Source: United States Department of Justice Criminal Division
The founder and chief executive officer of a California-based company that marketed stem cell-based products allegedly linked to 19 hospitalizations was sentenced today to 36 months in prison following his conviction under the Federal Food, Drug and Cosmetic Act.
John W. Kosolcharoen, 53, most recently of Orange County, California, pleaded guilty last month in the U.S. District Court for the Central District of California to one count of introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. Kosolcharoen is currently in federal custody on a separate, unconnected conviction. The court set a restitution hearing for Dec. 3.
According to court documents, beginning in 2016, Kosolcharoen created two companies, Liveyon LLC and 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. At sentencing, the government alleged that sales of Liveyon products generated approximately $21.6 million in revenue between 2017 and 2018.
“Misleading the public about the safety and effectiveness of purported cures and treatments is illegal,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will work with its law enforcement partners to prosecute individuals who market potentially dangerous products for personal gain.”
“Exploiting the hopes of patients suffering from serious illnesses is not merely greedy, it’s cruel,” said U.S. Attorney Martin Estrada for the Central District of California. “My office will continue to aggressively prosecute those who take advantage of victims’ fears and anxieties to line their pockets.”
In recent years, the Food and Drug Administration (FDA) has warned consumers that patients seeking cures and remedies for serious diseases and conditions may be misled about unapproved stem cell products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk. Stem cell products are regulated by FDA, and generally they must have FDA approval before being introduced into interstate commerce.
In 2018, FDA and the Centers for Disease Control and Prevention (CDC) 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. The government alleged in court filings that an investigation by CDC, with the assistance of state and local health departments, found that the stem cell products were linked to the hospitalization of 19 patients in eight different states.
The FDA’s Office of Criminal Investigations, FBI, Amtrak Office of Inspector General, Defense Criminal Investigative Service, Department of Health and Human Services Office of Inspector General, Department of Labor Employment Benefits Security Administration and the California Department of Health Care Services investigated the case.
Assistant U.S. Attorneys Mark Aveis and David Chao for the Central District of California and Assistant Director Ross S. Goldstein and Trial Attorneys Meredith B. Healy, Kathryn A. Schmidt and Peter J. Leininger of the Civil Division’s Consumer Protection Branch handled the case.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.