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.

The post Court Documents Show Indicted Veterinarian Fishman Was Subject Of 2011 Complaint Involving A Dead Racehorse appeared first on Horse Racing News | Paulick Report.

Source of original post

Navarro entered his guilty plea to the charge in August and will be sentenced Dec. 17. He may be ordered to serve as much as five years in federal prison.

On Dec. 3, Navarro's defense attorneys filed their pre-sentencing report, accompanied by 100 pages of character references from family, friends, and racing connections. The report indicated that although Navarro legally immigrated to the United States from Panama some 35 years ago, he faces “almost certain deportation to a country where he has almost no familial, social, or economic ties.”

Due to his immigration status, his attorneys say Navarro will likely not be permitted to serve a federal prison term in a minimum-security facility, which means he may be sent to a prison out of state, far from his home and family. At the conclusion of his sentence, he may be transferred into the custody of Immigration and Customs Enforcement and sent to one of their prisons ahead of deportation.

“Jorge recognizes that his conduct in this case calls into question his care for his horses, but those that know him as a horseman and trainer recognize his genuine love and devotion to his horses,” read the defense report. “At this juncture, having been absent from horse racing for almost two years, Jorge realizes the errors of his ways and is contrite, remorseful, and wishes he could roll back the hands of time.”

A number of former racing connections of Navarro wrote character references on his behalf, including former employees, owners, horse transporters, jockeys, and feed suppliers. Supportive former owners include Ron Hendrickson, Joseph Casciato, Jason Provenzano, Frank Rupolo, Dennis Amaty, and others. Jockeys Jose Ferrer, Isaac Castillo and Manny Jiminez, as well as former jockey Rene Douglas also wrote on behalf of Navarro. 

For several letter writers, Navarro's relationship with X Y Jet seemed to stand out.

“Because of his delicate knee conditions, the horse stayed in Ocala for a few months of the year every year to rest and rehab,” wrote veterinarian Dr. Joel Lugo of Ocala Equine Hospital, who noted the horse had two knee operations in 2015 and 2017. “We never discussed the use of any illegal or unethical treatment with him or with any of the other horses. The horse return [sic] to race when we though [sic] the horse was healthy and ready. There was never any pressure from Navarro or the owners. We even discussed his retirement on multiple occasions.”

“That horse loved Jorge; I mean I never seen anything like it,” wrote Navarro's mother-in-law, Cindy Harries. “That horse was mean with everyone and not easy to deal with. That horse was such a diva. Jorge would just stand there and X Y Jet would pin his ears flat against his head and come at Jorge who never twitched, and he would just stop and let Jorge pet him and kiss him on the nose. When X Y Jet died walking in the shed row after a routine gallop, a part of Jorge died too.”

X Y Jet was among the horses specifically named in the federal indictment as having been doped by Navarro, who admitted he gave the horse a blood builder before an allowance optional claiming race on Feb. 13, 2019, at Gulfstream Park and the Group 1 Dubai Golden Shaheen.

The prosecution's sentencing report is due to the court Dec. 10.

The post Navarro Attorney: Former Trainer Facing ‘Almost Certain Deportation’ appeared first on Horse Racing News | Paulick Report.

Source of original post

Fishman, 63, said he is of no relation to veterinarian Dr. Seth Fishman, who is also under indictment and with whom he had a working relationship. Jordan Fishman said he has a PhD in carcinogenesis and toxicology.

According to his testimony on Oct. 6, Fishman said from 2017 to March 2020 he formulated misbranded and adulterated drugs per Seth Fishman's instructions. Seth Fishman provided the materials and the instructions, he said, and Jordan Fishman followed the instructions to compound what he said were vitamins, amino acids, nutraceuticals, steroids and anti-inflammatory drugs. Jordan Fishman admitted he shipped the finished products to Seth Fishman's base in Florida and sometimes overseas, although he did not specify where. (Seth Fishman is known to have business contacts in the United Arab Emirates, according to documents filed in court.) These products, he said, were sent to Seth Fishman in unlabeled containers as he said Seth preferred to handle the labelling himself.

Jordan Fishman said the products were distributed by Seth Fishman through his company called Equestology. He said he did not know initially that the products he made were specifically destined for Thoroughbred racehorses, although he did know that Seth Fishman's business involved racehorses.

Prosecutors revealed that had the case gone to trial, they would have presented wiretap evidence from Seth Fishman's phone, evidence from a Dropbox account used to store documents related to Equestology, as well as emails exchanged between the two men which acknowledged investigative interest in their activities from the Food and Drug Administration.

