Cheryl Eckard, the whistleblower responsible for the recent GlaxoSmithKline settlement, recently received a reward of $96 million — the largest award in history to a single whistleblower. As a result of her whistleblowing activities, many sources have labeled Eckard as a “role model for whistleblowers.” In a statement given Tuesday, October October 26th, Eckard said, “This is not something I ever wanted to do, but I felt I had no choice because of the safety concerns.”
Eckard worked for GlaxoSmithKline from 1992 to 2003 and was a manager of global quality assurance at the company’s research center in North Carolina. In 2002, Eckard was asked to visit the company’s manufacturing plant in Cidra, Puerto Rico to address manufacturing violations cited by the FDA. At this time, the plant was GSK’s top performer, manufacturing over 20 products worth $5.5 billion annually.
After Eckard’s arrival, she discovered much more egregious violations than those previously cited by the FDA, later chronicled in her complaint. As a result, Eckard made strong recommendations to GlaxoSmithKline: that they stop shipping all products from the plant, suspend manufacturing for two weeks in order to resolve the problems, and notify the FDA about the product mix-ups stemming from the manufacturing violations.
GlaxoSmithKline declined to issue recalls or to correct the cause of the product mix-ups. In fact, Eckard’s recommendations were swiftly dismissed, apparently because the company was preparing for FDA inspections in the near future regarding the approval of two new drugs. Continuing to make visits to the plant through 2003, Eckard told her boss that “she would not participate in a cover-up of the quality assurance and compliance problems at Cidra,” and by mid-2003, Eckard was terminated.
Afterward her termination, Eckard continued to persuade GSK’s compliance department to resolve the problems at Cidra. After further inaction by the company, she felt compelled to report the fraud to the FDA in Puerto Rico. Based upon her findings, the FDA executed search warrants in October 2003 and in February 2005, and seized all stocks of Avandamet and Paxil CR- seizures in total worth approximately $2 billion. Later, in 2009, the Cidra plant closed.
Eckard’s story highlights the crucial importance of the False Claims Act, one of the most effective ways to unearth fraud on the government. In cases similar to this one, drug manufacturing fraud is oftentimes difficult to detect. This may be attributed to the fact that the final product – a pill – does not easily reveal flaws in terms of incorrect ingredient dosages, ratios, and sterility. Furthermore, government inspections – as the case here demonstrates – are often inadequate. Absent a more aggressive policy of implicating corporate executives, society is reliant upon the False Claims Act whistleblower and industry insider to reveal deceptive and fraudulent practices. For a Wall Street Journal article on Eckard’s struggles with GlaxoSmithKline, click here.