After years of legal battles, Philips has agreed to pay more than $1 billion to settle lawsuits waged by thousands of people who say they were injured by breathing machines capable of releasing toxic particles and fumes into their noses, mouths and lungs.
The proposed settlement unveiled Monday between the global manufacturer and plaintiffs’ lawyers will effectively end more than 700 lawsuits filed after the 2021 recall of millions of the company’s widely used sleep apnea devices and ventilators.
More than 50,000 people are involved in the litigation. It has yet to be determined how many will have claims that fall under the terms of the settlement, which will be filed in federal court in Pittsburgh.
Philips also agreed to provide $25 million to cover the cost of medical monitoring for users who are fearful that hazardous chemicals emitted from the machines could lead to long-term harm, including cancer. Since 2021, the Food and Drug Administration has received more than 500 reports of deaths reportedly associated with the machines since 2021.
Plaintiffs have said that Philips, which built the devices at two factories near Pittsburgh, should be held accountable for failing to pull the machines off the shelves years ago.
“I still don’t have my husband,” said Shawne Thomas of Louisiana, whose 51-year-old husband, Rodney, died from a rare form of nose and throat cancer in 2021 after using one of the recalled machines for months. “But it sounds like a good amount of money coming out of their pocket, so it makes me feel a little bit happier.”
An investigation by ProPublica and the Pittsburgh Post-Gazette last year revealed that Philips suppressed thousands of complaints about an industrial foam fitted inside the machines that could break down and send potentially dangerous material into the masks worn by users. Federal law requires medical device makers to turn over such reports to the FDA within 30 days.
Under the terms of the settlement, Philips did not admit fault or liability. In the company’s first quarter financial report on Monday, CEO Roy Jakobs said the settlement provides the company with a “clear path forward for sustainable value creation.”
He also cited what he called “reassuring test results” for the recalled machines.
In launching the recall, Philips said the degrading foam inside the machines could cause serious harm and carried cancer-causing materials. The company has since walked back those findings, saying further testing did not indicate using the devices could result in “appreciable harm to health.”
ProPublica and the Post-Gazette found that the FDA repeatedly questioned the safety claims by Philips, saying the tests were not adequate and further evaluation was needed. The news organizations obtained several reports detailing the results of tests on the foam. Those tests found that the material tested positive for genotoxicity, the ability of chemicals to cause cells to mutate, which can cause cancer.
This month, under the terms of a consent decree with the federal government, the company agreed to hire an independent safety monitor and submit to regular inspections for five years. Philips also agreed to stop selling its sleep apnea devices in the United States until the conditions in the agreement were met. The agreement does not restrict Philips from selling its breathing machines in other countries.
Last year, Philips also agreed to pay more than $479 million to compensate customers for the cost of the defective machines — an amount that plaintiffs’ lawyers say is now expected to top $600 million.
Several medical experts interviewed by ProPublica and the Post-Gazette say that it could take years to determine whether links exist between the machines and certain diseases, but that they believe the company should have warned the public about the health risks years earlier.
“I’m glad they’re taking responsibility for what they did because they knew,” said Louisiana Sheriff Brett Stassi, who was diagnosed with kidney cancer and rushed into surgery in 2021 after using one of the recalled devices for four years. “They put dollars over lives in my book.”
A criminal probe by the U.S. Department of Justice is ongoing, and the Government Accountability Office, the investigative arm of Congress, is launching an inquiry of the FDA’s oversight of medical device recalls for the first time in years.
Philips has said it is cooperating with authorities.
The FDA has defended its handling of the crisis, saying it acted as soon as it learned of the safety concerns in April 2021, just weeks before Philips launched the recall.
“The FDA welcomes the opportunity for GAO review of the agency’s oversight of medical device recalls,” the agency said in a statement early this year.
