COLUMBIA, Mo. - A sixth lawsuit was filed Wednesday against the University of Missouri and surgeons over a knee replacement surgery performed through the Mizzou BioJoint Center at the Missouri Orthopaedic Institute.
The knee replacement surgery uses cadaver knee tissue and uses a preservation method known as the Missouri Osteochondral Allograft Preservation System.
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.
All six lawsuits name James Cook, a veterinarian and orthopedic technologist, as the Director of Operations and Research at the Mizzou BioJoint Program.
Five of the six lawsuits name 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.
The first suit was filed in March. In a response to that lawsuit, MU Health says surgeons have been performing the procedure since 2016.
Christopher Cummings claims in the latest lawsuit that he contacted the Mizzou BioJoint Center after seeing advertisements and that Stannard said Cummings would be "an excellent candidate." Stannard told Cummings the surgery "would likely prevent him from ever needing an artificial knee replacement," according to court filings.
Cummings went through two BioJoint surgeries, which he claimed "ultimately failed."
"Since the Mizzou BioJoint revision Surgery, plaintiff (Cummings) continues to suffer from severe left knee pain and limited mobility," Cummings claims in the lawsuit. "Plaintiff lives with severe left knee pain and disability. He uses a cane and knee brace to walk."
The surgery is not recommended for patients with a body mass index (BMI) greater than 35, patients who use nicotine or those who are over 55 years old. MU Health recommends the operation for those who are active non-athletes and are experiencing consistent joint paint that will not go away.
Plaintiffs' claims in the six cases include:
- That they were never notified they were part of a clinical trial and never signed anything acknowledging it;
- That doctors knew some patients' BMI was greater than 35 but still performed the surgery;
- That doctors performed the surgery even though they knew at least one patient used nicotine;
- That no one told them Cook was not a physician;
- That Cook was listed as "surgeon-other" for surgeries;
- That Stannard said the knees looked "great" after surgery and during follow-up appointments;
- And that the surgery ultimately failed.
MU Health has responded to three of the six lawsuits. In its responses, MU Health said it did not tell patients Cook was a veterinarian and that it had no obligation to do so and acknowledged performing surgery on patients with BMIs greater than 35 and at least one who still used nicotine.
MU Health also acknowledged that some of the surgeries failed.
One plaintiff, Daniel Draper, was an active member of the military and was 33 years old when he came to doctors complaining of back pain.
Draper claims his first BioJoint surgery failed. Stannard then performed surgery to remove scar tissue, according to legal filings.
Stannard recommended Draper have a second BioJoint surgery, according to Draper's lawsuit. Draper claims before the second surgery, Stannard told him the operations have had a 90 percent success rate. Draper also claims the second surgery failed.
Stannard was awarded two new appointments effective Sept. 1 as the associate dean of the MU School of Medicine and as MU Health Care’s chief medical officer for clinical strategic initiatives.
In response to our inquiries regarding the lawsuits, MU Health provided ABC 17 News with the following 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 MOPSSM 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, more than 14 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
ABC 17 News has also left messages for all of the attorneys involved.
*Editor's note: This article has been updated with a statement from MU Health. An earlier version of this article stated the procedure had been tested on pigs and it had applied for a patent.