Jordan Fishman was based in Massachusetts, where he was president and majority shareholder in Twenty First Century Biochemicals. The company specialized in the production of customized “peptides and amino acids” according to documents filed in a civil suit by Seth Fishman against Jordan Fishman and Twenty First Century Biochemicals. In that suit, which was filed two months after the federal indictments, Seth Fishman accused Jordan Fishman of falsely inflating the value of stock in Twenty First Century, and of failing to repay loans or complete pre-paid work. That suit, filed in U.S. District Court for the Southern District of Florida, indicated that Seth Fishman had paid at least $1.25 million to Jordan Fishman's company since the start of their partnership in 2011. That case settled out of court in January 2021.

Jordan Fishman will face sentencing in February 2022. Per statute, the maximum prison sentence he may face is three years with up to one year of supervised release. Financial penalties by statute could include a fine of $10,000, twice the financial gain to Fishman or twice the cost to victims, whichever amount is greatest. Attorneys indicated that they have an agreement in place with Fishman that they will seek no more than 12 to 18 months in federal prison and a fine between $5,500 and $55,000, although that agreement does not bind the judge to confine her sentencing to those terms.

The post Jordan Fishman Enters Guilty Plea To Drug Adulteration And Misbranding In Federal Case appeared first on Horse Racing News | Paulick Report.

Source of original post

The defendants who remain in the active case (excluding those who have changed their pleas to guilty or those left off the superseding indictment in November 2020) have been divided into four groups delineating which will be tried together.

According to a document filed June 11, the groups are–

Group 1: Seth Fishman, Lisa Giannelli, Jordan Fishman
Group 2: Christopher Oakes, Marcos Zulueta, Rick Dane Jr.
Group 3: Dr. Erica Garcia, Michael Tannuzzo, Dr. Rebecca Linke
Group 4: Jason Servis, Dr. Alexander Chan

The case has been dogged with delays due in large part to the amount of evidence provided from federal investigators to the defendants, which now exceeds many terabytes and thousands of pages of information.

U.S. District Judge Mary Kay Vyskocil heard arguments from defense counsel regarding the projected date for the first trial. Originally, she had expressed a desire to conduct the first trial sometime in late 2021, but attorneys for Group 1 had conflicts with other trials being held in December. She suggested a gap had opened up in her calendar for Nov. 3 of this year, but defense attorneys balked at the fast-approaching date, leading to some testy exchanges with Vyskocil. At one point, an unidentified man using the telephonic conference option to attend the hearing could be heard saying, “I don't like this judge” before being asked to mute his line.

Defense counsel moved that the trial be conducted sometime in January 2022, pointing out that the court had already agreed they would have 60 days prior to trial to review the list of the prosecution's expert witnesses. A Nov. 3 trial date would not allow 60 days to elapse as previously ordered.

Patrick Joyce, attorney for Jordan Fishman, also registered concerns about the amount of time defense would have to review the voluminous evidence.

“As this court is aware, this is an extremely complicated case,” said Joyce. “There are a lot of issues … we're not asking for an adjournment into infinity. We're not saying next July. We're asking for two months.”

Vyskocil dismissed that concern, saying it was “not a valid reason to kick this trial” but the 60-day period of review already outlined was a good reason to delay until January. An exact date will be determined when the federal court releases its calendar.

“I do not control the trial calendar if we're still operating under these COVID-19 protocols, so I am telling you now that this case is going to trial in the first quarter,” she said. “I will request the earliest slot we can be given in the first quarter and we are going to trial. I am not going to listen to, 'Well I have something that's backed up.' … You are all on notice.”

Vyskocil did not rule on the various motions before her to exclude wiretap evidence collected by the FBI during Wednesday's status conference. Although she acknowledged considerable interest in the contents of exhibits traded in those motions, she said she could not make a determination on whether intercepted phone calls, emails, and text messages will be game at trial until the defense has had a chance to submit formal replies regarding the motions. Typically, a motion submitted by defense counsel generates a response from prosecutors, and then defense attorneys have a chance to file a formal response to the prosecution before it's considered that all arguments have been made. Vyskocil said the deadline for defense replies will be later this month, and she will endeavor to make a ruling as soon as all the arguments are in.

Read more about what we learned from new wiretap evidence in the U.S. Attorneys' response here.

