An Orange County man who ran a company that marketed stem cell-based products linked to multiple hospitalizations is expected to be sentenced next month for illegally selling a drug that lacked U.S. Food and Drug Administration (FDA) approval.
John Kosolcharoen, 53, most recently of Rancho Santa Margarita, pleaded guilty Aug. 26 to one federal count of introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead, according to the U.S. Department of Justice.
Kosolcharoen is currently in custody serving a sentence for a separate, unconnected conviction.
According to court documents, beginning in 2016, Kosolcharoen created two companies, the Irvine-based Liveyon LLC and the San Diego-based Genetech Inc., to manufacture and distribute injectable stem cell products made from human umbilical cord blood.
Liveyon marketed the products under different brand names, including ReGen. In pleading guilty, Kosolcharoen admitted that he and others misrepresented ReGen as suitable for the treatment of a variety of conditions, such as lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease, and others.
Liveyon marketed the products throughout the United States until about April 2019 using advertising materials that contained multiple false and misleading statements about their purported safety and effectiveness, federal prosecutors said.
“This defendant recklessly put people’s lives in danger, giving false hope to patients with serious illnesses,” U.S. Attorney Martin Estrada said in a statement.
As part of the plea agreement filed in L.A. federal court, Kosolcharoen admitted that to mislead the FDA about Liveyon’s activities, he directed Liveyon’s purchase orders to falsely state that the stem cell products were being sold for research purposes only.
In 2018, the FDA and the Centers for Disease Control and Prevention received reports of patients in multiple states requiring hospitalization for bacterial infections after receiving Liveyon products. Kosolcharoen admitted that he and others fraudulently induced customers into purchasing stem cell-derived Liveyon products by, among other things, misleading the public about the cause and severity of adverse events suffered by Liveyon patients, and falsely reporting and concealing material facts regarding the outcome of an FDA inspection of Genetech.
According to FDA records, that inspection documented evidence of significant deviations from good manufacturing and tissue practices.
“Unapproved stem cell treatments not only endanger public health but also exploit the hopes of patients who seek relief from the most serious of diseases,” said Brian Boynton, the DOJ’s principal deputy assistant attorney general.
U.S. District Judge Otis D. Wright II scheduled a Sept. 23 sentencing hearing, at which time Kosolcharoen will face up to three years in federal prison, according to the DOJ.
