Philips Sues SoClean Alleging Ozone Exposure Risks Over Injuries Related To Breathing Devices

Koninklijke Philips N.V. PHG has reportedly taken legal action against SoClean to allocate a portion of the recent $1.1 billion settlement concerning alleged injuries caused by Philips’ recalled devices. 

In June 2021, Philips initiated a voluntary recall notification for certain CPAP and BiPAP sleep therapy devices and ventilators related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices that were harmful to the users.

Last month, the Dutch medical technology firm reached a $1.1 billion settlement in the U.S. related to the recall of its Respironics ventilators.

SoClean is known for its ozone-based cleaning systems for breathing devices, Reuters reports.

Citing a complaint in a federal court in Pittsburgh, Pennsylvania, Reuters highlights the complaint alleges that injuries attributed to Philips’ machines could be linked, at least partially, to ozone exposure from SoClean products.

The lawsuit highlights that a significant portion, estimated at least 15%, of users covered in the settlement utilized SoClean products. 

These users may have experienced injuries due to direct ozone inhalation or deterioration of foam within the breathing machines caused by ozone exposure.

Additionally, Philips targets DWHP, a healthcare-focused private equity firm with investments in SoClean, alleging that SoClean functioned as an “alter ego” for DWHP.

Philips underscores that SoClean and DWHP promoted their cleaning systems specifically for use with Philips products. 

Laboratory tests indicated that these systems emitted ozone levels surpassing federal limits, with ozone persisting within the breathing machines post-cleaning.

Contrary to SoClean’s marketing, Philips never recommended their usage on its devices; instead, it advocated for mild detergent cleaning. 

The FDA has cautioned against ozone-based cleaning systems, emphasizing their lack of approval or proven safety.

Despite SoClean’s efforts to mitigate risks with manual revisions and adaptors in 2023, Philips alleges that the company was aware of the hazards for years before taking action.

Meanwhile, SoClean faces legal battles, including a lawsuit against Philips for defamation, underscoring the escalating legal dispute between the two companies.

In January, the company will not sell new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the U.S. until the consent decree’s requirements are met.

Price Action: PHG shares are up 0.39% at $27.07 at last check Tuesday.

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