A new status conference has been scheduled for Nov. 4 to allow attorneys to check in with the court regarding any remaining issues with discovery evidence.

The post First Trial In Federal Drug Misbranding Case Will Likely Come In January appeared first on Horse Racing News | Paulick Report.

Source of original post

Mangini had worked at various times in partnership with co-defendant Scott Robinson, who earlier this year was sentenced to 18 months in federal prison for drug adulteration and misbranding conspiracy.

In a letter to Judge Oetken, Mangini explains that he worked in human pharmacy at the start of his career, and also owned and trained harness horses on the side. While living in Florida, Mangini kept his horses at the South Florida Training Center in Lake Worth, and took over there as farm manager when the previous manager died. It was there he met Robinson, who was already in the business of selling what he called “horse supplements.” The two worked together under the banner of Horse Gold, then split off when Mangini launched Ergogenic Labs. Mangini supplied custom-made compounded drugs to Robinson and also sold them directly to consumers himself, under the online banners of RacehorseMeds or HorsePreRace.

Mangini depicts himself as a hard-working, hands-on horseman who was primarily interested in creating more affordable versions of recognized therapeutic drugs. His attorneys point to his loss of a young filly to equine protozoal myeloencephalitis (EPM) as the inspiration for his progression from human to equine pharmacy. Nearly a quarter of the sales of Mangini's business were for some form of omeprazole paste, while various forms of pentosan accounted for 13 percent, and EPM medications another 4.6 percent, according to documents from defense counsel.

Still, Mangini's attorneys admit, he did not apply to the Food and Drug Administration to become an authorized commercial manufacturer of these products and made them outside of federal oversight. He also falsified prescriptions to justify the compounding of some of those drugs – including “an omeprazole paste that could be used as an injectable product.”  Mangini said he was offering owners “an easy, low-cost option” to get drugs like omeprazole. The FDA-approved versions cost between $30 and $36 per tube, while Mangini sold it for $9.99. The price difference was apparently attractive to “a broad cross section of animal hospitals, clinics, humane societies, animal rescues, and veterinarians and included entities that treated not just horses, but also dogs, goats, llamas, alpacas, lambs, and livestock.”

“Your honor, I am extremely sorry for breaking the law,” Mangini wrote to Oetken. “My passion in life has been to always help people and animals and hopefully I have explained that to you. I tried to justify my need to earn income based on my financial situation at the time along with using the excuse that I was simply helping horses, trainers, and owners. These laws are made for a reason and there is no excuse to break the law no matter what you believe or tell yourself.”

Mangini's attorneys requested he be given a sentence of six months' home confinement.

“The products he made were safe,” Mangini's attorneys wrote. “They contained the active ingredients that were promised and advertised. And the products he sold are well-recognized as a reliable part of care for animals, including horses.”

But prosecutors say even that omeprazole paste wasn't as benign as Mangini would have the judge believe. In February 2020, an unnamed individual filed a complaint with the Food and Drug Administration about a shipment of they drug they gave to their horse.

“I ordered omeprazole oral paste from www.racehorsemeds.com and instead the syringe containing paste for a 30 days supply actually contained DMSO, which causes birth defects in humans and serious side effects to horses,” the complaint read. “It was mislabeled, placing me and my horse at risk for life threatening injuries. The owner … has been cited before. SHUT HIM DOWN BEFORE HE KILLS SOMEONE!

“I will be filing a civil federal lawsuit, but the FDA should be doing more to protect the public. This guy is not a vet or a legitimate pharmacy.”

The complainant, according to prosecutors, gave her horse the paste and saw it rapidly decline, dropping weight and ultimately requiring hospitalization.

No federal suits were filed against Mangini subsequent to the early 2020 FDA complaint.

HorsePreRace had already received a warning letter in 2014 informing the company it needed to seek approval for the paste as a new animal drug, based on its assertions that the paste worked like approved omeprazole. Further, the FDA stated it had tested the omeprazole paste sold via HorsePreRace and found it contained only 68.1 percent of the omeprazole advertised on the label.

The person who filed the complaint wasn't the only one noticing problems with Mangini's products. As documented in the Robinson case, the two men exchanged frequent texts about customer complaints, including people reporting bugs in boxes of medication and inside injectable products. Robinson told Mangini in 2015 he had received “a bad photo of pentosan” with “shit floating in it” and “mold inside,” to which Mangini advised he ”just replace it,” blaming the quality on the customer.

