endobj Success had come quickly to Liveyon. endobj Dorothy OConnell, now ninety, still lives by herself. Liveyon is a company that used to distribute an umbilical cord blood product manufactured by Genetech (not to be confused with the pharma company called Genentech). John W. Kosolcharoen Author: U.S. Securities and Exchange Commission Subject: Order Instituting Administrative Proceedings Pursuant to Section 15(b) of the Securities Exchange Act of 1934, Making Findings, and Imposing Remedial Sanctions Keywords: Release No. Liveyon has denied their claims and is fighting them in court. The doctors didnt think she was going to make it.. Starting around 2014, the market exploded, Turner says. Shes strong in her own right: in her twenties, she was one of the first women to operate a crane at the Dow Chemical plant in Lake Jackson. Sold as a miracle cure for a variety of intractable conditions, the injections have sickened people in five states, prompting new warnings from health officials about the risks of unproven stem cell treatments. He told me his bill was intended to allow doctors to grow a patients cells in the lab before injecting themthe procedure that had originally gotten Celltex into trouble and had prompted it to move its clinical operations from Houston to Cancn. Such materials have a long history in commercial marketing, said Jeanne Loring, a neurobiologist and stem cell researcher at California-based Scripps Research. If these products have any effect on patients, Fortier said, its not through live cells or growth factors.. At the time, Liveyon's chief executive officer, John Kosolcharoen, blamed the company's supplier, a San Diego-based firm called Genetech. As Laura pointed out, we dont know whose a good candidate and we dont know whats a safe treatment. United States, 19701 Fairchild They are part of C-Suite Department and Read More Contact John Kosolcharoen's Phone Number and Email Last Update 11/19/2022 6:07 PM Email j***@liveyon.com Engage via Email Contact Number (***) ***-**** Engage via Phone Mobile Number The CDC did not name the patients, but the date of Luncefords injection and the length of his hospital stay match those of a patient listed in the CDC report. Even when biology suggests a plausible mechanism, you dont know until you do the studies. He has signed a plea agreement and is awaiting a hearing. <>stream (I spoke with Pierce a few months after the seminar, and he told me he had since ended his association with Liveyon, partly because he himself read the CDC report. The bulk of the show is about John Kosolcharoen, the charismatic CEO of Liveyon, an ambitious stem cell company that raced ahead of existing research to provide cure-alls to patients who can afford the $5000 injections. He pleaded guilty on August 23, 2016 to one federal felony after it was alleged that he had headed a TRICARE kickback and fake prescriptions scheme from late 2014 through his arrest date. While the FDA passively allowed stem cell businesses to operate, the Texas Legislature actively sought to further promote them. Therefore, your products are not regulated solely under section 361 of the PHS Act [42 U.S.C. She eventually moved on to other jobs and raised a son. This is a BETA experience. Then, in 2016, Kosolcharoen was arrested in a federal crackdown on health-care fraud. iii. A couple of years later, he flew his mother to California so she could receive stem cell injections for a burn on her hand. The DT-001 Form 1 Recovery Site Assessment received from cord blood supplier (b)(4) did not adequately assess a donors residence in, or travel to, areas identified by the Centers for Disease Control and Prevention with active ZIKV transmission. In subsequent years, the FDAs efforts to enforce the rules proved weak, Turner says. Gaveck has had no formal training in stem cells, but he said he has spent the past nine years immersed in the industry. John Kosolcharoen has been associated with six companies, according to public records. At the time, inspectors reprimanded Genetech for not following safe manufacturing practices such as consistently screening donor cells for communicable diseases, FDA records show. Dilley and the medics had to haul her mother outside in a bedsheet. The companys story begins with a 2013 Super Bowl party in Arizona, where a California businessman named John Kosolcharoen (pronounced Co-soul-sharon) smashed his knee during a poorly executed jump into a swimming pool. CASE DISPOSED WITH DISPOSITION OF COURT FINDING, CASE DISMISSED WITH DISPOSITION OF COURT-ORDERED DISMISSAL. He and Gaveck said the company recently set up its own laboratory, so it wont have to rely on outside manufacturers. Ive never heard anybody scream like that.. *T0T0 Bf @ JOHN W. KOSOLCHAROEN Manager 7700 Irvine Center Dr Ste 800 Irvine, CA 92618 Reviews Write Review There are no reviews yet for this company. At first, we were looking at, Was it possibly the procedure? I certainly didnt know anything about umbilical cord blood stem cells, he says. When you read about it every day, she says, it gives you hope., Crawford cautioned her readers to do their own research. I was the middle person, transferring paperwork, he