Latest news with #Steadman
Yahoo
15-05-2025
- Business
- Yahoo
Stewartville pig-to-human transplant facility to be complete in 2026
May 14—STEWARTVILLE, Minn. — A very different kind of "hog farm" is being built by United Therapeutics Corp. on the edge of Stewartville to raise gene-edited pigs in a $110 million pathogen-free facility to harvest kidneys and hearts for transplantation into humans. Maryland-based United Therapeutics, a $14 billion pharmaceutical and biotech firm, paid $4.5 million to buy 32 acres in the Schumann Business Park in August 2024. Construction of the new 65,000-square-foot complex is moving quickly. United Therapeutics has two types of pigs that have been altered at the genetic-level to make their hearts and kidneys less likely to be rejected when transplanted into a human. UT's Head of Investor & Media Relations Dewey Steadman recently visited the site to "make sure that our neighbors know what we're doing." He explained that the plan is to complete the construction and introduce the first pigs in 2026. Once the first pigs are born inside the facility, the site will be commissioned in 2027 and start producing up to 125 organs — kidneys and hearts — for human transplantation. The Stewartville project is moving forward just as many aspects of UT's pig-to-human transplant efforts are gaining traction. It conducted the first successful pig-to-human heart transplant in 2022 and the first pig-to-human kidney transplant in 2024. In February, the U.S. Food and Drug Administration approved a clinical trial of United Therapeutics' "UKidney," which is derived from a 10 gene-edited source pig. The first transplant in this trial is expected to be performed around mid-2025. The 10 gene-edited animals at the Stewartville facility will produce "UKidneys" and "UHearts" and pigs with one gene-edit will be the source of "UThymoKidneys." This is the first human clinical trial of a xeno-organ, though UT has applied for more trials for other of their organs. Steadman said while the research is progressing, it will take some time for xenotransplantation to be a common practice. "We hope to have this approved by the FDA by the end of the decade," he said. UT believes the need for more organs is only going to grow as the demand for organs outstrips the supply. More than 557,000 patients in the U.S. are on dialysis, according to the American Kidney Fund. United Therapeutics estimates that approximately 500,000 dialysis patients in the U.S. will not qualify for the kidney transplant list or may not be prioritized high enough on the waiting list to receive a transplant. The Stewartville facility will need about 20 employees at a base wage of $75,000 a year. The animals producing United Therapeutics' three types of gene-edited organs will live their entire lives in the sterile environment. Dewey said the facility has the capacity to house up to 200 of the special pigs. The Stewartville complex will be a twin of UT's pathogen-free facility in Christianburg, Virginia, which opened in March 2024. Steadman explained why UT chose to build in Stewartville. "Stewartville checked a number of boxes for us. The town of Stewartville has been extremely cooperative and excited about working with us," he said. "... The proximity of Mayo Clinic, I-90 and the (Rochester International) Airport were all factors." Organs for transplanting have an ideal window of 10 to 12 hours, so access to transportation is crucial. The unique combination of a skilled medical and agricultural workforce also made Stewartville attractive. While swine are at the heart of this project, Steadman added that people in the area should not be concerned that the UT facility will smell like a traditional pig farm. "The air that goes into the pigs will be filtered and the air that comes out will be completely filtered, too. You won't know that pigs are in the facility," he said. "This is a very high-tech pharmaceutical plant first, and then a pig farm second." While Mayo Clinic is not currently involved with the xenotransplantation operation, UT and Mayo Clinic do work together on human lung transplants in Florida. The company's CEO and founder Dr. Martine Rothblatt is also a member of Mayo Clinic's Board of Trustees. Rothblatt is a medical ethicist, an inventor, an attorney and a pilot. Rothblatt, who co-founded Sirius Satellite Radio, created United Therapeutics in 1996 to find a cure for her daughter's medical condition — pulmonary arterial hypertension.
Yahoo
12-05-2025
- Yahoo
Libel, Feed Contamination, Employee Classification, HIWU, And More: Takeaways From The Equine Law Conference
The University of Kentucky conducted its 39th annual National Conference on Equine Law in Lexington, Ky., April 20 and May 1, featuring a range of topics from employment to liability to HIWU and more. Here are a few takeaways for our (mostly) non-attorney audience: When it comes to HISA cases, settling may be cheaper. Attorney Timothy Steadman presented on preparing defenses against HISA/HIWU cases, and pointed out that because of the fault structure from those organizations, clients often need a reality check. The organizations will typically give a trainer a reduced suspension in exchange for signing an agreement admitting to the charges, but that deal isn't available if the person takes the matter to an independent arbitrator. The cost of hiring an attorney and waiting out a case going through arbitration may not be worth it, because there is an official range of potential levels of 'fault' that may be assigned to the covered person that factor into sanctions. Steadman says he doesn't know of a HISA or HIWU case yet where a trainer has been able to establish zero in situations where a trainer is claiming a drug positive is the result of environmental contamination, they have to show specifically where in the environment the substance was accidentally introduced. Because trainers are legally considered to be responsible for all aspects of a horse's care and environment, even being able to prove the source of contamination may not result in a trainer being considered to have 'no fault.' The arbitrator system used by HISA/HIWU differs from court proceedings in a few key ways for attorneys. HISA/HIWU cases under dispute are decided by an independent arbitrator. (The arbitrator selection is random.) Because this is a private mediation proceeding, that arbitrator does not have the same authority and is not held to the same rules as a judge in a courtroom. There's no formal discovery process ahead of the case. In legal cases, 'discovery' is the portion of a proceeding where each side requests certain types of information and evidence from the other, and routes those requests through a judge. Various people associated with a court case could be subpoenaed to provide information or documents that are requested, and lawyers have the chance to depose potential witnesses in advance of trial. In private arbitration, Steadman told the