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GlaxoSmithKline to pay $750 mn to settle US adulterated drugs lawsuit news
27 October 2010

GlaxoSmithKline (GSK), Britain's largest pharmaceutical firm and the world's fourth-largest by revenue, yesterday agreed to pay $750 million to settle a US government lawsuit over manufacturing and distributing of certain adulterated drugs made at its now-closed facility at Puerto Rico.

Cheryl Eckard, a whistle-blower and the former global quality assurance manager for the London-based GSK had filed a civil lawsuit in 2004. She will receive $96 million from the settlement money.

In her lawsuit, Eckard alleged that instead of solving the issues raised by her regarding adulterated drugs, GSK opted to fire her.

According to the US Department of Justice (DoJ), GSK was selling adulterated drugs made from its Cidra, Puerto Rico, manufacturing facility between 2001 and 2005.

The affected drugs were Kytril, Bactroban, Paxil CR and Avandamet. Kytril is a sterile anti-nausea medication. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug.

The DoJ alleged that GSK sold certain batches, lots or portions of lots of drugs, the strength of which differed materially from, or the purity or quality of which fell materially below, the strength, purity or quality specified in the drugs' FDA applications or related documents.

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GlaxoSmithKline to pay $750 mn to settle US adulterated drugs lawsuit