- Law firms
- Related documents
- SoClean alleges false warnings intended as a diversion
- Company seeks $200 million in damages
The company and law firm names shown above are generated automatically based on the text of the article. We are improving this feature as we continue to test and develop in beta. We welcome feedback, which you can provide using the feedback tab on the right of the page.
(Reuters) – Dutch medical equipment company Philips has been hit with a $200 million lawsuit accusing it of deceiving the public and the healthcare industry by falsely linking the problems with its recently recalled sleep-apnea machines to ozone-based cleaning methods.
SoClean Inc, an independent supplier of ozone-based sanitizing systems, said in a lawsuit filed Tuesday in Boston federal court that Philips is “pointing the finger at SoClean’s ozone cleaners to divert attention away from Philips’ poor choice of materials and obvious design flaws” in the continuous positive airway pressure (CPAP) devices it recalled in June due to potential problems with the foam used to muffle the machines’ noise.
As a result SoClean’s “sales have plummeted, its brand reputation has been tarnished, and the company has lost an enormous amount of goodwill,” SoClean’s attorney Colin Cabral of Proskauer Rose wrote in the complaint.
No attorney was listed for Philips on the court docket on Wednesday, and company spokesman Steve Klink said it does not comment on pending litigation.
Amsterdam-based Koninklijke (Royal) Philips NV first warned of two “possible risks to users related to the sound abatement foam” used in some earlier models of its CPAPs, similar BiPAP devices and mechanical respirators in an April filing with the U.S. Securities and Exchange Commission.
Its voluntary recall in June affected an estimated 3 million to 4 million devices – about half of them in the U.S. – which it expects to repair or replace by September 2022.
Philips said it had determined that the polyester-based polyurethane foam used in the recalled models before April 2021 could emit toxic fumes, and that the foam also could degrade under certain circumstances, releasing small particles that users might inhale through the devices’ airways.
The recall notice said the foam degradation “may be exacerbated by use of unapproved cleaning methods, such as ozone.”
Philips repeated the warning on its website, in a July “update” letter to healthcare providers, in its second-quarter financial statement in July, in business conversations and in public interviews, the complaint said.
SoClean said Philips knew its statements were false from its own tests, and that its July update letter confirmed that the foam degradation was caused by contact with high humidity or water – not ozone.
The allegedly false statements were repeated and amplified in warning notices from the U.S. Department of Veterans Affairs, the 11,000-member American Academy of Sleep Medicine, several sleep institutes and associations and healthcare providers across the country, the complaint said.
Distributors dropped its products, CPAP users stopped using them, and SoClean “has been named in multiple lawsuits wrongfully alleging that its ozone cleaning products are ‘unhealthy’ and ‘unsafe,’” Cabral wrote.
SoClean is suing Philips and two of its U.S. units, Massachusetts-based Philips North America LLC and Pennsylvania-based Philips RS North America LLC, for false and unfair advertising under the federal Lanham Act and Massachusetts law, among other claims. It is seeking $200 million in actual damages plus unspecified amounts of enhanced damages and attorneys’ fees under those statutes.The Philips companies are also being sued by users of the recalled devices. The U.S. Judicial Panel on Multidistrict Litigation has consolidated 114 cases, so far, for pretrial proceedings.
The lawsuit filed Tuesday is SoClean Inc. v. Koninklijke Philips NV, U.S. District Court for the District of Massachusetts No. 21-cv-11662
For SoClean: Colin Cabral of Proskauer Rose
For Philips: No attorney listed