audience, there is no formal discovery process. Defense attorneys can ask HIWU to produce certain evidence, but the arbitrator decides whether that evidence is relevant and whether HIWU has to turn it over. If a third party has evidence, such as surveillance footage taken by a track that belongs neither to the trainer nor to HIWU, the arbitrator could order the third party to turn that evidence over on the day of the hearing, but doesn't give the attorneys time to review the evidence. Case law is mixed on whether an arbitrator could issue a subpoena to a third party witness, but the general consensus is that they don't have that legal power. Employee or independent contractor? You'd better be sure which category someone falls into. Catherine Salmen Wright said she's frequently asked about this, and incorrectly classifying an employee as an independent contractor can have major legal and financial implications for the employer. Independent contractors are supposed to be professionals who advertise their services and are able to work for more than one client. That means no, you can't subject your independent contractor to a non-compete agreement or require they work for you exclusively. An independent contractor also shouldn't be someone with supervisory responsibilities, because that is considered to limit their ability to work for others if they choose. Independent contractors also aren't permanent employees. All of this matters because employees are subject to overtime pay, and employers have to pay taxes on the wages of their employees. The Department of Labor can penalize employers who are found after the fact not to have done these things because the employer misclassified the person working for them. Why is the Department of Labor here? The DOL has recently shown an interest in racetrack employers, including a number of high-profile trainers in New York who were charged with Wage and Hour violations related to paying backstretch workers overtime and time-keeping. That left a lot of people wondering – what usually prompts a Department of Labor investigation? Most of the time, Salmen Wright said, the DOL audits employers based on an employee complaint – which may not relate to the violations the DOL ends up finding in their audit. (It's not known whether an employee complaint triggered any of the department's investigations of racing employers.) She recalled one case where someone applied for unemployment benefits after losing their job, but because they had been incorrectly classified as an independent contractor by the employer, those benefits weren't available. That triggered a full audit of the employer. Contracts, due diligence, and documentation are key in sales disputes – as are costs. One of the conference panels included a mock sales dispute, based on a fictitious case designed to be a synthesis of common situations equine lawyers are asked to deal with. The case involved the parent of a juvenile rider who wanted to sue the person who sold her a horse several months earlier because the horse had started refusing jumps. The fictitious sale had been for $65,000, and the fictitious plaintiff was seeking compensation for legal fees and other costs associated with trying to rehabilitate the horse from a possible kissing spines issue. The panelists explained that prospective clients in this type of situation are often shocked to learn their legal fees will be higher than the potential recovery amount. Legal fees en route to a lawyer-mediated settlement can also be steep enough they may not be worth also became clear, as teams of lawyers walked through their investigation process for this type of case, how important documentation and due diligence can be. In the example case, the plaintiff didn't have their veterinarian take blood work or back x-rays as a part of pre-purchase vetting, and didn't do research on the horses's show career prior to purchase. The plaintiff, who was established to be a newcomer to horses, also hadn't considered (and likely didn't know) the type of training and riding the horse had in the weeks and months leading up to its development of the behavior problem could be construed as causative. Feed contamination cases can get complicated. Another panel reviewed several feed and hay contamination cases throughout history. In the modern era, it's not uncommon for news to spread quickly when horses die following ingestion of potentially-contaminated feed. Most lay people assume the feed or hay supplier is totally to blame, and that would be the end of it legally wasn't always the situation in the cases profiled by W. Chapman Hopkins and Evelyn Latta. In one case from 1968, two Shetland pony stallions died after the owner mixed oats into a commercial grain mix and fed it to them. The owner sued the producer of the oats. The owner didn't notice the oats were moldy, but horse owners who bought oats from the same supplier around the same time didn't experience any issues. The producer of the oats prevailed in that case. The cases Chapman and Latta presented also demonstrated how important timely and high quality evidence gathering can be. In a 1965 Texas case, a Quarter Horse stallion died after eating feed that had recently been delivered to the farm. Tests later found the grain had been contaminated with arsenic. The stallion, General Champ, had been a sire of some repute and the owner had the chief of police take the feed sample from the farm and maintain its chain of custody. By contrast, the plaintiff in the Shetland pony case took a sample of the oats but waited four weeks to have it tested, raising questions about when the mold may have developed. In the social media age, defamation suits abound. But they're not as straightforward as you may think. Defamation isn't unique to the horse industry, but in the social media age, defamation cases involving professionals in the equine industry have become a hot topic for attorneys. It's important to remember that in the legal sense, defamation isn't just a statement you don't like, according to attorney Kathleen A. Reagan. It has to be provably true or untrue. Statements accusing someone of a crime or of fraud are considered provably true or untrue; posting about your side of an unwitnessed, undocumented he said/she said dispute probably doesn't contain something that's provably true or untrue in absence of other evidence. You have to show that damages have resulted from the statement, and that the person making the statement knew or should have known the statement was false. In the legal definition, slander is verbal and libel is written; for a long time, slander was difficult to prove because a verbal statement might not be witnessed or could be misremembered. In the era of smart phones, it's possible verbal statements can be recorded and transmitted at any more argument for the most common advice from attorneys – be careful what you say, and be even more careful what you put into writing.
