OtisKnee Knee Replacement Claims

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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 October 2008.

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 requirements.

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.