Glaxo Pays $750M in Settlement for Violations in Pharmaceutical Drug Manufacturing

Our Washington D.C. pharmacy error injury attorneys have been following the recent announcement by the U.S. Department of Justice (DOJ) that GlaxoSmithKline (GSK), a research-based pharmaceutical and healthcare company, has agreed to pay the government $750 million in an effort to settle criminal and civil charges alleging that the company sold adulterated drug products to Medicaid and other government health plans, risking the health and safety of consumers.

Cheryl Eckard, a former Quality Assurance Manager for GSK, was reportedly assigned to visit the company’s Cidra, Puerto Rico plant in 2002 with a group of 100 experts and scientists to survey violations cited by the FDA in drug manufacturing. Eckard reportedly discovered major manufacturing and quality testing issues that went beyond the FDA violations, and that could have caused medication error or patient harm.

Deficiencies found in the plant include the release of a topical antibiotic Bacrtoban ointment used to treat skin infections on babies that contained microorganisms, and the production of the Kytril injection, used by cancer patients for nausea that was reportedly not sterile. Deficiencies were also found in the manufacturing of the antidepressant Paxil CR tablets, causing the drug to have the incorrect amounts of active ingredients. Another manufactured drug, Avandamet, a derivative of the drug Avandia, used to treat diabetes, were reportedly found to be superpotent and subpotent.

As the Cidra plant was reportedly GSK’s top manufacturing facility in the world at that time, bringing in $5.5 billion every year, Eckard found that GSK could not assure that they produced contamination-free products that were made in accordance to the drug formula registered with the FDA. She reportedly advised GSK managers to close the plant, and submitted an extensive report to the compliance department at GSK, who claimed her report was unsubstantiated.

Eckard then reported the drug manufacturing fraud to the FDA, and was subsequently fired from GSK in 2003. Eckard filed a whistleblower lawsuit in February 2004. The civil portion of the settlement, $600 million, resolves the charges that GSK released adulterated drug products, posing risks to the health and safety of consumers, and the $150 million pays the criminal fine.

In a written statement, GSK claimed that the company regrets that Cidra was inconsistent with current Good Manufacturing Practice (cGMP) requirements, and that GSK worked hard to resolve the medication errors associated with drug manufacturing before the plant was closed in 2009. The drug company claims they are committed to complying with cGMP, and have not received a letter of warning by the FDA at any facility since the closing of the facility.

According to Eckard’s attorney, as a result of GSK’s guilty plea and settlement, prescription drug manufacturers now have even more of a reason to make patient health and safety a top priority. Eckard reportedly stated that she felt coming forward with this information was important in an effort to maintain patient safety, and prevent any injury or harm.

Lebowitz and Mzhen Personal Injury Lawyers represent victims of pharmacy error injury in the Washington, D.C. area. Contact our attorneys today for a free consultation.

GlaxoSmithKline Pays $750 Million for Fraud on Medicaid: Getnick & Getnick LLP Announces First Whistleblower Recovery for Pharmaceutical Manufacturing Violations, Market Watch Press Release, October 26, 2010
GSK Completes Previously Reported Settlement with U.S. Department of Justice Regarding Former Manufacturing Plant, GlaxoSmithKline Press Release, October 26, 2010
Blowing the Whistle on Glaxo Means Record Payout for Former Employee, The Wall Street Journal, October 27, 2010

Related Web Resources:

U.S. Department of Justice, DOJ

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