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According to allegations raised in a recent product liability lawsuit filed against Stryker, problems with OtisKnee cutting guides caused a Pennsylvania woman to require revision surgery because her bones were inaccurately cut by the device, which were later found to be on the market illegally.
The complaint (PDF) was filed by Edra Carvell in the U.S. District Court for the Middle District of Pennsylvania on December 2, indicating that thousands of OtisKnee Orthopedic Cutting Guides distributed throughout the U.S. were defective, unsafe and never approved by the FDA.
Stryker Corporation, as well as its Howmedica Osteonics and OtisMed subsidiaries were named as defendants in the lawsuit. More than 18,000 OtisKnee devices were sold by OtisMed between May 2006 and September 2009, according to the complaint. However, the manufacturer did not seek approval for the devices until October 2008, and the FDA ultimately denied approval in September 2009, indicating that the OtisKnee cutting device was neither safe nor effective. Stryker bought OtisMed two months later.
Carvell indicates that she underwent a right total knee replacement in May 2008, during which her surgeon implanted various Howmedica components and utilized Stryker Simplex bone cement. An OtisKnee device was also used to make measurements and to cut and reshape Carvell’s leg bones in order to accommodate the implant of the artificial knee.
Following the knee replacement, Carvell experienced progressively increasing pain and problems, ultimately requiring revision surgery less than one year later because the joint failed due to loosening of the tibial component and failure of the joint, among other reasons.
“Had Plaintiff Edra Carvell or her physician known that the OtisKnee device had not been approved byt he FDA at the time of surgery, the OtisKnee device would not have been used during Edra Carvell’s initial knee replacement surgery and she would not have suffered early failure of the prosthesis necessitating revision surgery,” according to allegations outlined in the complaint.
In late 2014, OtisMed Corp and its former chief executive officer pled guilty to distributing the FDA-rejected OtisKnee cutting guides for knee replacements, receiving a fine of $34.4 million fine and $5.16 million in criminal forfeiture. The company also agreed to pay $40 million in a civil settlement.
The FDA estimates that the fines and penalties amounted to about three times the revenue the company brought in by illegally selling the cutting guides.
However, the fines do not prevent Carvell and others from filing OtisKnee lawsuits over problems caused by the device. Carvell presents claims of defective design, manufacturing defect, failure to warn, negligence, negligent misrepresentation, fraudulent concealment, breach of warranty, fraud, and unfair and deceptive trade practices. She seeks both punitive and compensatory damages.