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Mangini Sentenced To 18 Months In Federal Prison For Role In Drug Misbranding Case

Former pharmacist Scott Mangini, who helped develop the products sold on RacehorseMeds and HorsePreRace, was sentenced to 18 months in federal prison on Sept. 10. U.S. District Judge J. Paul Oetken also ruled that Mangini would be on supervised release for three years after he completes his prison sentence.

Judge Oetken originally determined that Mangini would surrender himself to begin his sentence in October, but upon request from his attorney to let him spend the holidays with his family, moved his surrender date to January.

Mangini pleaded guilty to one count of conspiracy to unlawfully distribute adulterated and misbranded drugs with the intent to defraud and mislead. His prison sentence is the same as that of Scott Robinson, his co-conspirator who was sentenced in March 2021.

The indictments of Mangini and Robinson were made public at the same time as those against a number of prominent trainers, assistants, and veterinarians in the racing industry, all of whom prosecutors say were involved in the sale, distribution and use of illegal drugs to enhance the performance of racehorses.

Mangini's attorneys had requested a sentence of six months' home confinement, while prosecutors requested the maximum allowable sentence for the offense of 60 months in prison.

“I find the fact of imprisonment is more important than the length of the imprisonment,” said Oetken in rendering his decision. He cited his legal obligations to impose a sentence that would serve as an effective deterrent to others while not being harsher than necessary to do so.

Both men were ordered to forfeit over $8 million, which investigators say is the value of the illegal products that the two sold during the time in question. Attorneys revealed that in 20 months, sales records from RacehorseMeds indicated there were over 27,600 sales made by the company. The government is in possession of some sales records, but those have not been made publicly available.

There was considerable debate between attorneys before the sentencing about the characterization of Mangini's behavior in the pre-sentencing reports which will remain on his record. Mangini's counsel maintained that the majority of sales through his companies were for illegally compounded, “knock-off” versions of therapeutic prescription drugs and while not approved or appropriately prescribed, this made it unfair to call his behavior abusive towards animals. Prosecutors pointed to injectable products formulated by Mangini with names like Blast Off Red and Blast Off Extreme, which were advertised to behave as mimetics for epogen and other performance-enhancing drugs.

Mangini's attorneys said that most of those products did not behave as performance-enhancers and were instead dietary supplements because they did not have the same effects as the products they claimed to mimic. Oetken questioned whether this amounted to fraud on the part of the people marketing the drugs, which seemed problematic also. Ultimately though, he made clear that the nature of the drugs themselves was less important to him than the fact they were misbranded.

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“The performance-enhancing aspect of the case is not really, I think, relevant to sentencing. It may be relevant to press releases and reputations and things like that. You made a good point that it may not be most of what's been sold on these website, but the fact is there were still problems. It was a shoddily-run pharmacy,” said Oetken, describing the problems Mangini's facility had with safety and sterility, as well as his efforts to conceal his association with the websites. “All of that is related to the effort to evade regulation from state and federal authorities and that's what I'm focused on for sentencing.”

An emotional Mangini spoke during the proceedings, begging Oetken not to send him away from his wife and stepson.

“I thought I could help all kinds of horses and owners and trainers,” said Mangini. “I didn't know it was illegal.

“Now that I look back, I destroyed my life and I have no one to blame but myself. I am living with the consequences of my actions. I've ended my career as a pharmacist and I can't work with horses again…Since my arrest, I've tried to be better. I admitted that I violated the FDA rules. I met with the government every time they wanted and truly told them the truth. I admitted I broke the law. I am filled with regret and remorse. I am sorry.”

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‘Shut Him Down Before He Kills Someone’: Documents Paint Unsettling Picture On Eve Of Pharmacist’s Sentencing

As U.S. District Judge J. Paul Oetken prepares to sentence former pharmacist Scott Mangini on Sept. 10 as part of the federal anti-doping probe that yielded more than two dozen arrests in March 2020, documents filed by prosecutors depict an operation churning out dangerous products while ignoring and avoiding regulators' attempts to shut it down.

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.

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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.

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New Indictment, Court Documents Reveal More About Drug Makers In Federal Case

Two more people have been indicted as part of an ongoing federal case focusing on adulterated and misbranded performance-enhancing drugs in horse racing. On March 11, a new superseding indictment was filed in the United States District Court for the Southern District of New York in the case of former pharmacist Scott Mangini, who has since entered a guilty plea to a charge of conspiring to unlawfully distribute adulterated and misbranded drugs with the intent to defraud and mislead. The new indictment also names Carl Garofalo Sr. and veterinarian Dr. Michael Posner.

This is the third version of an indictment for Mangini, who was originally indicted alongside associate Scott Robinson in March 2020 and then was named in a superseding indictment that dropped Robinson. Robinson pleaded guilty to one count of drug adulteration and misbranding conspiracy in September 2020 and was sentenced in March 2021 to 18 months in prison.