said. 26S075SIr Paradoxically, the debate had the effect of publicizing the enormous promise of stem cell therapies, helping to create a receptive market for treatments that would eventually become available. endstream 26S075SIr While Parker refers to doctors and physicians, the Texas Medical Board believes that they arent the only ones administering stem cell treatments and that some chiropractors are not following the rules. I played Morrison the tape mentioning all the conditions Id heard discussed. He said he pleaded guilty because federal officials threatened to charge his relatives involved in the business. (Aguilar declined interview requests.). Within days, she started throwing up, and I had to call an ambulance, Dilley said, adding that her mothers pain was so intense, you couldnt touch her., OConnell was airlifted 50 miles north to a hospital in Houston. Tao purchased most of his stem cells from a company called Liveyon, which is based in Southern California and claims to be the number one regenerative medicine company in the country. Tao considered Liveyons product to be of higher quality and to yield better results than its competitors in the marketplace. Recent filings for . 9. She screamed bloody murder the whole time we were moving her, Dilley says. Meanwhile, a Genetech price list shows that Liveyon was buying the vials it sold to doctors for $1,800 at a price of $250. Instead, the company sells its treatments to chiropractors and other practitioners. Please include a copy of this letter with your initial submission to CBER. In recent years, though, her mothers pain had come to preoccupy her. AS SUCCESSOR BY MERGER TO WELLS FARGO HOME MORTGAGE, INC.; HSBC BANK USA, NATIONAL ASSOCIATION, AS TRUSTEE FOR WELLS FARGO HOME EWUITY TRUST 2004-2 ON 10/31/2012. Loren Elliott/The Washington Post via Getty. The agency is also seeking an injunction against a chain of stem cell clinics based in Rancho Mirage, California. The trail led them to Liveyon. Despite her age, OConnell had always been able to take care of herself, including mowing her own lawn, Dilley said. PROOF OF SERVICE OF 30-DAY SUMMONS & COMPLAINT - SUBSTITUTE FILED BY KOSOLCHAROEN, JOHN W ON 07/05/2019. English (7 reviews) Other English (7 reviews) 5.0 Current Employee, less than 1 year Great Nov 26, 2021 - Sales Associate Recommend CEO Approval Business Outlook The researcher had to go back to the laboratory and spend fourteen years trying to figure out how to do it safely and effectively, he says. It felt like someone stuck a knife into the middle of my back and just left it there, said Lunceford, a 52-year-old wildlife biologist from Athens, Tex. <>>>/StructParents 2/Contents 14 0 R/Parent 5 0 R>> Not intended for diagnostic or therapeutic procedures.. Kosolcharoen said authorities told him, We wont charge you with anything, but you have to agree to never get a security license. The SEC declined to comment on the agreement. He has signed a plea agreement stemming from allegations that he billed workers comp for $4.2 million between 2008 and 2014 from fraudulent patient reports based on templates with copied and pasted information. Theres a long lineup of people out there that are just waiting to defraud desperate patients by selling fake therapies that dont have the potential to benefit people, Morrison says. Liveyon charges doctors $1,800 for a vial it says contains 30 million cells (although not 30 million stem cells), which they sell to patients for $5,000. The clinic, Texas Regional Health and Wellness, later bought ads in the Brazosport Facts that highlighted Crawfords mention of the clinic in her column. Dear Ms. Panah and Mr. Kosolcharoen, During the inspection of your firms Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, co-located at 22667 Old Canal Road, Yorba Linda, CA 92887, conducted . Stem cells entered the public consciousness in the early 2000s, after scientists learned how to create stem cell lines for medical research using donated embryos left over from in vitro fertilization. If it would help her mother feel better, she wouldve been prepared to sell her house. Kosolcharoen attributes his arrest to aggressive prosecutors who leaned on unduly complicated military insurance rules and solicited the testimony of a former girlfriend. Hardy quit. I only want high-quality, reputable physicians that are doing good work providing these types of services to the people of Texas, he says. Since manufacturing operations began in (b)(4), you (b)(4) processed (b)(4)% of your (b)(4) batches. Nor did you commit to providing any follow-up response(s) to address any corrective actions once implemented. But mostly he worries about the patients themselves. There is a legitimate scientific supported use for stem cells, and the promise is legitimate but theyre being abused. In all, 22 defendants face federal charges in Santa Ana and Los Angeles as part of a nationwide sweep involving 301 people accused of falsely billing $900 million, the U.S. attorneys office said. 262(i)]. . That customer was Liveyon. The New York state attorney general recently sued the owner of a Manhattan stem cell clinic, claiming that it was misleading and defrauding