Maylin Deposition May Lay Groundwork For Commission To Question Medina Spirit/Otomax Theory

The legal teams for trainer Bob Baffert and owner Amr Zedan have given much credence to what they've said is new science as they've built their narrative around the positive betamethasone test from Medina Spirit after the 2021 Kentucky Derby. But the impact that science could have on the appeal is unclear.

Dr. George Maylin, director of New York's Equine Drug Testing and Research Laboratory, was deposed in the appeal case on June 10 as the Kentucky Horse Racing Commission tried to learn more about the testing he conducted on Medina Spirit's split sample.

The appeal hearing is scheduled to begin in the case on Aug. 22.

The Paulick Report recently acquired a copy of the transcript of Maylin's deposition via public information act request. When depositions are conducted in this context, each side of the legal case makes available the experts and witnesses they expect to call during the upcoming proceeding so opposing attorneys can gain a sense of what to expect during the hearing. While KHRC staff and stewards were deposed primarily by attorneys for Baffert and Zedan, Maylin was primarily deposed by KHRC's counsel. This means that we've had a look at one side's handling of each witness.

You can find our previous reporting on other evidence and depositions in the case here.

An editorial note: Some readers asked, after publication of the piece linked above, why we're still reporting on this case. For one thing, the appeal is ongoing and is expected to drag on for some time. For another, the narrative about the circumstances surrounding Medina Spirit's positive test and the commission's subsequent investigation has, to this point, largely been driven by the attorneys for Baffert and Zedan. The stewards' hearing took place behind closed doors, and so far the public has had only small glimpses of the commission's view in a limited number of public hearings in motions related to the requested stay of suspension. While the commission is still not making public statements or comments, it is now, after the ruling of the stewards, subject to some types of public information act requests. Taking a look at the way both sides are deposing experts and what they're discussing in correspondence can shed light on the state's perspective in a way we haven't seen before.

Here are a few things we learned from Maylin's deposition:

–It took a lot to get Maylin to agree to a deposition. Emails reveal that KHRC attorney Jennifer Wolsing was in touch with Maylin's counsel as far back as March, trying to arrange a deposition ahead of the appeals hearing.

Joseph Faraldo, attorney for Maylin, expressed the laboratory director's reluctance to participate in an in-person interview and for a while, would only agree to a Zoom interview. Maylin is 80 and Faraldo said he had serious concerns about the prospect of being deposed in person due to fears about COVID-19. After two months of back-and-forth, Wolsing had apparently had enough of that explanation.

“We are aware that Dr. Maylin is reluctant to engage in an in-person deposition due to alleged COVID concerns,” she wrote in early May. “However, our previous experience with Dr. Maylin indicates that he is comfortable with meeting people for extended periods of time, even without any COVID precautions. When the KHRC brought Medina Spirit's urine sample to New York in 2021, Dr. Maylin met with four people for 60 to 90 minutes without masks or social distancing. Some of his conversations with KHRC staff on that date included very close, face-to-face discussions and document review. He also drove one of our employees to and from the airport in his car, again without masks or social distancing.”

Nonetheless, Wolsing said the commission would agree to a Zoom deposition, which was eventually held in June.

–There was a lot of confusion about Maylin's official role in the case. In his deposition, Maylin does not frame himself as a member of either side in the case, even though his test results would appear to be beneficial to Baffert. He said that after Baffert's announcement that the horse's betamethasone test could be traced to the administration of Otomax, Maylin decided to investigate whether this was possible all on his own, in late May 2021. It was later that Maylin said Dr. Clara Fenger contacted him and suggested that he be the one to do additional testing on the remainder of Medina Spirit's urine sample.

Faraldo said in an April email that he had been “laboring under the assumption that Dr. Maylin was retained as an expert on behalf of Bob Baffert” but before the KHRC attorneys, Maylin indicated he had not been paid a dime by Baffert or Zedan. The expense of his research and the testing of the urine, which he estimated came to $10,000 or less, was absorbed by “the New York Racing and Wagering Board,” the former name for the modern-day New York State Gaming Commission, which regulates racing in New York.

The reason it matters whether Maylin is a paid witness or not is that it subjects him to different requirements of disclosure of his research materials. Since he said Baffert did not pay for the work he did, Maylin also asserted he could not be forced to provide all of the results of research because this would risk his ability to publish it in a scientific journal down the road. Accordingly, he turned over a huge volume of results sheets from the testing he did on Medina Spirit's urine, but has only provided his own summary of the research he did studying whether non-injection administrations of betamethasone could result in a positive test.

