Philips Claims Order A Hurdle To Fixing Sleep Apnea Devices

The U.S. arm of Koninklijke Philips NV has said a Pennsylvania federal court’s order to preserve evidence for a multidistrict litigation was preventing the company from taking back and repairing thousands of defective sleep apnea machines, but plaintiffs’ attorneys opposed letting the company dispose of the components it was replacing.

After objecting to a pretrial order barring any “tangible things” that could be evidence in the MDL over degrading, potentially harmful sound-dampening foam in the machines from being “destroyed” or “altered,” Philips RS North America, also known as Respironics, will have 3 days to show why the pretrial order would prohibit it from carrying out its recall and repairs.

Philips filed an emergency request asking the court overseeing the MDL to stay or modify the pretrial order, arguing that the company had to replace the foam at issue in the case under orders from the U.S. Food and Drug Administration, and was falling behind because one paragraph of the court order barred it from making those repairs.

Attorneys representing 71 of more than 130 cases filed against the device maker objected. The cases were consolidated in an MDL based in the Pittsburgh federal court in October, since it was closest to Respironics’ Western Pennsylvania offices and manufacturing facilities.

Respironics had gotten back about 335,000 recalled devices as of when it made the emergency request Friday, and had fixed and sent back about 115,000. The Nov. 10 order put a halt on repairs, which would put the company about 56,500 devices behind by the time the parties were scheduled to meet again in mid-December.

However, dozens of plaintiffs’ attorneys filed a brief opposing a stay on the order, arguing that Philips should at least preserve the defective foam it was removing from the recalled machines and should make copies of the devices’ memory cards as evidence of users’ exposure to the foam, which was being recalled because of its potential to degrade and release gases or pieces that could be inhaled.

Messages from Respironics to its customers during the recall had referred to “disposal” of the recalled machines or instructed customers to “throw out” machines after receiving a replacement.

In a talk with the plaintiff’s attorneys, Respironics representatives had said they didn’t think the foam being removed from all the machines was relevant as evidence and said they believed it was being thrown out for customers who weren’t named as plaintiffs or hadn’t retained counsel for potential litigation. The plaintiffs wanted all the foam kept.


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