A whistleblower at multinational pharmaceutical company GlaxoSmithKline has won £61m damages after the company sacked her for exposing a series of contamination problems at a drugs factory in Puerto Rico. The payout is believed to be the biggest ever for a whistleblower
Cheryl Eckard, 51, first complained about problems at Glaxo’s huge Cidra factory in July 2002. She alleged that staff were “skimming” drugs to sell them on the Latin American black market; drugs of different types and strengths were found in the same bottle; a diabetes medication (Avandamet) was shipped in tablets of the wrong strength; and an antibiotic ointment used to treat skin infections in babies (Bactroban) was contaminated with a micro-organism associated with bacteraemia, urinary tract infections, meningitis, wound infection, and peritonitis.
Court documents show that after receiving an initial presentation in July 2002 on the plant’s problems from Gloria Martinez, the quality assurance manager at Cidra, Ms Eckard “immediately phoned vice president for quality Steve Plating at GlaxoSmithKline’s headquarters and recommended the company stop shipping all product from the Cidra plant, stop manufacturing product for two weeks in order to investigate and resolve the issues raised and the impact on released batches, and notify the U.S. Federal Drugs Administration (FDA) about the product mix-ups”.
Over the next 10 months, she repeated the allegations and calls for remedial action in a series of communications to other senior Glaxo executives — including Janice Whitaker, senior vice president for global quality, and David Pulman, then vice president of manufacturing and supply for North America — only to be blocked and eventually sacked in May 2003.
Three months later, after Glaxo’s then chief executive JP Garnier refused to answer her phone calls, Ms Eckard reported the company to the FDA. She also commenced a private lawsuit for compensation under the U.S. False Claims Act.
Following a $750m criminal and civil settlement with the FDA, a Glaxo spokesperson released the following statement: “We regret that we operated the Cidra facility in a manner that was inconsistent with current good manufacturing practice. GlaxoSmithKline worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009.”
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