–Maylin's research sample is very small so far – so small he says the work he has done can't be published yet. Maylin said he administered Otomax to just two horses, but it turns out with one of them, researchers smeared the product in the horse's mouth, trying to mimic what may happen if a horse had Otomax on a skin lesion and subsequently licked the area – something that hasn't been suggested in the Medina Spirit case, as his skin lesions were limited to one hindquarter in the days just before the Derby.

As it turns out, Maylin's researchers only applied the substance topically to one horse. In that case, Maylin said Otomax was applied every day for four days to an area on the hindquarters of a mare. The skin was not damaged prior to application, and the mare's hair was not clipped. Maylin said the mare had a one-gram tube applied a day for four days. (Otomax doesn't appear to be available commercially in one-gram containers.) Maylin said components of Otomax, including clotrimazole and betamethasone valerate, were found in urine samples collected from both horses 24 hours after administration.

Of course, these conditions aren't exactly the same as what Medina Spirit encountered. According to Baffert, he was getting Otomax daily from April 9 until the day before the Derby. The areas of the colt's skin that had healing lesions would have been broken, with less hair in those spots, which could impact absorption. Veterinary records do not indicate the size of the containers of Otomax Baffert's staff were given, and it's unlikely the amount applied to the horse was exactly the same each day.

Maylin acknowledged that two horses isn't going to be a large enough sample size for a peer-reviewed journal to publish this work. He estimated he will need at least eight samples. When asked when that research could be done, Maylin emphasized that his lab's primary directive was testing and said he hoped to have eight samples collected June 2023. He said he had no idea where he would submit such a study for publication.

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–Depending on who you ask, there may be some question about whether Maylin's testing really did enough to establish there are two components of Otomax in Medina Spirit's urine sample. Wolsing spent some time asking Maylin about the signal to noise ratio he used when setting up testing equipment.

Signal to noise ratio, or S/N, is a numerical value used to determine the lower limit of detection (LOD), a measure of a mass spectrometer's sensitivity as it looks for a given compound, like betamethasone valerate, in a sample. The ratio is intended to assure that there is more 'signal' (the compound of interest, like betamethasone valerate) than 'instrument noise' in the test results. Maylin testified that the industry standard S/N should be at least 3:1 to claim the presence of a given drug.

But under questioning from Wolsing, Maylin admitted that the S/N for some of the tests he performed for betamethasone valerate fell below the 3:1 standard, suggesting he didn't find detect a sufficiently strong signal from the substance compared to the “background noise” in the colt's urine.

Elsewhere in the deposition, Wolsing confronted Maylin about similar data for clotrimazole, the antifungal component of Otomax that Zedan's attorneys claimed Maylin had also identified in Medina Spirit's sample. Some of the data turned over by Maylin showed that the apparent concentrations of clotrimazole he found were very close to the apparent concentrations in the negative control sample he also tested.

Maylin emphasized that his task was to see whether he could find any components of Otomax, not to quantify how much of each were present and that his testing methodology was appropriate for that task.

All of this could lay part of the groundwork for the KHRC's scientific experts to claim that Maylin's testing of Medina Spirit's sample did not meet industry (Association of Official Analytical Chemists) or other widely accepted forensic toxicology standards to identify either of the two key ingredients in Otomax.

–Maylin claimed his initial interest in the case was preventing a similar post-race positive after the Belmont. Of course, Medina Spirit didn't end up running in the 2021 Belmont Stakes, but Maylin said “the New York Racing and Wagering Board” was aware of his research and that there was some concern about whether a repeat situation could occur in New York.

“They were – they were aware of the study because of implications of this horse racing in the Belmont Stakes and what we would do to try to preclude the folly that you folks are dealing with,” Maylin said.
“To preclude the folly that we are dealing with, is that what you said?” asked Wolsing.
“Yeah.”
“What folly are you referring to there, Doctor?”
“The horse was treated with Otomax and allowed to run.”
“And you're saying it was folly to allow the horse to run after it had been treated with Otomax?”
“The answer is yes.”

Maylin went on to say that had the horse gone to New York, he would have been tested out-of-competition and not been allowed to run.

Out-of-competition testing in most places isn't designed to look for the presence of therapeutic drugs, but rather to catch the use of banned drugs like EPO or anabolic agents.

