PHOENIX (Thursday, June 23., 2011) -- Attorney General Tom Horne announced today that he, 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 alleged substandard manufacturing processes.
In a complaint filed today along with the settlement agreement, Horne alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of Kytril (a sterile drug used to prevent nausea and vomiting caused by cancer chemotherapy and radiation therapy), Bactroban (an antibiotic ointment used to treat skin infections), Paxil CR (the controlled release formulation of the popular antidepressant drug, Paxil), and Avandamet (a combination Type II diabetes drug) that were adulterated because the manufacturing processes used to produce these lots were substandard.
“When people are in need of pharmaceutical drugs, they have an expectation that those medications meet or exceed all industry and government standards,” Horne said. “The companies involved in this action failed to provide the safest and highest-quality products to their customers, which I characterize as a serious breach of the public trust. The makers of pharmaceutical drugs have an enormous responsibility to their customers. This settlement will serve as a reminder that they must live up to that responsibility.”
GSK and SB Pharmco are no longer manufacturing drugs at their Cidra facility, which has been closed since 2009. As a result of the settlement, GSK and SB Pharmco are enjoined from making false, misleading or deceptive claims regarding the manufacturing of all drugs 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 there is no current cause for concern regarding the drugs covered by this agreement because all adulterated batches have been recalled for many years and/or the products’ expiration date is past. If consumers do have concerns they should contact their health care provider.
The Attorneys General of the following states and the District of Columbia participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, 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.
Assistant Attorney General Noreen Matts handled the case for the Attorney General’s Public Advocacy Division.