A former quality control manager at GlaxoSmithKline (GSK) has received £61m, believed to be the largest ever reward for a whistleblower, after exposing a series of contamination problems at a drugs factory in Puerto Rico, and a subsequent cover-up by company management.
GlaxoSmithKline (GSK) has agreed to pay the US government $750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products to Medicaid and other government health plans. The settlement was the result of a whistleblower lawsuit filed in 2004 by the law firm of Getnick& Getnick LLP on behalf of Cheryl Eckard, a former quality assurance manager with GSK. "The success of this whistleblower lawsuit will change the way that drug companies run their factories," said Neil Getnick, managing partner of the Getnick firm. "Now every employee who works with manufacturing issues -- from quality assurance executives like Cheryl Eckard to machine operators -- has a viable option if they have evidence that management is putting profits ahead of patient safety by letting bad products out the door."
In August 2002, Ms. Eckard, then a global quality assurance manager with GSK, was sent to the Cidra factory to lead a team of 100 scientists and quality experts brought from around the globe to fix manufacturing violations cited by the FDA of the USA. Cidra was then GSK's No. 1 factory in the world, making over 20 products worth $5.5 billion annually, including blockbuster drugs Avandia, Paxil and Coreg.
What she discovered went far beyond the manufacturing violations previously uncovered by the FDA. The company repeatedly ignored serious failings, including allegations that staff were "skimming" drugs to sell them on the Latin American black market and that its factory had mixed drug types and doses in the same bottle. Over the next 10 months, she repeatedly alerted a string of GSK executives to a catalogue of breaches, only to be blocked and eventually sacked in 2003.
In a statement, the drugs group said: "We regret that we operated the Cidra facility in a manner that was inconsistent with current good manufacturing practice. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009
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