New York's regulation on out-of-competition testing states that “A race-day prohibition or restriction of a substance by a commission rule is not applicable to an out-of-competition test unless there is an attempt to race the horse in a manner that violates such rule.”

–Maylin said hypothetically, it's possible the horse could have received both topical Otomax and betamethasone in an injection. Although Maylin believes his results establish that Medina Spirit was given Otomax, he could not say this eliminated the possibility the horse had been exposed to betamethasone via injection. Both exposures could have taken place, he said, and there would be no way to tell from the testing he did.

Maylin did not test for so-called 'free betamethasone' meaning betamethasone that didn't have the valerate ester attached to its molecule. The valerate ester is what enables it to be absorbed topically in drugs like Otomax. When the drug enters the horse's body, the valerate is cleaved off, and plain old betamethasone is what circulates through the bloodstream and tissues. This also happens with betamethasone phosphate and betamethasone acetate, the two injectable forms of the drug – all of it ends up as free betamethasone by the time it gets to the tissues. When asked why he didn't look for free betamethasone, Maylin said that was not on the list of substances in Judge Thomas Wingate's order from Franklin Circuit Court guiding the release of excess urine sample to the New York lab.

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Marathoner Red Knight Wins Colonial Cup Off Lengthy Layoff

Trinity Farm's Red Knight returned from an 11-month layoff to score his ninth lifetime win Wednesday in the inaugural $150,000 Colonial Cup turf test at Colonial Downs in New Kent, Va. The stakes attracted a field of 11 that battled 1 1/2 miles over the Secretariat Turf Course and was the first stakes race in Colonial's history to ever be contested at that distance.
The 8-year-old Pure Prize gelding crossed the finish 1 1/2 lengths the best and pushed his career bankroll to $893,258. The winner is trained by Michael Maker and was ridden by Horacio Karamanos.
Both Red Knight and runner-up Another Mystery had to steady shortly after the start when Nathan Detroit clipped heels with another horse and lost his rider, William Humphrey. Both horses stayed mid-pack through the one-mile distance while betting favorite Cellist and La Lune battled back and forth for the lead.
Karamanos maneuvered Red Knight into fourth approaching the final straightaway, came outside and passed Another Mystery and the two frontrunners en route to victory in 2:27.31.
“I got a good break and saved ground early”, said Karamanos. “The trainer told me the horse is ready to win so save ground and wait for your moment. In the second turn he wanted to go but I wouldn't let him go. I tried to hold him back as best I could. At the top of the stretch, I finally let him go. He gave me a nice kick. He's got a long beautiful stride so I just let him go. I've won many races at 1 1/2 miles,” added Colonial's all-time leading rider. “In my country, we run long distance so I love it. I'm very confident when I run long distance.”
Red Knight in fact set the Gulfstream Park track record at the two-mile distance in 2018 when he won the $100,000 H. Allen Jerkens Stakes.
Owner Tom Egan of Trinity Farm was nearly as confident as his jockey heading into Monday's “Cup.”
“I had high expectations because this horse is a terrific race horse,” he said. “Mike Maker thought he'd run a very big race and he did. He was coming off a long layoff. He needed every bit of that layoff. He was in bad shape last September. He came back and came back all the way at the age of eight. He has a lot of zest for racing. We bred him and we owned his mother,” added Egan. “We love horse racing and it's been very kind to us.”
Team Block's Another Mystery finished second and Bruton Street's Snap Decision was third.
Rider Humphrey suffered a laceration on his right elbow which was stitched up at the track. He did not go to the hospital.
Colonial Downs continues its race season on Monday, Aug. 1. with first post at 1:45 p.m. ET. Featured race is the $100,000 Housebuster Overnight Handicap.

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View From The Eighth Pole: Jockeys’ Guild Hurting Their Own Cause In HISA Lawsuit

Earlier this year, two federal judges dismissed lawsuits filed in Texas and Kentucky alleging the federal legislation that created the Horseracing Integrity and Safety Authority was unconstitutional. Both cases are being appealed.

On Tuesday, a federal judge in Louisiana issued an injunction that prevents the Authority from enforcing its rules in West Virginia and Louisiana, two states whose racing commissions were among the plaintiffs filing a suit in late June hoping to stop HISA from leaving the starting gate nationwide as scheduled on July 1. They failed to prevent the nationwide start-up but have succeeded in getting an injunction blocking HISA in those two states by convincing a judge that they will suffer harm in a variety of ways under HISA rules.