the public. For example, the following components were not tested before release: a. According to one study, stem cell treatments now constitute a $2billion global industry. I had to say something, and I started telling him, Look, have you checked into this? Before Liveyon, both men experienced professional setbacks, according to court documents and other records. Last month, Los Angeles health officials reported two patients had become seriously ill after being injected with a similar product sold by a different company. x+r Her new podcast Bad Batch, from Wondery, is an extended investigation of the Texas infection outbreak and the pitfalls of the stem cell industry. Meanwhile, the company is planning a rapid expansion. FDA officials declined to discuss the details of the Liveyon-Genetech case. Last March, the medical boards executive director sent a letter to the Texas Board of Chiropractic Examiners, emphasizing that the law requires stem cells to be administered by a physician. She still suffers from damage to her eyesight and hearing, as well as vertigo. LIVEYON IRVINE LLC Company Number 201814210847 Status Suspended Sos Incorporation Date 14 May 2018 (over 4 years ago . They all just hear all this fantastic stuff.. He tried to set up a video conference to discuss the problem, but it never happened. 8 Liveyon reviews. By mid-December, the CDC had found 12 patients, its report said: seven in Texas, four in Florida and one in Arizona. Join hosts, Liveyon CEO John W. Kosolcharoen and Director of Education Dr. Alan . endobj Cancellation and Refund Policy, Privacy Policy, and At first, the message made no sense. Throughout the hour-and-a-half-long presentation, the doctor, Darrel Pierce, and the Liveyon sales rep, Tim Martin, promoted the healing powers of stem cells. They stopped for a hamburger along the way, and once they were home, Dilley helped her mother to bed. Office of Biological Products Operations - Division 2, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm488582.pdf. In addition, you failed to track which batches have been processed (b)(4) potentially failing to identify contaminated umbilical cord blood product if one of the batches failed sterility or was processed using cord blood from an ineligible donor. Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 CFR 211.113(b)]. He was not new to the art of medical salesmanship. Specifically, the products, manufactured from donated umbilical cord blood, are dependent on the metabolic activity of living cells for their primary function and are not for autologous use, allogeneic use in a first-degree or second-decree blood relative, or reproductive use. And he worries that the industry could siphon off patients who might otherwise participate in controlled clinical trials but instead opt to try the treatment on their own. MINUTES FINALIZED FOR EX PARTE 08/02/2019 08:30:00 AM. A month ago, he was matched against former UCLA . The DT-001 Form 4 Donor Risk Assessment Interview received from cord blood supplier (b)(4) did not indicate if the donor has been diagnosed with Creutzfeldt-Jacob disease (CJD) or variant Creutzfeldt-Jacob disease (vCJD). I probably did have a conversation with him, Gaveck said. arrested in nationwide health, Click to share on Facebook (Opens in new window), Click to share on Twitter (Opens in new window), Click to share on Reddit (Opens in new window), Seven from O.C. As noted above and in the FDA Warning Letter issued on November 29, 2018, to your former contract manufacturer Genetech, Inc. with a copy to Liveyon LLC and Mr. Kosolcharoen, to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. SILVER SPRING, Md.The U.S. Food and Drug Administration (FDA) has warned Liveyon Labs Inc. and Liveyon LLC, of Yorba Linda, Calif., and their president and chief executive officer, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. No corrective actions were implemented, and four impacted in-process batches were subsequently distributed. Gaveck, meanwhile, no longer holds a medical license. Stem cell clinics multiply, with heartbreaking results for some patients. In an interview, Kosolcharoen said he didnt deliberately defraud anyone. iv. The deficiencies include, but are not limited to, the following: 1. In 2012, the FDA sent Celltex a warning, saying that the companys practice of extracting a persons cells and growing more of them in the laboratory put the treatment outside the bounds of minimally manipulated. Still, the company continued to thriveby moving its clinical operations to Cancn. Its free. She said they also contained very few growth factors substances that many companies often claim stimulate healing. OConnell at her Brazoria County home with her daughter on January 28, 2019. OConnell received Liveyon injections for her arthritic back and neck on Sept. 12, according to her daughter, Elaine Dilley. She warned that stem cell injections werent cheap and werent covered by insurance. ORDER TO SHOW CAUSE RE: DISMISSAL SCHEDULED FOR 03/04/2013 AT 10:00:00 AM IN C12 AT CENTRAL JUSTICE CENTER. In real stem cell therapies, we do pay close attention clinically to numbers of stem cells, he says. Before that, Kosolcharoen ran into trouble with the Securities and Exchange Commission. 