4 0 obj *T0T0 Bf @ The agency says it is giving many in the industry time to become compliant while targeting riskier treatments, such as injections into the eye and spinal cord, for enforcement. <>>>/Type/XObject/Subtype/Form/BBox[0 0 612 792]/Matrix[1 0 0 1 0 0]/FormType 1>>stream This case was filed in Orange County Superior Courts, Central Justice Center located in Orange, California. To launch the company, he brought on Alan Gaveck, 59, a podiatrist who serves as Liveyons top medical expert. They learned that a few others were also from Brazoria County and had read about stem cells in Conversations With Gin. Theyd come seeking relief from neck pain, back pain, and arthritis. Specifically, the umbilical cord blood products fail to meet the 21 CFR 1271.10(a)(2) criterion that the HCT/Ps be intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturers objective intent.2 As noted above, the umbilical cord blood products are intended to treat a variety of orthopedic conditions. And for almost a year, he says, he had no problems. Gaveck, meanwhile, no longer holds a medical license. Why is this public record being published online? b. And Martin addressed Liveyons product recall. And since there are no requirements that the provider use special techniques and lab equipment, as there are for cells taken from bone marrow or fat, its easy to turn these particular stem cells into a lucrative line of business. Yet he plays serious hoops in a competitive League. Failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)]. Starting around 2014, the market exploded, Turner says. DEMURRER TO COMPLAINT SCHEDULED FOR 09/14/2012 AT 02:00:00 PM IN C12 AT CENTRAL JUSTICE CENTER. The trail led them to Liveyon. By the nature of their routes of administration, your products purport to be sterile and are expected to be sterile. 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. Mark Holzer, 49, of Huntington Beach, charged earlier this month with making a fraudulent claim that he was disabled and unable to perform his job at the U.S. Orange County Superior Courts | Contract | In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). For 58 days, Lunceford remained hospitalized, wracked by intense pain. 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 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. John K, as hes referred to in the podcast, was more than happy to talk to her because he did not see himself as the villain, which made the story more complicated. They keep denying there was anything wrong with the stem cells., In all, at least seven patients in Texas in the summer of 2018 suffered bacterial infections from stem cell injections. Your firm did not implement corrective or preventive actions. E-FILING TRANSACTION 2802650 RECEIVED ON 06/06/2019 01:57:33 PM. Im like, First customer? 11 0 obj It copied Liveyons Kosolcharoen on the letter. To launch the company, he brought on Alan Gaveck, 59, a podiatrist who serves as Liveyon's top medical expert. 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. 2017-09-01, Los Angeles County Superior Courts | Property | I obtained an internal training call for its sales force, in which representatives are instructed to remind doctors that the vial can be used for more than one injection on the same patient$5,000 for one knee, with a discount price of $2,500 for the second kneeincreasing the doctors markup to $5,700 for a couple of quick procedures. You may opt-out by. You identified the contaminating organism(s) for your sterility failures but destroyed these batches without initiating/conducting an investigation using FORM-LL-037, entitled Positive Sterility or EM Failure-Root Cause Analysis. During this time, (b)(4) lots were manufactured, totaling (b)(4) final product vials. 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. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. We recommend that you review the violations listed above, consider the potential serious risks to patients your manufacturing violations present, and consult with third-party experts to implement comprehensive corrective action. Before sharing sensitive information, make sure you're on a federal government site. Providers figured out how to operate just inside the margins or simply ignored the regulations. A nurse practitioner from a clinic that Pierce was partnering with at the time told the audience about a stroke patient whose symptoms had improved after she gave him stem cells mixed with mannitol, a substance to help them cross into his brain. Everyone in the room listened to her story. Texass Biggest Coastal Wildlife Rescue Center Is Now Open in Corpus Christi, West Texans Are Learning What It Means to Live in Bear Country, A Texas Professor Has Cured Hiccups, Folks, One of Texass Coolest Caves Lies Beneath an Upscale San Antonio Neighborhood, Its Okay to Fear the Robot Dogs Coming to UT. After a series of tests and scans, doctors discovered the source of the problem: all were suffering from life-threatening bacterial infections. That firm had previously received an FDA warning letter and has since ceased operations after a series of lawsuits. REQUEST FOR JUDICIAL NOTICE