http://online.wsj.com/article/SB10001424052702303443904575578713255698500.htmlOCTOBER 28, 2010
Whistleblower's Long Journey
Glaxo Manager's Discovery of Plant Lapses in '02 Led to Her $96 Million Payout
By PETER LOFTUS
In 2002, drug maker GlaxoSmithKline PLC sent one of its quality-assurance managers, Cheryl Eckard, to Puerto Rico to help clean up a mess at one of its biggest manufacturing plants. U.S. authorities had just cited the plant for several violations, including making a contaminated ointment used to treat skin infections on children.
Ms. Eckard's journey from North Carolina to the Caribbean set off a chain of events culminating in this week's announcement that she would collect at least $96 million for her role in helping the government secure a criminal guilty plea and a $750 million payment from Glaxo to settle an investigation of manufacturing deficiencies. Ms. Eckard's bounty is believed to be the largest award given to a single whistleblower in U.S. history...
Ms. Eckard worked at Glaxo from 1992 to 2003 and was a manager of global quality assurance at the company's Research Triangle Park, N.C., site at the time she was asked to visit the plant in Cidra, Puerto Rico. What Ms. Eckard found were even more problems than those cited by the U.S. Food and Drug Administration. The plant had received complaints that drugs of different types and strengths were being mixed up in the same bottle, and plant managers had made no attempt to issue a recall or correct the cause of the mix-ups. She learned of one consumer complaint that a boy was given double the dose of the antidepressant Paxil due to such mix-ups. Ms. Eckard made some strong recommendations to her superiors: Stop shipping all products from the plant, suspend manufacturing for two weeks to allow time to resolve the problems, and notify the FDA about the product mix-ups.
But Ms. Eckard's recommendations were ignored... She eventually told her boss that "she would not participate in a cover-up of the quality assurance and compliance problems at Cidra." By mid-2003, Ms. Eckard was terminated in what the company called a "redundancy" related to the merger of Glaxo Wellcome and SmithKline Beecham PLC a couple of years before. After she left the company, she continued to try to persuade its compliance department that more needed to be done at Cidra. But she says the company took no action. Finally, in August 2003, she called the FDA's San Juan office and spent more than two hours detailing her concerns...