Glaxo settles tainted drugs suit for $750 mn

Wednesday, October 27, 2010

WASHINGTON - British pharmaceutical giant GlaxoSmithKline (GSK) will pay $750 million to settle a US government lawsuit related to the manufacture and sale of adulterated drugs, the US Justice Department said Tuesday.

GSK was accused of manufacturing and selling certain adulterated drugs that were made at its now-closed facility in Cidra, Puerto Rico.

Among the 20 affected drugs were anti-depressant Paxil CR, diabetes treatment Avandamet, anti-nausea medication Kytril and an ointment for skin infections Bactroban.

“We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society … or those who cut corners that result in potentially dangerous consequences to consumers,” Carmen Ortiz, the US attorney for Massachusetts, told a news conference in Boston.

Justice Department officials said they had not found evidence of patients being sickened by the adulterated batches of drugs.

The lawsuit was filed in 2004 by Cheryl Eckard, the company’s former global quality assurance manager. “This is not something I wanted to do, but because of patient safety it was necessary,” Bloomberg news quoted Eckard, 51, as saying.

As a whistleblower, she will receive $96 million from the settlement money, the report said. The total settlement was the fourth-largest amount ever paid by a pharmaceutical company to the US, the Justice Department said.

“Whether drugs are contaminated during the manufacturing process, lack the proper mix of ingredients, or are mixed up and put in the wrong bottles, the consequences can be very real,” said Tony West, assistant attorney general.

“Consumers have the right to rely upon the claims that drug companies make about the products they sell. And that is why, when it comes to the sort of conduct at issue here, we will hold pharmaceutical companies accountable,” he added.

PD Villarreal, GSK’s senior vice president, said in a statement: “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 … and we are committed to continuous improvement in our manufacturing processes.”

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