Owners of three Thoroughbreds hospitalized after receiving a compounded drug from Wickliffe Veterinary Pharmacy allege the Lexington company not only was negligent in product preparation but also failed to halt distribution after it knew at least one horse death in Kentucky had been linked to the compound.
Thoroughbred owners Galen Ho LLC and Robert Harvey and Al Wortzman filed lawsuits seeking at least $250,000 in damages June 9 in U.S. District Court in Ocala, Fla. Also filing a lawsuit is Dennis Narlinger's JMJ Stable, which had four horses harmed, including 3-year-old Free Association who died. The owners allege their horses at an Ocala training center were hospitalized after receiving a compounded drug to treat or prevent equine protozoal myeloencephalitis.
On June 11, a Wickliffe Veterinary Pharmacy representative said the company had just received notice of the litigation and is reviewing the complaints. The company said it will comment further after additional review of the lawsuits.
Free Association, a $100,000 purchase by JMJ Racing and Sequel Stallions at the 2012 Fasig-Tipton Saratoga yearling sale, is one of two horses who died after receiving the compounded drug. According to the lawsuit, JMJ Racing had three other horses harmed after receiving the compounded drug: Unknown Road, a promising, winning son of Bernardini ; unraced Imposing Figure, by Repent; and an unraced and unnamed son of Pulpit.
One of the Thoroughbreds allegedly harmed is Harvey and Wortzman's Hollinger, Canada's 2009 champion 2-year-old colt. The owners say Hollinger, who has won two stakes races and earned more than $700,000, will not be able to compete in 2014 and may have to be retired.
The lawsuit alleges a Wickliffe compound of toltrazuril and pyrimethamine had more than 13 times the amount of pyrimethamine that was supposed to be in the product, as listed on the label. The U.S. Food and Drug Administration has reported a similar finding in the Wickliffe product in question, noting that adverse events associated with high doses of pyrimethamine include seizure, fever, and death.
The complaint alleges that eight Thoroughbreds suffered severe distress May 5, beginning about 90 minutes after receiving the compound. Two of the affected Thoroughbreds died and the other six were hospitalized at the University of Florida Large Animal Hospital for care and treatment after suffering seizures, elevated temperatures, and convulsions. Several continued to suffer seizures and weakness in all four limbs and all of the surviving horses saw radical decreases in white blood cells, which required large doses of folic acid, according to the complaint.
The horses involved in the litigation filed against Wickliffe survived the ordeal but their owners are not sure if the horses will be able to return to racing. Named as defendants were Jacqueline Kemezy Bernard, identified as Wickliffe president; Kelly Zaccarelli, identified as company pharmacist; and William Bernard, identified as Wickliffe's chief veterinarian;
Harvey and Wortzman are seeking more than $250,000 for costs of vet fees and veterinary treatment following Hollinger's ordeal, as well as money for vanning costs, decreased value of Hollinger, and loss of immediate earning potential.
Galen Ho outlines similar damages in seeking more than $250,000 following the hospitalization of its placed 3-year-old colt Empire Road and its unraced 2-year-old colt out of Finish With Class.
The FDA has reported that two horses died in Kentucky after receiving the compound. The lawsuits allege that Wickliffe knew, or should have known, about the problem after the Kentucky deaths but did not take action to halt further use of the product in Florida.
The litigation outlines a horrible scene in which the eight Thoroughbreds quickly fell into extreme distress beginning about 90 minutes after receiving the compound at an unnamed Ocala training facility. According to the lawsuit, veterinarian Jonathan McLellan decided to administer the compound after determining that the eight horses were either suspected of early EPM infection or were considered at-risk of infection.
The litigation says FDA-approved drugs to treat EPM may have side effects and success rates "that are less than optimal," and that McLellan previously had successfully used the compound as a treatment. All eight horses were in good health until the compound was orally administered at about 10:30 a.m. May 5.
At noon, "there was a loud disturbance in one of the horse's stall and the trainer's personnel found the horse in extreme distress, unable to stand and demonstrating extreme neurological symptoms," the suit says. "He also had a large lesion on the top of his head and was bleeding. An immediate call for veterinarian help was placed and the first vet on the scene was present within 15 minutes."
According to the suit, while that horse was being treated, a second began to have violent seizures and thrashed uncontrollably within his stall to the point that he kicked the metal door off the track and thrashed in the shed row. Similar incidents would follow with the other seven horses, according to the account. With horses injuring themselves or putting themselves in danger while thrashing in their stalls, the staff moved horses to the lawn.
"The trainer's stable suddenly became a place of triage for the emergency care of horses," the lawsuit states.
By 2:15 p.m., one of the horses perished. A second would die after not responding to two days of treatment at the University of Florida, where all of the surviving horses were treated, the suit states.
The lawsuit alleges that more than one month before the problems in Florida, a University of Kentucky Veterinary Diagnostic Laboratory representative contacted Wickliffe to advise the pharmacy that a horse had died in the state after receiving a lethal overdose of pyrimethamine following an administration of a Wickliffe-prepared compound. The lawsuit contends that despite this information relayed on April 1, Wickliffe "took no additional measures to correct its compounding practices."
The suit alleges the listed amount of pyrimethamine on the label was 17 mg/ml, but the actual amount supplied was 229 mg/ml; and the true concentration of toltrazuril was 22 mg/ml, not the listed 416 mg/ml.
After the incident, the FDA stated its position on compounded drugs, noting that substances like toltrazuril have not been approved for use in the horse.
"In general, FDA has serious concerns about unapproved animal drugs, including certain compounded animal drugs," the FDA said in its statement. "These drugs are not evaluated by FDA and may not meet FDA's strict standards for safety and effectiveness. Unapproved animal drugs also may not be labeled or advertised appropriately. Horse owners or caretakers should consult with their veterinarians about other therapies."
Drugs that have been evaluated and approved by FDA for the treatment of EPM include ponazuril, diclazuril, and a combination drug of pyrimethamine and sulfadiazine.
