The lawsuit was started by an employee who acted as a whistleblower by alerting investigators to problems with how the tablets were manufactured. The improperly made pills were manufactured between 2001 and 2005, according to The Wall Street Journal (10/27/10). The whistleblower is now entitled to $96 million from the settlement.
An investigation into GlaxoSmithKline's plant in Cidra, Puerto Rico, found that between 2001 and 2005, some tablets had improper amounts of the active ingredient. Furthermore, some tablets were prone to splitting apart. Although there was no evidence of any injury to patients, investigators filed charges, saying companies must follow the rules.
GlaxoSmithKline was alleged to have knowingly manufactured, distributed and sold medications that fell below strength, quality and/or purity standards set by the FDA.
Paxil CR is a controlled-release tablet. The tablet, however, could split in two, either causing patients to take pills with no active ingredient or causing them to take pills that had only the active ingredient but no controlled-release mechanism, possibly resulting in higher than expected doses.
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As part of the settlement, GlaxoSmithKline will pay $150 million in fines and forfeitures and a $600 million civil settlement under the False Claims Act. Various states will receive payouts from the settlement.
Earlier this year, GlaxoSmithKline reportedly agreed to settle certain lawsuits alleging Paxil was responsible for birth defects in babies exposed to the antidepressant prior to birth. According to reports, GlaxoSmithKline agreed to pay more than $1 billion to settle approximately 800 Paxil birth defects claims. The drug manufacturer has not commented on a report announcing the settlement. The company did announce that it had reached an agreement to settle certain cases but that the details of those settlements were confidential.