I tend to agree with bb254 and Chaudhry that as marketed by its company, Fitbit PurePulse tracker is pitched as a “general wellness use and present a low risk to the safety of the user.” As long as the Fitbit company didn’t make any medical claims and the FDA had the chance to (but didn’t) regulate the device, the Fitbit company holds no legal liability. Now if the FDA were to consider the Fitbit as a medical device, I agree with Chaudhry and would place it under the Class I. This classification is just due to their being numerous similar products on the market along with the fact that the device itself poses relatively low risk when used correctly.
In addition to what was said above about the lawsuit, if blame was to be placed on anybody/ entity, I would question the physicians judgement of recommending a non-medical device to keep track of a serious medical condition. If the plaintiff turned their attention towards the doctor instead of the Fitbit company, I believe they would have a better chance at receiving compensation for their lawsuit. An actual FDA regulated heart rate monitor would have been a more appropriate option for the patient with a heart condition.