Three plaintiffs filed a class-action lawsuit against Fitbit, alleging that the company deceptively marketed its heart rate-monitoring devices, Modern Healthcare reports.
Experts say the case raises questions about FDA oversight of such products (Castellucci, Modern Healthcare, 1/7).
Background
Last year, FDA issued final guidance documents detailing the agency's plans to loosen its regulation of medical device data systems and mobile applications.
In one final guidance document, FDA said it will not enforce regulations -- such as registration and listing, premarket review and postmarket reporting -- for medical device data systems that receive, store, send or display data from medical devices because they pose a low risk to patients.
Meanwhile, FDA in separate final guidance said that it plans to regulate mobile health apps based on functionality, rather than their sale.
According to the guidance, FDA would take a "hands-off" approach for apps that are not considered to have a medical function, such as those used to:
- Automate simple tasks for providers;
- Interact with providers via electronic health record systems;
- Organize or track health information; and
- Self-manage conditions, without offering specific treatment suggestions (iHealthBeat, 2/9/15).
Lawsuit Details
The lawsuit was filed in U.S. District Court in San Francisco on behalf all individuals who purchased one of two Fitbit PurePulse devices:
While none of the plaintiffs purchased a Fitbit device on the recommendation of a physician, one plaintiff said he was motivated to purchase a Fitbit product because his physician recommended he lower his heart rate.
The plaintiffs alleged that:
- Fitbit's heart rate monitors under-recorded heart rates by as much as 78 beats per minute compared with other monitoring methods; and
- Such errors can be harmful to consumers with medical or cardiac conditions (Modern Healthcare, 1/7).
The lawsuit also argued that Fitbit's anti-arbitration clause in its user agreement is an unfair and deceptive business practice because users were only informed of it after they purchased the device (MobiHealthNews, 1/7).
The plaintiffs are asking that Fitbit:
- Cease "deceptive" marketing practices; and
- Provide refunds to unsatisfied customers (Modern Healthcare, 1/7).
The lawsuit stated, "Plaintiffs and many consumers like them have experienced -- and testing confirms -- that the PurePulse trackers consistently misrecord heart rates by a very significant margin, particularly during exercise." It continued, "This failure did not keep Fitbit from heavily promoting the heart rate monitoring feature of the PurePulse Trackers and profiting handsomely from it. In doing so, Fitbit defrauded the public and cheated its customers."
Reaction
A Fitbit spokesperson said, "Fitbit stands behind our heart rate technology and strongly disagrees with the statements made in the complaint and plans to vigorously defend the lawsuit." The spokesperson added, "PurePulse provides better overall heart rate tracking than cardio machines at the gym, as it tracks your heart rate continuously -- even while you're not at the gym or working out. But it's also important to note that Fitbit trackers are designed to provide meaningful data to our users to help them reach their health and fitness goals, and are not intended to be scientific or medical devices" (MobiHealthNews, 1/7).
Spyros Kitsiou -- an assistant professor in biomedical and health information sciences department at the University of Illinois at Chicago -- noted that health monitoring products such as Fitbit are not subject to federal regulation because they are not designed to:
- Diagnose a condition; or
- Provide treatment.
However, he said that the health implications of such products warrant regulation, noting, "Before these devices get out, we need to have validation tests" (Modern Healthcare, 1/7).
Source: iHealthBeat, Friday, January 8, 2016