One of the plaintiffs in the Louisiana lawsuit is the Jockeys' Guild Inc., whose attorneys are interpreting the judge's order in a way, they believe, that exempts all of its members from having to follow HISA rules anywhere.

In his order, U.S. District Court Judge Terry A. Doughty from the Western District of Louisiana's Lafayette Division, enjoined and restrained HISA from implementing racetrack safety, enforcement and assessment methodology rules against the following plaintiffs: the states of Louisiana and West Virginia; the Louisiana State Racing Commission; Louisiana Horsemen's Benevolent and Protective Association 1993 Inc.; Louisiana Thoroughbred Breeders Association; Jockeys' Guild, Inc.; West Virginia Racing Commission; and five individuals – Louisiana HBPA president Bernard Chatters; Louisiana HBPA executive director Edward Fenasci; veterinarian Dr. Larry Findley Sr.; LTBA president Warren J. Haran III; and jockey Gerard Melancon.

“It is further ordered,” Doughty wrote, “that the geographic scope of the injunction shall be limited to the states of Louisiana and West Virginia, and as to all plaintiffs in this proceeding.”

That last phrase, “and as to all plaintiffs in this proceeding,” reportedly has led the Jockeys' Guild to tell its members throughout the country they no longer have to follow HISA's rules limiting them to a maximum of six strikes of the riding crop to the hind quarters in increments of two or fewer strikes and allowing at least two strides before using it again.

“Should HISA, or any of its designated representatives, attempt to enforce any of the enjoined rules against a Guild member in any state, the Guild intends to take immediate action to ensure compliance with the Court's order,” Kate Swearengen, general counsel for the Jockeys' Guild, said in a statement.

Not so fast, said HISA.

“HISA will continue to enforce its rules in all applicable jurisdictions, with the exception of Louisiana and West Virginia,” a HISA spokesperson said. “Outside of those states, the court order applies only to the five individuals specifically named in the case.”

Stewards have been notified to continue enforcing HISA rules.

Attorneys for HISA believe the listing of “Jockeys' Guild Inc.” as a plaintiff does not mean every Jockeys' Guild member is a plaintiff. They concede that Gerard Melancon would be exempt from HISA rules wherever he rides – unless, of course, an appeal of Doughty's injunction is successful.

In other words, if the Jockeys' Guild wants to back up its contention that all of its members are exempt from HISA rules nationwide, they'll have to go to court and prove it.

I have to wonder if the Jockeys' Guild and the organizations in Louisiana and West Virginia who brought this lawsuit have really thought this through all the way.

For years, Guild leadership has raised concerns about the absence of adequate medical staffing and concussion protocols as well as the quality of emergency equipment at some racetracks. HISA has adopted rules that will eventually mandate that all tracks provide properly staffed and equipped Advanced Life Support ambulances. Tracks will also be required to hire a medical director to oversee medical care of jockeys and adhere to a 13-point plan outlined in HISA regulations.

This looks to be a significant benefit to the health and safety of jockeys, one that was not going to happen without HISA.

One of the issues raised in the Louisiana lawsuit is the so-called Assessment Methodology Rules, which we'll simply refer to as “who pays how much?”

The Horseracing Integrity and Safety Act calls for the cost of the Authority to be shared evenly among racing states, with assessments based on the number of starts per year by “covered” or HISA-registered horses. Reacting to concerns from tracks and horsepeople in states with a large number of races but relatively low purses, the HISA board came up with a blended assessment formula that takes into account both starts and purses.

Two of the states that benefited from the blended assessment formula are, you guessed it, Louisiana and West Virginia. If the assessments have to be changed to starts only as a result of this lawsuit, Louisiana and West Virginia will have a significantly higher assessment.

Like the Jockeys' Guild, Louisiana and West Virginia may be hurting their own cause by going down this road.

That's my view from the eighth pole.

 

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Does HISA Injunction Hint at Eventual Rules Rewrite?

One day after a preliminary injunction handed down by a federal judge halted the Horseracing Integrity and Safety Act (HISA) Authority's rules from being implemented in the states of Louisiana and West Virginia, Thoroughbred industry participants and legal experts continued to sift through the order seeking clues for how the judge in the case might eventually rule on a national level as the civil suit continues its journey through the legal system.

