Philips Respironics has battled multiple recalls since June 2021 over the dangerous complications stemming from the noise-canceling foam used in its CPAP machines. Although Philips only started recalling CPAP machines due to the dangerous foam in June 2021, a new report suggests the company had concerns about the foam as early as 2015.
June 2021: The Recalls Begin
In June 2021, Philips issued a recall of CPAP, Bi-level PAP, and mechanical ventilators due to the potential for the noise-canceling foam (polyester polyurethane – PE-PUR foam) in the devices to degrade and, if inhaled, cause severe complications to patients. These complications include headaches, nausea, and cancer.
Philips Likely Knew About the Dangers Much Earlier
According to the multidistrict litigation documents that were filed in a Pittsburgh federal district court, Philips knew as early as 2015 through a “variety of sources” that the black debris many consumers found in the bottom of their devices was the degraded foam. The complaint explains: “Based on its investigation, the US Food and Drug Administration (FDA) concluded that Philips’ upper management was aware of the foam degradation issues, discussed it at numerous management review meetings, and yet delayed doing anything about it.”
The FDA concluded that Philips first found out about the foam degradation in October 2015. That same month, Philips asked the foam supplier and fellow defendant in the lawsuit, PolyTech, via email about the durability of the PE-PUR foam when it was exposed to “high humidity.” Messages between PolyTech employees revealed that if the PE-PUR foam was exposed to high humidity such as 104 degrees Fahrenheit, the foam would chemically break down “in as short a time as a year.”
Despite not recalling the products until June 2021, the FDA inspection points to warnings from inside the company that the foam could be dangerous. There were internal emails that the FDA inspectors cited, including one from 2015 sent from a Philips employee to the raw foam supplier that “implies that a customer made [Philips] aware of polyester polyurethane foam degradation issues.” The warnings also included “at least 14 tests or assessments” from as early as 2016 where Philips’ staff were “aware of issues and concerns related to potential foam degradation.”
In 2018, Philips project mechanical engineer Vincent Testa disclosed that he received customer complaints about the disintegrating foam that had made its way into the machine’s air stream. Testa emailed this information to the foam supplier. The content of the email was unsealed by a federal judge in Pittsburgh due to the hundreds of lawsuits against Philips related to the recalled CPAP devices. Testa said in 2018: “The material sheds and is pulled into the ventilator air path. As you can imagine, this is not a good situation for our users.” Testa asked one of the suppliers what could cause the foam to break down because the supplier claimed the foam “has excellent resistance to heat, moisture, and chemicals.”
In internal email discussions between Philips’ foam suppliers, employees discussed Testa’s questions and said that if the foam was subjected to “high humidity” it would “exhibit signs of hydrolysis in as short a time as a year.” Hydrolysis is the chemical breakdown of a compound due to its reaction to water.
After Philips received complaints about the foam degradation in 2018, inspectors found a conversation between a Philips engineer who acknowledged that the company’s own internal tests confirmed that the foam could fall apart when exposed to high heat or humidity. However, in the same conversation, Philips’ employee said that the company had “made the decision to not change the design” and continue to include the foam in the devices
In addition, the FDA found that Philps received more than 100 complaints about decaying foam in devices between 2014-2017; however, the recall was not initiated until June 2021. The FDA concluded that there is “sufficient evidence for the FDA to determine there are reasonable grounds to believe the recalled devices that Philips manufactured after November 2015 were not properly manufactured with reference to the state of the art as it existed at the time.”
How Goldenberg Lauricella Can Help
If you or a loved one were harmed after using a recalled Philips Respironics CPAP device, contact the Minneapolis Medical Device Attorneys at Goldenberg Lauricella. We know how terrifying it is to realize that a device that is supposed to help you breathe could actually be harming you. Our team has the expertise and knowledge to help you get the justice you deserve. Contact us today for a free CPAP Recall Lawsuit consultation.