In light of a recent FDA investigation, lawyers predict that Philips will be hit with a slew of CPAP lawsuits, and Multi-District Litigation is readying for the onslaught.
Philadelphia, PAA recent FDA investigation has determined that Philips, the manufacturer of up to 15 million potentially defective sleep and breathing devices worldwide, knew its machines were faulty years before it issued a recall last June. The CPAP (Continuous Positive Airway Pressure) and BiPAP devices were recalled because sound abatement foam (PE-PUR Foam) in the machines had been degrading and causing users to inhale toxic particles. Now the investigation has been made public, CPAP sleep machine lawsuits are rolling in.
According to Reuters, shares in Philips plunged 15 percent on January 12, after the conglomerate raised the number of devices subject to the June 2021 recall from three million to five million (The FDA states that 15 million devices worldwide are affected). Philips faces over a hundred class action lawsuits and CPAP complaints have surged since a damning FDA investigation. And it would seem that Philips can no longer shift the blame of its defective devices on SoClean’s ozone cleaning products –a smear campaign that has only added to distrust – which resulted in SoClean filing a federal lawsuit against Philips seeking damages of more than $200 million. Philips is going to need deep pockets.
The FDA Investigation
After Philips Respironics recalled its devices, the FDA last August and November inspected the company’s manufacturing facility in Pennsylvania. The agency sifted through digital records, product testing and facility operations to determine what factors could have caused or contributed to the foam problems that amounted to the recall and whether Philips had indeed met federal manufacturing requirements. It found that Philips “knew of problems for years, but didn’t act,” reported NBC News. The FDA reported that “there were at least fourteen instances, assessments, and/or test reports, dated from 04/01/2016 to 01/22/2021, where [Philips] was aware of issues and concerns” related to the June 2021 recall. The FDA went on. “A risk analysis is inadequate and no further design change, corrective action, or field correction was conducted when appropriate or within an appropriate timeframe.”
The FDA investigators found that Philips knew as far back as 2015 that PE-PUR foam in its breathing machines could degrade. They also discovered that Philips’ executive managers knew of the problems for more than a year before issuing the voluntary recall. Included in the FDA report is one internal email dating back to 2015 from a Philips employee to the company’s raw foam supplier that “implies that a customer made [Phillips] aware of polyester polyurethane foam degradation issues.” This means that Philips knew of potential harm to millions of users for six years before doing anything about it.
In November 2021, the FDA listed all machines affected by the recall, which was updated from the June recall. And Philips test labs showed degraded foam from devices included in the Philips CPAP recall may release many toxic chemicals, including: Toluene diamine, toluene diisocyanate, diethylene glycol, dimethyl diazine, and phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl). Philips received reports of side effects from possible foam and gas inhalation and ingestion from these chemicals, which have been known to cause a number of side effects, including:
As of December 2021 the FDA has received 220,000 complaints about the devices.
CPAP Multi-District Litigation
Last November the multi-district litigation (MDL) panel agreed with plaintiffs’ lawyers that there should be an MDL class action lawsuit and have it based in Pennsylvania, a decision that resulted in 114 CPAP lawsuits pending in federal court transferred to one single judge. U.S. District Judge Joy Flowers Conti in Pittsburgh is presiding over the MDL—comprising both CPAP consumer class action lawsuits and personal injury claims--in the Western District of Pennsylvania. Conti has set a hearing for January 27th, when she will interview and select lead counsel and liaison counsel from a group of at least 12 lawyers (one attorney suggested that six more lawyers are needed) on a plaintiffs’ steering committee for possible leadership appointments. By mid-December there were 137 CPAP lawsuits in the MDL and thousands more are expected.
Judge Conti said that a registry or separate docket to house unfiled claims would be “high on the priority,” similar to the methods used to keep track of the 150,000 cases involving heartburn Zantac and 250,000 over 3M’s dual-ended combat earplugs. She also said that this MDL is her fourth and the largest one and predicts it will be the largest of her career. It is expected to last about two years.
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