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THE FINE PRINT

After recalling millions of sleep apnea machines, Philips sued by consumers

A machine used to treat obstructive sleep apnea, which manufacturer Philips is recalling. In its recall announcement, Philips said the foam used in its machines for noise reduction can break down and be ingested by users, causing serious and even life-threatening injury.
A machine used to treat obstructive sleep apnea, which manufacturer Philips is recalling. In its recall announcement, Philips said the foam used in its machines for noise reduction can break down and be ingested by users, causing serious and even life-threatening injury.David L. Ryan/Globe Staff

Medical equipment maker Philips is facing a raft of lawsuits following the announcement last month that it was recalling about 2 million machines used by obstructive sleep apnea patients in the US.

In its recall announcement, Philips said the foam used in its machines for noise reduction can break down and be ingested by users, causing serious and even life-threatening injury, though no deaths have been reported.

Among the most serious allegations made in the lawsuits, which include 10 filed in US District Court in Boston since June 17, is that Philips failed to disclose the defect as soon as it knew about it.

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“The central allegation is that Philips had knowledge of the defect but failed to alert the public of the serious dangers it presented,” said Shanon J. Carson, of the firm Berger Montague, who is a lawyer in one of the suits filed in Boston.

Patients who have used the Philips machines “have complained about black particles in their machines for years,” the complaint says, apparently referring to a visible byproduct of the breakdown of the foam.

Carson said he expected lawyers to try to determine what Philips knew and when it knew it as part of the early stages of litigation.

Carson also called the timing of the recall “highly suspicious.”

“Philips timed its recall … to coincide with the launch of its next generation of products,” which apparently do not include the foam Philips now regards as dangerous, the complaint says.

“Thus, the only safe option that Philips offers to its customers … is to purchase Philips’s new model, thus profiting Philips further,” the complaint says.

A spokesman for Philips North America, a subsidiary of the Dutch multinational company, said Philips does not comment on matters of litigation.

Philips North America is headquartered in Cambridge, which is one reason lawsuits were filed in Massachusetts.

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Lawyers who filed complaints in Boston requested on Wednesday that a judge consolidate the complaints into one. The lawyers are also asking a judge to treat their combined complaints as a class-action lawsuit.

A class-action suit would include as those claiming injury not only those named in the lawsuits, but everyone who purchased a recalled machine and who is “similarly situated” as those named in the suits, Carson said.

A hearing on the request for consolidation is scheduled for September.

The lawsuits seek to compensate users of the machines for economic loss, as well as for pain and suffering, Carson said. Given the number of people affected by the recall, damages could total “in the billions of dollars.”

People with sleep apnea repeatedly stop breathing while they sleep, only to be partially or fully awakened when their brains don’t get enough oxygen. It deprives those who have it of restful sleep, and is linked to a range of ailments, including high blood pressure, heart disease, type 2 diabetes, and liver dysfunction.

Using a machine known as a CPAP is the most widely used treatment for sleep apnea. Users wear a mask or nosepiece attached to the machine that provides a steady flow of pressurized air while they sleep.

Philips has said it received “a limited number” of reports of users complaining of headaches, upper airway irritation, cough, chest pressure, and sinus infection.

After an investigation, the company has said, it determined that patients exposed to the degradation of the foam risk serious consequences, including “asthma, adverse effects on other organs (e.g., kidney and liver) and toxic carcinogenic effects.”

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Philips has said it first discovered the breakdown of the foam and its risks to patients through its own quality management system.

No timeline has been established for repairing or replacing the affected CPAP machines, though the company is “working to address this issue as expeditiously as possible,” a spokesman said last month. The Food and Drug Administration must approve the company’s repair and replacement program.

Dr. Anjali Ahn, medical director of the Sleep Disorders Center at Beth Israel Deaconess Medical Center, said in a previous Globe article that only high-risk patients should continue to use their Philips CPAP devices while they await repair or replacement.

A high-risk patient is anyone with severe breathing or cardiac problems, patients who can’t sleep well without their device or have a lot of daytime sleepiness, or patients who work in high-risk occupations, such as commercial drivers or pilots.

Those who are not at high risk should discontinue use of their CPAP machines, she said.

Jim Curran, 70, of Marshfield, discontinued use of his machine after learning about the recall. He said he hopes the lawsuits “shine a light” on Philips.

“This is a positive development,” Curran said of the lawsuits. “Anything that makes a company accountable for the products it makes is a positive development.”


Got a problem? Send your consumer issue to sean.murphy@globe.com. Follow him on Twitter @spmurphyboston.