ZofranLegal.com announced that on September 25th, 2015, the mother of a young boy filed a lawsuit in the U.S. District Court for the Central District of California under case number 8:15-cv-01552. The complaint names GlaxoSmithKline (GSK) as the defendant.
She alleges that because her son was exposed to Zofran in utero, he was born with a cleft palate. As a result, he has already required one surgery and will need several more in the future.
Zofran is an anti-nausea medication that was approved by the U.S. Food and Drug Administration (FDA) in 1991 for the treatment of nausea and vomiting in patients being treated with chemotherapy and radiation, or patients who have been under anesthesia. The drug was never approved for the treatment of morning sickness during pregnancy.
Nonetheless, GSK marketed Zofran “off-label” to both the public and medical community as a safe treatment for morning sickness. Doctors prescribed the drug to countless expectant mothers.
In 1999, the FDA sent GSK a letter, warning them that they were aware that the company had been marketing the drug “off-label” and that this practice did not adequately warn consumers of the risks associated with the drug. Years later, the U.S. Department of Justice filed a lawsuit against GSK, alleging that they had unlawfully promoted the use of several of their products “off-label”, including Zofran. In 2012, GSK agreed to a settlement and paid 3 billion dollars in fines.
Throughout the legal process, GSK also allegedly began to receive medical reports indicating that children born to mothers who took Zofran were born with birth defects. It wasn’t long before those mothers started filing lawsuits of their own. To date, there are more than 60 lawsuits filed, all alleging that Zofran caused a birth defect in an unborn child. Noted birth defects include cleft palate, cleft lip, transposition of the greater vessels, atrial septal defect, ventricular septal defect, and clubfoot.
Recently, the Judicial Panel on Multidistrict Litigation announced that they had agreed to consolidate all Zofran lawsuits into MDL 2657. Both the plaintiffs and defendant were in favor of this move because it will prevent duplicate discovery and expedite the legal process. The trials will be held in the District of Massachusetts under the Hon. Judge F. Dennis Saylor. This decision will not prevent anyone else from filing a lawsuit, in fact, lawsuit numbers are expected to continue growing.
Currently, the Monheit Law Firm is offering free consultations for anyone looking to explore their legal options in the pending litigation. Individuals who have used Zofran while pregnant and subsequently given birth to a child with defects may be entitled to compensation.
For additional information on this release, or to ask questions, contact Michael Monheit, Esq. by calling 877-620-8411.
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Contact ZofranLegal.com:
Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046
