– Attorney General Paula T. Dow announced
today that New Jersey has entered into a
multi-state settlement agreement with GlaxoSmithKline
and a subsidiary, SB Pharmco Puerto Rico,
Inc., that resolves allegations the companies
sold drugs that were adulterated during
faulty manufacturing processes.
terms of the settlement, 38 states will
share in the total settlement payout of
$40.75 million. New Jersey will receive
approximately $1.1 million.
is an important settlement for all New Jersey
residents because we are all, at one time
or another, health care consumers,”
said Attorney General Dow. “Drug manufacturers
have a responsibility to engage in strict
quality control, and to ensure the products
they send to market are pure and unadulterated.
We are committed to ensuring they meet that
a Complaint filed in Superior Court in Mercer
County today along with the Final Consent
Judgment, the State alleges that GlaxoSmithKline
and SB Pharmco engaged in unfair and deceptive
practices between 2001 and 2004 when they
manufactured and distributed certain lots
of four prescription drugs: Kytril, a sterile
drug used to prevent nausea and vomiting
caused by cancer chemotherapy and radiation
therapy; Paxil CR, a controlled-release
formulation of the popular antidepressant
drug, Paxil; Avandamet, a combination Type
II diabetes drug, and Bactroban, an antibiotic
ointment used to treat skin infections.
Specific lots of the four drugs at issue
– all of which were recalled from
the market years ago -- were alleged to
have been adulterated because the manufacturing
processes at a GlaxoSmithKline and SB Pharmco
facility in Cidra, Puerto Rico, were substandard.
The Cidra facility was closed in 2009.
a result of the settlement announced today,
GlaxoSmithKline and SB Pharmco are enjoined
from making false, misleading or deceptive
claims about the manufacturing of drugs
formerly made at the Cidra location. In
addition, the companies must not misrepresent
the drugs’ characteristics, or contribute
to confusion or misunderstanding about the
way they were manufactured.
General Dow noted that there is no current
cause for concern regarding the drugs covered
by the GlaxoSmithKline agreement, because
all adulterated batches were recalled many
years ago. However, if consumers do have
concerns, they should contact their health
In addition to New Jersey, the following
states 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, Oregon, Pennsylvania, Rhode Island,
South Dakota, Tennessee, Texas, Vermont,
Washington, West Virginia and Wisconsin.
Deputy Attorney General Alina Wells, assigned
to the Division of Law’s Consumer
Fraud Prosecution Section, handled the GlaxoSmithKline
matter on behalf of the State.