Following an investigation by the North Dakota Attorney General's office, a Bismarck stem cell clinic has agreed to pay nearly $20,000 in consumer refunds and discontinue stem cell injections not approved by the U.S. Food and Drug Administration.
An agreement was recently reached between the attorney general's office and West 2 Medical Solutions, which is located in north Bismarck. In November, the state Consumer Protection Division launched an investigation of the clinic after receiving several consumer complaints.
West 2 Medical Solutions owners Dean Jones, of Colorado, and Terry Guthmiller, of Bismarck, must refund $19,733 to patients, as well as pay $4,000 in civil penalties, attorney's fees and other costs to the attorney general's office.
"For us, it's mission accomplished," said Parrell Grossman, director of the Consumer Protection Division. "We needed to stop these injections due to our concerns about the misrepresentations and any potential adverse consequences, and otherwise make sure the clinic can engage in other forms of medical treatment that is in compliance with federal and state law."
Because the clinic leadership and its employees "fully cooperated" with the investigation, Grossman said the attorney general decided against pursuing a formal filing of a consumer fraud action.
"Sometimes defendants don't cooperate, they don't accept responsibility and here they cooperated with our investigation throughout the process, and I think the attorney general took that into consideration," he said.
At the time the attorney general's office initiated its investigation, the clinic had been offering stem cell injections for about a week and a half.
The stem cell injections in question were amniotic tissue, called allograft, injections, Grossman said. There were concerns about "many misrepresentations" the clinic made in terms of the medical or quality of life benefits of these injections, as well as failure to disclose any possible negative consequences to patients. At least one patient indicated to the attorney general's office that there was pain in both knees after receiving the injections.
The attorney general's office made separate agreements with Jones and Guthmiller, as well as an agreement with two nurse practitioners, Julie Landsiedel and Lisa Watkins, who worked at the clinic. In the agreements, Jones, Guthmiller, Lansiedel and Watkins deny the allegations.
"The attorney general's office, themselves, have taken the position that the products we were using were not compliant with the FDA, and so, accordingly, we just agreed to refrain from using those products," Jones said in an interview Tuesday.
The clinic will continue to operate as normal, according to Jones, adding that other stem cell injections in accordance with FDA requirements may be considered.
West 2 North Medical Solutions has offices in North Dakota, Colorado and California. According to its website, it offers a number of other services, including chiropractic care and weight management.
Landsiedel and Watkins, who are licensed nurse practitioners in the state of North Dakota, must each pay $500 to the attorney general's office. Grossman said they negotiated separately with them because they no longer work at the clinic.
The nearly $20,000 in patient refunds does not represent all patients who went to the clinic. There were at least five complaints filed with the attorney general's office, and four of those asked for their money back, according to Grossman.
Grossman said, throughout the investigation, which concluded in early March, there were also a number of boards who shared concerns about the stem cell injections and the operation of clinic, including the North Dakota Board of Medicine, the North Dakota State Board of Chiropractic Examiners, the North Dakota Board of Nursing, the North Dakota Medical Association and the state Department of Health.