Medical device maker Philips, already a defendant in numerous lawsuits after it recalled millions of machines used by obstructive sleep apnea patients, is now being sued by a major New Hampshire-based cleaning products company.
SoClean Inc. on Tuesday filed a lawsuit in US District Court in Boston demanding $200 million in damages, saying Philips wrongly implicated its products for the problems that prompted Philips in June to issue the massive recall of devices commonly known as CPAP and BiPAP machines.
“Philips’s false and misleading statements” regarding SoClean products “have had a devastating impact on SoClean,” the lawsuit says. “SoClean’s sales have plummeted, its brand reputation has been tarnished, and the company has lost an enormous amount of goodwill.”
The Peterborough, N.H.-based company said it is the market leader in ozone cleaners, which are used by many sleep apnea patients to clean CPAP and BiPAP machines and its masks, hoses, and other accessories.
”Philips has engaged in deliberate misdirection, pointing the finger at SoClean’s ozone cleaners to divert attention away from Philips,” the lawsuit says.
A spokesman for Philips North American, a subsidiary of the Dutch multinational company, said Philips does not comment on matters of ongoing litigation. The North American subsidiary is headquartered in Cambridge.
The recall of about 2 million machines in the United States came after Philips said it discovered 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.
SoClean, in its 30-page complaint, pointed to numerous statements made by Philips and its CEO and chairman, Frans van Houten, after it initiated a voluntary recall.
In a Q&A published on its website after the recall, Philips wrote that it recommends that patients “halt use of ozone-related cleaning products,” the complaint says.
Philips also told consumers “the foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone,” the complaint says.
And in an earnings call in July, van Houten said of ozone cleaners, “It’s a very aggressive cleaning method that should not be used on medical devices at all,” the complaint says.
The suit also says that van Houten falsely said the Federal Drug Administration “put out a safety notice to say don’t use ozone for sleep apnea machines,” the complaint says.
The SoClean complaint says the real reason that foam is breaking down in some CPAP machines is a faulty design by Philips. “Simply put, the safety concerns that led to the recall arose because of Philips’s poor choice of foam,” the complaint says.
The complaint also says the cleaning instructions provided by Philips “are wholly inadequate to disinfect the entire machine. A superficial cleaning with soap and warm water is not sufficient.”
Sleep apnea patients 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 CPAP machine 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 is also facing a raft of lawsuits on behalf of users of its machines, including 10 filed in US District Court in Boston last summer. Among the most serious allegations made in those lawsuits is that Philips failed to disclose the defect as soon as it knew about it.
“The central allegation is that Philips had knowledge of the defect but failed to alert the public of the serious dangers it presented,” Shanon J. Carson, a lawyer in one of the suits filed in Boston, said last summer.
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.”
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.”
Philips has said it first discovered the breakdown of the foam and its risks to patients through its own quality management system.
Philips has pledged to repair or replace the affected CPAP machines. In a statement released Wednesday, a company spokesman said completion of that task may take a year or more.
Given that as many as 4 million CPAP are in use worldwide (about half in the US), “we expect to complete the repair and replace program in each country within approximately 12 months” after getting regulatory clearances, the spokesman said.
In the US, the Food and Drug Administration must approve the company’s repair and replacement program.
Meanwhile, Philips has implemented a “large-scale patient awareness initiative” that in recent weeks has included advertisements in newspapers, including The Boston Globe.
Philips does not have complete contact information to communicate directly with CPAP uses via mail or e-mail, the spokesman said. That information belongs to equipment providers, he said, and Philips is working with those providers to contact CPAP users.
“We fully understand and regret the impact that this is having on patients,” the spokesman said. “We are working around the clock to continue to reach out to our customers and patients.”