GlaxoSmithKline PLC agreed to pay $750 million on Tuesday to settle a U.S. government false-claims lawsuit over the sale of adulterated drugs.
The U.K. pharmaceutical company must pay $150 million in criminal fines, plus $600 million in civil penalties relating to quality problems with drugs manufactured between 2001 and 2005 at a Puerto Rican plant, which was shut down in 2009.
Cheryl Eckard, a former global quality assurance manager for the company, originally filed the lawsuit in 2004, after visiting the Cidra factory in 2002. She had urged Glaxo managers to address the manufacturing quality issues but was fired in 2003 for raising the complaints.
The drugs in question include the antidepressant Paxil CR, anti-nausea medication Kytril, Bactroban ointment, and diabetes drug Avandamet.
“This is not something I ever wanted to do, but because of patient safety and issues, it was necessary,” Eckard said in Boston at a news conference after the plea.
The informant is due to receive $96 million from the settlement money, the largest settlement ever for a single whistleblower, said Taxpayers Against Fraud spokesman, Patrick Burns.
Glaxo said in a statement that it regrets running the facility in a manner that violated good manufacturing practice requirements.
“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 M. Ortiz, the U.S. attorney in Boston, said at the news conference.
Ortiz said there was no evidence to suggest any patients had been harmed by the defective drugs.
The U.K. pharmaceutical company must pay $150 million in criminal fines, plus $600 million in civil penalties relating to quality problems with drugs manufactured between 2001 and 2005 at a Puerto Rican plant, which was shut down in 2009.
Cheryl Eckard, a former global quality assurance manager for the company, originally filed the lawsuit in 2004, after visiting the Cidra factory in 2002. She had urged Glaxo managers to address the manufacturing quality issues but was fired in 2003 for raising the complaints.
The drugs in question include the antidepressant Paxil CR, anti-nausea medication Kytril, Bactroban ointment, and diabetes drug Avandamet.
“This is not something I ever wanted to do, but because of patient safety and issues, it was necessary,” Eckard said in Boston at a news conference after the plea.
The informant is due to receive $96 million from the settlement money, the largest settlement ever for a single whistleblower, said Taxpayers Against Fraud spokesman, Patrick Burns.
Glaxo said in a statement that it regrets running the facility in a manner that violated good manufacturing practice requirements.
“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 M. Ortiz, the U.S. attorney in Boston, said at the news conference.
Ortiz said there was no evidence to suggest any patients had been harmed by the defective drugs.