FILED BY WELLS FARGO BANK, N.A. xY[s~W]R&fOR ? Just before a critical deadline, Representative Drew Springer, a Republican from Muenster, gave a tearful speech, saying that he hoped that stem cells would one day help his wife, who has a spinal cord injury. A stem cell treatment returned his mother to good health. The clinic, Texas Regional Health and Wellness, later bought ads in the Brazosport Facts that highlighted Crawfords mention of the clinic in her column. There were roughly thirty seats, and all were filled. Her new podcast Bad Batch, from Wondery, is an extended investigation of the Texas infection outbreak and the pitfalls of the stem cell industry. In a test of nine products none of them from Liveyon Fortier found that none contained stem cells, or a single live cell of any kind. According to one study, stem cell treatments now constitute a $2billion global industry. The websites and phone numbers for the companies no longer work, and top executives did not respond to multiple emails or repeated calls and texts to their cellphones. Please be advised that to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. They still are. After obtaining 10 unopened vials of Liveyon treatments from clinics in Texas and Florida where patients had fallen ill, the CDC report said, investigators found bacteria in eight of them. The next year, that figure more than doubled, to roughly $15million. While the FDA passively allowed stem cell businesses to operate, the Texas Legislature actively sought to further promote them. <>>>/StructParents 2/Contents 14 0 R/Parent 5 0 R>> Information and records gathered at the time of and after the inspection, including product labeling and information on the Liveyon LLC website, https://liveyon.com, reflect that your products are intended to treat a variety of orthopedic conditions. There was a man talking to this woman that was sitting next to him, and he started talking about having stem cells done in his knee, she says. In 2017, members of the Texas Legislature decided to tailor the right-to-try concept to stem cells. Kosolcharoen was not charged with any crime but was described in the SECs complaint as having parroted the false claims of the company to potential investors, and as a result, he was permanently barred from selling securities. On a Wednesday afternoon in September 2018, Dilley and her mother arrived at the Houston clinic and, while in the waiting room, chatted with the other patients. Yet even as scientists touted the medical potential of stem cells, antiabortion groups opposed the use of embryos, and in 2001 President George W. Bush banned federal funding for the creation of new cell linesthose not already in laboratories for research. It referenced two names she didnt immediately recognize. I asked him if anybody else has gotten sick off the stem cells. Everyone else in the waiting room, she recalls, started to discuss all the wonderful things they had heard about stem cells. Dorothy OConnell, now ninety, still lives by herself. 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. Unfortunately, theres evidence that 90 percent of drugs that go into clinical trials dont work and the general public is often misled by slick advertising that often uses exaggerated or misleading claims. Before Liveyon, both men experienced professional setbacks, according to court documents and other records. I keep questioning Liveyon. The manufacturer of the products for Liveyon, a company named Genetech (not the much larger and better-known Genentech), was hit with a November 28, 2018 FDA Warning Letter (cc to Liveyon) for having neither an investigational new drug application (IND) nor an approved biologics license application (BLA). This product contains cells, stem cells and growth factors which may serve as a therapy for various degenerative. Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. Neither did the other patients Dilley met in the waiting room that day, among them Galen Dinning, a Dow Chemical retiree from Lake Jackson, and Deborah Williamson, also retired, a former teacher who was spending her life savings on the treatments. The CDC report revealed a specific risk: bacterial infection. As soon as I saw Liveyon, Im like, Oh, crap, Hardy says. 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. So Dilley made an appointment for OConnell at the clinic, where a chiropractor recommended stem cell injections, at a cost of about $17,000. 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. MINUTES FINALIZED FOR EX PARTE 08/02/2019 08:30:00 AM. And two people died shortly after being injected with stem cell treatments in Florida, most recently in 2012. By the next day, Friday, even the slightest touch made her cry out in pain. Such materials have a long history in commercial marketing, said Jeanne Loring, a neurobiologist and stem cell researcher at California-based Scripps Research. c. Step 3.4 states that investigations shall be initiated on the day information is received by QA. However, complaint investigations were not initiated on the day of receipt by QA. 2019-08-23. Other officials are also cracking down. The root cause and source of the contaminating organisms was not identified. Many clinics use patients own tissue belly fat, blood or bone marrow to fashion treatments. This UT Scientist Helped Spare Millions From COVID-19. That customer was Liveyon. Your response also does not address your continued failure to have an IND in effect to study your products, nor your lack of an approved BLA to lawfully market your products. Dorothy OConnell and her daughter Elaine Dilley at OConnells Brazoria County home on October 26, 2019. x+r Like many other researchers, he believes in the potential of stem cells. 