GlaxoSmithKline (GSK) reached a settlement with the U.S. Attorney’s Office over alleged manufacturing violations of government drug standards. According to Business Wire, GSK will pay $750 million in fraud charges. $600 million will go to settle the civil case against the company while the remaining $150 million will pay a criminal fine. This case is groundbreaking because it is the first time a whistleblower lawsuit has been successfully filed, holding this drug manufacturer accountable for violating government standards.
According to the Department of Justice, the drug maker sold the adulterated medication to Medicaid and other government health plans. Business Wire reports, “GSK released to the market Bactroban ointment, a topical antibiotic used to treat skin infections in babies, that contained microorganisms and Kytril injection, an anti-nausea drug used by cancer patients, that was not sterile.” Also covered by the settlement were Paxil CR tablets, an anti-depressant, and Avandamet, a derivative of the diabetes medication, Avandia. Both drugs were manufactured improperly, with Paxil lacking the active ingredient and Avandamet tablets that were “superpotent and subpotent,” according to Business Wire.
Market Watch reports that Cheryl Eckard, formerly a Quality Assurance Manager with GSK, filed the lawsuit in 2004. This settlement comes “after more than six years of investigation and negotiations, which began when Ms. Eckard reported GSK’s fraud to the FDA and filed a qui tam whistleblower lawsuit,” the website reports. GSK fired Eckard in 2003 after her complaints about conditions at its Cidra, Puerto Rico production plant, formerly its top-producing site.
Business Wire reports that in 2002 as a Global Quality Assurance Manager with GSK, Eckard “was sent to the Cidra factory to lead a team of 100 scientists and quality experts brought from around the globe to fix manufacturing violations cited by the FDA.” At that time, the Cidra factory was GSK’s primary manufacturing site, “making over 20 products worth $5.5 billion annually,” Market Watch reports. Among those 20 produced were Avandia, Paxil and Coreg, considered “blockbuster drugs,” according to the website.
However, during this trip meant to fix previously-cited violations, Eckard found conditions in the factories even worse than what the FDA initially reported. Her 2004 lawsuit “included details about mixed-up products, super and subpotent diabetes drugs, an area of the factory used to make injectible drugs that was not sterile, air handling systems that misdirected the flow of product powders, a water system contaminated with microorganisms, and a host of other manufacturing and quality testing problems,” according to Business Wire. After these revelations, Eckard explained that it would be impossible for GSK to assure the public that its product was “free from contamination and made according to the drug formula registered with the FDA,” the site reports.
The managing partner of the firm that filed the lawsuit explains this case will “change the way that drug companies run their factories,” by holding them much more accountable. “Now every employee who works with manufacturing issues — from quality assurance executives like Cheryl Eckard to machine operators — has a viable option if they have evidence that management is putting profits ahead of patient safety by letting bad products out the door,” he said.
“Drug manufacturing is vulnerable to abuse because consumers can’t see the defects,” and that “Once the pill is swallowed, it’s gone and there may be no way of telling whether someone got sick because the product was bad,” according to the firm that filed the lawsuit. Now, that firm explains, drug manufacturers will “have more reason to live up to their motto that patient safety is their first priority.”
References:
Getnick & Getnick LLP. (October 26, 2010) “GlaxoSmithKline Pays $750 Million for Fraud on Medicaid: Getnick & Getnick LLP Announces First Whistleblower Recovery for Pharmaceutical Manufacturing Violations.” Retrieved on October 27, 2010 from Market Watch.