Philips DreamStation Recall Repairs Allowed To Proceed, Subject to CPAP Foam Preservation Requirements

Philips must preserve any replaced devices, and any foam, blower box, and SD card removed from any sleep apnea machines it repairs.

The U.S. District Judge presiding over all federal Philips DreamStation recall has issued an order authorizing the manufacturer to move forward with plans to remove and replace defective sound abatement foam in the sleeping machines, but requires that certain critical evidence be preserved.

A massive Philips Respironics sleep machine recall was issued in June, impacting millions of CPAP and BiPAP breathing devices that contained a polyester-based (PE-PUR) sound abatement foam, which was intended to reduce sounds and vibrations during use. However, the manufacturer now acknowledges that the CPAP foam degrades over time, and may release black particles or debris directly into the sleep apnea machine’s air pathways, exposing users to a number of toxic chemicals and gases.

Over the past few months, dozens of personal injury and class action lawsuits over the Philips sleep apnea machine recall have been filed throughout the federal court system, each raising similar allegations that exposure the deteriorating sound abatement foam exposed users to a risk of cancer, severe respiratory problems and other health complications.

Given common questions of fact and law raised in product liability and class action lawsuits over recalled Philips CPAP devices and other breathing assistance machines, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided last month to centralize the litigation before Senior U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania for pretrial proceedings as part of a multidistrict litigation (MDL).

In an emergency motion (PDF) filed on November 12, attorneys for the manufacturer asked the court to modify a prior preservation order, and allow Philips DreamStation recall repairs to begin, where the PE-PUR foam will be removed from sleep apnea machines and replaced with a different material.

Philips Respironics indicated that as of that date, it had received approximately 335,000 recalled sleep apnea machines from consumers, and had already reworked and returned approximately 115,000 devices, with plans to repair about 2,500 machines per day until it is able to increase capacity, and allow it to repair up to 5,500 devices per day.

The motion came after the Court issued a preservation order early in the litigation, which may have barred the sleep machine repairs in order to maintain evidence relevant to the cases.

In a response (PDF) filed on November 15, plaintiffs pursuing lawsuits indicated that they have no problem with Philips repairing recalled machines, but objected to the likely, and unnecessary, destruction of evidence.

“Plaintiffs do not take issue with Philips repairing recalled machines and sending them to Class members, so long as the repaired machines are safe for Plaintiffs and Class members,” the opposition brief notes. “But Philips proposes to destroy evidence unnecessarily. Philips should preserve all relevant evidence, including the PE-PUR foam that is at issue in this litigation, memory cards in the devices, and other component parts of machines that are removed in the retrofitting process, for possible inspection and testing at a later time.”

Judge Conti agreed and issued a pretrial order (PDF) on November 19, which allows Philips Respironics to repair and replace the recalled devices, but requires them to preserve any devices in their entirety that they replace. In addition, the order calls on Philips to preserve, store and catalogue any blower box, PE-PUR foam, and SD card from any recalled CPAP machines which they are retrofitting, along with the original serial number so the device can be traced back to the specific individual who used it.

Philips DreamStation CPAP Health Risks

Due to concerns about the serious health risks from the Philips sleep apnea machines, the FDA issued a safety communication on June 30, urging people who use Philips DreamStation, CPAP or BiPAP machines to immediately stop using their device and contact their healthcare providers for a suitable treatment alternative.

Unfortunately, there has been a limited supply of the breathing machines available, and alternative treatments for sleep apnea or lifestyle changes may not provide immediate relief, leaving many users concerned about side effects they may experience without the CPAP machine to keep their airway open at night.

In the wake of the recall, Philips has not provide replacement CPAP machines to all consumers or offered to immediately refund sleep apnea machines with the defective PE-PUR foams. It was not until September that Philips announced a replacement plan, which it estimates will take up to a year to complete.

The Dutch manufacturer, Koninklijke Philips, N.V. generated over $23 billion in revenue last year, and is expected to face massive liability from lawsuits and CPAP machine settlements over the next few years.