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.
Jack D. Lebowitz
Vadim A. Mzhen
