A Cumming scientist says a Duluth-based company made false claims about its popular heart worm-prevention medication for dogs, and then fired her when she repeatedly complained the company knowingly fed federal regulators false data.
Kari Blaho-Owens said that based on her analysis, Heartgard Plus did not work on one out of five dogs, as Merial Inc. promoted in its advertising. According to Blaho-Owens, the company fired her when she persisted in her campaign to correct information filed with the U.S. Food and Drug Administration, and when she refused to destroy documents pertaining to a federal lawsuit several years earlier.
“I was put in a place to do a job as long as that job was in line with business,” said Blaho-Owens, who has sued in federal court in Atlanta.
"I was told to stop investigating,” Blaho-Owens said.
Merial declined to comment on pending litigation or personnel matters. But the company said in an email, "Merial believes we have acted appropriately and responsibly in all matters related to the allegations.”
For a time, Heartgard was the only heart worm-prevention product to claim 100 percent effectiveness. The FDA began sending warning letters in 2004 after receiving “numerous reports of ineffectiveness for heart worm prevention despite ‘Heartgard’ Plus being used according to labeled directions." The FDA wrote those reports were not consistent with data Merial sent regulators.
The FDA told Merial to stop distributing promotional material that is “false or misleading."
Blaho-Owens said the company dropped the claim that Heartgard was 100 percent effective in 2008, but it did not include a warning on the box that medication may not work on all dogs.
“Merial stands by the effectiveness of our products,” the company said in its statement.
Heart worms are spread by mosquitoes and they attack dogs' hearts. Eventually the parasite will kill a dog that otherwise had shown no symptoms.
Blaho-Owens, hired in 2006, said in her lawsuit the company knew the heart worm medicine was not 100 percent effective but officials feared a “marketing disadvantage” if Merial had to change its labels.
Blaho-Owens said the data used to support effectiveness claims was “cherry picked" and based on inflated sales numbers -- the subject of a class-action lawsuit pending in Mississippi.
Two months after she told the company's lawyer that she had been asked to destroy records, Blaho-Owens was put on a performance improvement plan because of a “lack of understanding of differences in levels of priorities.” Blaho-Owens said until then she had received only positive job performance reviews as well as several merit pay raises.
Blaho-Owens also claims she was excluded from meetings and reprimanded for things that didn't warrant correction for other employees. Consequently, Blaho-Owens filed a retaliation claim against Merial with the U.S. Department of Labor on Jan. 29, 2010.
She was fired on July 29, 2010.
“It’s about remaining competitive and that comes down to profit,” Blaho-Owens said.
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