Multinational electronics and medical device manufacturer Philips knew for over a decade about the defects in its respiratory devices before issuing a recall in 2021, it has been reported.
According to a ProPublica and Pittsburgh Post-Gazette joint investigation, the company’s respirator subsidiary, Respironics, altered the design of its ventilators and sleep apnoea machines in 2010, packing them with polyester-based polyurethanesame, a foam used in sofas and mattresses, to prevent a persistent rattling. This decision was taken despite journal articles indicating that the foam in question broke down under heat and humidity.
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Soon after the change, however, the company is said to have begun receiving reports of contaminants within the devices, describing “black particles”, “dirt and dust” and an “oily-like substance”.
Rather than fulfil its legal duty to send these reports to the US Food and Drug Administration (FDA), Philips reportedly kept them to itself. ProPublica indicates that, over the next 11 years, thousands more reports would be concealed and millions more machines sold.
It adds that internal testing revealed that the cause was the breakdown of the foam releasing dangerous levels of toxic chemicals including formaldehyde, a known carcinogen and respiratory irritant.
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According to ProPublica, at least 370 deaths were linked to the machines before the recall.
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By GlobalDataAt the beginning of the pandemic, Philips promoted its new ventilator aimed at Covid-19 patients. The device was still filled with the foam, despite the company claiming that it was made “with the needs of healthcare workers and Covid-19 patients in mind while also complying with medical device quality standards.”
In its 2020 end-of-year filing with the US Securities and Exchange Commission (SEC), the company boasted that it “combined the right monitoring equipment, respiratory devices, consumables and services to innovate solutions to help tackle Covid-19.” The same year the company made over €1bn in profit according to GlobalData, the growth of which was helped along by increased sales of respirators.
Respironics was bought by Philips in 2007, apparently under the threat of a hostile takeover if the founder would not sell. At the time the company’s revenue was over $1bn a year. GlobalData’s market share database shows that Respironics currently holds almost 10% of the global market share for anaesthesia and respiratory devices, alongside Philips’ 5.3%. Their combined revenue in the market totals $1.39bn.
This is not the first time in recent years Respironics has faced allegations of illegal activity. In 2022, the company paid more than $24m over claims it illegally gave kickbacks to suppliers of its respirators, defrauding US government programmes including Medicare and Medicaid.
In a response published on Wednesday (27 September), Philips claimed that the investigation “do[es] not present new facts and we do not agree with the characterizations made in these articles.”
The company also claims that its priority is patient safety and quality. Notably, the allegations are not denied, and no evidence is given to refute the suggestion that the company was aware of claims prior to the recall, making the second statement ring rather hollow.
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