34-73378; File No. xY[s~W]R&fOR ? Federal prosecutors declined to comment because the case remains open. <>>>/StructParents 0/Contents 4 0 R/Parent 5 0 R>> While the FDA passively allowed stem cell businesses to operate, the Texas Legislature actively sought to further promote them. He started offering stem cell treatments in 2017 because hed heard they were effective, he says, adding that his initiative was not related to the change in Texas law that year. I asked him if anybody else has gotten sick off the stem cells. Instead, patients received massage and acupuncture, which are not covered by Medicare. Because the umbilical cord blood products are not intended to perform the same basic function or functions of umbilical cord blood in the recipient as in the donor, such as forming and replenishing the lymphohematopoietic system, using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c). Last week, Herzog filed a lawsuit alleging negligence against Liveyon, Genetech and Gaveck. While they were waiting to see the doctor, she overheard a nearby conversation. The first reports of infected patients reached the CDC in September. 1 0 obj Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process. I could tell by the way he was looking at me, and the way he was shaking his head, that there was.. Dinning and Williamson also survived but are in more pain than before their stem cell injections. Asked to comment on the case, Gaveck said the phone call occurred before Liveyon had gotten the first reports of bacterial infections in patients. Liveyon, founded in 2016, sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. The chiropractor who owns Texas Regional Health and Wellness, Sammy Tao, has been practicing since 2002. And its full of great reads, yall. United States. Comparing himself to other stem cell experts, he said: Ill stand up to any of them as far as knowledge of stem cells is concerned.. Everything was glowing, glowing, Herzog said. 2. c. From February 9 to February 13, 2019, Liveyon Labs used contact (b)(4) plates as settling (b)(4) plates to monitor the BSCs during each fill when your firm no longer had any settling plates in stock. Four days after his arrest, Kosolcharoen signed an agreement with a San Diego biotech startup called Genetech (not to be confused with biotech giant Genentech), founded by a young scientist named David Aguilar, to make a stem cell product from donated umbilical cord blood. He, OConnell and three other Texas patients have filed lawsuits against Liveyon, alleging negligence. He will be arraigned July 18. Although Kosolcharoen says he intended to eventually build his own lab and manufacture the product himself, he partnered with Genetech so he could start selling the product more quickly. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed. Yet their experimental status has not impeded a boom in sales. Discover anonymous reviews now! The trail leads to a stem cell company with a charismatic CEO, and to an entire multibillion dollar industry where greed and desperation collide. %PDF-1.4 You may opt-out by. 2016-05-16, Orange County Superior Courts | Contract | Its the FDA that stands between us and all of that fraud. Or at least thats what its supposed to do. John K. is a quintessentially American figure, a smooth talker who got in over his head Liveyon and he comes across as a very sympathetic character which makes him hard to hate. The media fill batch sizes used for your validation study LL-VAL-004, entitled Validation of Aseptic Processing of the PURE Product, did not represent the maximum commercial batch size. Ive been writing about medicine for 25 years, Laura says, and the placebo effect is powerful. Warner Bros. The root cause and source of the contaminating organisms was not identified. Kosolcharoen said he started Liveyon in 2016, after years of working as an entrepreneur in the insurance, real estate and telemedicine industries. The SEC barred him in 2014 from the securities industry after he made material misstatements and committed fraud and deceit, according to a settlement agreement between the SEC and Kosolcharoen. Then, in late 2017, Dilley happened to read a column in her local newspaper, the Brazosport Facts, about stem cellscells that have the potential to serve as a repair system for injured or diseased tissue. Elaine Dilley and her husband live in Brazoria County, south of Houston, on an eight-acre lot with pecan and oak trees and a well-stocked pond. Then, in 2012, he became aware of a new Houston company called Celltex Therapeutics, which had connections to a South Korean business hed been tracking. John W Kosolcharoen is a CEO,Medical in Orange County CA, See reviews on mycity.com John W Kosolcharoen Compounding pharmacies formulate personalized medicines, but prosecutors said those involved prepared formulas aimed at the highest possible profit, not maximum effectiveness. So as to avoid the appearance of speaking out against a private firm, he agreed to help, with one stipulation: he didnt want to know which company the seminar was representing. Daniel Vaughn is the countrys first