What’s a medical device? The courts are going to have a field day for years to come with the first of what I predict will be many lawsuits about alleged inaccuracies in the growing number of consumer health and fitness products. A class-action lawsuit, alleging faulty heart-rate monitoring with an activity tracking device, has made headlines because it’s against the manufacturer of the popular Fitbit.
The lawsuit dredges up the hotly debated question of whether consumer mobile devices or apps should be regulated by the FDA as medical devices. Some might argue that if consumers are relying on these products to monitor their health (which the above article about the lawsuit suggests), then from the consumer’s perspective, aren’t they medical devices?
I will refrain from commenting about whether fitness wristbands should be considered medical devices, whether they are accurate, whether the plaintiffs’ attorneys in this case are just trying to get rich, or whether people with heart issues are just stupid to rely on such products to monitor their heart rate.
What’s most instructive about this lawsuit is the reminder that as healthcare is being driven toward “treat yourself at home” regimens, lawsuits like this one will become more and more common. I’m not an economist, but I see a wave of income redistribution in our future because there are fewer dollars to pay for “real” healthcare and corporate earnings are at stake in big lawsuits attacking consumer health-oriented devices. While this particular lawsuit may be laughable, think about the possibilities if the lawyers can get past a motion to dismiss and we wind up with some case law on the books. At some point, there will be a case alleging that a patient’s cardiac arrest was precipitated by her own or her physician’s reliance on a consumer health device that is truly more of a health device than a fitness wristband.
For those readers who are shaking their heads in disbelief and asking what happened to personal responsibility, think about the notion of personal responsibility in the context of very different types of devices. What about water skis and those users who sue the manufacturers of boat engines when they are injured in skiing accidents? What about go-carts and riders who sue the manufacturers when they flip the cart? My personal favorite: “attractive nuisance” lawsuits involving “devices” that are in yards everywhere, such as a trampoline, swimming pool, or hockey rink that isn’t fenced in with a large “keep out” sign.
Just because it seems obvious to anyone with a brain cell that we should not use a personal fitness wristband to monitor our real health, ambitious plaintiffs’ attorneys will still work every angle to create a whole new line of case law.
I optimistically or naively hope that these lawsuits result in important policy discussions on questions such as:
- What true medical devices should consumers be using without the supervision of their physician?
- What’s the real line between a medical and a fitness device?
- Does every person who uses one of these devices or apps understand that distinction?
- Should training on true health devices be mandatory?
- What about cleaning, repair, and maintenance?
- What about counterfeit devices?
In the meantime, while we wait for those important discussions to occur, it will be fun to watch the litigation games begin.
Mary Logan, JD, CAE, is president and CEO of AAMI.