer announced in January it had reached a tentative agreement with the FDA and the Department of Justice. But U.S. regulators wouldn't confirm the deal at the time because it had not yet been reviewed by a federal judge.
A company spokesman said Tuesday the agreement provides "a roadmap of defined actions, milestones, and deliverables to meet relevant regulatory requirements,” in an emailed statement. He noted that Philips will still be able to export some machines for sale outside the U.S.
The FDA’s website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions and more serious problems.
An FDA inspection of Philips’ Pennsylvania offices in the fall of 2021 uncovered a spate of red flags, including emails suggesting the company was warned of the problem with its foam six years before the recall.
Between 2016 and early 2021, FDA found 14 instances where Philips was made aware of the issue or was analyzing the problem. “No further design change, corrective action or field correction was conducted,” the FDA inspectors repeatedly noted.
In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including “clearer information about the health risks of its products.” At the time, the agency estimated only about half the people in the U.S. with affected machines knew they had been recalled.
Customers trying to obtain refunds or new or refurbished devices from the company have reported long delays.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
FILE - Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses with the device at his home, Oct. 20, 2022, in Marysville, Ohio. The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements under a long-awaited settlement announced Tuesday, April 9, 2024 by federal officials. (AP Photo/Jay LaPrete, file)
Hamas said Thursday it will send a delegation to Cairo as soon as possible to continue cease-fire talks, in response to Egypt's latest proposal. In a statement, Hamas leader Ismail Haniyeh said he had spoken to Egypt’s intelligence chief and “stressed the positive spirit of the movement in studying the cease-fire proposal.” The statement did not say when the delegation would travel.
If the Israel-Hamas war stopped today, it would still take until 2040 to rebuild all the homes that have been destroyed in nearly seven months of Israel’s bombardment and ground offensives in the territory, according to United Nations estimates released Thursday.
The United States has pressured Israel to increase aid deliveries during the war, and on Wednesday, Israel reopened a border crossing with hard-hit northern Gaza Strip for the first time since it was damaged at the start of the war.
Meanwhile, on his seventh visit since the latest war between Israel and Hamas broke out in October, U.S. Secretary of State Antony Blinken pressed for a cease-fire deal. The proposed truce would free hostages held by Hamas in exchange for a halt to the fighting and the delivery of much needed food, medicine and water into Gaza. Palestinian prisoners are also expected to be released as part of the deal.
On Oct. 7, Palestinian militants launched an unprecedented attack into southern Israel, killing around 1,200 people — mostly civilians — and abducting around 250 hostages. Israel says militants still hold around 100 hostages and the remains of more than 30 others.
The death toll in Gaza is more than 34,500 Palestinians, according to local health officials, as the territory faces a humanitarian catastrophe. The war has driven around 80% of Gaza’s population of 2.3 million from their homes, caused vast destruction in several towns and cities and pushed northern Gaza to the brink of famine.
Currently:
— Nonstop Mideast coverage of the Israel-Hamas war pauses for protests and police action at U.S. schools.
— Colombia’s president says the country will break diplomatic relations with Israel over the war in Gaza.
— The Biden administration is weighing measures to help Palestinians bring family from the region.
— Blinken presses Hamas to seal cease-fire with Israel, saying “the time is now” for a deal.
Follow AP’s coverage of the war at https://apnews.com/hub/israel-hamas-war
Here's the latest:
JERUSALEM — Israel’s national security council has issued a warning urging people to reconsider travel to Malmo, Sweden, for the upcoming Eurovision song contest.
In a statement, the council described Malmo as “a focus for anti-Israel protests” that include calls to attack Israelis and the burning of Israeli flags.
“These developments raise the tangible concern that terrorists will exploit the protest and the anti-Israel atmosphere to carry out an attack on Israelis who will arrive for the Eurovision,” it said.
It said it considers travel to Malmo to pose a “moderate threat” and recommends that Israelis heading to the city “reconsider the necessity of the trip.”
It said the warning would remain in effect for the duration of the Eurovision contest — scheduled to run from May 7-11.
