Litigation is progressing slowly in MDL 3014, with the case currently in discovery. On December 12, 2022, the parties jointly stipulated to the Deposition Protocol, which limits most depositions to seven hours. This was approved in Pretrial Order #29.
On September 14, 2022, in Pretrial Order #25, Judge Conti granted a joint motion to approve a census registry form, which allows plaintiffs to file complaints on a short form directly with Philips Respironics. Completing this information has the effect of tolling the statute of limitations until a case can be filed or Philips withdraws the agreement. This replaces a private tolling agreement that had been approved on February 8, 2022.
The case against Philips has garnered the attention of the U.S. Justice Department. Philips is currently engaged in negotiations with the Justice Department regarding a consent decree the Justice Department proposed in 2022 with regards to the recall.
In May 2022, the Food and Drug Administration’s Center for Devices and Radiological Health issued a “Notice of Opportunity for a Hearing” to Philips Respironics that the FDA had determined the Philips CPAP machines create an unreasonable risk of substantial harm to the public.
In the notice, the FDA specifically refuted Philips Respironics’ claim that the use of ozone cleaners may be the true cause of the foam breaking down, with the following statement:
“There is sufficient evidence for FDA to determine that there are reasonable grounds to believe that the risk associated with the devices was not caused by the failure of a person other than Philips to exercise due care in the installation, maintenance, repair, or use of the devices at issue. In particular, although the use of ozone cleaners by device users may have exacerbated degradation of the PE-PUR foam, evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”
According to a December 2022 FDA update, the silicone material being used to replace the foam may move and block the air pathway, resulting in reduced air flow and the potential to activate the device alarm. The FDA also found residual foam in the replacement devices.
The devices affected include the first-generation DreamStation CPAP and BiPAP machines, with Philips’ DreamStation CPAP machines accounting for about 80 percent of the recalled sleep apnea devices, according to ConsumerNotice.org. The other 20 percent are mechanical ventilators.
Personal injury lawyers opting to litigate CPAP cases could see many clients interested in recovering damages for serious injuries caused by Philips Respironics’ sleep apnea devices and the defects found with the sound abatement foam. Case Works offers case development and management tasks for lawyers with large caseloads, including those caseloads arising from CPAP litigation.