Judge to decide on dismissal of BioJoint lawsuits

A Boone County judge will decide whether or not to dismiss a series of lawsuits against the University of Missouri curators and surgeons over a knee replacement surgery performed through the Mizzou BioJoint Center

The Boone County Court heard arguments Monday morning for a motion to dismiss six of the 12 cases filed, as well as two motions to compel, which would have the court order the university to provide specific information.

In the motion to dismiss, the defendants argued that the university has sovereign immunity in this case. The defendant and plaintiffs also argued who is protected under the Missouri Merchandising Practices Act, a law that prohibits deception in business.

The judge said he will decide whether the cases will be dismissed within the next week.

One of the motions to compel that was filed by the plaintiffs asked the court to make the curators turn over their complete insurance policies. This motion was denied by the judge.

The second motion to compel filed by the plaintiff, which was granted by the judge, will require the defendants to produce de-identified data about the procedures that have been done.

The plaintiff in this case claimed that defendants sold him on the surgery by saying there was a 90 percent success rate.

The defendants also had posted statistics on their website and elsewhere, telling patients that the surgery would have a success rate as high as about 92 percent, without indication of how they had gotten those numbers.

This motion will provide the plaintiffs with the age, BMI and surgery type of each procedure in its original form.

According to the lawsuits, patients claim they were not told they were part of a “research study and/or clinical trial for an experimental procedure.”

According to MU Health, some patients at the Mizzou BioJoint Center are in a clinical study that is a post-market trial of an FDA-approved tissue and procedure. MU Health said all of the patients in the study signed consent forms that say they know and agree to being in a clinical study.

The knee replacement surgery uses cadaver knee tissue and uses a preservation method known as the Missouri Osteochondral Allograft Preservation System.

The lawsuits name James Cook, a veterinarian and orthopedic technologist, as the Director of Operations and Research at the Mizzou BioJoint Program.

The lawsuits also mention Dr. James Stannard as a surgeon with the Mizzou BioJoint Center. The lawsuits claim the patients had complications with their BioJoint knee replacement surgeries performed through the Mizzou BioJoint Center.

MU Health Care sent ABC17 News the folling statement:

“At MU Health Care’s Mizzou BioJoint® Center at Missouri Orthopedic Institute, providing safe, quality care is our top priority. While we are unable to comment on this particular situation pending litigation, we are confident in the Mizzou BioJoint program and very proud of our outstanding team who provides treatment options to patients with knee, ankle, shoulder and other joint problems. The program pioneered by James Stannard, MD, and James Cook, PhD, DVM, OTSC, has helped improve the lives of people from around the world.

The Missouri Osteochondral Allograft Preservation System (MOPSSM) technology used to preserve and verify the quality of grafts has been adopted by other health systems and hospitals across the country.

The MOPS SM technology used for the restorative surgeries at Mizzou BioJoint has undergone rigorous review and meets applicable requirements set by the Food and Drug Administration (FDA) for use of human tissues for transplantation, including sterility assessments (USP71) by an accredited outside laboratory (WuXI App Tech, Marietta, GA).

The grafts used within the procedure are procured from tissue banks accredited by the American Association of Tissue Banks (AATB), and every graft is evaluated for sterility and safety prior to use. Moreover, Mizzou BioJoint Center holds a number of patents within the United States and other countries related to advancements in osteochondral allograft transplantation. Additionally, 17 peer-reviewed studies have been published that examine the safety and validity of the surgical and non-surgical procedures performed at the Mizzou BioJoint® Center.

As with all medical procedures, it is our practice to discuss and provide extensive information about the benefits and risks prior to all surgical and nonsurgical procedures performed at the Mizzou BioJoint® Center. More information about the procedure and our outcomes is available on our website, biojoint.com.”