AG Van Hollen: Van Hollen and 37 state attorneys general reach $40.75 million settlement with GlaxoSmithKline and SB Pharmco

For More Information Contact:

Bill Cosh

608/266-1221

Wisconsin to receive $922,494.00

MADISON – Attorney General J.B. Van Hollen announced today that he, along with 37 other state Attorneys General, 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, Attorney General Van Hollen alleged that GSK and SB Pharmco engaged in untrue, deceptive, or misleading 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.

“Adulterated drugs have the potential of exposing patients to substandard or ineffective drugs, or worse, negatively impacting a patient’s health,” said Attorney General Van Hollen. “The Wisconsin Department of Justice will continue to work with other states to hold pharmaceutical companies accountable for this type of conduct and protect consumers from these types of deceptive trade practices.”

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.

Illinois Attorney General, Lisa Madigan and Oregon Attorney General, John Kroger led the investigation into GSK and SB Pharmco’s manufacturing practices. 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 Lara Sutherlin handled the case for the State of Wisconsin.

A copy of the complaint and the consent judgement are available at:

http://www.doj.state.wi.us/news/files/complaintfiled.pdf

http://www.doj.state.wi.us/news/files/UnsignedConsentJudgmentFinal.pdf