A lawsuit by Bayer HealthCare LLC against a Tennessee animal shelter for nonpayment on a supply order could unintentionally cast a spotlight on drug deals that might not be legal.

In question is whether it was lawful for Bayer to sell and deliver 100 tablets of the antibiotic Baytril as well as a 56.8 ml-bottle of Droncit injectible and a case of Advantage Multi, both heartworm medications, to a shelter without a licensed veterinarian on staff.

Bayer’s case against Native Way Society for the Prevention of Cruelty to Animals of Dresden, Tenn., is scheduled to be heard in General Sessions Court of Weakley County on Dec. 2. According to court records, Bayer is seeking payment on an unpaid balance on drugs and other products sold to Native Way as part of the company’s Friend in Need Shelter Program. 

A $5,546 judgment was filed against Native Way last August when shelter officials failed to show for court. But now the case's status appears to be in question based on new information provided by shelter staffers that the drug company is seeking payment for drugs that the shelter contends were sold illegally. 

The revelation came out Oct. 7, report Native Way officials who were ordered to appear in court bearing tax records and other financial statements. 

Bayer officials as well as the company’s attorney listed in court documents, Paul Mendelson, did not respond to repeated requests from the VIN News Service seeking information about the case.

Josh Pool, who runs Native Way with his wife and financially supports the struggling shelter, reports that he was cold-called by a Bayer representative in January concerning the company's Friend in Need Shelter Program. According to Pool, shelters in the program are required to purchase large amounts of Advantage Multi, Advantage, K-9 Advantix, Droncit, Baytril and 200 microchips in order to receive a free microchip scanner and drugs nearing their expiration date at costs lower than those offered to veterinarians. 

A description of Bayer's Friend in Need Shelter Program cannot be found via a search on the company's website, though the name appears on documentation supplied by Pool to the VIN News Service.

Pool contends that when he enrolled the shelter in the discount program, he told the Bayer representative the name of his veterinarian and explained that the practitioner does not work at the shelter. He also thought that buying a "box" of Advantage, for example, meant one package of the topical parasiticide, not a case of 10.

Now Pool, admitting to being unsophisticated when it comes to pharmaceuticals, realizes he can't legally use the prescription drugs he ordered and wants to return them.

“What I will pay for is legally what can be sold, but what I will not pay for are substances that I cannot use legally," he says.

Referring to what's known in the veterinary profession as the diversion of drugs to gray market channels, Pool adds: "People wonder how places like online pharmacies get a hold of these drugs. This is a classic example. I could turn around and sell these at a 10-percent profit, and make a living doing it.”

It is unclear if the court will fully explore whether the drugs were sold legally or simply address Bayer's unpaid invoice. Pool reports that the court continued the case until December in order to investigate, though court records do not specifically indicate that. 

The U.S. Food and Drug Administration (FDA), which regulates the approval and manufacture of drugs on a national level, did not immediately respond to a query from the VIN News Service.

The Board of Pharmacy, which operates under the auspices of the Tennessee Department of Health, refused to weigh in on state laws as they pertain to the sale and distribution of drugs. The agency regulates drug manufacturers and wholesaler licensing at the state level.

It took days for a communications official with the department confirm that the pharmacy board’s purview includes the sale of animal health medications. Ultimately, spokeswoman Shelley Walker stated to the VIN News Service that it would be "inappropriate" for board members to comment on matters that are tied to litigation.
 
Veterinary drugs aren't known to top the pharmacy board’s agenda, explains Phil Seibert, a Veterinary Information Network (VIN) consultant in Tennessee with expertise in safety and regulatory issues pertaining to the profession. Seibert states that drug companies usually will ask for a veterinarian’s license number before selling legend drugs to a shelter or practice — identification that's publicly available and on the Internet.

"This is the first I’ve heard of a case like this,” he says. “Obviously, this shelter shouldn’t have gotten these drugs in the first place. But who’s to blame for the violation is something the courts will have to sort out, if they’re even going to consider it.”