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. Kosolcharoen said he started Liveyon in 2016, after years of working as an entrepreneur in the insurance, real estate and telemedicine industries. Listen to author Laura Beils hit Wondery podcast. The future for Liveyon, Kosolcharoen said, is the brightest its ever been,. In ads and on its website, Liveyon says its product is as miraculous as the birth of a child itself and stimulates regenerative healing.. Its quite common for people to come back from those clinics to do these testimonials. Because the providers arent being tracked as they would be in a clinical trial, theres no data demonstrating actual results, but many people likely still succumb to their diseases, he says, and you dont hear about it on the company websites.. Inside the Bro-tastic Party Mansions Upending a Historic Austin Community, The Campaign to Sabotage Texass Public Schools. What do you say to the argument that we know it works? I asked. Were just the tip of the iceberg, and were the cleanest in the iceberg, Kosolcharoen said. Meanwhile, doctors have found evidence of harm: Several people have gone blind after receiving stem cell treatments, according to reports in the New England Journal of Medicine and elsewhere. Among its first customers was Rick Perry, then the governor of Texas, who received stem cell injections in conjunction with spine surgery. ADDITIONAL LINKS Post Question For This Company Contact Us Regarding Your Company Profile Search All California Companies This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. Everything was glowing, glowing, Herzog said. After years of minimal regulation of the stem cell industry, the FDA issued guidelines in 2017 making clear that many products are unapproved drugs being marketed illegally. 2. 355(i); 42 U.S.C. 262(a)(3); and 21 CFR Part 312]. Almost all of these are the subject of intense research, he said, but the evidence is still inconclusive. John W. Kosolcharoen, or John Kosolcharoen, has been involved in companies like: Liveyon LLC&#x20AC; Finanstra&#x20AC; Premier Funding USA (PFUSA) John is currently the Chief . The Brazoria County patients who received the contaminated stem cells live in the shadow of what happened to them. NOTICE OF CONTINUANCE (CMC) FILED BY HSBC BANK USA, NATIONAL ASSOCIATION, AS TRUSTEE FOR WELLS FARGO HOME EWUITY TRUST 2004-2; WELLS FARGO BANK, N.A. d. Liveyon Labs used a non-sterile (b)(4) and the associated non-sterile (b)(4) to manufacture approximately (b)(4) batches of your products between January 16, 2019 and May 20, 2019, raising the potential for microbiological contamination. Neither Genetech nor Exeligen could be reached for comment. Her mother had a few injections into her shoulders, then was told that she should also have shots into her back, which would be administered by an affiliate, a pain-management specialist shed never met in an office shed never seen, in west Houston. 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. Herzog said he injected himself in May after some of his patients asked for cord-blood injections. Miraculous stem cell therapy has sickened people in five states, Roger Goodell, Muriel Bowser discussed future of RFK site in December call, Everything you need to know about the National Cherry Blossom Festival, Kyle Kuzma, Wizards start fast and dont look back in win over Raptors, violate Food and Drug Administration rules. Did we not have a clean environment? He was not new to the art of medical salesmanship. Lunceford said his wife rushed him to a hospital, where doctors found E. coli and a second type of bacteria in his blood. John Kosolcharoen 's Email Chief Executive Officer at Liveyon LLC Contact Details Phone +1******44 Get Phone Number Email jo*******@liveyon.com Get Email Address Department Finance & Administration Location Irvine, California, United States Liveyon LLC Company Information Website http://www.liveyon.com Head Count 100 - 250 While cells taken from the patients bone marrow or fat must be extracted in a doctors office, products made from donated umbilical cord blood or other birth products, which are sold in ready-to-use form by private companies, are easily administered via a quick injection. Stem cells were billed as would-be replacement parts, biological shape-shifters that might be transplanted and grow into whatever the body needed. Malpractice attorney Hartley Hampton, of Houston, says they had no way of knowing otherwise. Until recently, Liveyon also did not engage directly in manufacturing. The procedure, which takes less than ten minutes, often costs a patient $5,000 or more. Now Hes Unmasking Other Killer Viruses. Call 844-548-3966 for more information to join the frontline in helping rejuvenate damaged tissue for injury & pain patients. 