“Vitamin c is exploding” Robinson informed Mangini in 2014 via text message, referring to a product quality concern.

“That's common on all of them,” Mangini replied.

It remains unclear exactly what Robinson meant.

Robinson also warned Mangini about horses who were “infected and blowing” after getting shots of “poly p” and a mare who became depressed and unable to move after getting her first injection of a pentosan product. Another customer reported two horses that were unable to walk, appearing heavily sedated for 36 hours after getting a pentosan injection, and a third said their horse had experienced a stiff neck, which their treating veterinarian suspected was caused by “some impurity in the branch.”

“Ur not turning ur inventory as fast,” Mangini texted Robinson upon hearing these complaints about pentosan. “So bottles sitting longer which makes them more susceptible – only thing I can think of but these people also to blame too.

“These Momo's [sic] have no clue on injecting.”

It was around this time Ergogenic Lab, where Mangini was making the items being sold online, received a dismal inspection from Florida's Department of Health. The compounding pharmacy had no working sink, so employees who were making sterile injectable solutions were washing their hands in a bucket. The prescription counter and floors were covered in layers of dust and unidentified powder, and one inspector said the floor was so dirty he was able to scrawl the initials 'DOH' on the floor with an alcohol swab. Ingredients, many of which Mangini imported from Wuhan, China, were mislabeled or unlabeled. The state restricted the pharmacy's licenses, and it eventually closed down. But that didn't stop Mangini.

“After receiving this report and agreeing to restrictions on his license, Mangini did not seek to reform,” the prosecutors' report read. “Instead, with little interruption, he transplanted his operations to a new location, transferred certain staff, hired new staff, and continued supplying others with adulterated and misbranded drugs (in many cases, with the exact same adulterated and misbranded drugs he had sold previously.) In other words, Mangini was undeterred.”

It's also worth noting, according to prosecutors, that Mangini's catalogue was not limited to omeprazole or EPM products. His websites also peddled injectable prescription drugs available without prescriptions, as well as proprietary products with names like Blast Off Red, Numb It, Plug It, Purple Pain, Green Speed, White Lightning, and other formulas. Those products did not come with ingredient lists but did come with claims that they “will not test” and included instructions that they should be administered four to six hours before competition – a clear violation of racing regulations in most jurisdictions. Blast Off Red was described to customers as “an extremely potent blood builder injection” while Blast Off Extreme was said to “increase the force of heart muscle contraction, thereby increasing blood flow and oxygen to the muscles in race horses, greyhound, dogs, and camels.”

Further, prosecutors revealed that RaceHorseMeds was also selling its own version of a bisphosphonate. In 2015, Dechra filed a civil lawsuit against the company in U.S. District Court in Kansas claiming patent infringement, trademark infringement, false designation, unfair competition and false advertising. Dechra is one of two companies with FDA approval to make and sell bisphosphonates for use in horses in the United States. Dechra's version, clodronate, is sold under the trade make Osphos. Dechra discovered that RaceHorseMeds was selling OsteoPhos, which was described on its website as having “the same mechanism of action as Osphos.” After Dechra emailed the company warning it of possible patent and trademark infringements, the product's name changed to OzPhoz Explosion and the reference to Osphos was removed from the description.

Ultimately, Dechra dismissed the civil case largely because it could not figure out where RaceHorseMeds was actually located or how to properly serve the principals with documents. Its website claimed RaceHorseMeds was a Panamanian company with operations in the United States and Canada. A return mailing label from one of its products listed a Kearney, Neb., address which turned out to be invaiid.

(This publication launched an investigation to try uncovering the real ownership and location of RaceHorseMeds and HorsePreRace in 2016. The resulting story was attached as an exhibit to the prosecutors' sentencing report.)

In fact, prosecutors say, Mangini and others worked very hard to make sure they were difficult to reach for this kind of correspondence. According to them, Mangini and others hired a 1099 contractor to handle outgoing shipping for them, so any mailed orders would be traced to the contractor and not the websites' owners. They misrepresented the company's location on its website and set up a corporation in the name of a co-conspirator to make it appear as though that person, and not Mangini, was the operator RaceHorseMeds.

Prosecutors are requesting a five-year prison sentence, which is the maximum allowed by law for the charge at hand.

The post ‘Shut Him Down Before He Kills Someone’: Documents Paint Unsettling Picture On Eve Of Pharmacist’s Sentencing appeared first on Horse Racing News | Paulick Report.

Source of original post