Migliaccio & Rathod LLP is currently investigating manufacturers of pulse oximeters for failing to disclose that the efficacy of these devices differs for those with dark skin. On February 19, 2021, the FDA issued a public warning about the “limitation” of pulse oximeters that implicitly suggests patients with darker skin are at a greater potential for receiving inaccurate oxygen level readings. For years, medical studies have raised concerns regarding the health disparities that result from medical devices that have been calibrated for some skin types to the detriment of others. Researchers at the University of Michigan, for example, published a December 2020 letter in the New England Journal of Medicine detailing their research that found oximeters were nearly three times as likely to miss hypoxemia, or below-normal levels of oxygen in the blood, in Black patients compared to white patients.
The COVID-19 pandemic raised the popularity and need for these devices as patients quarantining at home are advised to monitor their oxygen levels. Inaccurate readings that either over or under-record one’s oxygen levels would either keep a patient from seeking emergency help if their oxygen levels are actually below 90%, or would raise the risk of exposure to a patient’s family if they sought out emergency help when it wasn’t necessary.
Did you purchase a pulse oximeter and receive inaccurate or inconsistent results from the device?
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Attorneys Committed to Consumer Protection
The lawyers at Migliaccio & Rathod have years of experience in class action litigation against large corporations, including in cases involving defective products and unfair & deceptive trade practices. More information about our current cases and investigations is available on our blog.