According to the indictment, Mangini collaborated with others, including Robinson and Garofalo, to operate a series of online marketplaces which advertised substances designed to enhance performance or serve as copies of prescription drugs. Court documents filed in Mangini's case before his guilty plea detail the tangle of businesses Mangini and his associates created in an attempt to make it harder for consumers and regulators to work out who was behind their various storefronts.

Mangini apparently kept busy with multiple businesses operating on overlapping timeframes. As reported by the Paulick Report in 2016, Mangini was the pharmacist at Ergogenic Labs in Wellington, Fla., before the facility closed following a particularly negative inspection by state health department regulators. Mangini surrendered his license after that state inspection, which highlighted unsanitary facilities and mislabeled product ingredients. According to prosecutors, some of the products Mangini made at Ergogenic were sold to Robinson, who distributed them to the public via HorsePreRace.

During the same time he was working at Erogenic, Mangini, Robinson, and others were also making illegally-compounded ulcer medication under the banner of Horse Gold. Mangini, HorseGold, and HorsePreRace were all recipients of FDA warning letters in 2014 regarding ulcer products called GastroMax3 and Gastrotec which the agency said were illegally compounded. A series of knock-off omeprazole products on the market at the time had remarkably similar logos of a running horse outline with a starburst behind or near the horse.

One document from prosecutors acknowledged the same group was behind various iterations of the ulcer medication and were trying to walk a line between maintaining branding and escaping the notice of state authorities.

In November 2015, Robinson allegedly wrote to someone: “Don't use that artwork for gastromax 3 that my guy sent u – u get us all ****ed – too close-why wouldn't u use original artwork I'm serious-I don't need board of pharmacy seeing that and linking to me.”

According to a press release from Horse Gold in 2011, its ulcer products were carried in racing tack shops around the country and were also donated to aftercare charities.

After Ergogenic shuttered in 2016, prosecutors say Mangini and Robinson stopped working together and Mangini and Garofalo incorporated Pegasis Investment Group, which served as a shell for RacehorseMeds. Garofalo is accused of helping to manufacture and ship “identical drugs to those Mangini had produced while operating Ergogenic” and of enlisting family members to do the same. Documents reveal that one of the people on the government's witness list helped Mangini and Garofalo create a shell company called Diamond Enterprise Group to obscure the identity of the “true manufacturer and shipper of the drugs sold to consumers.” The person identified only as “Witness-1” was paid $1,000 a month and opened bank accounts and multiple mailboxes outside the state of Florida in the company's name to make it appear as though Diamond Enterprise was based elsewhere.

Indeed, it would seem as though the scheme was successful at making it difficult for consumers to figure out how to report a problem with products purchased from one of the companies. A government motion told the story of an unidentified owner whose trainer advised her horse needed ulcer medication and directed the owner to RaceHorseMeds. The owner purchased omeprazole paste from the website without being prompted for a prescription and began giving the paste to her horse. Eight days later, she “observed a serious deterioration in her horse's health, resulting in the horse's hospitalization at an animal hospital.

“Witness-3 attempted to contact the company operating the Racehorsemeds website to find out what was in the product she ordered, but the only person Witness-3 could link to Racehorsemeds was Witness-1.”

Federal regulations require, among other elements of labeling, that the manufacturer of a drug be clearly identified on the label so consumers can report adverse drug reactions if needed.

Prior to entering his guilty plea, Mangini's attorneys had been trading motions with prosecutors about which pieces of evidence would be admissible at his trial. One point of contention was that Mangini was apparently on the radar for U.S. Customs and Border Patrol. The agency seized two packages that were addressed to people other than Mangini – one in 2020 from Wuhan, China, was bound for “Frank Stef” and one in 2018 from Jalisco, Mexico, was addressed to “Michael O'Donnell.” A defense motion sought to have this evidence excluded, pointing out that Mangini was not the addressee on either package but did not explain exactly how he related to either package. The motion did point out that the accusations against Mangini related to his sale of products in the United States, not to his receipt of drugs from foreign countries.

Garofalo, Mangini and Robinson were all longtime owners on the Standardbred racing scene, but Mangini and Garofalo did make a foray into the Thoroughbred world. In late 2015, trainer Maria Borell claimed two horses for their Pegasis Investment Group. One was claimed away and the other was later transferred to trainer Sal Santoro after Borell left Florida. A third Thoroughbred racing for Pegasis Investment Group the following year was trained by Barry Kirkham.

The indictment accuses Posner of allowing Mangini to use his name and veterinary licensing credentials to create prescriptions for horses which neither Posner nor Mangini (who is not a veterinarian) had examined. The March 2021 indictment points to a check to Posner issued by Ergogenic Labs for $243.50, with “March 2016 commissions” written in the memo line.

Mangini and Posner were charged with one count of drug adulteration and misbranding conspiracy, while Mangini and Garofalo were charged in a separate count of drug adulteration and misbranding conspiracy. Garofalo and Posner have entered not guilty pleas.

