BALTIMORE (June 23, 2011)—Attorney General Douglas F. Gansler announced today that his Consumer Protection Division, along with 37 other state Attorneys General, have reached a $40.75 million settlement with GlaxoSmithKline, LLC (GSK) and SB Pharmco Puerto Rico, Inc. (SB Pharmco) arising from allegedly substandard manufacturing processes at a plant in Cidra, Puerto Rico.
The complaint alleges that the lots of certain drugs were adulterated because the manufacturing processes used to produce these lots were substandard and resulted in product mix-ups and false representations of product identity, strength, quality and purity.
Consumers, especially those whose health is already compromised, should be able to rely on the safety of the drugs they take and the safety and quality control systems used in the drug manufacturing processes, said Attorney General Gansler. Fortunately, the affected drug lots have long since been recalled. However, any consumer who has concerns about these medications should talk with their health care provider.
In the complaint that accompanies the consent order filed today, Attorney General Gansler alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of Kytril (a drug used to prevent nausea and vomiting caused by chemotherapy and radiation therapy), Bactroban (an antibiotic ointment used to treat skin infections), Paxil CR (the controlled-release formulation of the antidepressant drug, Paxil), and Avandamet (a combination type 2 diabetes drug).
GSK and SB Pharmco are no longer manufacturing drugs at their Cidra facility, which closed in 2009. In 2010, SB Pharmco pled guilty to federal charges of introducing adulterated products into trade or commerce stemming from manufacturing practices at the Cidra plant in 2003 and 2004. As a result of todays settlement with the Attorneys General, GSK and SB Pharmco are enjoined from making false, misleading or deceptive claims regarding the manufacturing of any drug that was formerly manufactured at the Cidra facility, regardless of where these drugs are now produced. In addition, the companies must not misrepresent those drugs characteristics, or cause likelihood of confusion or of misunderstanding about the way in which they are manufactured.
Consumers should note that the batches of drugs found by the federal government to have been adulterated were recalled years ago and are past their expiration dates.
The Attorneys General of the following states and the District of Columbia participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
Attorney General Ganslers office was on the Executive Committee, led by Illinois and Oregon, which investigated the case and negotiated the agreement on behalf of the group.
Source: Office of Attorney General Douglas F. Gansler