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 .
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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 .
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This article originally appeared on ProPublica and is reprinted according to their guidelines .
30 x The Trial Lawyer