Orange County man pleads guilty to distributing unapproved drug to treat serious illness – Orange County Register

An Orange County man who ran a company that marketed stem cell-based products linked to numerous hospitalizations is set to be sentenced next month for illegally selling a drug that was not approved by the U.S. Food and Drug Administration.

John Kosolcharoen, 53, who last lived on Rancho Santa Margarita, pleaded guilty Monday to introducing an unapproved new drug into interstate commerce with fraudulent and deceptive intent, according to the U.S. Department of Justice.

Kosolcharoen is currently in custody serving a sentence for another, unrelated conviction.

According to court documents, starting in 2016, Kosolcharoen founded two companies — Irvine-based Liveyon LLC and San Diego-based Genetech Inc. — to manufacture and distribute injectable stem cell products derived from human umbilical cord blood.

Liveyon marketed the products under various brand names, including ReGen. In his guilty plea, Kosolcharoen admitted that he and others falsely claimed that ReGen was effective in treating a range of diseases, including lung and heart disease, autoimmune disorders, Alzheimer's, Parkinson's and others.

Liveyon marketed the products throughout the United States until about April 2019, using promotional materials that contained numerous false and misleading statements about their alleged safety and effectiveness, federal prosecutors said.

“This defendant recklessly endangered human lives and gave false hope to patients with serious illnesses,” U.S. Attorney Martin Estrada said in a statement.

As part of the settlement filed in federal court in Los Angeles, Kosolcharoen admitted that in order to mislead the FDA about Liveyon's activities, he falsely stated in Liveyon's purchase orders 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 several states who had to be hospitalized for bacterial infections after receiving Liveyon products. Kosolcharoen admitted that he and other customers fraudulently induced them to purchase Liveyon stem cell-derived products by, among other things, misleading the public about the cause and severity of Liveyon patients' side effects and misreporting and concealing material facts about the outcome of an FDA inspection of Genetech.

According to FDA records, this inspection documented evidence of significant deviations from good manufacturing and handling practices for tissue.

“Unapproved stem cell treatments not only endanger public health, they also abuse the hopes of patients seeking relief from the most serious diseases,” said Brian Boynton, assistant attorney general for the Department of Justice.

U.S. District Judge Otis D. Wright II has scheduled a sentencing hearing for September 23, at which time Kosolcharoen faces up to three years in a federal prison, according to the Justice Department.