Attorney General Kamala D. Harris and 37 Other Attorneys General Announce $40.75 Million Settlement over Allegations of Substandard Drug Manufacturing Processes

Friday, June 24, 2011
Contact: (415) 703-5837, agpressoffice@doj.ca.gov

SACRAMENTO --- Attorney General Kamala D. Harris and 37 other attorneys general announced a $40.75 million settlement with GlaxoSmithKline, LLC and SB Pharmco Puerto Rico, Inc. for alleged substandard drug manufacturing processes.

The settlement resolves allegations that GlaxoSmithKline and its subsidiary in Puerto Rico engaged in unfair and deceptive practices when they manufactured and distributed certain lots of drugs, which were adulterated because the manufacturing processes used to produce them were substandard.

“Consumers shouldn’t need to wonder if the drugs prescribed by their doctors are safe,” said Attorney General Harris. “This settlement resolves an unacceptable and potentially dangerous practice of GlaxoSmithKline and underscores my commitment to protecting the health and well-being of Californians.”

The drugs include: 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 form of Paxil, the popular antidepressant drug; and, Avandamet, a combination Type II diabetes drug.

GlaxoSmithKline and SB Pharmco no longer manufacture drugs at the facility in Puerto Rico, which closed in 2009. Consumers should be aware that there is no current cause for concern regarding the drugs covered by this agreement because the adulterated batches have been recalled for many years and/or the products’ expiration dates have passed. If consumers do have concerns, they should contact their health care provider.

As part of the settlement, GlaxoSmithKline and SB Pharmco agreed not to make false, misleading or deceptive claims regarding the manufacturing of all drugs formerly manufactured at the Puerto Rico facility – regardless of where these drugs are now produced. In addition, the companies must not misrepresent the characteristics of those drugs, or describe them in ways likely to cause confusion or misunderstanding about the way in which they are manufactured.

Illinois Attorney General Lisa Madigan and Oregon Attorney General John Kroger led the investigation into GlaxoSmithKline and SB Pharmco’s manufacturing practices.

States joining California, Illinois, Oregon and the District of Columbia in today’s settlement include Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

Supervising Deputy Attorney General Daniel Olivas and Deputy Attorney General Judith Fiorentini handled the case for Attorney General Harris’ Consumer Law section. California will receive more than $3.3 million from the settlement, the largest share among the states.

Copies of the complaint and settlement are attached to the online version of this release at ag.ca.gov.

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AttachmentSize
PDF icon Complaint1.19 MB
PDF icon Stipulation4.75 MB
PDF icon Final Judgement2.28 MB