The DOJ announced that John W. Kosolcharoen, founder and chief executive officer of Liveyon LLC and Genetech Inc., was sentenced to 3 years in federal prison for one count of introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. Kosolcharoen previously pleaded guilty to the foregoing charge, which stemmed from manufacturing and distributing stem cell products throughout the United States.

According to the DOJ, Kosolcharoen marketed stem cell products, made from human umbilical cord blood, as treatment for a host of medical conditions. Kosolcharoen’s company, Liveyon, marketed the stem cell product “ReGen”, and Kosolcharoen admitted he misrepresented that the product was suitable to treat Azheimer’s disease, Parkinson’s disease, heart diseases, and various autoimmune disorders. ReGen was marketed throughout the United States and, according to court documents, the advertising materials contained false and misleading statements about the product’s effectiveness and safety. In 2018, the FDA and the Centers for Disease Control and Prevention (CDC), found that at least 19 patients in eight different states patients were hospitalized with bacterial infections after receiving stem cell products from Liveyon. Between 2017 and 2018, the government alleged that Liveyon products generated approximately $21.6 million in revenue.

Kosolcharoen was convicted under the Federal Food, Drug and Cosmetic Act. Upon announcement of Kosolcharoen’s conviction, U.S. Attorney Martin Estrada for the Central District of California commented “[The U.S. Attorney’s Office] will continue to aggressively prosecute those who take advantage of victims’ fears and anxieties to line their pockets.”

The attorneys at Chilivis Grubman represent clients of all types and sizes in connection to healthcare fraud investigations and litigation. If you need assistance with such a matter, please contact us today.