Wedgewood rebuffs compounding lawsuit

Wedgewood rebuffs compounding lawsuit

Plaintiffs petition court for $375,000 for defective antibiotic design and/or labeling
Dec 01, 2005

ALBANY, N.Y. — Wedgewood Pharmacy says initial tests vindicate the compounder of allegations that it made its chloramphenicol palmitate product inconsistent with its label.

A group of owners are charging Wedgewood with compounding the antibiotic too strong, spurring adverse events that led to the demise of four high-profile Thoroughbreds.

Wedgewood President and CEO George Malmberg says the company has conducted preliminary tests that show the batch in question was created properly.

"The medication was appropriately compounded and was delivered to the patients as labeled," he says. "The other side and our attorneys have agreed to have the material tested extensively for definitive analysis, which we feel will absolutely clear Wedgewood Pharmacy of any charges of compounding the medication incorrectly."

According to court documents, three of the four horses, including Saratoga County — winner of the $2-million Gulf News Dubai Golden Shaheen, were staying in the same Saratoga, N.Y., barn where they contracted Arytenoiditis, a laryngeal infection. The treating veterinarian ordered and received 192 syringes of chloramphenicol palmitate. Four administrations of the antibiotic were given about six hours apart on or about June 8. A fifth administration was given the next day. Shortly after, the horses manifested signs of lost appetite, intestinal distention, depression, elevated heart rate and symptoms of colic, among others. The horses were diagnosed with colitis and thereafter, laminitis. The fourth horse, 3-year-old sprinter Egghead, was treated with the antibiotic after suffering a cut over one of his hocks at Belmont Park May 30.

The lawsuit alleges the product "was improperly designed, manufactured, compounded, formulated, mixed and/or labeled, thereby constituting an unsafe and dangerous medication for its normally intended administration and use." Plaintiffs suggest the antibiotic "led to the slow, painful demise of these horses, eventually causing Saratoga County, Cathy's Choice and Egghead to be humanely destroyed, and causing the severe injury and damage to Yankee Penny."

Malmberg says any strong antibiotic can cause the types of reaction that occurred in these cases. Dr. Elizabeth Davis, PhD, Dipl. ACVIM, agrees. The associate professor of equine medicine at Kansas State College of Veterinary Medicine says some classes of antibiotics can trigger antibiotic-associated colitis, especially animals that work very hard for a living.

"Occasionally, we have cases where antibiotics cause life-threatening diarrhea," Davis says. "Any antibiotic can do it, especially in horses under a lot of stress like high-performance horses. But it comes down to the status of the horse and what the antibiotic does to the (gastrointestinal) flora count."

Each of the five owners (two plaintiffs each had a share of Saratoga County) are demanding no less than $75,000 for allegedly distributing a mis-labeled product