Although the National Horsemen's Benevolent and Protective Association (NHBPA) isn't a party to the suit filed in United States District Court (Western District of Louisiana), its chief executive officer, Eric Hamelback, said in a prepared statement that Judge Terry Doughty “determined that the Plaintiffs established a likelihood of success on the merits for their claims” and that the July 26 ruling “shows the HISA regulations are not in the best interest of Thoroughbred racing's participants [and] will cause harm to the participants.”

Frank Becker, a noted Lexington-based equine lawyer and former adjunct professor at the University of Kentucky College of Law, told TDN in a Wednesday phone interview that the NHBPA's take could be accurate.

“I think it's worth noting that this was a fairly drastic remedy-a preliminary injunction against the government from enforcing regulations,” Becker said.

“I would comment that it is certainly significant because it reveals considerable HISA regulatory overreach,” Becker continued. “If the ruling is upheld either by the later decisions of the court or on appeal, then HISA and the Federal Trade Commission (FTC) will have to revise several of their rules and effectively start over with the comment period.”

The plaintiffs, led by the states of Louisiana and West Virginia, plus the Jockeys' Guild and various Louisiana-based “covered persons” under HISA rules, crafted their June 29 lawsuit against the HISA Authority, the FTC, and overseers of both entities slightly differently from two previously unsuccessful attempts by other plaintiffs to derail HISA based on constitutionality allegations alone. Instead, this most recent suit focused on the alleged illegality of the rules that were enacted July 1.

“The federal court  is taking a stricter approach to examining regulators, and the ability for regulators to draft fairly broad regulations,” explained Becker, who does not have a client on either side of this case. “It definitely indicates that federal courts are looking at regulations much more closer than they used to, and not giving the regulators then benefit of the doubt any more.

“Regulators have traditionally felt like they had a great deal of leeway in drafting regulations,” Becker continued. “And this federal court obviously is not very kind to the leeway that HISA and the FTC took.”

Part of the plaintiffs' argument is based on HISA and the FTC allegedly going beyond statutory authority in their rulemaking, especially in terms of whether public commentary was properly solicited and considered.

Becker said HISA and the FTC might eventually be ordered to start the rulemaking processes all over again in order to “write those regulations more narrowly.”

And, as Becker noted, “they were already taken to task for short-circuiting the process. So they're going to have to go through the process all over again with regard to replacing regulations that were held invalid.

Becker was quick to clarify that even though the issuance of a preliminary injunction didn't actually invalidate all of the HISA rules across the board, it hinted at the type of overall judgment that Doughty might eventually order.

“The court technically ruled that there's a substantial likelihood that ultimately the court will rule them invalid,” Becker said. “So ss a practical matter, they held these regulations invalid. They made the analysis on the substantive basis, and they held that there's a high likelihood that they'll be ruled invalid.”

If that ends up being the case, Becker said the halting of the rules in a final judgment would likely apply to every racing jurisdiction in the nation, and not just in Louisiana and West Virginia, like the preliminary injunction stipulates.

Becker also agreed with the NHBPA's stance that the court recognizes the potential for harm in HISA's rules.

“One interesting thing is that the plaintiffs succeeded in showing that if the regulations went into effect, that it would be economically harmful to them,” Becker said. “The court didn't totally agree that it would be 'untold economic havoc,' like the plaintiffs wrote. But in effect, the court gave some credence to that.”

When asked if the preliminary injunction would apply to other states if they subsequently joined the lawsuit as plaintiffs, Becker said he wasn't quite sure how to read between the lines of the geographical scope that Doughty wrote into his July 26 order.

“That's a really good question,” Becker said. “If a state filed its own suit, this would be what's called 'persuasive authority.' So it wouldn't technically mandate the same result in a separate suit. But if a state joined this suit, then it could have that effect.”

Or, Becker explained, the court could instead not allow other plaintiff states to reap the benefits of the injunction spearheaded by Louisiana and West Virginia.

“The court might say, 'You should have been here in the beginning,” Becker said. “I don't know what the court would do, to be honest.”

The Jockeys' Guild, in a statement of its own, argued on Wednesday that because the preliminary injunction order used language that specifically stated “The geographic scope of the injunction shall be limited to the states of Louisiana and West Virginia, and as to all Plaintiffs in this proceeding,” that means the injunction “applies to all of the members of the Jockeys' Guild, regardless of the U.S. jurisdiction in which the jockey is riding.”

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