By: Natalie Voss
Two owners horse owners have brought a civil lawsuit against Wickliffe Pharmacy, the Lexington, Ky., veterinary compounder cited by the Food and Drug Administration for selling mislabeled paste intended to treat equine protozoal myeloencephalitis (EPM). The two plaintiffs, LuAnn Burton and Max Domaschko, also are suing Benchmark Farm LLC and farm owner Sheldon Ulrich for damages surrounding the death of Bernsteins Star, who according to court documents, died March 31, 2014, after being given a half tube of mislabeled paste purchased from Wickliffe.
The plaintiffs did not outline the amount they were seeking in damages in connection with the horse’s death.
According to the original complaint filed earlier this year, Burton and Domaschko sent Bernsteins Star, a non-winner of seven races, to Benchmark Farm for boarding and training in early 2014. The horse was working on the farm by Feb. 1, and sometime in the first week of March, an exercise rider allegedly told Benchmark owner Sheldon Ulrich that the horse felt weak in the hind end, which often can could be a symptom of EPM.
Burton and Domaschko allege that Dr. Cory Williams, a private practitioner at Lexington’s Griggs and Kidder, called Wickliffe requesting Baycox, a drug that has been used to treat EPM. A compounded version of the medication purportedly was to treat another horse, and farm representatives subsequently picked up a tube of paste containing toltrazuril and pyrimethamine. Burton and Domaschko claim that half the tube was given to Bernsteins Star, and half to a stablemate. Both horses died, according to the suit, and a necropsy on Bernsteins Star revealed the cause to be pyrimethamine poisoning.
According to court documents, the usual amounts of the two drugs found in most pastes to treat EPM is 416 mg/ml of toltrazuril and 17 mg/ml of pyrimethamine. The FDA tested the lot of compounded paste and found it to contain 184 mg/ml of toltrazuril and 283 mg/ml of pyrimethamine. The label of the paste given to Bernsteins Star claimed that the tube contained 227 mg/ml of toltrazuril and 340 mg/ml of pyrimethamine, the latter of which the plaintiffs claim would certainly be enough to kill a horse. There was no speculation provided as to why the pharmacy would sell paste labeled as containing more pyrimethamine than would be needed to poison a horse.
The same compound was linked to the illnesses of eight horses in Florida, two of which died. The FDA issued a warning letter to Wickliffe in August 2014 for selling product that contained a different concentration of active ingredients than what was listed on the label.
Burton and Domaschko are suing Wickliffe Pharmaceutical, Wickliffe Veterinary Pharmacy, as well as Dr. William Bernard (identified as Wickliffe’s chief veterinarian), Jacqueline Bernard (identified as Wickliffe’s president), and Kelly Zaccarelli (identified as Wickliffe’s head pharmacist), claiming they knew — or should have known — that the product was dangerous. The suit also alleges that Ulrich and Benchmark Farm should not have administered the product without consulting the horse’s owners. In answers to the suit, the defendants associated with Wickliffe deny the bulk of Burton and Domaschko’s charges. Bernard claims that he was not in a position to oversee operations at Wickliffe at that time and should not be held responsible for the company’s actions.
In a cross-claim filed in May, Wickliffe associates responded that it was impossible to prove that the horse’s death was caused by the compound, but that Benchmark and Ulrich “failed to follow the instructions of veterinarians and these defendants, and/or the instructions on the medication itself when administering,” making them responsible for any negative effects the horse could have suffered from the drug.
Wickliffe and its associates filed a third-party suit against Williams, who they claim failed to issue adequate instructions for giving the medication. Jamie Corbett, then-farm manager at Benchmark, has also been named as a third-party defendant.
This is not the first lawsuit Wickliffe has faced in connection with equine deaths from the compounded EPM drug; owners of three Thoroughbreds filed a civil suit against the company last year, at which point it was unclear whether the surviving animals would recover well enough to return to the track.
Correction: An earlier version of this story and its headline incorrectly stated that Dr. Cory Williams was named as a third-party defendant by both the pharmacy and the plaintiffs. He is named as a third-party defendant by the pharmacy only. The Paulick Report apologizes for the error.