Claiming that she was extortionately fired for refusing to destroy a document regarding Heartguard’s effectiveness, the former global head of pharmacovigilance for Merial, Ltd. has filed a wrongful termination suit against the drug manufacturer.
Kari Blaho-Owens, Ph.D., had been global head of pharmacovigilance for 4 years at Merial, Ltd. when she was fired in July 2010. Her responsibilities included driving best practices for compliance and innovation – and ensuring that proper processes and procedures were followed. So when a Nov. 30, 2004 letter from the U.S. FDA’s Center for Veterinary Medicine “noted that there were numerous reports of ineffectiveness for heart worm prevention despite ‘Heartgard Plus’ being used according to the labeled directions,” Merial opened an internal investigation. That decision would ultimately cost her her job.
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.
According to the complaint filed by Blaho-Ownes, “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.”
Her own investigation confirmed Merial’s awareness of the problem. 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, and that “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 says the company responded with an “investigation that 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 the study was intentionally skewed, because
- 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 Plus’ cases.
- 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.
In September 2009, Merial was named in a class-action lawsuit against Heartguard. At that time, 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,” according to the complaint. Blaho Owens said the company official “also instructed her 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 did not destroy the document, but instead reported the incident to Merial’s legal counsel. She says Merial retaliated 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.”
Blaho-Owens said she was terminated after filing a claim of retaliation with the Labor Department’s OSHA division, and she’s seeking a declaratory judgment, an injunction and damages, including reinstatement with back pay for violations of whistleblower provisions of the Sarbanes-Oxley Act.