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The filing of a federal lawsuit last week has brought attention to yet another corporate scandal, this time known as the Heartgard Plus cover-up.
Former Global Head of Pharmacovigilance Dr. Kari Blaho-Owens has sued Merial, Ltd., the manufacturer of the canine heartworm medication, alleging that she was fired after discovering that the company had intentionally utilized improper data analysis methods to ward off an FDA investigation.
There are also allegations that she was instructed to destroy documents.
Blaho-Owens was hired in 2006 after the FDA began to inquire into the pre-approval performance data submitted for the Heartgard Plus product, according to the lawsuit. It was found to be inconsistent with consumer reports regarding effectiveness.
While reviewing the data, Courthouse News Service reports that she discovered that the company was aware that Heartgard Plus was not 100% effective as early as 2002, despite claims otherwise. It had also used flawed data analysis to respond to the FDA's inquiry.
She reported this to supervisors, who Consumer Affairs reports were more concerned with marketing than safety.
The Heartgard Plus cover-up got worse, when in 2009, a class action suit was filed against Merial. Blaho-Owens alleges that she was instructed to destroy relevant litigation documents.
After she reported the request to corporate counsel and eventually filed a retaliation complaint, she was fired.
Though we all know that these are only allegations, this story is actually a prime learning opportunity for your corporate clients. Not only is the Heartgard Plus cover-up a useful reminder about the preservation of evidence, it is also the perfect example of why corporations should not lie to investigators and how they should not handle whistleblowers.
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