Twelve patients have been hospitalized after receiving stem cell therapies contaminated with E. coli and other bacteria. People in Florida, Texas and Arizona received the treatments for varying reasons, including degenerative joint disease, back pain and a rotator cuff tear. The illnesses resulted in multiple hospitalizations, some for at least 30 days and another for 58 days. Luckily all survived, but not before experiencing life-altering complications.
The Center for Disease Control (CDC) tested the stem cell product called ReGen, which is sold by Liveyon. It found the contamination took place prior to Liveyon’s sale of the treatments. Liveyon issued a voluntary recall of the product, which is manufactured by Genetech, Inc. The recall included all ReGen Series products due to “possible adverse reactions.”
The Food and Drug Administration (FDA) has approved stem cell treatments only for blood disorders, however, the treatments may still be sold by clinic operators who say they are not subject to FDA regulations.
In September of 2018, the FDA inspected Gentech and stated it found several deficiencies. In a follow up warning letter two months later, the FDA stated Gentech had not properly corrected the issues.
If you believe your medical complications were a result of a defective, contaminated, or otherwise unsafe product, consult with an attorney who handles product liability cases. The Ruth Law Team can be reached night or day at 888-783-8378.