The war in Gaza has heightened tensions around Israel’s participation in Eurovision. Pro-Palestinian groups are expected to stage large protests in Malmo, and contest organizers say they reserve the right to remove any Palestinian flags or pro-Palestinian symbols at the show.
CAIRO — Hamas says it is sending a delegation to Cairo to continue cease-fire talks.
Hamas had been expected to deliver an answer to Egypt’s latest proposal as soon as Thursday.
In a statement, the group’s supreme leader, Ismail Haniyeh, said he had spoken to Egypt’s intelligence chief and “stressed the positive spirit of the movement in studying the ceasefire proposal.”
The statement said Hamas negotiators would travel to Egypt as soon as possible “to complete the ongoing discussions with the aim of working forward for an agreement.”
The statement did not say when the delegation would travel.
BERLIN — German Chancellor Olaf Scholz and Israel’s Prime Minister Benjamin Netanyahu discussed efforts to secure the release of hostages held by Hamas and a cease-fire in a phone call Thursday, German government spokesperson Wolfgang Buechner said, without providing details.
Further improvements in the supply of humanitarian aid to people in Gaza was also a topic, Buechner said in an emailed statement.
According to the Stockholm International Peace Research Institute, Germany is the second-largest supplier of arms to Israel, behind the United States. It's also among the countries that announced it would resume cooperation with the United Nations relief agency for Palestinians in Gaza after the publication of an independent review of its neutrality — a decision Israel's Foreign Ministry had called “regrettable and disappointing.”
BEIRUT — The Gaza Health Ministry said Thursday the bodies of 28 people killed by Israeli strikes were brought to local hospitals over the past 24 hours. Hospitals also received 51 wounded, it said in its daily report.
That brings the overall Palestinian death toll from the Israel-Hamas war to at least 34,596, the ministry said, and 77,816 wounded. The Health Ministry does not distinguish between fighters and civilians in its tallies, but says that women and children make up around two-thirds of those killed.
The Israeli military says it has killed some 13,000 militants, without providing evidence to back up the claim.
AMMAN, Jordan — If the war in Gaza stopped today, it would still take until 2040 to rebuild all the homes that have been destroyed in nearly seven months of Israel’s bombardment and ground offensives in the territory, according to United Nations estimates released Thursday.
“Every additional day that this war continues is exacting huge and compounding costs to Gazans and all Palestinians” said United Nations Development Programme Administrator Achim Steiner.
At least 370,000 housing units in Gaza have been damaged, including 79,000 destroyed completely, according to the new report by the UNDP and the Economic and Social Commission for Western Asia, which details how Israel’s assault, launched after Hamas’ Oct. 7 attack, has devastated the economy of the Palestinian territories, and how the impact will increase the longer the conflict goes on.
After previous Israel-Hamas conflicts, housing was rebuilt at a rate of 992 units year. Even if Israel allows a five-fold increase of construction material to enter Gaza, it would take until 2040 to rebuild the destroyed houses, without repairing the damaged ones, the report said.
In Gaza, the Israeli offensive has virtually shut down the economy, which contracted 81% in the last quarter of 2023. The report said the “productive basis of the economy has been destroyed,” with sectors experienced losses of more than 90%.
Gaza, home to some 2.3 million Palestinians, has been under blockade by Israel and Egypt since Hamas’ 2007 takeover, putting tight controls on what enters and exits the territory. Even before the war, it faced “hyper-unemployment” of 45%, reaching nearly 63% among younger workers. Since the war began, it lost some 201,000 jobs.
The war has also impacted the West Bank, where for months Israel has imposed restrictions on movement. In 2024, the entire Palestinian economy — including both Gaza and the West Bank — has so far contracted 25.8%, and if the war continues the loss will reach 29% by July, equivalent to $7.6 billion, the report said.
BEIRUT — The militant Palestinian group Hamas praised Columbia's announcement that it would break relations with Israel, saying such a move is a recognition of the suffering of Palestinian people.
In its statement Thursday, Hamas called on other leaders of Latin America to cut their countries’ diplomatic relations with Israel, which it described as “a rogue and Fascist entity that is continuing its crimes against our people.”
