GlaxoSmithKline whistleblower wins record £61m payout | Business | The Guardian: "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 bosses.
Cheryl Eckard, 51, will pocket the $96m share of a $750m criminal and civil settlement between US regulators and the British pharmaceuticals group. The case showed that 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.
Eckard first warned of the numerous violations after being sent by GSK to investigate problems in the group's huge factory in Cidra, Puerto Rico, in July 2002, following a warning letter to the company from US health officials.
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 July of that year, Eckard phoned JP Garnier, the then chief executive, who declined to take the call to speak to her about the findings and the cover-up. Eckard, who is from North Carolina and is married with children, now works as a freelance consultant for the pharmaceutical industry.
Legal papers show that GSK employees in Cidra lied to US Food and Drug Administration (FDA) inspectors and that Eckard believes the company's executives refused to acknowledge the gravity of the violations and act, because the FDA would not consider approvals for two new treatments until the issues in the warning letter had been resolved. The two products – the diabetes treatment, Avandamet, and Factive, which is used for chest infections – were subsequently approved by the regulator.
Court documents show how Eckard was gradually sidelined, despite increasing complaints to a growing number of senior bosses.
After receiving an initial presentation in July 2002 on the plant's problems from Gloria Martinez, the quality assurance manager at Cidra, Eckard 'immediately phoned [vice president for quality, Steve] Plating at GSK's headquarters [and] recommended that GSK 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 FDA about the product mix-ups'.
Eckard also alerted Janice Whitaker, senior vice president for global quality, and, subsequently, David Pulman, then vice president of manufacturing and supply for North America.
After 10 weeks investigating the plant up to August 2002, Eckard – who had no authority to recall products, suspend manufacturing or report concerns to the FDA – returned to her base in North Carolina, but was sent back to Puerto Rico three weeks later to work on a 'longer-term correction' of the plant's compliance problems. However, Plating put Adalberto Ramirez, Cidra's director of laboratories, in day-to-day control of the project with Eckard only given 'an 'oversight' role'. She subsequently learned 'that Ramirez had repeatedly lied to her about the status of work' and that the 'compliance action teams' had been disbanded immediately after the FDA's October re-inspection.
That deception was also reported to Plating and to Eckard's immediate boss, Diane Sevigny. Eckard said 'that she would not participate in a cover-up ... and would not take part in any further meetings with the FDA about the Cidra plant'. The testimony continues: 'During this period and thereafter, Eckard and Sevigny were in frequent and increasing conflict about GSK's management of the quality and compliance problems at Cidra.'
The court papers also reveal how GSK employed a private investigator, who identified connections between an unnamed senior manager at Cidra and companies alleged to be distributing GSK's drugs on the black market.
By then, Eckard had been sidelined and in May 2003 she was made redundant at a meeting, during which she had her security badge confiscated and was escorted from the premises.
After being ignored by Garnier and passed to other departments, she then reported the company to the FDA in August 2003. In October, after another conversation with GSK's compliance department, the whistleblower told the regulator that the company had no intention of acting on her report, and three weeks later it was forced to announce that the FDA had begun its own investigation.
Eckard's lawsuit was filed under the False Claims Act, which is designed to allow private citizens with knowledge of fraud on the government to sue and share in the proceeds of the recovery.
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.'
However, while the company said it had received no reports of anybody becoming ill because of its failures, it declined to comment on whether further lawsuits from patients might be expected.
Eckard's lawyers, Getnick & Getnick, who said the award was the largest whistleblower penalty yet, added that the case was significant because patients cannot easily spot deficiencies with medicines. Getnick partner Lesley Ann Skillen said: 'Once the pill is swallowed, it's gone and there may be no way of telling whether someone got sick because the product was bad. As a result of this settlement and guilty plea, drug makers will now have more reason to live up to their motto that patient safety is their first priority.'
Problem plant
GlaxoSmithKline's now-closed Cidra plant, in Puerto Rico, produced the top-selling antidepressants Paxil and Paxil CR as well as the diabetes medications Avandia and Avandamet. During the period surrounding Cheryl Eckard's complaint, Paxil and Avandia were in the world's 50 top selling drug products. Other drugs affected included the chest infection treatment Factive; Bactroban ointment, an antibiotic used to treat skin infections in babies; Kytril, an anti-nausea injection for cancer patients; and Tagamet, for heartburn and peptic ulcers. Drugs of different types and strengths were found in the same bottle; Avandamet was shipped in tablets of the wrong strength; and Bactroban was 'contaminated with a micro-organism associated with bacteraemia, urinary tract infections, meningitis, wound infection, and peritonitis', court documents show.
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