RMTC

Compounding Pharmacy, Supplier Sued For $6 Million Over Viagra Positives

By Ray Paulick

Quarter horse trainer John Stinebaugh, suspended 16 years and fined $40,000 after four of his horses tested positive for the active ingredient in human erectile dysfunction drug Viagra at Ruidoso Downs in New Mexico, is suing a Texas compounding pharmacy and one of its suppliers for $6 million, alleging negligence in the manufacture of a compounded product used to treat internal bleeding.

Named as defendants in the suit, filed July 6 in El Paso County District Court in Texas, are Weatherford Compounding Pharmacy in Weatherford, Texas, and its owner, Joe Landers, along with Canada-based Attix Pharmaceuticals and two of Attix’s principals, David Liu and Syveon Liu.

The four positive tests for sildenafil were from Rainbow Futurity and Rainbow Derby Trials on July 5 and 6, 2013, after veterinarian Boyd Clement treated the horses with a compounded paste from Weatherford Pharmacy known as “Tourniquet,” which claims to stop exercise-induced pulmonary hemorrhage. Seldenafil, the active ingredient in Viagra, is a Class 3 drug with Class A penalties under Association of Racing Commissioners International guidelines.

According to the suit, Landers had “numerous conversations” with Stinebaugh and Clement prior to the races in question in which he “touted the benefits of the Weatherford Tourniquet Compound Paste and expressly stated that it did not contain any illegal substance or ingredient prohibited by any State Racing Commission.” The product, to be administered 24 to 36 hours before a race, purportedly contains herbal extracts, amino acids and vitamins.

The suit claims that Clement, on a conference call with Landers and Stinebaugh, specifically asked Landers if the Tourniquet Compound Paste “contained any ‘Viagra’ because it was known to Dr. Clement and around the race track that Viagra stopped bleeding in race horses.”

Landers “specifically represented” to Stinebaugh and Clement that the product “did not contain any illegal or prohibited ingredient, specifically including Viagra,” the suit claims.

Appearing before a Feb. 8, 2014, hearing of the board of stewards of the New Mexico Racing Commission, the suit claims Landers said in sworn testimony that the positive tests were “every bit our fault as a compounding company… it is the responsibility of my compounding pharmacy 100 percent.”

A letter from Attix Pharmaceuticals, which supplied products used in Tourniquet, states that the manufacturer that produced the herbal extract used in Tourniquet “also makes erectile dysfunction products. We feel the cross-contamination probably occurred during the process of making the herbal premix. We contacted the manufacturer about the contamination; and they are investigating what could have probably happened.” The letter said Attix gets its products from “FDA approved facilities in China, India and Europe.”

The Attix letter stated that the product sent to Weatherford was accompanied by a Certificate of Analysis “verifying the content of the product. We are not required by FDA law to do independent testing on chemicals or herbal extracts and neither are the pharmacies. The pharmacies upon receipt of products with COA may test products, but are not required to do any further testing.”

The complaint states that Landers “apparently…relied on the Certificate of Analysis for the ginseng extract ingredient from (Attix) without doing additional testing for prohibited ingredients, such as Viagra.”

Weatherford and Attix were negligent in their representations, the suit alleges. It states that Stinebaugh’s “career has been permanently damaged” as a result of the suspension and fine levied against him by the New Mexico Racing Commission. In addition, the suit claims, because the American Quarter Horse Association has suspended his membership, Stinebaugh has been prevented “from training and racing horses in all states, including Texas, and has caused him substantial damages and irreparable damage to his reputation.”

Stinebaugh is seeking a maximum $6 million in damages.