OtisKnee Knee Replacement Claims
Contact a Portland Defective Product Attorney
OtisMed Corporation is under fire for allegedly selling its knee replacement
product, OtisKnee, before it was cleared by the U.S. Food and Drug Administration
(FDA). When OtisMed finally did seek clearance from the FDA to market
OtisKnee, after it had already begun marketing the product, the FDA rejected
the application due to OtisMed’s failure to supply evidence validating
the product’s safety and effectiveness.
In an FDA announcement released in December 2014, OtisMed and its CEO
agreed to pay $80 million to resolve criminal and civil liability in connection with its knee replacement
device. More than $40 million of this is reserved for resolving civil claims.
Said the FDA’s criminal investigations director, “We will continue
to investigate and bring to justice those who potentially endanger patient
safety by distributing unapproved medical devices.”
OtisKnee Used in Total Knee Arthroplasty
OtisMed began selling its OtisKnee product for use in total knee arthroplasty
procedures (also known as knee replacement surgery) in May 2006 and continued
sales through September 2009. During this time, OtisMed made more than
$27 million in revenue from these devices. Although OtisMed began selling
the devices in 2006, it didn’t seek clearance from the FDA until
According to the Justice Department, to sell OtisKnee guides to healthcare
providers, OtisMed claimed that the devices could preserve more bone and
ligaments, which could in turn improve the longevity and the fit of knee
replacements. The problem is, none of these claims had been substantiated
by the FDA.
So how did OtisMed sell its knee replacement guides without FDA clearance?
According to the FDA’s news release, OtisMed misled physicians and
hospitals by saying that the OtisKnee was exempt from pre-market FDA approval
The FDA notified OtisMed in September 2009 that pre-market approval for
OtisKnee was not granted. Even after the manufacturer received the denial,
it continued to ship the guides to knee surgeons throughout the country.
About the OtisKnee Guide for Knee Replacement Surgery
OtisMed saw an opportunity in the growing knee replacement market – more than 700,000 patients
undergo knee replacement surgery in the U.S. annually. OtisMed’s
OtisKnee guides were designed to guide the surgeon’s incisions.
Precise incisions are crucial for a properly aligned knee replacement.
Some patients who received knee replacement surgery using the OtisKnee
guide had to undergo revision surgery because of claims that their replacement
was not aligned properly. The misaligned replacement caused excruciating
pain and decreased mobility, some claimed.
FDA’s Class System for Regulating Medical Devices
There are three different classes the FDA uses to regulate medical devices.
Class three devices have the most stringent requirements – think
pacemakers, because the quality of the device creates a life or death
situation. Class one devices, on the other end of the spectrum, are things
like bandages. OtisMed classified its OtisKnee guide as a class one device,
meaning OtisMed could sell its device without undergoing a pre-market
FDA review. But after OtisMed submitted its pre-market notification, the
FDA responded by denying the device clearance and reclassifying the guides
as Class three. By the end of 2009, the FDA had received 58 complaints
of OtisKnee malfunction, but it is uncertain how many patients were actually
injured in connection with the devices.
The attorneys at Paulson Coletti are currently investigating potential
claims involving OtisMed’s OtisKnee guides for knee replacement
surgery. Contact our firm to learn your legal rights and options.