Historically, Colombia was one of Israel’s closest partners in Latin America. But relations between the two nations cooled since Gustavo Petro was elected as Colombia’s first leftist president in 2022.
Petro announced his government would break diplomatic relations with Israel effective Thursday, describing Israel’s siege of Gaza as “genocide.” He previously suspended purchases of weapons from Israel and compared that country’s actions in Gaza to those of Nazi Germany. Hamas said it valued Petro's stance highly.
Weeks after the Oct. 7 Hamas attack on southern Israel that sparked the current war in Gaza and killed some 1,200 people, Petro recalled Colombia’s ambassador to Israel as he criticized the country’s military offensive.
Activists block a highway as they demand the release of the hostages from Hamas captivity in the Gaza Strip, in Tel Aviv, Israel, Thursday, May 2, 2024. (AP Photo/Oded Balilty)
Patriarch Theophilos III, the Greek Orthodox Patriarch of Jerusalem, left, performs the Washing of the Feet ceremony during the Holy Week at the Church of the Holy Sepulcher, where many Christians believe Jesus was crucified, buried and rose from the dead, in Jerusalem's Old City, Thursday, May 2, 2024. (AP Photo/Mahmoud Illean)
A line of Pima County Sheriff's deputies form a shield line as law enforcement gathers outside an encampment of pro-Palestinian protesters encamped on the University of Arizona campus, early Wednesday, May 1, 2024 in Tucson, Ariz. (Kelly Presnell/Arizona Daily Star via AP)
Israeli soldiers stand near their vehicles, displaying t-shirts calling for the return of hostages, on the Israeli side of the Erez crossing into the Gaza Strip from southern Israel as trucks carrying humanitarian aid supplies bound for the Gaza Strip are inspected, Wednesday, May 1, 2024. (AP Photo/Ohad Zwigenberg)
Israeli soldiers gather on the Israeli side of the Erez crossing from southern Israel into Gaza, bordering a battle-ravaged area of the northern Gaza Strip, Wednesday, May 1, 2024. (AP Photo/Ohad Zwigenberg)
Boxes from Jordan wait an inspection area for trucks carrying humanitarian aid supplies bound for the Gaza Strip, on the Palestinian side of the Erez crossing between southern Israel and Gaza, Wednesday, May 1, 2024. (AP Photo/Ohad Zwigenberg)
Pro-Palestinian demonstrators watch police activity behind a makeshift barricade on the UCLA campus Wednesday, May 1, 2024, in Los Angeles. (AP Photo/Jae C. Hong)
Israeli soldiers gather near a gate to walks through an inspection area for trucks carrying humanitarian aid supplies bound for the Gaza Strip, on the Israeli side of the Erez crossing into Gaza, Wednesday, May 1, 2024. (AP Photo/Ohad Zwigenberg)
Secretary of State Antony Blinken, centre, is welcomed by Israeli Ambassador to the U.S. Mike Herzog, as he arrives at Ben Gurion Airport near Tel Aviv, Israel, Tuesday, April 30, 2024. (Evelyn Hockstein/Pool Photo via AP)
U.S. Secretary of State Antony Blinken speaks to the press at the port of Ashdod, in Ashdod, Israel, May 1, 2024. (Evelyn Hockstein/Pool Photo via AP)
Col. Moshe Tetro, head of COGAT's Coordination and Liaison Administration (CLA) for Gaza, speaks to journalists at an inspection area for trucks carrying humanitarian aid supplies bound for the Gaza Strip, on the Palestinian side of the Erez crossing from southern Israel, Wednesday, May 1, 2024. (AP Photo/Ohad Zwigenberg)
Pro-Palestinian demonstrators continue their encampment at Library Mall on the campus of the University of Wisconsin in Madison, Wis., Wednesday, May 1, 2024. (Samantha Madar/Wisconsin State Journal via AP)
Israeli soldiers are seen at a staging ground near the border with the Gaza Strip, in southern Israel, Wednesday, May 1, 2024. (AP Photo/Ohad Zwigenberg)
Palestinians look at the destruction after an Israeli airstrike in Deir al Balah, Gaza Strip, Tuesday, April 30, 2024. (AP Photo/Abdel Kareem Hana)
