Attorneys for the prosecution and defense have been trading motions in federal court over the past few weeks as they work out what evidence will be permitted in the upcoming trial of veterinarian Dr. Seth Fishman and Lisa Giannelli, the first two defendants to be tried in the 2020 drug adulteration and misbranding case that involves more than two dozen trainers, veterinarians and suppliers.. Fishman is charged with two counts of conspiracy to commit drug adulteration and misbranding, and two counts of conspiracy to defraud the United States, while Giannelli is charged with one count of each.
Fishman, who is licensed as a veterinarian, is accused of creating and distributing adulterated or misbranded drugs that were marketed as performance enhancing substances he then sold to others outside the context of a valid prescription. Giannelli is alleged to have acted as a sales associate on Fishman’s behalf.
It’s still unclear when the trial may begin; it is the “back-up” case for a Jan. 19 start date and is also the back-up option for a date in March. Attorneys in the case have been notified they should be ready to proceed in January.
Both the prosecution and defense have filed motions in limine, which refers to motions asking for the judge to rule on limiting or allowing certain pieces of evidence at trial. The documents included a few partial previews of evidence and arguments that may come up at trial:
- Fishman and Giannelli’s drug sales have been the focus of a state investigation before. In early 2011, the Delaware Division of Professional Regulation received a complaint from an unnamed veterinarian who believed a racehorse had died after receiving an injection of a product sold by Giannelli for Fishman. The horse, a Standardbred named Louisville, was owned by Nanticoke Racing Stables, though the trainer and attending veterinarian’s names were not immediately available in court documents. The prosecution’s description of the complaint (which was filed under seal) stated the complaining veterinarian suspected Fishman and Giannelli were selling equine drugs without first examining the horses and diagnosing medical conditions. Attorneys for Fishman and Giannelli point out the horse’s ownership did not permit a necropsy, but that state investigators wondered whether the cause of death was related to the injected substance going incorrectly into an artery, rather than a reflection of some impurity of the drug itself. At the time, Fishman maintained that he did perform examinations of horses to establish valid veterinary relationships with his clients; Giannelli indicated at the time that she acted as a delivery person with little knowledge of what substances Fishman was sending out or why.Defense attorneys also stated the substance was Pentosan Gold, which they said was produced by a company called NatureVet. Counsel for the pair at that time characterized the substance as a “supplement” and prescribed use was “a generally acceptable off-label use in this industry.”
The complaint was ultimately dismissed with no regulatory action taken.
Pentosan is commonly known as a drug used to treat osteoarthritis either through intramuscular or intra-articular administration.
The defense is seeking to preclude evidence of the horse’s death and some of the investigative file, asserting it will unfairly bias the jury.
- The prosecution is seeking to introduce information Fishman gave to investigators ahead of the 2010 prosecution of harness owner David Brooks. In 2013, Brooks was sentenced to 17 years in prison in connection with a fraud and obstruction of justice case surrounding his DHB Industries. Fishman offered evidence to prosecutors in that case related to performance-enhancing products, human growth hormone and other drugs he said he supplied to Brooks for use on Brooks’ horses. At that time, Fishman told authorities Brooks’ horses were not testing positive because the substances were designed to evade tests. The two sides disagree over whether the terms of Fishman’s participation in the Brooks case allow his statements at that time to be used against him in the current case.
- Both sides take issue with each other’s veterinary experts and seek to limit or exclude their testimony. Prosecutors plan to call Dr. Diana Link, veterinary medical officer/Master Reviewer for the FDA Center for Veterinary Medicine, Dr. Jean Bowman, veterinary medical officer in the Division of Surveillance for the FDA Center for Veterinary Medicine, and Dr. Cynthia Cole, director of the Racing Laboratory at the University of Florida. The defense argues that Cole should not be able to opine on whether the products were adulterated or misbranded according to their labeling, and that she should not testify to the “safety and efficacy” of the products. Likewise, the defense wants to introduce Dr. Clara Fenger, longtime expert witness and detractor to new drug regulations, to testify to the “safety and efficacy” of Fishman’s products, as well as the “propriety of using these products for the purpose of maintaining the health and welfare of horses involved in racing.” Prosecutors argue that it’s unclear which, if any, seized substances Fenger has analyzed or how she determined that they were safe and effective for horses and want her precluded from testifying.
- Fishman has admitted to making substances for foreign distribution in addition to his domestic business. One of the details the defense is hoping to preclude from the trial is an allegation from the prosecution that Fishman was solicited by the United Arab Emirates’ Presidential Affairs Department, Sector of Scientific Centers and Presidential Camel Department “to distribute performance enhancing drugs and to create and distribute other illegal drugs.” The defense points out that the documents it has seen so far from the government do not describe illegal or performance-enhancing products.The defense’s in limine motion also makes reference to a person referred to only as “Bengawi” who is supposed to have solicited Fishman for this purpose. Prosecutors also say they have intercepted communication in which Bengawi asks Fishman to create a substance “intended for use in spiking a woman’s unattended drink, i.e., a ‘Viagra for ladies.’”
“The Government alleges that the defendant responded to the request with an offer to make ‘BI-AGRA’ which he described as ‘female Viagra it makes the woman bisexual.’ It is unclear whether the defendant was responding in a humorous vein; or even taking the request seriously. There is no indication that the defendant subsequently shipped a substance for this purpose.”
- Prosecutors allege that Fishman was selling products to “a veterinarian engaged in training horses for Olympic equestrian events. Those sales were, nevertheless, intended to dope those horses using Fishman’s same suite of purportedly untestable, misbranded and adulterated drugs.”The veterinarian is not named, nor is any detail given about which Olympic equestrian sport or team may have been involved.
Also this week, U.S. District Judge Mary Kay Vyskocil heard arguments from prosecutors that Fishman should have his bail revoked after saying they uncovered evidence that Fishman has continued making and distributing illegal substances since his arrest. Fishman’s attorneys argued that the products he was making in Florida were for foreign distribution only, which was not prohibited under federal statutes on drug adulteration and misbranding. Judge Vyskocil did not revoke Fishman’s bail as requested, but did accept an agreement between the two sides to add new restrictions to the terms of bail. Fishman has been ordered to surrender all substances and drugs housed in a storage unit in Boca Raton, Fla., to either the FBI or FDA, not to enter the unit or send any agents or employees to the unit, and to refrain from manufacture or distribution of any drug or substance.
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