Unapproved Knee Replacement Device Used in SurgeryFeb 11, 2015
When undergoing surgery, most patients would assume that the tools being used have been proved to be safe and effective. Unfortunately, this is not always the case, as is demonstrated by OtisKnee. The New York Times reports that OtisMed Corporation, the Alameda, California based maker of OtisKnee, sold and distributed thousands of devices without proper approval from the U.S. Food and Drug Administration (FDA). The company paid $80 million in criminal and civil fines involving the device.
The OtisKnee is supposed to be a guide that directs the angle of the surgeon's cut to ensure that the artificial knee being implanted is properly aligned. The product was intended to help surgeons tailor bone cuts to a patient's anatomy. However, an increasing number of patients began reporting problems.
According to a ProPublica review of injuries and side effects reported to the FDA, problems with the OtisKnee appeared as early as November 2007; in that month alone, there were 11 reports of adverse events. By the end of 2009, that number rose to 58. Most of the reports were classified as malfunctions, according to NYT "Femoral guide does not fit, rocks freely." "Too much anterior slope in the tibia cut." "Femur and tibia guides would not seat correctly. Both slid around freely."
Carla Muss-Jacobs told NYT that her surgeon used the OtisKnee during her knee replacement surgery in May 2008. He told her that the device was associated with less pain and faster recovery times. However, she says that upon waking up from her surgery the pain was so unbearable that she could not stop crying. In the months following surgery, Ms. Muss-Jacobs hobbled around with a walker and could not continue her job as a real estate agent. She went to see a different surgeon in Portland six months later, and was told that the new knee had failed and was not properly aligned. A complex revision surgery was performed and she was able to walk the next day, although a long and painful recovery was ahead. The surgeon who used the OtisKnee contends that the revision surgery was unnecessary.
With mounting bills and an inability to work, Ms. Muss-Jacobs declared bankruptcy in 2009. In her attempts to pursue litigation, she discovered a number of complaints about the OtisKnee. She found out that some surgeons questioned its safety and that it had not been FDA-approved.
The FDA regulates medical devices based on how they are classified. Class III requires the most testing because they are implanted or sustain or support life and can pose serious risks to the patient; this includes device such as pacemakers. Class II medical devices can be approved if companies show that the product is similar enough to another device on the market. Class I devices are low risk devices such as bandages and dental floss. These products need to be registered with the FDA, but the agency does not regulate them any further.
Companies have some freedom when classifying their device. According to the Justice Department, OtisMed classified OtisKnee as Class I. OtisMed collaborated closely with Stryker to market the product, the agency's legal filings show. Stryker has been named in a number of metal-on-metal hip implant lawsuits.
In 2009, a former Stryker sales employee filed a whistleblower lawsuit alleging that OtisMed had been selling unapproved devices. OtisMed paid $80 million in criminal and civil fines to settle the case. The whistleblower received $7 million as part of the resolution.