Dive Brief:
- Philips CEO Roy Jakobs approved the sale of respiratory devices despite having evidence that the machines posed health risks to users, according to a report by the Pittsburgh Post-Gazette and ProPublica.
- The publications reported that Jakobs, who led Philips’ connected care unit before becoming CEO in October 2022, approved the sale of the machines held by distributors after the company stopped shipping new devices. A Philips spokesperson said in an emailed statement to MedTech Dive that the company “does not agree with the characterizations made in the recent ProPublica articles related to the Philips Respironics recall.”
- Philips argued in the statement that it was “not in a position” to tell customers and distributors to stop distributing devices without an authorized recall in place, which came in June 2021 after “additional data and further analyses became available.”
Dive Insight:
The Pittsburgh Post-Gazette and ProPublica reported last month that Philips began receiving reports of “black particles” or “dirt and dust” inside its machines in 2010, shortly after it added foam to soften the sounds that kept users awake at night.
According to the publications, Philips withheld more than 3,700 complaints over 11 years from the Food and Drug Administration. The company began a formal investigation into the complaints in 2019, the reports state, and took action the next year.
The latest report focuses on the two-month window between Philips stopping shipments and starting a recall.
Philips set aside 250 million euros ($302 million at the time) to cover the costs of repairing machines affected by foam degradation in April 2021. At that time, the company said the problem was limited to its older devices. In June 2021, Philips launched its recall of millions of devices.
Philips defended its actions between April 2021 and June 2021 in its statement to MedTech Dive.
“We would like to emphasize that in April 2021, Philips’ understanding of the component quality issue and the potential mitigating actions was still progressing. As part of the technical investigation, Philips Respironics took precautionary measures, including stopping the manufacturing and selling of sleep therapy devices to its distributors and customers,” the spokesperson wrote. “At that time and pending the conclusion of the technical investigation, Philips Respironics’ ship hold decision would not extend to devices already in the possession and control of distributors and customers. In the absence of an authorized recall, Philips Respironics was not in a position to communicate to its distributors and customers to halt distributing devices.”
Philips initiated the recall in June 2021 when “additional data and further analyses became available and after alignment with the relevant regulators and competent authorities,” according to the statement
The latest Pittsburgh Post-Gazette and ProPublica report follows a court hearing in Pittsburgh. According to the article, Philips’ lawyers argued that the parent company should be shielded from claims brought by users of the respiratory devices. The argument rests on the claim that the U.S. subsidiary, Philips Respironics, is responsible for the situation.
