#AIM SPECIALTY HEALTH LAWSUIT SKIN#

Around the same time, plaintiffs filed a lawsuit in the Southern District of California alleging 23andMe misleads consumers when promoting their test. In November 2013, the FDA sent a letter to 23andMe warning the company that their direct-to-consumer spit DNA testing kit raises a public danger because of potential inaccurate results. Private sector litigation has previously accompanied public regulatory action when the public learns about inaccurate or unfair direct-to-consumer medical devices.

This FDA action following class action litigation is not unprecedented. Because the plaintiffs relied on representations that they could use their Apple Watches for this function, they request relief including monetary damages. The complaint cites recent scientific studies concluding that while the Apple Watch pulse oximeter function was able to detect reductions in blood oxygen levels as well as a medical-grade device, both the Apple product and medical-grade devices fail to accurately detect oxygen levels in people of color. In the complaint, the plaintiffs allege consumer fraud, breaches of expressed warranty, implied warranty of merchantability/fitness for a particular purpose, and unjust enrichment. On December 24 th, 2022, plaintiff, Alex Morales, on behalf of other similarly situated, filled a class action lawsuit in the Southern District of New York against Apple, Inc. Even without a medical incident, consumers of wearables with built in pulse oximeters feel entitled to financial relief for purchasing and relying on inaccurate devices. Severe low oxygen levels in the blood can cause damage to the brain, liver, and other organs in a matter of minutes.Ĭhanges in guidelines may prevent harm to future users, but real people have already been harmed by inaccurate pulse oximeter readings. The FDA is in the process of rethinking pulse oximeter regulatory clearance and approval guidelines, which aim to prevent situations where inaccurate and ineffective monitors lead to failure of the device to detect hypoxia, low level oxygen in the blood.

#AIM SPECIALTY HEALTH LAWSUIT SKIN#

I specifically highlighted recent news about inaccuracies in pulse oximeters based on skin tone. I then discussed how the strength of regulatory oversight may not be robust enough to prevent the production, sale, and use of devices that are not as accurate for some individuals as others. I discussed how companies like Apple and Fitbit have applied for FDA clearance under 510(k) to produce and sell wearables that contain medical device functions such as ECG, Irregular Rhythm Notification (Irnf) and Atrial Fibrillation history.įDA regulations aim to prevent unsafe devices from entering health care systems or the general marketplace. In a blog last month, I wrote about wearable medical devices and FDA law.

Aim specialty health lawsuit