Apple, Inc. was slapped with a new class action lawsuit Christmas Eve alleging the pulse oximetry feature on the Apple Watch product doesn’t work on people with a “darker skin tone.”
Plaintiff Alex Morales of New York filed a multi-state lawsuit on behalf of the state and nine others under consumer fraud laws against the tech giant in the Southern District of New York last week.
Morales, who said he purchased an Apple Watch between 2020 and 2021, claims he was unaware the pulse oximetry feature, which measures the oxygen level of a wearer’s blood directly from their wrist, was biased against people with darker skin tones.
“For decades, there have been reports that such devices were significantly less accurate in measuring blood oxygen levels based on skin color,” the lawsuit alleges. “The ‘real world significance’ of this bias lay unaddressed until the middle of the Coronavirus pandemic, which converged with a greater awareness of structural racism which exists in many aspects of society.”
According to the lawsuit, researchers claim the clinical significance of racial bias in pulse oximetry came from records of patients taken during and before the pandemic.
The conclusion showed that “reliance on pulse oximetry to triage patients and adjust supplemental oxygen levels may place Black patients at increased risk for hypoxemia.”
Health care recommendations base blood oxygen levels on readings, the lawsuit says, allegedly giving white patients more access to care than those with darker skin when faced with equally low blood oxygenation.
Representatives for Apple, the lawsuit reads, affirmed and promised that it did not incorporate biases and defects of pulse oximetry concerning persons of darker skin tone.
The Food and Drug Administration held a panel last month, which USA Today reported discussed studies that found pulse oximeter devices register higher oxygen level readings in people with darker skin tones.
Amal Jubran, a pulmonologist at Loyola University Medical Center in Illinois, told the outlet that researchers identified the problem in the 1990s.
“It never got any traction, then the COVID pandemic brought everything to the forefront,” Jubran said.
Jubran and a colleague published a peer-reviewed study in the European Respiratory Journal that found inaccurate oximeter readings in darker-skinned patients remained “unchanged” for 32 years.
Michael Sjoding, a fellow University of Michigan clinical professor, told the outlet that past work showed pulse oximeters produced less accurate results in darkly pigmented patients.
“What was described in these older studies might still be happening,” Sjoding said.
The clinical professor conducted a study in 2020 along with other colleagues, which found that 11.7% of black patients registered higher than accurate oxygen levels on pulse oximeters compared to 3.6% of white patients.
Apple released its signature Watch product nearly eight years ago. It quickly became one of the most wearable devices after 4.2 million users purchased one in the second quarter of the fiscal year 2015. By December 2020, more than 100 million people were estimated to use an Apple Watch.
Apple Insider reported in 2015 that the tech giant faced another lawsuit concerning the skin when users complained that black wrist tattoos interfered with the device’s heart sensor.
“Permanent or temporary changes to your skin, such as some tattoos, can also impact heart rate sensor performance,” read an updated Apple support page, according to the outlet. “The ink, pattern, and saturation of some tattoos can block light from the sensor, making it difficult to get reliable readings.”
Such issues happened before the blood oxygen sensor problem came to light, which Apple added to the Apple Watch Series 6 in 2020.
Apple has yet to respond to media requests for comment.