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It turns out even if a company markets its products with big bold "not for diagnostic/medical use", and its customers use the products for diagnostic or medical use, the company can still be on the hook. It depends on a number of things, not least of which is the company's knowledge of the actual use of their devices.


It shouldn't matter. It says it can read your heart rate. That's what it advertises as. It should be able to do so.

I'm curious if there are legal precedents on how accurate a thing must be to advertise as a being a measurement device.


This is a bullshit argument. They do read your heart rate. But they explicitly say that it isn't up to a medical or diagnostic level of reliability.

Everything has some level of quality or tolerance expected. Car parts break all the time, it is just a normal part of owning a car. You don't get to sue a car company when your battery dies and you need a jump. You only get to do it when there is a significant or dangerous breach in the guarantees that they actually made, even if only made implicitly. Fitbit explicitly does not rate themselves for that purpose.


Actually it's quite unlike car parts breaking. Car parts have infant/random failures and wear-out failures. These kinds of failures are usually a very small percentage of the total number of devices shipped.

Fitbit's HR monitor fails to provide accurate readings whenever you move on almost everybody. What they don't do is advertise that you have to be still to get an accurate reading. Fitbit is marketed in such a way as to make you think it tracks HR during motion, I'd say it's not the same as a car parts that break at all. It's more like lying by omission.


Maybe your experience is different from mine then. My device was inaccurate enough to be useless. Further there doesn't seem to be any allegation that people are expecting it to have a medical or diagnostic level of reliability. That seemed to be a throwaway line in OP's article, not something core to the lawsuit. As far as I can tell from other news sources, they are suing because it can't read heart rate for crap.


You're exactly right. "Diagnostic level" of testing would tell you the difference between 120 and 121 bpm. Fitbit would read 85 bpm. That's not even close to right, which means it's completely useless for what it's marketed as.

With the same logic as Fitbit, my watch tells reads my heart rate. Right now it's saying my heart is beating 9:21am. Sure, that's not as accurate as a real medical device, but it's a number so it's in the right ballpark.


Where do they explicitly say that? I poked around their site and all I could find was mountains of bragging about how awesome their heart rate measurement technology is, and a few disclaimers about how it might not work if your activity involves rapid arm movements, like boxing. But maybe I missed the other disclaimers.


This is not a bullshit argument. It is similar to labor laws in some states. You can claim someone as a indy contractor but if they are working with your tools or at your job site or under your instruction ... guess what? some states don't care what you call them ... they will be processed as employees not contractors.

Not bullshit.


If there were a special tax on heart rate monitors that _are_ medical devices, and FitBit was calling theirs not a medical devices to avoid paying that tax, then the analogy would be reasonable.

The whole employee/contractor thing is all about payroll taxes. You have to pay them yourself if you get a 1099, but your employer pays them if you're on a W-2. Employers have a much better track record of paying that, so the government wants to avoid too many 1099s.

I've been a contractor before. I got a W-2, but no benefits. Now everyone is happy.


All mobile phones advertise calling. All of them warn that they are not meant for emergency calling.


Is that true? That would be rather odd given that they are required by law to be capable of it, to the extent that it has to work even when you don't have an active mobile account for the device.


That doesn't seem fair. What's a company supposed to do in that situation? Just close up shop?

Makes me wonder if it would be possible to intentionally drive a company out of business by convincing a bunch of people to use their products incorrectly.


I don't know about Fitbit per se, but there are cases where a company says one thing in it's legal interface, but does another with it's sales interface. IOW (pure speculation on my part), Fitbit could say "don't use this for such and such" and the sales people say "yeah, we say that (wink, wink), but we don't really mean it." To be clear, I am not saying Fitbit does that, but I am familiar with other companies that have done such and gotten in trouble for it.


Oh they totally do it, but even more sneakily. After the whole Internet hypes itself up, the salesmen don't have to say a word. Random blogs, newspaper articles and word-of-mouth have already done it for them.


GNC Pill Pushers


This is where legal concepts (in the US) such as 'reasonable person' come into play. Courts usually hold that any use of a product that a 'reasonable person' would do is an acceptable use (regardless of what the instructions say - a reasonable person, it would seem, doesn't read the instructions :P). However, a company doesn't need to be held responsible for an un-reasonable use.

In this case, would courts find that a reasonable person would assume that a heart rate monitor can accurately monitor their heart rate? My guess is, yes.


So this would be similar to where a lawn more is designed to cut grass. And a reasonable person would assume that it can also cut weeds that are growing in the lawn. But it isn't reasonable to assume that you could pick it up in the air and use it as a hedge trimmer.


If you sell a device that monitors heart rates, and that device doesn't properly monitor heart rates... then you need to fix it or stop making it. I don't see why that is unfair?

If I buy a desk lamp and it doesn't work reliably then you sold me a lemon and I want my money back. It doesn't matter why I need light on my desk.


For a measurement device, "accurate" and "reliable" aren't binary conditions, they're continuums. Not every sensor in the world has to be medical grade. There are plenty of applications where a less accurate sensor at a much lower price point is the right choice.

Remember, I'm talking about situations where the company actually says "not for medical/diagnostic use". They're not trying to get away with selling lemons.

To use your analogy: If I sell you a small LED (say for use as a power indicator on a computer) and you try to use it as a desk lamp, you shouldn't be able to sue me on the grounds that "you should have known I was going to use it as a desk lamp and made it fit for that purpose". That's what seems unfair to me.


That's technically fair, but everyone knows it's not what's going there. A small LED equivalent of a heart rate monitor is your optical mouse hacked into being a crude pulse oximeter. By the way, you know your mouse is also a 1-D camera / scanner, and can be used to somewhat digitize something?

They totally advertise it as a working heart rate monitor. If they have a problem with accuracy, they should not be making it. Otherwise it's like making a tape measure that has marked distances within +/- 20% of the real value (i.e. 1cm becomes anything from 0.8cm to 1.2cm), and marking it with a small caption that it's not for construction use. Oh, and having the product website say "it measures distance" and elaborate on the benefits of measurements for building stuff.

--

I'm conflicted about it. On the one hand, I feel like people should be free to build whatever trinkets their like (as long as they are safe). OTOH, I feel like they should totally not be free to sell crap tools.


>your mouse is also a 1-D camera / scanner, and can be used to somewhat digitize something?

On a totally unrelated note, the image sensors in optical mice are actually low-resolution (16x16) 2D arrays.

https://pickandplace.wordpress.com/2012/05/16/2d-positioning...


Come on. They put a heart rate monitor into the device, and they plastered information about it all over their website. I didn't manage to find a single mention that it's crap.

You don't do that unless you want people to believe you're selling a working heart rate monitor. So if it turns out the monitor is not usable for its stated purpose, then they either fucked up the engineering, or they're literally scamming people. In both cases the comapny is supposed to either address the problem or close shop. That's exacly what should happen.


They could try harder to influence who buys their product and how those buyers use it before they just close up shop.

It's not like Fitbit has gigantic text on their web site and product packaging saying "NOT FOR MEDICAL USE." In fact, I challenge you to find any such statement anywhere on their web site. I couldn't, but maybe I suck at it.

They could try a little harder to educate their buyers, here.




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