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Robinson, Defendant In Federal Doping Indictment, Sentenced To 18 Months In Prison

Scott Robinson, one of the defendants in the federal case that rocked horse racing in March 2020, has been sentenced to 18 months in prison. The Thoroughbred Daily News reported that U.S. District Judge J. Paul Oetken handed down the sentence on Tuesday after Robinson pleaded guilty to one count of drug adulteration and misbranding conspiracy in September 2020.

Robinson, together with pharmacist Scott Mangini, was accused of operating consumer-facing websites such as HorsePreRace, peddling products which purported to be blood builders and pain blockers which were allegedly untestable, as well as discounted versions of prescription drugs despite not being an FDA-approved manufacturer. Robinson is neither a veterinarian nor a pharmacist.

Click here to read the Paulick Report's investigation of HorsePreRace from 2016.

A pre-sentencing report filed by federal prosecutors ahead of Oetken's ruling revealed even more disturbing details about the conditions in which those products were made. A state pharmacy board inspection report dated February 2016 which was published by the Paulick Report had picked up on unsanitary conditions at co-conspirator Scott Mangini's facility in Florida: the Florida Department of Health Records noted that there was no working sink in the pharmacy for hand washing, and employees were instead using a ten-gallon bucket. The department noted so much dust on the counters where prescriptions were made that an investigator was able to trace letters in the dirt with an alcohol swab — a particular problem since some products were injectables. Ingredients were mislabeled.

Click here to read more about Mangini's facility from this 2016 investigative feature by the Paulick Report.

Even before that inspection however, the report cited communications from Robinson to Mangini indicating he knew something could be wrong with the products he was selling. In spring 2015, Robinson began asking Mangini whether there had been changes to manufacturing processes.

“R u making stuff different? I have a lot of stuff that doesn't look same and has stuff floating in it. Blood building peptide has black particles,” one message to Mangini read.

“[Employee] has been complaining of bugs coming out of boxes u send. I told him he was crazy until I found one floating in bottle today when labeling,” read another, also to Mangini.

The Board of Pharmacy conducted its inspection in December 2015, but Robinson was dismissive of any danger resulting from the inspection, writing to Mangini, “And board of pharmacy worries about u? They got bigger problems! Lol.”

(Mangini, who has been charged with two counts of drug adulteration and misbranding, has entered a not guilty plea and his case is ongoing.)

Between December 2015 and January 2016, Robinson fielded complaints from trainers who had injected Pentosan into their horses, only to see the horses become severely depressed and unable to move. The horses' veterinarian attributed the reactions to a bad batch. The pre-sentencing report indicated Robinson “was dismissive of these complaints.”

When federal agents executed search warrants on premises used by Robinson in September 2019, prosecutors say he became incensed and “attempted to extort the federal agents involved in the seizure by threatening to release a letter to certain members of the racehorse industry informing them of of the existence and scope of the FBI's investigation if the FBI did not immediately return his electronic devices the same day they were seized. After being informed his threat was itself a crime, Robinson retracted his threat hours later.”

After he became aware the FBI was investigating him, prosecutors say Robinson continued distributing adulterated and misbranded drugs, generating “millions of dollars in revenue.”

Prosecutors had requested the maximum available sentence of five years in prison, while Robinson's defense team, pointing out his lack of prior criminal convictions, suggested he serve no time. Defense attorneys painted a picture of a man who had risen to business success from near-homelessness and who battled depression and chronic traumatic encephalopathy (CTE) due to injuries sustained in the United States Navy. Letters from friends and family framed Robinson as a caring person who gave liberally to charity and financially supported family members.

Although Robinson had no criminal history, prosecutors did note that he was court martialed in 1998 and dishonorably discharged from the Navy after he admitted to reselling anabolic steroids to other enlisted members of the Navy.

One character reference letter in support of Robinson's defense came from New Vocations Racehorse Adoption Program, where executive director Dot Morgan wrote that Robinson “donated a massive amount of his compounded omeprazole ulcer treatment” to the program in 2010 and 2011. In 2014, HorsePreRace and HorseGold (of which Robinson was president) were the recipients of warning letters from the Food and Drug Administration warning them to stop marketing omeprazole and other products designed to act as prescription drugs because they were not approved as mass manufacturers of drugs.

Another letter, from Robinson's psychiatrist, highlighted the defendant's feelings for horses.

“From my three years of work with Mr. Robinson, I have become aware of his great knowledge of and love for racehorses,” wrote Dr. Ronald E. DeMao. “Horses and horse racing have literally “been his life.” It is inconceivable to me that he would ever do anything to intentionally harm a horse. In fact, he has developed products to aid in the physical health and rehabilitation of horses. I have heard him speak in very pejorative terms about others who 'dope' or harshly train racehorses.”

Robinson is required to surrender himself on Sept. 7, 2021 to begin his sentence. He will have another three years of supervised release after serving his time.

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