This mass tort lawsuit alleges that knee replacements pateients may have suffered harm through the use during surgery of the OtisKnee cutting guide, medical device that was not approved by the FDA.
The OtisKnee, designed and made by the OtisMed company, used MRI imaging of individual patient knees to make patient-specific guides that they claimed increased the accuracy of bone cuts made during knee replacement surgery. It was intended to reduce both the time the surgery took and the patient’s recovery time afterwards.
OtisMed marketed and sold the OtisKnee at meetings of the American Academy of Orthopedic Surgeons. They told surgeons that the device did not need FDA approval because it was a Class 1 medical device.
The FDA divides medical devices into three classes. Class I devices are items like bandages, dental floss, and forceps. These items need to be registered but do not require FDA approval because they represent a low risk to patients. Class II devices include items such as pregnancy tests and powered wheelchairs, which the FDA may approve if companies attest that they are similar to other products on the market. Class III devices are items like joint implants and pacemakers, which require greater regulation because they represent the greatest risk to patients.
Companies are given some freedom to classify their own medical devices. OtisMed classified its OtisKnee cutting guide as a Class I device, even though it should have been classified as a Class III.
From May 2006 to September 2009, OtisMed sold more than 18,000 OtisKnee cutting guides, earning more than $27 million from the sales. When Stryker, a company that made knee implants, became interested in buying OtisMed, it requested that the company obtain FDA clearance for the OtisKnee. OtisMed applied to the FDA in 2008. In 2009, the FDA notified the company that its application had been rejected because it had failed to prove that the OtisKnee was safe and effective. It noted that the OtisKnee was a Class III device and specifically warned OtisMed against selling it without approval.
At that point, the OtisMed board voted to cease selling the guides. However, its chief executive, Charlie Chi, told employees to ship out another 218 of the devices.
In the meantime, fifty-eight reports were received of malfunctions or other problems in surgeries that used the OtisKnee cutting guide. The Journal of Arthroplasty published a study of four surgeries using the devices and said, “The potential for malalignment with this system places implants at high risk of early failure.”
Criminal and civil charges were filed by the US Justice Department. The company agreed to pay $80,000,000 to settle the charges and was banned from participating in Medicare or Medicaid for twenty years. OtisMed’s Charlie Chi was sentenced to twenty-four months in prison and a year of supervised release. He was also ordered to pay $75,000 in fines. Stryker, which acquired OtisMed in 2009, agreed to cooperate with the government’s investigation, maintain a compliance program, and review whether its other medical devices have been properly approved.
However, these cases have not taken into consideration any liability to individual patients for specific problems they have had because of the use of the OtisKnee during surgery. This mass tort will now attempt to address these problems.
Unlike a class action lawsuit, where one plaintiff or group of plaintiffs stands in for all those harmed, in mass tort lawsuits, each case is tried individually, but all of them benefit from reduced expenses and legal proceedings.