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Zofran is a prescription medication manufactured by GlaxoSmithKline (GSK) that was originally approved by the FDA in 1991 to treat chemotherapy induced nausea and vomiting. Since its introduction into the market, Zofran has become a common prescription used by pregnant women in the first trimester to quell the side effects of morning sickness. However, the use of Zofran in pregnant women was not approved by the FDA and there was never adequate information about the drug’s safety to indicate Zofran could be used safely in pregnant women.
In 2012, a Justice Department investigation occurred regarding GSK, the manufacturers of Zofran. As a result of the investigation, GSK settled civil claims for $2 billion and criminal claims for $1 billion related to allegations concerning their illegal promotion of Zofran and other drugs.
GSK admitted that during the time period of January 2002 through December 2004 it
· Promoted the sale of Zofran for unapproved uses, specifically for nausea in pregnant women;
· Made fictitious representations about the effectiveness and safety of Zofran in pregnant women; and
· Offered and paid illegal kickbacks to doctors for promoting Zofran.
You can read the full allegations and settlement agreement from the Department of Justice here.
The Manchin Injury Law Group is actively pursuing claims for individuals who have been harmed due to the ingestion of Zofran and suffered birth defects as a result of such usage. If you or a loved one has been injured due to the ingestion of Zofran, call us immediately at 1-800-557-4LAW or email us for a free consultation