HJNO Jan/Feb 2024

HEALTHCARE JOURNAL OF NEW ORLEANS I  JAN / FEB 2024 33 obtained through a public records lawsuit filed against the FDAby ProPublica and the Post-Gazette . “This is especially important,” Shuren emailed the company. The records do not make clear what transpired in those meetings, but more than a year later, the FDA has continued to advise patients that the agency will provide information on the testing when it becomes available. While the FDAwas meeting with Philips, tensions flared among the company’s scien- tists and managers responsible for handling the crisis, interviews and internal commu- nications show. Philips “didn’t believe the results,” said the engineer familiar with the testing. “The Philips folks gnashed their teeth at it and they went to test more devices.” ProPublica and the Post-Gazette obtained communications sent by a scientist at Phil- ips who was alarmed about test results showing formaldehyde over the “threshold for safe exposure.” “FDA has the data. Are they just waiting for the final report from Philips? How is this sustainable?” Though the chemical tends to quickly dissipate, experts say that even brief expo- sure at high levels can pose serious risk to patients who are already vulnerable, includ- ing infants, the elderly and others with chronic illnesses. In June 2022, then-Philips biological safety engineer Adam Majka sent an email to several colleagues, writing, “We need to start finalizing reports where we have acceptable results and we do not expect further changes.” One of the recipients was Denver Faulk, a senior safety engineer at Philips who was charged with helping to lead the compa- ny’s response, according to interviews and emails. That same month, Philips put out an update saying that draft test reports on the foam had “not identified any safety issues.” Around that time, Faulk sent an inter- nal message about a safety threshold for formaldehyde proposed by Philips to one of the independent labs brought on by the company. Toxicologists can assess the level of can- cer risk against different thresholds used “The experts said that one of the most vexing concerns is that formaldehyde — linked to respiratory problems and certain cancers — showed up in multiple tests and at varying levels, at times low and at others higher.”