When GSK Cock Up… They Do It Spectacularly …


The following are a series of articles regarding GSK monetary legal settlements in various states across the US. Basically GSK were producing shoddy quality drugs in their Puerto Rican manufacturing plant, they were caught by a whistleblower and these fines came as a result. Some of the drugs got mixed up, including Paxil (Seroxat). Heart medications were mixed with Anti-depressants and all sorts of shenanigans ensued. Will we ever know how many people were harmed because of this almighty Cock Up by GSK?…

http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml

Eckard was a quality control inspector for the company when she found trouble at Cidra in 2002. According to the CBS News coverage, Eckard found a host of mess-ups there. “All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career,” she told 60 Minutes. Tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles, she now says.

http://www.fiercepharma.com/story/gsk-whistleblower-details-cidra-plant-woes/2011-01-03

http://www.guardian.co.uk/business/2010/oct/27/glaxosmithkline-whistleblower-awarded-96m-payout

A whistleblower who exposed serious contamination problems at GlaxoSmithKline’s (GSK) pharmaceutical manufacturing operations has been awarded $96m (£60m).

Cheryl Eckard’s payment is thought to be the biggest ever handed to a US whistleblower. It was awarded after an eight-year fight, which ended yesterday, when GSK agreed to pay the US government $750m to settle civil and criminal charges that it manufactured and sold adulterated drug products.

Speaking outside the federal courthouse in Boston after the award was agreed, Eckard admitted she was “a little emotional”.

“It’s difficult to survive this financially, emotionally, you lose all your friends, because all your friends are people you have at work,” she said. “You really do have to understand that it’s a very difficult process but very well worth it.”

The case centred on a factory in Cidra, Puerto Rico, where GSK made a range of products including an antibiotic ointment for babies, and drugs to treat nausea, depression and diabetes. In August 2002, Eckard, a global quality assurance manager, led a team sent to the plant to investigate manufacturing violations that had been identified by the US Federal Drugs Administration (FDA). Eckard lost her job nine months later after warning that the problems ran deeper than the FDA realised.

Eckard’s lawyers, Getnick & Getnick, said she was made redundant against her will in May 2003 after repeatedly complaining to GSK’s management that some drugs made at Cidra were being produced in a non-sterile environment, that the factory’s water system was contaminated with micro-organisms, and that other medicines were being made in the wrong doses.

“Cheryl Eckard is a role model for whistleblowers,” said Lesley Ann Skillen, a partner at Getnick.

Carmen Ortiz, US attorney for Massachusetts, said the case should serve as a warning to other pharmaceutical companies. “We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society,” Ortiz told a press conference last night.

Eckard tried to alert GSK’s management to the situation in Cidra even after she left the company. According to the lawsuit brought by Eckard, she tried to call GSK’s chief executive JP Garnier in July 2003, but he declined to speak to her. She took her concerns to the FDA in August 2003 after concluding that GSK’s compliance department lacked the authority to address her concerns.

Getnick & Getnick said the case was particularly significant because it was so difficult for patients to spot deficiencies with medicines.

“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, drugmakers will now have more reason to live up to their motto that patient safety is their first priority,” Skillen said.

The Cidra factory had been GSK’s largest manufacturing operation but was closed last year. Drugs made at the plant include Bactroban ointment, a topical antibiotic used to treat skin infections in babies, Kytril, an anti-nausea drug used by cancer patients, anti-depressant treatment Paxil CR and Avandamet, a derivative of the diabetes drug Avandia.

GSK announced in July that it would pay $750m to settle the charges, and the details were finally agreed on Tuesday in Boston. It will pay fines totalling $150m, plus related claims of $600m.

GSK said that it had worked hard to resolve the problems at Cidra, adding that it has not received any warnings from the FDA since 2002.

“We regret that we operated the Cidra facility in a manner that was inconsistent with current good manufacturing practice requirements and with GSK’s commitment to manufacturing quality,” said PD Villarreal, GSK’s senior vice-president and head of global litigation.

Eckard’s lawsuit was filed under the False Claims Act, legislation that dates back to the days of Abraham Lincoln. It is designed to allow private citizens with knowledge of fraud on the government to sue and share in the proceeds of the recovery.

http://www.citizen-times.com/article/20110630/NEWS/306300046/Glaxo-agrees-40-75-million-national-settlement?odyssey=mod%7Cnewswell%7Ctext%7CFrontpage%7Cp

Glaxo agrees to $40.75 million national settlement

RALEIGH — Drug makers GlaxoSmithKline and SB Pharmco Puerto Rico have agreed to pay $40.75 million to 38 states including $1.2 million to North Carolina, Attorney General Roy Cooper announced.

“Consumers depend on medication to be safe and reliable, and quality manufacturing is key,” Cooper said.

The settlement resolves allegations that GSK and SB Pharmco used substandard manufacturing processes when making certain drugs at a plant in Cidra, Puerto Rico. Cooper and the other attorneys general contend that the drug companies engaged in unfair and deceptive practices when they manufactured and distributed medications that did not meet standards for quality and purity.

The drugs manufactured at the Cidra plant were: Kytril (used to prevent nausea and vomiting caused by cancer treatment); Bactroban (an antibiotic ointment used to treat skin infections); Paxil CR (the controlled release version of the popular antidepressant drug, Paxil); and Avandamet (used to treat Type II diabetes).

GSK and SB Pharmco are no longer manufacturing drugs at their Cidra facility, which has been closed since 2009. All adulterated batches of the drugs covered by this agreement were recalled years ago and/or their expiration date has past, so there is no reason for consumers currently taking these medications to be concerned.

GSK and SB Pharmco are barred by today’s settlement from making false, misleading or deceptive claims regarding the manufacturing of the drugs at issue, regardless of where they are now produced. In addition, the companies must not misrepresent the drugs’ characteristics, or create confusion or misunderstanding about the way in which they are manufactured.

Earlier this year, North Carolina recovered $11.8 million as part of a $600 million national Medicaid fraud settlement involving similar claims against GSK.

Delaware to receive more than $550K in settlement with GSK

As part of a 38-state settlement, pharmaceutical giant GlaxoSmithKline (GSK) will pay $551,426 to the state of Delaware.
In a complaint filed last week, Attorneys General from 38 states assert GSK and SB Pharmco Puerto Rico (SB Pharmco) made deceptive claims about how four drugs were produced at their facility in Cidra, Puerto Rico.
“It was more centered on quality control and making sure that what they were producing was a product that was consistent with the chemical makeup of the drugs,” said Ian McConnel, Director of the Delaware Department of Justice’s Fraud Division.
The drugs in question: Kytril, a sterile drug used to prevent nausea and vomiting caused by chemotherapy and radiation cancer treatments; Bactroban, a topical antibiotic ointment used to treat skin infections; Paxil CR, a controlled-release form of the antidepressant medication Paxil; and Avandamet, a combination Type II diabetes drug. Delaware Attorney General Beau Biden blames substandard manufacturing processes for the drugs’ compromised makeup.
“Pharmaceutical manufacturers have a responsibility to produce drugs that are safe and generated according to strict guidelines,” said Attorney General Biden.
Biden announced Tuesday, the $550-thousand award will be deposited into the state’s Consumer Protection Fund and added this settlement resolves the allegations of substandard manufacturing practices against GSK.
“We hold drug companies to a high standard because that’s what consumers and their families deserve,” said Biden.
The Cidra facility shut down in 2009 and the Department of Justice says consumers need not worry since the drugs in question were recalled many years ago and/or have passed their expiration dates.
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