First Trial In Federal Drug Misbranding Case To Begin Jan. 19

The first trial in the well-publicized federal drug adulteration and misbranding case that focused on doping in horse racing will begin Jan. 19 in New York. Veterinarian Dr. Seth Fishman and Lisa Giannelli will be the first two defendants from the case announced in March 2020 to go to trial. A number of co-defendants, including high-profile former trainer Jorge Navarro, have entered guilty pleas and been sentenced for their role in making, distributing, or using adulterated or misbranded drugs on racehorses.

The remaining co-defendants have been broken down into three groups that will be tried together. Fishman and Giannelli are the first, while Dr. Rebecca Linke and Rick Dane Jr., are in the second, which could start in March. (Linke has already made a deal to defer prosecution.) No date has been set for the third trial grouping, which includes trainers Jason Servis and MIchael Tannuzzo, as well as Drs. Alexander Chan and Erica Garcia.

Fishman, who was trained as a veterinarian, has been accused of concocting performance-enhancing drug combinations he marketed to clients on the premise they would not test. Intercepted communications between Fishman and others revealed that he claimed he made different drug cocktails for each trainer who bought his products, so that if new drug tests detected one substance, his other clients would still be protected.

Giannelli worked for Fishman, though she disputes her role was more as a courier than a sales representative, as alleged by the prosecution.

A recent release of evidence against Fishman in court documents claims his products were implicated in a 2011 case of a horse who died after receiving an injection. It also raised questions about a connection between Fishman and his products and an official in the United Arab Emirates government connected with camels. Read more about that evidence in this story from Dec. 22, 2021.

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Court Documents Show Indicted Veterinarian Fishman Was Subject Of 2011 Complaint Involving A Dead Racehorse

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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Fishman: Lab Employee Had ‘Little Choice But to Succumb’ to FBI Search

The legal team for Seth Fishman responded to allegations by federal prosecutors that the indicted Florida veterinarian is still selling purportedly performance-enhancing drugs (PEDs) while awaiting trial in the international racehorse doping conspiracy case by telling the court Monday that the government “cannot meet its burden in demonstrating that the defendant's bail should be revoked.”

In a Dec. 13 filing in United States District Court (Southern District of New York), Fishman's attorney, Maurice Sercarz, wrote that the administrative assistant who permitted Federal Bureau of Investigation (FBI) agents to search Fishman's place of business where drug evidence was seized Dec. 1 “had little choice but to succumb to the demand by agents that they be permitted to search the premises.”

That's because, “At the time that her consent to the search was sought and obtained, she had participated in [two previous interviews] in which she revealed her involvement, over a seven-year period, in the manufacture and distribution” of Fishman's products.

“In other words,” the filing continued, “at the time her consent to the search was obtained 1) she was at risk of prosecution for the very offenses with which Dr. Fishman was charged; and, (2) subject to a proffer agreement that allowed ample opportunity to use her statements against her both at trial and at sentencing.”

Fishman is charged with two felony counts related to drug alteration, misbranding, and conspiring to defraud the government. The employee, unnamed in court documents, is not known to be facing any charges. Fishman's trial is tentatively expected to start in mid-January.

On Dec. 6, federal prosecutors asked the judge overseeing the case to consider revoking the bail terms of Fishman's pretrial release.

The basis for that request was that “Employee-1 informed the Government, in substance and in part, that Fishman's business was creating 'energy drinks' for foreign distribution and that Employee-1 remained tasked, by Fishman, with continuing to create a 'bleeder' paste [that] Employee-1 also described as being for foreign distribution,” the Dec. 6 filing stated.

“The drugs found in Fishman's offices continue to be manufactured through the same unregistered, unlicensed business that forms the basis of the charged offense,

and include the drug 'HP Bleeder' previously obtained from multiple searches of premises controlled by Jorge Navarro, Lisa Giannelli, Christopher Oakes, as well as [other defendants],” the Dec. 6 filing stated.