barbecue editor, and he has eaten more barbecue than you have. The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah. She is a graduate of Northwestern University's Medill School of Journalism. UniCourt uses cookies to improve your online experience, for more information please see our Privacy Policy. b. Complaint C-19-001 was received on April 26, 2019, forwarded to QA on the same day, and QA did not commence their investigation until May 1, 2019. ii. We dont even have a lab yet, Hardy says. Genetech closed shortly thereafter. Liveyons tax returns reveal that the company brought in more than $6million in sales in 2017, its first full year of operation. MINUTES FINALIZED FOR ORDER TO SHOW CAUSE RE: DISMISSAL 03/04/2013 10:00:00 AM. Defendant John Kosolcharoen is directed to appear for Preliminary Hearing on 7/12/16 at 4:30 PM and for Post Indictment Arraignment on 7/18/16 at 10:00 AM before the Duty Magistrate Judge. endstream However, Liveyon Labs does not qualify for any exception in 21 CFR 1271.15, and the products fail to meet all the criteria in 21 CFR 1271.10(a). DEMURRER TO COMPLAINT SCHEDULED FOR 09/14/2012 AT 02:00:00 PM IN C12 AT CENTRAL JUSTICE CENTER. The for-profit stem cell business is nonetheless booming. E-FILING TRANSACTION 1650648 RECEIVED ON 08/01/2019 11:01:55 AM. If anyone else knew whats going on in this industry, they would roll over in their grave.. If you have any questions, please contact Mr. Cline at (949) 608-4433 or via e-mail. The FDA has responded only to written questions for this story. 12 0 obj For reasons that are still unclear, a series of patients had suffered permanent vision damage after the cells were injected into their eyes. A free inside look at company reviews and salaries posted anonymously by employees. The next morning, around five, OConnell called her daughter to say she felt sick. <> So-called right-to-try laws, originally scripted in 2014 by the Goldwater Institute (a Libertarian-leaning think tank based in Phoenix) and since passed in more than forty states and federally, allow patients with terminal diseases access to experimental medicines that have passed basic safety tests in clinical trials, even if their effectiveness has not been proven. The number of colonies were not counted if greater than 1 and marked as 1+. 8. (b)(4) vials were distributed without any environmental monitoring data demonstrating control of the immediate manufacturing environment. 26S075SIr But he has an explanation for why they were in such a hurry to get started. Your complaint procedure LL-QA-015, entitled Product Complaint is not followed and is inadequate: a. 262(i)]. One evening in April, I attended a seminar hosted by a Liveyon sales representative and a family doctor who does not accept health insurance and has embraced alternative therapies as part of his practice. State representative Tan Parker, who sponsored the law that expanded access to unproven therapies in Texas, says he wants stem cells to be administered safely while also giving ill patients the freedom to try something experimental. But OConnell had severe arthritis, and doctors could do little to help her. Liveyon CEO John Kosolcharoen granted reporter Laura Beil an extensive interview that offered insights into the current business of stem cell therapy, which the FDA has long been trying to. But in the absence of conclusive studies, its hard to know whether the improvement comes from something in the cells themselves or from the considerable power of the placebo effect. (Liveyon began distributing its own product, made in-house, in early 2019.). This week, CDC officials said they confirmed a 13th case of infection. Therefore, your products are drugs as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. You should take prompt action to correct these violations. Liveyons product contained 300,000. EXHIBIT LIST (EXHIBITS A TO N) FILED BY KOSOLCHAROEN, JOHN W ON 08/01/2019. Complaint closure is also performed by the CCO of Liveyon LLC/Liveyon Labs instead of Liveyon Labs QA. Texas has become a wild, wild West, says David Bales, of Texans for Cures. Cases involving other agreements or torts not classified elsewhere, 190, 1190, 2190, 3190, 4190, 4194, 5190, 5196. Since operations began in January 2019, Liveyon Labs has processed cord blood units from(b)(4) donors supplied by (b)(4), located in (b)(4), and cord blood units from (b)(4) donors supplied by (b)(4), located in (b)(4). Contact plates are not an appropriate substitute for settling plates, as they are intended to recover organisms through direct contact with surfaces and not passive air sampling. Background Report for John W. Kosolcharoen Those from Orange County charged and arrested Tuesday in the pharmacy cases are: John Garbino, 46, of Dana Point, charged with receiving illegal kickbacks after his marketing business referred prescriptions to compounding pharmacies who then paid him as much as 65 percent of the reimbursement. We realized that theres a systemic problem.. endobj More recently, practitioners have begun offering treatments manufactured from birth-related products, including discarded placentas, amniotic tissue, umbilical cords and cord blood.