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Oakland, California – The Roots Community Health Center in Oakland, California, led by physician and researcher Noha Aboelata, has filed a groundbreaking lawsuit against 12 companies over the continued sale of pulse oximeters, devices that researchers say inaccurately measure blood-oxygen levels in people of color. The lawsuit, the first of its kind targeting device manufacturers, seeks an injunction to halt sales in California until the devices provide accurate readings for individuals with dark skin or attach warning labels about their inaccuracies.
Pulse oximeters, commonly clipped onto a fingertip, measure blood-oxygen levels by shining light through the skin and gauging its absorption by the blood. However, studies have shown that these devices can overestimate oxygen levels in individuals with dark skin, potentially leading to delayed or withheld treatment.
During the COVID-19 pandemic, concerns about inaccurate readings gained prominence as individuals infected with the virus sometimes exhibited abnormally low oxygen levels. Despite the spotlight on the issue, the response from the medical-device industry and the US government has been deemed slow by researchers.
The lawsuit invokes consumer-protection laws in California, alleging that companies falsely advertise the devices’ efficacy for people of color. It requests an injunction on sales until accurate readings for diverse skin tones are provided or warning labels are attached.
The devices’ historical training on white individuals contributes to the inaccuracies, a problem known for decades but brought to wider attention during the pandemic. Studies, including a 2020 paper co-authored by researcher Michael Sjoding, revealed that pulse oximeters could provide misleadingly ‘safe’ readings for Black individuals with dangerously low blood-oxygen levels.
Companies named in the lawsuit, including Medtronic and Masimo, have defended their technologies. Medtronic stands by its technology and emphasizes compliance with FDA guidelines, while Masimo points to a study showing no significant differences between Black and white individuals in its oximeter readings.
Legal experts believe the lawsuit could have broader implications due to the size of California’s medical-device market. The FDA, which regulates medical devices, has acknowledged the devices’ limitations and the need for improved studies to evaluate their performance.
Roots Community Health Center hopes that legal action will prompt faster and more effective responses than previous research papers have achieved. If successful, the lawsuit could impact medical-device practices nationwide and prompt the industry to address systemic inequities in healthcare.
