Philips Sues CPAP Cleaner SoClean to Share Settlement Costs

Philips Sues CPAP Cleaner SoClean to Share Settlement Costs

Introduction

Philips has filed a lawsuit against SoClean, a company that manufactures ozone-based cleaning systems for breathing devices, seeking to make SoClean contribute to a $1.1 billion settlement Philips reached with users who claim they were injured by Philips’ recalled devices.

The complaint, filed in Pittsburgh, Pennsylvania, federal court, asserts that any injuries sustained by users of Philips' machines for sleep apnea and other breathing issues were caused, at least in part, by ozone exposure from SoClean's products. Philips highlighted that approximately 15% of users of the affected positive airway pressure (PAP) machines used SoClean products, with the actual figure likely being higher. The injuries may have resulted from inhaling ozone directly or from the ozone causing the foam in the machines to deteriorate.

The lawsuit also names DWHP, a private equity firm that invests in SoClean, alleging that SoClean acted as DWHP's "alter ego." Neither DWHP nor SoClean responded immediately to requests for comment. Philips, which denies that its products caused injuries, claims that SoClean and DWHP marketed their cleaning systems as compatible with Philips devices.

Laboratory tests indicated that SoClean's systems released ozone levels exceeding federal limits and that ozone remained inside the breathing machines after cleaning. Philips has always recommended using mild detergent for cleaning its devices and has never endorsed the use of SoClean's products. The U.S. Food and Drug Administration (FDA) has issued multiple warnings that ozone-based cleaning systems are neither approved by the agency nor known to be safe.

In November 2023, SoClean updated its manual and provided an adapter to prevent ozone from entering the machines. The following month, the FDA announced that it was working with SoClean to ensure compliance with its regulations. Philips' lawsuit claims that SoClean had been aware of the risks for years before taking action in 2023. Philips recalled its devices in June 2021 due to concerns that foam used to muffle the machines' sound could degrade, releasing toxic gases and particles that could irritate airways and potentially cause serious health conditions, including cancer. Philips replaced the foam with silicone in the recalled devices.

Claims from individuals alleging injuries from using the devices, including respiratory illnesses and cancer, were consolidated in the Pittsburgh court later in 2021. By the time of the settlement, tens of thousands of claims had been filed. SoClean is also facing lawsuits in the same court and, in October, it filed a lawsuit accusing Philips of disparaging its cleaning products, which is still pending.