ATLANTA (CN) - The maker of Heartgard Plus, a heartworm drug used by millions of dog owners, "extortionately fired" its head of "global head of pharmacovigilance" after she refused to destroy a document relevant to a class action lawsuit regarding the drug's effectiveness, the Ph.D. claims in Federal Court.
Kari Blaho-Owens, Ph.D., says she had been global head of pharmacovigilance for 4 years for defendant Merial, Ltd., a British pharmaceutical firm, at its Gwinnett County office when she was fired in July 2010. Her responsibilities included ensuring that standard practices for compliance, innovation and procedures were followed.
In 2005, before she was hired, Merial conducted an internal investigation on an "increase in the number of reported cases of the lack of efficacy of Heartgard," according to the complaint.
The investigation was conducted after Merial received a Nov. 30, 2004 letter from the U.S FDA's Center for Veterinary Medicine, which "noted that there were numerous reports of ineffectiveness for heart worm prevention despite 'Heartgard Plus' being used according to the labeled directions," the complaint states.
"At this time, FDA-CVM notified Merial that the adverse event data Merial had submitted to gain FDA's approval (pre-approval performance data) was not consistent with its adverse event data that was being reported after the drug became available on the market (post approval data). This means that the adverse events Merial received after the FDA approved the product to be marketed in the United States was not consistent with what Merial had provided to FDA to obtain marketing approval from FDA." (Parentheses in complaint.)
After reviewing the findings of that internal investigation, Blaho-Owens says, she "discovered that Merial had been aware of serious lack of efficacy adverse events reported regarding 'Heartgard Plus' since as early as 2002."
The complaint continues: "Had Merial appropriately monitored their post marketing data, the company should have known and notified FDA-CVM at a much earlier time, at least back to 2000 that its marketing and promotional advertisement, as well as the drugs' FDA approved label was no longer accurate."
Blaho-Owens said the situation concerned her fellow executives, who worried "that FDA-CVM would require a change in the written label for 'Heartgard Plus'. This new labeling would require that the adverse event listing specify that 'Heartguard [sic] Plus' was not 100% effective in preventing dogs from becoming infested with heartworms. Thus, anyone who read the 'Heartgard' product package or label would now be aware that 'Heartgard' was not 100% effective in preventing heartworm disease and all of its sequelae, including death of the animal."
This would put Merial's product at a competitive disadvantage.
Blaho-Owens says the company responded by announcing that its "investigation showed that the increase in lack of effectiveness claims was the direct result of increases in sales, lack of compliance on the part of the owner, etc. - not product failure of the active ingredients in 'Heartgard' products."
Blaho-Owens says she was given a copy of this study, and the raw data used in its analysis, shortly after she became global head of pharmacovigilance.
She says she had problems with it, among them: "a. The statistical analysis used in the 2005 study does not conform to recognized scientific standards.
"b. The study was not blinded, and was conducted using 'cherry-picked' data, so as the persons evaluating the data would be led to support the conclusion sought
by Merial, i.e., that the drug was 100% effective.
"c. The study included and evaluated only 7% of the total number of 'Heartgard
"d. ... Despite Dr. Blaho-Owens' efforts, including reporting to her supervisors and meetings with multiple persons within the finance department, no one within Merial would take responsibility or remedy these problems. Thus, because high level management was aware of the methods used in this study, it is difficult to understand how the conclusions of this study could have been accepted. ... Therefore, the rates of lack of efficacy for 'Heartgard Plus' documented in the 2005 study could not be scientifically reliable."
Blaho-Owens said that over the next few years, as Merial continued to try to delay the labeling change, she repeatedly raised concerns about the lack of transparency in the company's reports to the FDA.
Finally, Blaho-Owens says, she "came across documentation from another Merial employee in Lyon, France, F. Beugnet, who had done his own statistical analysis and
determined that 'Heartgard Plus' was not 100% effective, but was only 95% effective."
In September 2009, Merial was named in a class-action lawsuit regarding 'Heartguard,' [sic] and the company's director of U.S. regulatory affairs "instructed Dr. Blaho-Owens to destroy a document that was likely relevant to the pending class action lawsuit and was in her possession," the complaint states. Blaho Owens says the company official "also instructed Dr. Blaho-Owens to stop generating any new analysis of data regarding 'Heartguard' despite her ongoing concerns relating to the LOE [undefined - presumably lack of effectiveness] of 'Heartguard'."
She says she did not destroy the document, but reported the exchange to Merial's legal counsel. She says that led Merial to retaliate by putting her on a "performance improvement plan, which cited a 'lack of understanding of differences in levels of priorities' between Dr. Blaho-Owens and management."
She says she was fired after she filed a claim of retaliation with the Labor Department's OSHA division.
Blaho-Owens seeks declaratory judgment, an injunction and damages, including reinstatement with back pay, interest and benefits from July 29, 2010 to today for violations of whistleblower provisions of the Sarbanes-Oxley Act.
She is represented by Christopher D. Vaughn of Decatur, Ga.
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