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:
- Airway irritation and inflammation
- Carcinogenic effects
- Chest pressure
- Inflammatory response
- Organ damage (liver, kidney and others)
- Sinus infection
- Skin, eye and respiratory tract irritation
- Upper airway irritation
As of December 2021 the FDA has received 220,000 complaints about the devices.
CPAP Multi-District Litigation
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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.