In June, 2015, former CEO and a founder of OtisMed Corporation was sentenced to two years in prison, one year of post-release supervision, and a $75,000 fine. Chi was largely responsible for falsely marketing and distributing the OtisKnee cutting guide which was rejected by the FDA in 2008.
An FDA News Release of December 8, 2014 reported that OtisMed Corporation and Chi pled guilty in a Newark Federal Court of the ‘intent to defraud and mislead adulterated medical devices into interstate commerce in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act.)’ OtisMed agreed to pay $34.5 million in fines, $5.16 in criminal forfeiture, and $40 million with interest to settle civil liability cases relating to injuries suffered by the product.
18,000 Knee Surgeries Using FDA-Rejected OtisKnee Cutting Guide
The OtisKnee was marketed as a tool for surgeons to accurately cut bone during total knee arthroplasty surgery. Specifications of a patient’s anatomy were derived from magnetic resonance imaging (MRI) performed before surgery. Surgeons used the cutting guide to remove the ends of bones and reshape the remaining bones to fit the artificial knee implants. Without precision, the guide was not only ineffective, but could cause extreme pain and the need for revision surgery much sooner than the life expectancy of similar devices.
In 2008, the Journal of Arthroplasty reported on four patients who underwent total knee arthroplasty with the OtisKnee cutting guide. The journal reported that specification of the cutting guide’s ranges were off of mechanical axis by more than 3 inches, placing patients in a high risk situation for misalignment and high failure rates.
OtisMed Corporation marketed over 18,0000 knee cutting guides from 2006 through 2009, but the company did not seek FDA approval until October, 2008. In September, 2009, eleven months later, the FDA notified OtisMed that its application for approval of the cutting guide was denied for failing to demonstrate the safety and effectiveness of the device.
Manufacturers of Total Knee Replacement Devices Use FDA-Rejected Bone Cutting Guide
OtisMed continued to market the bone cutting guide to doctors, medical facilities and, even other medical device manufacturers without FDA approval. Stryker Orthopedics utilized approximately 75% of the knee cutting guides for its Triathlon Total Knee Replacement System. Biomet also used the guide for surgeries involving VanGuard Complete Knee Systems.
Neither Stryker nor Biomet has been charged with complicity in OtisMed’s fraudulent marketing practices, but in 2013, Stryker’s ShapeMatch Cutting Guide, used with Stryker’s Triathlon Knee System, was also recalled by the FDA.
Stryker ShapeMatch Cutting Guide Recall
In April, 2013, the FDA issued a recall of the Stryker ShapeMatch Cutting Guides after Stryker admitted that information was entered manually into the system to compensate for the pre-existing software defects. The manual edits to the system may have effectively removed the FDA’s 510(k) approval. The recall was for ‘cutting guide ranges not cleared by the FDA,’ causing adverse health consequences such as joint instability, fractures, the need for revision surgery, chronic pain, and limitation of mobility.
This is another case of manufacturers placing profit before safety. Call Saunders and Walker, P.A. toll-free at (800) 748-7115 for a free consultation.