Sen. Richard Blumenthal, D-Conn., has expanded his call to take action against medical device powerhouse Philips Respironics, sending a letter to federal regulators demanding aggressive enforcement against the company for withholding thousands of warnings about a dangerous defect in its breathing machines.
In the letter on Tuesday to Food and Drug Administration Commissioner Robert M. Califf and Attorney General Merrick Garland, Blumenthal cited a ProPublica and Pittsburgh Post-Gazette investigation last month that revealed the company sold millions of sleep apnea machines and ventilators even after finding that an industrial foam placed inside them was breaking down and emitting chemicals at dangerous levels.
Calling the investigation “explosive,” Blumenthal told the officials that their agencies “must urgently use all of their authorities to protect current and future patients by investigating these allegations thoroughly, taking the strongest enforcement action possible, including criminal charges, if the allegations are substantiated.”
Last week, Blumenthal, a member of the Senate Judiciary Committee and chairman of a subcommittee that probes potential violations of laws and regulations impacting national health and safety, also called on the Justice Department to take swift action.
In the letter, he urged the two agencies to “deter future wrongdoing and hold the company accountable for past violations.”
FDA spokesperson Carly Kempler said the agency received the letter and will respond to the senator. The Justice Department did not immediately respond to a request for comment.
A yearlong investigation by the news organizations found that Philips kept secret more than 3,700 complaints about the faulty devices over the course of 11 years before launching a massive recall.
When the recall was announced in 2021, Philips said the foam could release chemicals or break into particles capable of causing life-threatening injuries.
Since then, the company has changed course, saying recent testing on the DreamStation continuous positive airway pressure, or CPAP, machine and similar devices shows that chemical emissions fall within safety thresholds.
The FDA challenged the company on its test results, saying in a statement last week that the studies were not adequate and that Philips had agreed to conduct additional tests.
The foam was placed inside more than 15 million machines since 2009, prompting a recall that affected patients in the United States and around the world.
“We may not know the full impact of Philips’ negligence for years to come,” Blumenthal said in his letter.
Philips has said it evaluated complaints about the foam on a case-by-case basis and launched the recall shortly after the company became aware of the potential significance of the problem. Philips also said it regrets any “distress and concern” caused by the recall and is cooperating with prosecutors and regulators.
Update, Oct. 11, 2023: This story was updated with comment from the FDA.
Debbie Cenziper of ProPublica and Michael D. Sallah of the Pittsburgh Post-Gazette contributed reporting.
