Columbus Ga. (WRBL) – A lawsuit has been filed against Philips following the recall of one of the company’s medical devices. Legal representation from Beasley Allen law firm filed a lawsuit on behalf of Fredrick Heller; related to his development of lung cancer, after using one of Philips recalled CPAP Devices.
Heller had used the device for “a number of years,” according to the lawsuit.
The device used by Heller was one of many recently recalled by Philips for “potential harm” caused by volatile organic compounds (VOCs).
In a memo to care providers Philips spoke of the risks, “Lab testing performed for and by Philips has also identified the presence of VOCs which may be emitted from the sound abatement foam component of affected device(s). VOCs are emitted as gases from the foam included in the CPAP, BiLevel PAP and MV devices and may have short- and long-term adverse health effects.”
“In the Lawsuit, we allege that Mr. Heller’s lung cancer was caused by his prolonged use of one of Philips recalled devices that’s intended for the treatment of obstructive sleep apnea,” Said Beau Darley, Attorney at Beasley Allen Law
“Philips Respironics has not disclosed when it first received reports from users of its Sleep & Respiratory Care devices of the presence of black debris or particles within the airpath circuit. But given how long the devices have been on the market, it’s unlikely that the company only recently learned of these issues,” Darley said in a news release. “Meanwhile, Philips continued to rake in profits from its CPAP and BiPAP machines while putting users at risk of serious health issues, including cancer.”
According to the FDA recall notice, “The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract; inflammatory response; headache; asthma; and toxic or carcinogenic effects to organs, such as the kidneys and liver.”
The FDA Statement continued to say, “The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.”
On April 26, 2021, Philips made it publicly know that they had received numerous complaints of “black debris within the device’s air pathway” and reports of headache, upper airway irritation, cough, chest pressure, and sinus infection in users of the devices.
Those reports led to the understanding that the “sound abatement” foam Philips used to minimize noise in several CPAP and BiLevel PAP (BiPAP) respirators posed serious health risks to users.
Seven weeks later, on June 14, 2021, Philips issued a recall for millions of its CPAP and BiPAP machines, as well as a number of its ventilator devices manufactured between 2009 and April 26, 2021.
“These devices that Philips recalled are what is known as class 2 devices,” Darley said explaining how something like this could make it to market undetected. “And class 2 devices are not required to undergo what’s referred to as the premarket approval process that’s required for more serious class 3 medical devices.”
“Under the pre-market approval process things like clinical studies and data are required in order for a device to be legally marketed and sold in the United States.”
“For class 2 devices like these recalled by Philips only a showing of substantial equivalence to a legally marketed device is required in order for a company like Philips to legally market and sell these devices in the United States,” said Darley.
Darley also told WRBL that there could be more of these lawsuits to come for Philips. “Given the Number of devices that Phillips recalled it is a possibility that there could be a number of lawsuits filed related to the number of injuries that they actually identify in their recall.”
When we reached out for comment Phillips said it has no comment on the lawsuit at this time.