The Dec. 13 reply by the defense alleged that the move by the feds to get Fishman's bail revoked was a ploy to undermine his legal preparation.

“[T]he Government now seeks to have the defendant detained four weeks before his trial is scheduled to begin, when his ongoing contact with defense counsel will be most necessary in order to prepare his defense for trial,” Monday's filing stated.

The defense filing also pointed out that, “Dr. Fishman has never made a secret of his intention, following his arrest, to continue exporting his products while redoubling his efforts to comport with the requirements of the export exemption to the adulteration and misbranding statutes. He expressly advised the Government of this fact as part of his application for a deferred prosecution agreement.”

The Dec. 13 filing also stated that the government's motion “glosses over” the “voluntariness” of Fishman's employee's consent to the Dec. 1 search of the workplace.

“The agents noted that upon arriving at the premises, the Administrative Assistant had to unlock the door to let the agents into the premises,” Fishman's filing stated. “The fact that the door was locked indicates that the premises did not function as an office, open to the public; but rather, as a location devoted to the manufacture and shipment of Dr. Fishman's products.

“The [FBI] report reflects that upon entering the premises, the agents and Administrative Assistant held a conference call with [federal prosecutor] Sarah Mortazavi and [the employee's] attorney to discuss the parameters of the search. No comparable effort was made to contact counsel for the defendant,” the filing stated.

A Dec. 20 hearing on the bail revocation request is the next step in the process.

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Fishman, Feds Spar Over Admissibility of Evidence

Seth Fishman and federal prosecutors are at odds over what types of evidence and expert testimony will be admissible in court when the veterinarian who allegedly made and sold purportedly performance-enhancing drugs (PEDs) goes on trial in early 2022.

In the form of dueling motions filed by each party Dec. 1 in  United States District Court (Southern District of New York), the two sides sparred over whether a jury should hear a wide range of evidence that involves what the government is alleging as Fishman “specifically target[ing] clients in the racehorse industry” by “peddling dozens of new drugs that purported to have performance-enhancing effects on racehorses [in a manner] squarely focused on ensuring that [he and his] customers would not get caught doing so.”

Some of what the prosecution wants admissible dates back at least a decade and involves Fishman being investigated in 2012 in Delaware when a Standardbred died after being injected with one of his prescribed products, plus separate PED-related admissions Fishman made in a different investigation that resulted in the prosecution of then-prominent Standardbred breeder David Brooks, who was convicted in 2013 in a $200 million fraud and obstruction of justice case.

The two sides also took umbrage at each other's choices of veterinary “experts” who have been submitted on witness lists to testify on the safety, efficacy, and clinical pharmacology of the drugs Fishman is alleged to have misbranded, adulterated, and conspired to distribute to other racetrack-based defendants in America and abroad.

Some of the motions made by both sides Wednesday that asked the court to exclude evidence relate to aspects of the case that have already been raised in previous court documents.

But one bizarre new offshoot that Fishman's legal team doesn't want brought up in front of a jury concerns a wiretapped phone conversation in which Fishman is allegedly asked by a camel-racing client in the United Arab Emirates (UAE) if he can also produce a “Viagra for ladies” that could be covertly added to a woman's drink.

The government is asserting that in February 2018, an individual identified only as “Bengawi” who purportedly worked for the UAE's Scientific Centers & Presidential Camel Department “solicited Seth Fishman to distribute PEDs, and to create and distribute [an aphrodisiac that] 'can be added in juice, for example.'”

Prosecutors wrote in a Nov. 17 court filing that, “In the course of these communications, the contact provided Seth Fishman with a video of what appeared to be an individual spiking a woman's unattended drink. In response, Seth Fishman offered to make 'BI-AGRA,' which he described as “Female Viagra so strong it makes the woman bisexual.”

The government's intent in wanting this exchange admissible appears to be rooted in establishing a pattern of what substances Fishman was able or willing to produce for clients.

