GSK, Facing Likely Denture Cream Lawsuit Settlements, Paid $750 Million to Settle Federal Charges in
Drugmaker GlaxoSmithKline, currently facing the prospect of paying millions or billions of dollars in denture cream lawsuit settlements over accusations that the zinc contained in Poligrip caused patients to develop nerve damage, is only months removed from an agreement that saw it pay a hefty fine to resolve charges that it improperly manufactured drugs.
Last October GSK agreed to pay $750 million to settle Justice Department claims that the company sold drugs, including Kytril (an anti-nausea medicine), Bactroban (a skin ointment), Paxil CR (anti-depressant), and Avandamet (diabetes drug), that were adulterated and incorrectly made at its former manufacturing plant in Cidra, Puerto Rico. Among the problems with the drugs produced there were contamination by microörganisms of Kytril and Bactroban, splitting of Paxil tablets, Avandamet made with a mix of active ingredients not approved by the FDA, and the commingling of drugs (both of the same type but different strengths, and of different types).
According to the Justice Department, the terms of the settlement include a criminal fine of $150 million and a civil settlement under the False Claims Act of $600 million. The total of $750 million paid by Glaxo is the fourth-largest amount ever paid by a drug company for the resolution of a government investigation.
Cheryl Eckard, a former GSK manager of quality assurance who became a whistleblower and filed a lawsuit under the U.S. False Claims Act after the company fired her, will receive nearly $100 million from the federal share of the settlement.
In a statement, GSK senior vice president and head of global litigation, PD Villarreal, said, "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."
GlaxoSmithKline, one of the world's largest drugmakers, is facing the prospect of paying more in settlements in 2011 as Poligrip lawsuits get set to go to trial. Suits filed by injured denture cream users allege, among other things, that GSK failed to properly warn the public about the dangers of zinc, used to improve adhesion and reduce odors in denture cream. A study published in 2008 by researchers from the University of Texas revealed that heavy use of denture cream could result in neuropathy, a disorder of the peripheral nervous system. Although GSK no longer sells denture cream containing zinc in the United States, it made numerous formulations of Poligrip with zinc available to the public since it obtained the rights to the product in 2001. Until the publication of the UT study, GSK never listed zinc as an ingredient in Poligrip or included instructions for safe use.
Last October GSK agreed to pay $750 million to settle Justice Department claims that the company sold drugs, including Kytril (an anti-nausea medicine), Bactroban (a skin ointment), Paxil CR (anti-depressant), and Avandamet (diabetes drug), that were adulterated and incorrectly made at its former manufacturing plant in Cidra, Puerto Rico. Among the problems with the drugs produced there were contamination by microörganisms of Kytril and Bactroban, splitting of Paxil tablets, Avandamet made with a mix of active ingredients not approved by the FDA, and the commingling of drugs (both of the same type but different strengths, and of different types).
According to the Justice Department, the terms of the settlement include a criminal fine of $150 million and a civil settlement under the False Claims Act of $600 million. The total of $750 million paid by Glaxo is the fourth-largest amount ever paid by a drug company for the resolution of a government investigation.
Cheryl Eckard, a former GSK manager of quality assurance who became a whistleblower and filed a lawsuit under the U.S. False Claims Act after the company fired her, will receive nearly $100 million from the federal share of the settlement.
In a statement, GSK senior vice president and head of global litigation, PD Villarreal, said, "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."
GlaxoSmithKline, one of the world's largest drugmakers, is facing the prospect of paying more in settlements in 2011 as Poligrip lawsuits get set to go to trial. Suits filed by injured denture cream users allege, among other things, that GSK failed to properly warn the public about the dangers of zinc, used to improve adhesion and reduce odors in denture cream. A study published in 2008 by researchers from the University of Texas revealed that heavy use of denture cream could result in neuropathy, a disorder of the peripheral nervous system. Although GSK no longer sells denture cream containing zinc in the United States, it made numerous formulations of Poligrip with zinc available to the public since it obtained the rights to the product in 2001. Until the publication of the UT study, GSK never listed zinc as an ingredient in Poligrip or included instructions for safe use.
