Medical Device Manufacturers Facing Criminal Charges for Distributing Adulterated Medical Devices

The medical device manufacturer OtisMed, the maker of a surgical knee replacement guide called the OtisKnee, recently pleaded guilty in New Jersey federal District Court for selling an adulterated medical device. The company reached an $80 million settlement of the civil and criminal charges it faced from the federal government for defrauding thousands of doctors and placing their patients’ health and safety at risk.

The OtisKnee was a cutting guide, used by surgeons to determine where to cut while performing knee replacement surgeries. OtisMed started selling the OtisKnee in 2006, prior to applying for or receiving FDA approval. The company sold some 18,000 devices between 2006 and 2009, all unapproved by the FDA. Upon submitting an application for FDA approval, the device was deemed not to have met the FDA’s standards for safety and effectiveness, and the application was rejected. Then-CEO of OtisMed Charlie Chi nevertheless shipped over 200 OtisKnee devices after the FDA rejected their application.

Medical Devices a Multi-Billion Dollar Industry

According to the CDC, some 719,000 total knee replacement surgeries were performed in the US in 2010. Total knee replacement is the nation’s most common elective surgery. About 10% of these surgeries are replacements of existing artificial joints, and while knee replacements can often relieve chronic pain, such surgeries come with substantial risks and can involve long recovery times. According to Pro Publica, the medical device business is a $110 billion industry, growing every day due to the increasing average age and longevity of the American population.
The FDA uses three classification categories—I, II, and III—to determine how risky a medical device is, and thus how intensive a review process the FDA should use to determine whether to approve a device. Class I is the lowest risk and would be an appropriate label for devices such as surgical gloves. OtisMed labeled the OtisKnee a Class 1 medical device, thus leading the FDA to believe that the device was low-risk and should be subject to less regulatory scrutiny. As a result, the FDA did not closely evaluate OtisMed’s claims about the device until examining the application for FDA approval.

Seek Experienced Alabama Legal Help to Obtain Compensation for Failed Surgeries

Recovery from an unsuccessful knee surgery can be painful and involve high costs. If your knee replacement resulted in pain or needed to be redone, and you believe your surgeon may have used the OtisKnee surgical guide, contact Alabama attorneys at J. Allan Brown LLC for help getting compensated for your medical and rehabilitation expenses, as well as compensation for your pain and suffering possibly caused by this fraudulently-marketed device.