A federal court ordered Philips to preserve as evidence its CPAP machine parts, but Philips hit back, saying it hinders the FDA order to repair the recalled devices.
Philadelphia, PAIn response to a federal court order requiring Philips RS North America to preserve evidence for a multidistrict litigation, the company says it hinders the recall and repairs of its defective CPAP sleep machines, as per the FDA’s order. But plaintiffs say Philips proposes to destroy evidence—defective sound-dampening foam and memory cards—unnecessarily.
U.S. District Judge Joy Flowers Conti doesn’t buy into Philips (also known as Respironics) excuse that preserving evidence is in conflict with the FDA’s recall remediation and prevents them from taking back and repairing thousands of defective sleep apnea machines, according to Law360.
The Court Order
In its pretrial order, the court overseeing the MDL has barred Philips from making repairs to its CPAP sleep machines, according to Philips. It argues that:
"Paragraph 13 imposes obligations on the parties that are in conflict with the FDA recall remediation. The preservation of evidence provision also arguably applies to absent class members, which could lead to users failing to submit their devices for replacement, and Respironics being unable to rework devices and provide replacements to users."
Judge Flowers responded: “The court, however, lacks information about why Respironics is unable to preserve the items identified in the brief in response to its emergency motion, i.e., the PE-PUR foam, memory cards in the devices, and other component parts of the machines that are removed in the retrofitting process."
Plaintiffs’ attorneys said that the PE-PUR foam should be preserved, along with all data on the memory cards so that each piece of removed PE-PUR foam can be traced back to the specific individual who returned the device. And the memory cards should be backed up to also document the chain of custody.
Law360 reported that Respironics messaged its customers during the recall and had referred to "disposal" of the recalled machines or instructed customers to "throw out" machines after receiving a replacement [see below], the plaintiffs' brief said. Respironics representatives tried to backtrack by saying the defective foam wasn’t relevant and they believed it was being thrown out for customers who weren't named as plaintiffs or hadn't retained counsel for potential litigation.
Understandably, plaintiffs want all the foam preserved as evidence.
More Defective Foam?
After the June recall of its CPAP sleep machines, the FDA approved Philips’ proposal to repair and replace the defective foam with a different silicone-based foam. But the agency later discovered that this alternative foam used in a similar device had failed a safety test for the release of “certain concerning chemicals” that could release harmful gasses –a repeat performance. Consequently, 250,000 replacement devices Philips sent out could also be defective.
The Wall Street Journal reported that:
FDA has asked Philips to hire an independent laboratory to run further tests on devices that use the silicone-based foam to identify any potential safety risks.
FDA is currently awaiting the results of that testing. Philips said it would continue to send out replacement machines in the interim.
Philips Chief Executive Frans van Houten said that “We remain fully committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.”
As of mid-November, Philips Respironics has received about 335,000 recalled devices and repaired and returned about 115,000. The company argues that the Nov. 10 order to preserve evidence related to CPAP lawsuits will put 56,500 devices behind schedule for repairs according to a mid-December timeline.
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