The defense is objecting to the admissibility of those wiretapped sex-drug communications on the grounds that “the allegation that 'Bengawi' solicited the defendant to 'create and distribute illegal drugs' is a conclusion of law without any basis in fact…. 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 intended for this use.'”

But even if the judge ends up disallowing that portion of evidence, the feds appear to be armed with a solid base of other wiretapped evidence to try and establish “Fishman's overall intent in his drug design–to avoid testability while increasing performance.”

One such intercepted conversation disclosed by the government in Wednesday's filing is a Mar. 31, 2019, call in which Fishman allegedly explains to a foreign potential client what his business strategy is at his Florida firm, Equestology:

“I design programs for people. So, if you're somebody who's got a bunch of endurance horses and you know what you are doing–and that's why I technically only work with trainers that have a certain amount of horses or more, because it would make sense to do it…I mostly work in regenerative peptides, and I work in things that are not commercially available.

“Every now and then people will ask me to make products because they want to go sell them to people who really don't know what's going on. Mostly camel guys that are in the desert. I don't have to tell you how it is, right?…But, I can meet with you [in Dubai]. You can explain to me your needs and wants and I can tell you how there's things that I made for other people that are not exclusive to them.

“If you want your own exclusive stuff, I'll tell you how we go about doing it. The reason I say that certain people want exclusivity is because, obviously, if these horses are being tested and they have something that somebody else has and that person is irresponsible, then it becomes a problem for them,” the government's motion stated.

When the judge does, in fact, rule on the admissibility questions, the crux of the decision might come down to which veterinarians will be allowed to testify and what they will be allowed to say in front of jurors.

The feds are objecting to Fishman's choice of Clara Fenger as a witness to opine on the nature of the pharmaceuticals he sold. She previously worked as a veterinarian with the Kentucky Horse Racing Commission for 15 years and is currently the sole proprietor of a Kentucky-based company called Equine Integrated Medicine.

Fenger's name might be familiar to racetrackers who have followed other drug-related cases. Her curriculum vita states she has provided “expert testimony” in no fewer than 19 international, federal, and state jurisdictions involving criminal, civil and administrative cases.

Recently, Fenger's work has included testifying on behalf of trainer Bob Baffert when his legal team overturned the 2020 lidocaine disqualifications of Charlatan and Gamine in Arkansas. Fenger also was hired by Baffert this past summer to escort the urine sample of GI Kentucky Derby winner Medina Spirit (Protonico) when it was sent to New York for additional betamethasone-related testing.

The prosecution's objection to Fenger is “because none of Dr. Fenger's opinions are admissible…insofar as they are unsupported and not based on facts, data, reliable

principles, or specialized knowledge, and because they concern issues that will serve only to sow confusion and distract the jury.”

In turn, Fishman's legal team is objecting to the three veterinarians the government wants to call as “experts”: Jean Bowman, veterinary medical officer in the Division of Surveillance for the Food and Drug Administration (FDA); Diana Link, a veterinary medical officer at the FDA Center for Veterinary Medicine, and Cynthia Cole, the Director of the Racing Laboratory at the University of Florida who was responsible for the regimen of drug testing at the Florida Department of Pari-Mutuel Wagering.

“First, the Court should preclude testimony suggesting that the purpose of the statutory scheme is to ensure the well-being of the racehorses,” Fishman's counsel wrote in a memorandum accompanying the Dec. 1 motions.

“Second, the Court should preclude evidence regarding the 'safety and efficacy' of those products allegedly manufactured and distributed by Dr. Fishman. The defendant is not charged in the instant Indictment with crimes relating to the manufacture or distribution of substances that are unsafe for use by animals…Opinion evidence regarding the 'safety and efficacy' of Dr. Fishman's products is, therefore, not relevant to the issues at trial.”

Fishman is charged with two felony counts. In a separate court order signed Dec. 2 by the judge in the case, it was noted that his case (along with co-defendant Lisa Giannelli) received the first back-up slot on the court calendar to begin a trial Jan. 19, 2022.

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