Mary Logan: ‘Fit’ to Be Tied? Claims Aside, Fitbit Lawsuit Underscores Important Questions

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.

9 thoughts on “Mary Logan: ‘Fit’ to Be Tied? Claims Aside, Fitbit Lawsuit Underscores Important Questions

  1. I believe that the intent of this posting is about the definition of medical devices, but it is overshadowed by a more important issue: how we think and feel about the consumer/patient. After all, the consumer/patient is why we do what we do. I hope the attitude expressed in this post toward the consumer/patient is an anomaly or misunderstanding and not the direction AAMI leadership is going.

  2. I am sure there are many misinformed people out there about using “health trackers” as monitors and thinking they are accurate. All the fitness apps out there are not meant to be monitors, just more of a motivational tool. If you are tracking what you are doing, you are more likely to pay closer attention to what you do.

    The problem I have with this article is calling people “stupid” and “if they have a brain cell.” How could someone in your position be so callous towards people while expressing your opinion? There may be many people out there with lower understanding of these devices but does that make them stupid? In my opinion, no it does not, just misinformed.

    • As a consumer, I am responsible to learn how the product works when I purchase it. When I buy it, I have expectations it will work as advertised. These days, quite often I find it has more functions than I was expecting. If it does not work as advertised, I return it. I blame the manufacture for making a bad product and contact a consumer reporting group. I don’t blame the manufacture if I continue to use it knowing its not working as advertised. I don’t go blaming my ignorance on the manufacture and call a lawyer and sue them. These days, too many people bring up bad lawsuits due to their own ignorance, clogging the courts with needless torts. Another phrase comes into play: Caveat Emptor.

      • Caveat Emptor has obvious limitations. That is why we have laws, regulatory agencies and courts. Not using things that aren’t working is a good practice. But how do you know it isn’t working if it appears to work as advertised, but in fact is not?

  3. I have a few questions about other fitness heart rate monitoring devices like treadmills, stair steppers, cycling machines, many of which have heart rate monitors on them. How close are these units tracked? Does the OEM supply calibration procedures? Do the owners, maintenance, or service manuals say how often it should be calibrated? Do these units fall under 60601? Have they been approved by the FDA? Has ECRI evaluated them? Do these units fall under CMS? Hospital owned physical therapy centers use these. If we are going to open a can of worms, we need to look at all of them.

    There is a certain bit of responsibility the consumer should take upon themselves. How about taking responsibility for your own decisions? If you want to get fit, talk with you doctor first. These little devices are just another form of people being lazy by taking shortcuts. The perfect fitness has not been made yet. So it looks like people are just being fat and lazy. Or they need to start eating right, in the right quantities and get more active. You don’t need a device to track your fitness. Get out and do a fast-pace walk for 30 minutes a day.

    • It is highly unlikely any were “approved” since approved is limited to Class III medical devices. More generally, exercise equipment that does not make health claims are not regulated by the FDA. They are consumer devices which might fall under CPSC and FTC, but neither of those agencies have before-market screening. The key issue is “intended use.”

  4. Mary raises important issues. Fitness devices provide important feedback during daily activities, especially for patients with chronic diseases. I have been using my consumer (non-medical) device to provide me constant feedback to help me manage my disease. I could not justify the cost of an equivalent medical-grade device, and it would be too intrusive to my daily professional life. Those of us familiar with medical device performance standards would never expect the Fitbit or any similar device to perform at the same level as a medical monitor. Even if Fitbit did submit to the FDA, what standards would it reference? How could the FDA determine substantial equivalence, safety, or effectiveness? And does the overhead of setting up an FDA compliant Quality System justify the pricing premium required to support the business? In my opinion, no!

    In reading the summary of the Fitbit case, I suspect even well-established medical grade monitors would, on occasion, report similar erroneous readings. It is a matter of how often.

    The next wave of medical device disruptive innovation is likely to come from novel consumer-oriented wearable devices and less likely from established medical device companies (The Innovators Dilemma, Clayton Christensen). In my opinion, the benefits of these devices far outweighs their limitations. I encourage the wellness industry to continue to refine and improve these device but to be clear in their advertising regarding performance claims.

  5. Instead of worrying about plaintiff lawyers getting rich, why aren’t you worried about manufacturers getting rich selling things that at least allegedly don’t do what they claim to do? And we might note that defense lawyers also earn a good income, and they get paid whether they win or not. And how did you determine what is obvious to people? Did you do a survey? Did I miss the empathy for people injured because they believed the manufacturer, or does calling them stupid cover your empathy spectrum?

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