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 12/26/2012, COMPLAINT FILED BY KOSOLCHAROEN, JOHN W; KOSOLCHAROEN, ROYA ON 07/02/2012. Liveyon LLC filed as a Domestic Limited-Liability Company in the State of Nevada on Friday, June 10, 2016 and is approximately seven years old, according to public records filed with Nevada Secretary of State. SILVER SPRING, Md., Dec. 6, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration has warned Liveyon Labs Inc. Lacking insurance at the time, he decided to try stem cells as a cheaper alternative to surgery. No corrective actions were implemented, and four impacted in-process batches were subsequently distributed. This article was published more than4 years ago. He found the existing studies to be of poor quality, lacking a true control. Hardy holds a patent on a method to extract stem cells from a placenta, and he thought a startup like Genetech could help him commercialize his idea. 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. John Kosolcharoen works as a Chief Executive Officer at Liveyon Pure, which is a Business Services company. (b)(4) used in association with the (b)(4) to remove the red blood cells from the umbilical cord blood. Her kidneys were shutting down, and they were worried she was going to have a heart attack, Dilley said. By mid-December, the CDC had found 12 patients, its report said: seven in Texas, four in Florida and one in Arizona. Nor did you commit to providing any follow-up response(s) to address any corrective actions once implemented. According to a complaint by the U.S. Attorneys Office, Kosolcharoen was encouraging service members to seek prescriptions, receiving commissions from the compounding pharmacy that made the cream, and recruiting others to find him more patients. Background Report for John W. Kosolcharoen The companies were formed over a four year period with the most recent being incorporated four years ago in September of 2018. ii. Williamson had pain in her back. Then, in 2016, Kosolcharoen was arrested in a federal crackdown on health-care fraud. iii. Liveyon officials said executives at Exeligen set up a third company in San Diego, called Genetech, to produce Liveyons vials. It has also gone to court to try to stop procedures at two clinics. In recent years, though, her mothers pain had come to preoccupy her. All but two of the illnesses have been linked to a single company: Liveyon of Yorba Linda, Calif. Program Division Director 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. 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. So far, he said, the clinic has injected hundreds of patients, including people with spinal cord injuries, people with Parkinsons disease and many children with autism. Nonetheless, an information packet from one Liveyon-associated clinic includes a dosing chart with recommended numbers of cells for knee injections, erectile dysfunction, autism, neuropathy, and a host of other conditions. COURT ORDERS THE ENTIRE ACTION DISMISSED WITHOUT PREJUDICE. 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. People who are desperate and have an incurable disease, they have a capacity to suspend disbelief, says Sean Morrison, a stem cell researcher at the University of Texas Southwestern Medical Center, in Dallas, and the former president of the International Society for Stem Cell Research. PAYMENT RECEIVED BY FOR 195 - ANSWER OR OTHER 1ST PAPER, 195 - ANSWER OR OTHER 1ST PAPER, 210 - COURT REPORTING SERVICES IN CIVIL PROCEEDINGS LASTING UNDER 1 HOUR IN THE AMOUNT OF 900.00, TRANSACTION NUMBER 11203758 AND RECEIPT NUMBER 11027650. It doesnt take a scientist to know which one may be more effective, Martin said. 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. After decades of research, scientists are still optimistic that cellular therapy might one day treat a host of diseases. That changed the weekend of September 14, 2018, when he began getting frantic calls notifying him that three of his patients were in intensive care. b. Liveyon Labs processed cord blood units from two different donors (b)(4). d. Liveyon Labs failed to accurately record the number of colony-forming units (CFUs) for each positive settling plate: i. Patricia Sharpe writes a regular restaurant column, Pats Pick, for Texas Monthly. Other people criticize them when something makes it to the market and hurts some people in a way that wasnt anticipated.. Public Records Policy. (According to Crawford, she never gave permission to use her name in the ads.). . NOTICE OF RULING FILED BY WELLS FARGO BANK, N.A. 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. Texas has become a wild, wild West, says David Bales, of Texans for Cures. Seven months after his July injections, Lunceford, the patient from Athens, Tex., said he still experiences persistent stabbing pains and has been unable to return to work. 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. