Royal Philips NV has been subpoenaed by the U.S. Department of Justice related to the recall of defective sleep apnea machines and respirators — a recall that’s led to more than 100 lawsuits and multidistrict litigation — the company announced in a U.S. Securities and Exchange Commission.
The company said that Philips Respironics, which manufactured the faulty devices, and several of its U.S. subsidiaries received the subpoena on April 8. They were asked “to provide information related to events leading to the Respironics recall,” Philips said in the filing. “The relevant subsidiaries are cooperating with the agency.”
Philips had come under fire in more than 100 cases filed across the country following a recall of the company’s CPAP, Bi-Level PAP and mechanical ventilator devices containing polyester-based polyurethane sound abatement foam, or PE-PUR foam. According to the June recall, that foam can degrade, releasing bits of foam or chemicals into the machines where patients can inhale them.
The Judicial Panel on Multidistrict Litigation sent the cases to an MDL in the Western District of Pennsylvania, where Philips RS North America LLC — formerly Philips Respironics — had a factory that had manufactured most of the recalled machines.
In November, Philips said that preserving evidence for the MDL was preventing the company from taking back and repairing thousands of defective sleep apnea machines.
Philips objected to a pretrial order barring any “tangible things” that could be evidence in the MDL from being “destroyed” or “altered.”
Respironics had gotten back about 335,000 recalled devices as of when it made the emergency request, and had fixed and sent back about 115,000, Philips said. 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.