| The complaint is also available at https://archive.org/details/gov.uscourts.nysd.591590 - the pdf is https://ia601507.us.archive.org/26/items/gov.uscourts.nysd.5... The initial part of the complaint: 1. Apple, Inc. (“Defendant”) manufactures, markets, and sells the Apple Watch, purporting to measure the oxygen level of a wearer’s blood directly from their wrist (“Product”). 2. The interest in blood oxygen levels extends began at least two hundred years ago hot air balloon flyers and mountain climbers needed to ensure survival. 3. Later, these groups included astronauts, pilots and divers. 4. The early devices, were used in a person’s ear, used light-based technology or
spectrophotometry to measure oxygen levels. 5. In the 1970s, a fingertip oximeter was invented that was easier to use than its predecessors. 6. For decades, there have been reports that such devices were significantly less accurate in measuring blood oxygen levels based on skin color. 7. 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. 8. Researchers confirmed the clinical significance of racial bias of pulse oximetry using records of patients taken during and before the pandemic. 9. The conclusion was that “reliance on pulse oximetry to triage patients and adjust supplemental oxygen levels may place Black patients at increased risk for hypoxemia.” 10. Since health care recommendations are based on readings of their blood oxygen levels, white patients are more able to obtain care than those with darker skin when faced with equally low blood oxygenation. 11. While traditional fingertip pulse oximeters are capable of measuring blood oxygen levels and heart rate, wrist-worn devices like the Product determine heart rate, as blood oxygen measurements from the wrist are believed inaccurate. 12. Algorithms designed for fingertip sensing are inappropriate when based on wrist measurements, and can lead to over 90% of readings being unusable. 13. Though one recent study concluded the Product was able to detect reduced blood oxygen saturation in comparison to medical-grade pulse oximeters this fails to recognize the failings of pulse oximetry in general with respect to persons of color. 14. As a result of the false and misleading representations, the Product is sold at a premium price, approximately no less than $400, excluding tax and sales. |