In a blog last month, I wrote about wearable medical devices and FDA law. 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. 

FDA regulations aim to prevent unsafe devices from entering health care systems or the general marketplace. 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 specifically highlighted recent news about inaccuracies in pulse oximeters based on skin tone. 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. Severe low oxygen levels in the blood can cause damage to the brain, liver, and other organs in a matter of minutes.

Changes in guidelines may prevent harm to future users, but real people have already been harmed by inaccurate pulse oximeter readings. 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.

On December 24th, 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. In the complaint, the plaintiffs allege consumer fraud, breaches of expressed warranty, implied warranty of merchantability/fitness for a particular purpose, and unjust enrichment.[1] 

The complaint[2] 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. Because the plaintiffs relied on representations that they could use their Apple Watches for this function, they request relief including monetary damages. 

This FDA action following class action litigation is not unprecedented. Private sector litigation has previously accompanied public regulatory action when the public learns about inaccurate or unfair direct-to-consumer medical devices. 

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. Around the same time, plaintiffs filed a lawsuit in the Southern District of California alleging 23andMe misleads consumers when promoting their test. In March 2014, this suit, Casey v. 23andMe, Inc., consolidated with a similar class action suit, Tomkins v. 23andMe, Inc, in the Northern District of California.[3] In both, the plaintiffs alleged false advertisement because the advertisements led consumers to believe they could use the kits to learn about health conditions and genetic carrier status. In 2016, the 9th Circuit Court of Appeals, affirmed the district court’s granting of 23andMe’s motion to compel arbitration.[4] While we do not know the results of the arbitration, we know that 23andMe also faced complaints filed before the American Arbitration Association, Livingston v. 23andMe Inc. and Davis-Hudson v. 23andMe, Inc., with similar claims.[5]

The 23andMe story suggest that more complaints are likely brewing against Apple and other companies selling wearable pulse oximeters. The story also shows that when the FDA announces new warnings or changes to regulations for direct-to-consumer medical devices, companies need to think about the consumers who have already bought and rely on the devices. 

Even if Apple defeats the plaintiffs’ claims, the negative press may have substantial effects on Apply Watch sales or company loyalty. As of December 29th, the lawsuit has already been covered by major news sources including USA today, Forbes and the New York Post. Apple has not commented on the lawsuits, but they do maintain their devices are for general fitness and wellness. Likely trying to distinguish their product from medical devices requiring higher regulation and oversight and trying to escape liability, Apple reminds users that the watch Blood Oxygen App measurements are not “intended for medical use.”[6]

[1] New York General Business Law (“GBL”) §§ 349 and 350, Consumer Fraud Multi-State Class, Breaches of Express Warranty, Implied Warranty of Merchantability/Fitness for a Particular Purpose, and Magnuson Moss Warranty Act, 15 U.S.C. §§ 2301, et seq.

[2] https://storage.courtlistener.com/recap/gov.uscourts.nysd.591590/gov.uscourts.nysd.591590.1.0.pdf.

[3] https://dockets.justia.com/docket/california/casdce/3:2013cv02847/429459.

[4] Tompkins v. 23andMe, Inc., 840 F.3d 1016 (9th Cir. 2016).

[5] See Ironshore Specialty Ins. Co. v. 23andMe, Inc., No. 14-cv-03286-BLF, 2015 U.S. Dist. LEXIS 64145, *3 (N.D. Cal. May 14, 2015).

[6] https://nypost.com/2022/12/27/apple-faces-class-action-lawsuit-alleging-racial-bias-in-watchs-blood-oximeter/