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. For those who still want to try stem cells please do your research first.. How Florence ButtNot Her SonLaunched the H-E-B Empire, Jimmy Carters Peanut-and-Egg Taco Made Quite the Impression on San Antonians, The Top 50 Texas BBQ Joints: 2021 Edition. Such products are not approved by federal regulators or supported by clinical research, but businesses selling them say they provide relief to many patients. Rose Cahalan is an associate editor who focuses primarily on stories about travel and the outdoors. Not intended for diagnostic or therapeutic procedures.. Stem cells can divide and renew themselves over long periods, and some can grow into any kind of cell in the body. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an IND in effect as specified by FDA regulations [21 U.S.C. All other uses remain unproven. Failure to screen a donor of cells or tissues by reviewing the donors relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. It didnt look like my mother, Dilley says. A free inside look at company reviews and salaries posted anonymously by employees. JOHN W KOSOLCHAROEN VS. WELLS FARGO BANK, N.A. The biggest sellers are treatments for orthopedic conditions, due in large part to the prevalence of knee osteoarthritis among older Americans. Complaint closure is also performed by the CCO of Liveyon LLC/Liveyon Labs instead of Liveyon Labs QA. 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. Dilley has spent her whole life on the Gulf Coast, always in her mothers orbit. The most recent email I sent to Kosolcharoen some months back did not receive a reply. 9 0 obj All complaints are forwarded directly to the Chief Compliance Officer (CCO) of Liveyon LLC/Liveyon Labs for logging into the Liveyon LLC complaint system prior to routing to Liveyon Labs QA for logging into the Liveyon Labs complaint system, which initiates the investigation. Salaries, reviews, and more - all posted by employees working at Liveyon. The FDA is between a rock and a hard place, says Morrison. Most of the injections are administered in his office by his nurse practitioner, he says, but for shots into the spinal column, he has partnered with the pain specialist that Dilley and her mother saw in Houston. Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)]. His arraignment was set for July 18. Source California Secretary of State, https://bizfileonline.sos.ca.gov/sear., 30 Apr 2021. And beyond all the science and the explanations, theres the story of the man behind it all. Cancellation and Refund Policy, Privacy Policy, and Yorba Linda, CA 92887 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 did more research into what I was just told and didnt find the answers that I liked, he says. If you do not agree with these terms, then do not use our website and/or services. He returned home to Orange County on crutches. But theres nothing inherently magical about placental tissue or the amniotic sac.. Internal company records obtained by The Post show that Liveyon received reports of patients falling ill and testing positive for E. coli as early as June 5, 2018 nearly four months before the recall. She had flown to Arizona with her daughter so that both could have stem cell injections, intended to relieve her leg pain and help her daughters aching knee. 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. Awed by stem cells apparent effectiveness, he decided to get into the business. After Gin Crawford mentioned his clinic in her column and he bought the ad in the Brazosport Facts, more patients began driving up from Brazoria County. Network Visualizer. A Federal Judge in Amarillo Could Effectively Ban the Abortion Pill. You should take prompt action to correct these violations. endobj Such lawsuits, he said, are a common occurrence for anyone who has been in medicine long enough.. Im real slow, she says. Fire Ants Have Unleashed Chaos in Texas for Decades. <>>>/StructParents 1/Contents 11 0 R/Parent 5 0 R>> The race is on to track down what went wrong with several patients in Texas before more people get hurt. We realized that theres a systemic problem.. AMENDED COMPLAINT DISPOSED WITH DISPOSITION OF COURT-ORDERED DISMISSAL. FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. 5 0 obj x+r <>>>/Type/XObject/Subtype/Form/BBox[0 0 612 792]/Matrix[1 0 0 1 0 0]/FormType 1>>stream Cases involving other agreements or torts not classified elsewhere, 190, 1190, 2190, 3190, 4190, 4194, 5190, 5196. John Kosolcharoen, 44, of Santa Ana, charged with paying $100,000 in kickbacks for his work with Irvine Wellness Pharmacy, which received more than $11 million in 2015 from TRICARE. 2021-12-17, Pinellas County Courts | Personal Injury | Peter Marks, the head of the FDAs Center for Biologics Evaluation and Research, recently told an audience of health journalists that the agency is playing a game of Whac-A-Mole and focusing on the most dangerous actors in the stem cell industry. If these products have any effect on patients, Fortier said, its not through live cells or growth factors.. He said federal officials charged him because he wasnt directly employed by the pharmacy and therefore was receiving payment for his work under an improper tax status.