Despite these early complaints, Philips Respironics did not promptly report the issues to the Food and Drug Administration (FDA), as is required by federal law, according to an explosive new investigation by ProPublica and the Pittsburgh Post-Gazette. Over the following decade, the number of complaints grew from dozens to hundreds, and eventually to thousands, with the descriptions becoming more alarming. The common thread was that the foam used in these devices was breaking down, deteriorating, and disintegrating within the machines. By 2015, it became evident that the foam was the specific source of the problem.

In June 2021, more than a decade after the initial reports, Philips announced a recall of millions of machines that had been distributed across the United States and numerous other countries. The company acknowledged that the foam used in these devices could disintegrate due to heat and humidity, releasing potentially "toxic and carcinogenic" materials into the respiratory tracts of users. Philips asserted that it acted promptly upon learning of the potential significance of the issue. However, the investigation by ProPublica and the Pittsburgh Post-Gazette, covering the 11 years leading up to the recall, tells a different story.

What Was Uncovered
The investigation revealed that Philips systematically concealed mounting evidence that their lucrative breathing machines posed serious health risks to users, in some cases causing severe illnesses or possibly even death. Federal law mandates that medical device manufacturers report patient injuries, deaths and malfunctions to the FDA within 30 days, but Philips failed to do so. Furthermore, the company didn't initiate a formal investigation into the issue until 2019, nine years after the initial wave of complaints and three years after internal tests confirmed the foam's degradation. During this time, Philips continued an aggressive global marketing campaign to promote the sale of these machines, even introducing new models equipped with the problematic foam.

The consequences of Philips's actions were far-reaching. These devices were used by infants, the elderly, and approximately 700,000 veterans. The company also introduced a new ventilator with the same hazardous foam during the early months of the COVID-19 pandemic. Philips's failure to warn the public meant that countless individuals were unknowingly exposed to potentially harmful substances, resulting in various unexplained health issues such as vomiting, dizziness, headaches, and newly diagnosed cancers of the lungs, throat, sinuses, and esophagus. Philips's actions were criticized by healthcare professionals, with one sleep clinic doctor describing the situation as "unconscionable." The ProPublica investigation interviewed over 200 individuals, including former company employees, doctors, toxicologists, patients, and family members of those affected. It also reviewed thousands of complaints submitted to Philips and government agencies, uncovering over 370 reports of deaths linked to the devices.

Since the recall, Philips has attempted to downplay the health risks associated with the foam, arguing that tests have shown the chemicals released fall within safety thresholds. Nevertheless, experts dispute these claims and have identified multiple instances of genotoxicity in the foam—meaning the material has the potential to cause cell mutations, a process that can lead to cancer. The health implications for affected individuals are significant, and many of them have taken legal action against Philips to seek accountability for their health issues. The investigation is ongoing as patients and healthcare professionals continue to grapple with the consequences of Philips's actions.

Signs of Trouble
As Philips Respironics faced a growing tide of complaints related to their breathing machines, the company simultaneously launched aggressive marketing campaigns to promote their devices worldwide. These campaigns reached cities like Toronto, Paris, and Sydney. Their advertisements declared that their machines were quieter than those of their competitors. 

Despite their vigorous marketing, Philips encountered legal scrutiny. Beginning in 2012, the company struck deals with local medical equipment suppliers to sell their devices directly to patients, which attracted the attention of federal investigators. These arrangements allegedly involved providing suppliers with a database detailing doctors' prescribing practices, with an expectation that they would recommend Philips's machines, often covered by Medicare and other public programs. The government later accused Philips of running an illegal kickback scheme, ultimately reaching a $24 million settlement with the company, although Philips denied wrongdoing and agreed to the settlement to avoid the expense of further litigation.

In 2015, Philips was making efforts to dominate the market when the foam issue threatened to undermine their progress. According to the report, concerns were sparked within the company after an engineer inquired about the foam's condition. Subsequently, as new complaints emerged from Australia, Philips scientists convened emergency meetings to address the issue. An engineer explicitly raised the safety risk in an email to the foam supplier uncovered by the investigation, indicating that the foam was shedding and being drawn into the ventilator's air path, potentially endangering users. Although Philips started replacing the foam in some ventilators without notifying the FDA or the public, the vast majority of machines, including the popular DreamStation, remained unchanged. Customers were unaware of the issue even as debris began showing up on their bedsheets, pillows, and faces.

The Recall
Despite being aware of potential risks related to the foam used in their devices, Philips remained largely silent about the issue until they unveiled a new device, the DreamStation 2, in April 2021. With this new model, Philips transitioned to foam designed to withstand heat and humidity, differentiating it from the older models. During an earnings call that month, the company disclosed the foam's risks for the first time, setting aside 250 million euros to address the problem. Philips reassured investors that the device remained safe for use. However, the company neglected to inform its customers, and complaints continued to pour in over the next six weeks. 

Reports included patients experiencing black particles, respiratory ailments, and in some cases, life-threatening injuries. Philips eventually issued a voluntary recall in mid-June 2021, admitting that the foam could release chemicals or break into harmful particles. Potential health issues ranged from asthma and respiratory tract irritation to kidney and liver problems, and even cancer. Philips faces ongoing lawsuits from affected individuals and healthcare providers.

The recall prompted thousands of individuals to share their experiences of emergency room visits and unexplained illnesses caused by their devices. While Philips maintains that these reports do not prove a causal relationship between the devices and the illnesses, medical experts contacted by ProPublica claim that the reports are compelling evidence of a public health crisis that may have long-term repercussions. 

Concerns over the safety of the foam persist, with research indicating genotoxicity, the ability to cause cellular mutations. Experts believe that the foam's chemical emissions pose unacceptable risks to patients. Despite the company's attempts to downplay these concerns, employees and testing insiders expressed doubts about Philips' claims regarding the foam's safety. The company is currently under investigation by the Justice Department regarding its testing practices and safety assertions. The full extent of the crisis and its health impacts may not be fully realized for years.

Looking Ahead
More than two years after the first recall, many patients remain upset over Philips’s handling of the crisis. The company recently reached a settlement in one of the federal lawsuits, agreeing to pay at least $479 million to reimburse affected customers and others for the costs of the defective machines. Ongoing legal challenges include more than 600 personal injury claims and a class-action suit seeking ongoing medical monitoring and research on the devices' dangers. Philips has attempted to distance itself from the crisis, however. Former company managers who spoke with ProPublica suggested that officials in Amsterdam were likely aware of the problem due to its significant impact and the devices' importance to the company's financial performance.

Ventilator users who have spoken to IVUN have almost universally expressed frustration and anger over how the company has handled the crises. Poor communication and insufficient solutions have led to rising anger from ventilator users and their families over how Philips has addressed the problem. “Right now, there’s a lot of confusion and fear over how these ventilators have affected us,” said Mary Williams of Houston, Texas. “It seems they had a chance to do the right thing but stayed silent. I feel like they really let us down.”