Knee replacement surgery is very common and has been effective in relieving pain caused by arthritis of the knee joint. The artificial joint is expected to last about 10 years.
Knee replacement involves opening the knee joint, cutting away the arthritic bone, and replacing the removed bone with an artificial joint covering, which permits the joint to move pain free.
Failed knee replacement surgery can be caused by using an improperly sized artificial joint, cutting too much or too little bone, cutting the bone at an improper angle, rotating the joint in an improper position. They can also fail due to falls, trauma, failing to comply with instructions pertaining to limitations in activities.
Some surgeons use cutting guides to assist in making accurate bone cuts specific to the patient's anatomy based on MRI performed prior to surgery.
Otis Med Corporation was in the business of manufacturing and distributing knee replacement cutting guides. Between May 2006 and September 2009 it sold more than 18,000 OtisKnee devices generating revenue of about $27.1 million.
Medical devices, including cutting guides, require approval from the Federal Drug Administration ("FDA"). On Oct. 2, 2008, OtisMed submitted for the first time, a pre-market notification to the FDA seeking clearance to market the OtisKnee. It had previously been selling OtisKnee without clearance. On Sept. 2, 2009, the FDA denied clearance since OtisMed failed to show the OtisKnee was safe and effective. One week after the FDA denied clearance, OtisMed shipped approximately 218 OtisKnee guides to surgeons.
On Dec. 8, 2014 OtisMed and its former chief executive officer admitted to intentionally distributing knee replacement surgery cutting guides after their application for clearance had been rejected, and agreed to pay more than $80 million dollars to resolve related criminal and civil liability. The chief executive officer also pled guilty to introducing adulterated medical devices into interstate commerce. OtisMed agreed to pay $40 million plus interest to resolve its civil liability, fines of $34.4 million, and 5.6 million in criminal forfeiture.
Weisfuse & Weisfuse LLP represents victims of negligently performed knee replacement surgery. Call for a free consultation at 212 983 3000, or send us an email at: [email protected]