TRENTON – New Jersey and 37 other states have entered a 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, state Attorney General Paula T. Dow announced.
Under 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.
“This is an important settlement for all New Jersey residents because we are all, at one time or another, health care consumers,” said 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 responsibility.”
The state alleged 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.
As a result of the settlement, 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.
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 care provider.
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.
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