{"id":57370,"date":"2024-08-27T16:31:44","date_gmt":"2024-08-27T23:31:44","guid":{"rendered":"https:\/\/cjnotebook.com\/?p=57370"},"modified":"2024-08-27T16:31:44","modified_gmt":"2024-08-27T23:31:44","slug":"founder-ceo-of-injectable-stem-cell-product-pleads-guilty-of-distributing-unapproved-drug","status":"publish","type":"post","link":"https:\/\/cjnotebook.com\/?p=57370","title":{"rendered":"Founder\/CEO of Injectable Stem Cell Product Pleads Guilty of Distributing Unapproved Drug"},"content":{"rendered":"

\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0LOS ANGELES<\/strong><\/span><\/p>\n

\"\"<\/p>\n

The founder and chief executive officer of a California-based company that marketed stem cell-based products linked to multiple hospitalizations has pleaded guilty to a felony violation of the Federal Food, Drug, and Cosmetic Act, the Justice Department announced today.<\/span><\/p>\n

John Warrington Kosolcharoen, 53, most recently of\u00a0<\/b>Rancho Santa Margarita, pleaded guilty to one count of introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. <\/span><\/p>\n

Kosolcharoen is currently in custody, serving a sentence for a separate, unconnected conviction.<\/span><\/p>\n

\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u201cThis defendant recklessly put people\u2019s lives in danger, giving false hope to patients with serious illnesses,\u201d said United States Attorney Martin Estrada. \u201cToday\u2019s guilty plea shows that we will hold accountable corporate executives and healthcare professionals who put profits over patients.\u201d<\/span><\/p>\n

\"\"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. <\/span><\/p>\n

Liveyon marketed the products under different brand names, including \u201cReGen.\u201d <\/span><\/p>\n

In pleading guilty, Kosolcharoen admitted that he and others misrepresented ReGen as suitable for the treatment of various conditions, such as lung and heart diseases, autoimmune disorders, Alzheimer\u2019s disease, and Parkinson\u2019s disease. <\/span><\/p>\n

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.<\/span><\/p>\n

\"A\"MalletIn recent years, the U.S. Food and Drug Administration (FDA) has warned consumers<\/a>\u00a0that 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. <\/span><\/p>\n

The FDA regulates stem cell products, and in most cases, they require FDA approval before entering interstate commerce.<\/span><\/p>\n

As part of the plea agreement, Kosolcharoen admitted that he directed Liveyon\u2019s purchase orders to falsely state that the stem cell products were being sold \u201cfor research purposes only\u201d to mislead the FDA about Liveyon’s activities.<\/span><\/p>\n

In 2018, the FDA and the Centers for Disease Control and Prevention (CDC) received reports of patients in multiple states being hospitalized due to bacterial infections after using Liveyon products. <\/span><\/p>\n

\"\"\"\"Kosolcharoen admitted to fraudulently inducing customers to purchase these stem cell-derived products by, among other things, misleading the public about the cause and severity of adverse events experienced by Liveyon patients. <\/span><\/p>\n

He also falsely reported and concealed critical information regarding the outcome of an FDA inspection of Genetech.<\/span><\/p>\n

FDA records show that this inspection uncovered significant deviations from good manufacturing and tissue practices.”<\/span><\/p>\n

\u201cUnapproved stem cell treatments not only endanger public health but also exploit the hopes of patients who seek relief from the most serious of diseases,\u201d said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department\u2019s Civil Division. \u201cThe Department of Justice is committed to safeguarding the public from these schemes and will vigorously pursue legal action to hold accountable those who unlawfully market and sell these unproven therapies.\u201d<\/span><\/p>\n

\u201cWe are grateful for the work by the Department of Justice to hold accountable establishments that prey upon vulnerable populations by marketing potentially dangerous stem cell products with false and misleading claims about their safety and effectiveness,\u201d said Director Peter Marks, M.D., Ph.D. of FDA\u2019s Center for Biologics Evaluation and Research.<\/span><\/p>\n

\u201cWhen unscrupulous providers offer umbilical cord blood stem cell products and treatments that are both unapproved and unproven, they put consumers\u2019 health at risk, and multiple users of this firm\u2019s products in fact suffered adverse events,\u201d said Special Agent in Charge Robert Iwanicki of FDA Office of Criminal Investigations Los Angeles Field Office.\u00a0<\/span><\/p>\n

\u201cThis investigation was a joint effort between multiple federal agencies and state and local health departments to quickly put a stop to the distribution of unsafe, contaminated products,\u201d said Director Michael Bell, M.D. of CDC\u2019s Division of Healthcare Quality Promotion. \u201cThe rapid response by our public health system identified products marketed as stem cell treatments to be the source of serious infections in dozens of patients. Our message to all consumers and providers is to heed the warning against the use of unapproved products like these with unproven claims of effectiveness for conditions like joint disease, chronic pain, or COVID-19. Please don\u2019t let products like these put you or your patients\u2019 health at risk.\u201d<\/span><\/p>\n

FDA\u2019s Office of Criminal Investigations, the 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 California Department of Health Care Services investigated the case.<\/span><\/p>\n

Assistant United States Attorneys Mark Aveis of the Major Frauds Section and David H. Chao of the General Crimes Section, Assistant Director Ross S. Goldstein and Trial Attorneys Meredith B. Healy, Kathryn A. Schmidt and Peter J. Leininger of the Justice Department\u2019s Consumer Protection Branch are prosecuting the case.<\/span><\/p>\n

United States District Judge Otis D. Wright II scheduled a September 23 sentencing hearing, at which time Kosolchareon will face a statutory maximum sentence of three years in federal prison.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

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