A proposed class action alleges the maker of the Omron Platinum Upper Arm Blood Pressure Monitor has defrauded thousands of consumers in that blood pressure readings from the in-home medical device are “wildly inaccurate.”
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The 63-page case, filed in Illinois on October 25, says that although the blood pressure monitor is warranted by Omron Healthcare as accurate within a range of “+/- 3 mmHg,” users’ experiences show that the allegedly defective product’s accuracy “varies widely,” such that the device simply cannot accurately and reliably measure a consumer’s blood pressure.
As the lawsuit tells it, the general inaccuracy of the Omron Platinum Upper Arm Blood Pressure Monitor, model BP5450, effectively renders the product useless and an unreasonable safety hazard to consumers, many of whom, after using the device, “incorrectly believe their blood pressure is far higher or lower than it actually is.”
The case stresses that at-home blood pressure monitors have become increasingly popular among consumers, and many doctors rely, at least in part, on at-home testing as a means to guide treatment. Thus, inaccurate blood pressure readings could, for instance, cause consumers to take too much or too little medication, seek unnecessary treatment or incorrectly forgo treatment altogether, the suit says.
“Defendant’s misleading representations and omissions about the Product concern its central functionality, as the Product is effectively rendered useless and unreliable,” the complaint summarizes, noting that Omron has neither recalled the device nor offered reimbursements to consumers.
Omron knew its monitor’s readings were inaccurate, lawsuit alleges
Highlighted in the Omron blood pressure monitor lawsuit is a study commissioned by the company to validate the accuracy of the device. The study, performed by Northwestern University researchers, concluded that the Omron blood pressure monitor was accurate within a range of +/- 3.7 mmHg for diastolic pressure, more than 23 percent greater than the “3 mmHg” disclaimed in the user manual, the lawsuit shares.
Even worse, for those who test with the “wide range” cuff that comes with the blood pressure monitor, the product tallied diastolic pressure readings that swung by an average of 4.30 mmHg from the true level, meaning users with a larger arm circumference are particularly susceptible to inaccurate readings, the filing relays.
Omron’s Amazon listings, like the product’s readings, are inaccurate, suit claims
The Omron Platinum Upper Arm Blood Pressure Monitor is sold by the company exclusively through Amazon, the lawsuit relays. The suit charges that listings for the product on Amazon.com are false or “at minimum misleading,” namely because the blood pressure monitor is incapable of consistently producing accurate readings for all users.
In particular, the case says that the device’s Amazon.com listing does not disclose that, according to Omron, the blood pressure monitor is, at best, accurate within a range of +/- 3 mmHg for systolic and diastolic pressure. The filing contends that a reasonable consumer, based on Omron’s representations, would believe that the monitor is “actually accurate” and that blood pressure readings displayed by the product reflect their actual blood pressure.
“A Product is ‘accurate’ and ‘reliable’ if it produces correct results every time it is properly used,” the lawsuit asserts.
In truth, the case alleges, the blood pressure readings produced by the Omron monitor are regularly inaccurate by 10 mmHg to 30 mmHg, meaning even the company’s own representation that they are “accurate within a range of +/- 3mmHg,” stated only in the user manual, is off the mark. The suit highlights that more than 100 user-posted reviews on Amazon, including some authored by doctors, share that the readings from the Omron blood pressure monitor can be “wildly different … within minutes of testing” and sometimes “nowhere near the levels generated at a physician’s office.”
“Additionally, several reviews of the Product posted to Defendant’s own website similarly conclude that the Product was wildly inaccurate when compared to a physician’s clinical blood pressure reading—including where users brought the Product with them to their physician’s office for a direct, side-by-side, comparison.”
Lastly, the lawsuit says Omron has failed to conspicuously disclose in its Amazon listings that its blood pressure monitor produces “particularly inaccurate readings” for users with a larger arm circumference and has not been validated for use on pregnant patients, even though the company advertises that the product is validated and accurate for all users in general.
“None of the above limitations were disclosed by Defendant to consumers at the point of purchase,” the lawsuit says, arguing that Omron, by touting the device’s purportedly positive attributes, was obligated to disclose the monitor’s “inherent limitations.”
Ultimately, the case contends that the sheer number of negative reviews about the Omron Platinum Upper Arm Blood Pressure Monitor is “unusually large and is indicative of a widespread problem” with the devices.
Who’s covered by the blood pressure monitor lawsuit?
The lawsuit looks to cover all persons in the United States who bought an Omron Platinum Upper Arm Blood Pressure Monitor, model BP5450, within the applicable statute of limitations period.
I bought one of these blood pressure monitors. What comes next?
For now, consumers who bought an Omron blood pressure monitor should sit tight and check back with this page regularly. ClassAction.org will update this post with any developments as the legal process plays out.
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