Knee Replacement Device Used Without FDA Approval

 Posted on March 03, 2015 in Defective Medical Devices

When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them. Such is the case with a device that until very recently was used to aid with knee replacement surgery, the OtisKnee, distributed by OtisMed Corporation.

In December, according to The New York Times, the former CEO of OtisMed pled guilty in a New Jersey federal court to criminal charges of distributing adulterated medical devices. The OtisKnee was not cleared by the Food and Drug Administration before OtisMed began to distribute and sell the device to American hospitals, and 18,000 of the adulterated devices were sold and distributed between 2006 and 2009. The device was marketed as one that would speed knee surgery and aid in patient recovery, but many patients experienced the exact opposite. In one case, a woman experienced intense and lasting pain after the surgery, and ended up having to have a second knee replacement. Another patient said that the revelation that the device that had been used was likely at fault for her persisting knee problems made her feel like she "had been a guinea pig."

The Times reports that had it not been for a whistleblower, presumably at OtisMed, the public may never have been made aware that this device was being distributed without FDA approval. Knee replacements are the most common elective surgery performed in the U.S.—roughly 700,000 such operations are performed annually. The FDA medical device approval process is long and arduous, and can cost thousands of dollars for the company attempting to have a single device approved. According to the Times, OtisMed, a California-based start-up, saw an opening in a crowded market. While doctors and other experts say that the device is a good idea, because it was not fully vetted by the FDA, it was never decided if the device was actually able to perform the function it purported to do.

If you have had a knee replacement surgery or any other elective surgery that went badly and suspect that a device or medical professional may be at fault, you are likely eligible for compensation. Do not go through it alone. Contact an experienced Chicago medical device attorney today.