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Zofran Birth Defect Lawsuit Cases Are Reviewed In Fox News Boston Article reports on news recently released by which takes a closer look at the lawsuits surrounding anti-nausea medication Zofran and reviews its potential lack of safety for use by expectant mothers. The report follows a recent surge in lawsuits filed against GlaxoSmithKline, the manufacturer of Zofran, which all commonly allege that fetal exposure to the drug can cause unborn babies to develop a broad range of serious, and sometimes fatal, congenital birth defects.

The U.S. Judicial Panel on Multidistrict Litigation has consolidated these mounting cases to a single court in Boston, Massachusetts, in an attempt to help the litigation process move more smoothly. Defects which have been linked to Zofran by parents filing lawsuits are cleft lip and palate, clubfoot, atrial septal defect and ventricular septal defect, transposition of the greater vessels, tetralogy of fallot, and kidney defects.

The Fox article explains the frequency with which Zofran has been given to pregnant women to treat nausea and vomiting associated with morning sickness, although the drug was never FDA-approved for this use. Instead, the drug was specifically approved to treat patients battling nausea after undergoing chemotherapy, radiation, or anesthesia treatments. This approval was given in the 1990’s, however, just after this approval, GSK made the controversial decision to market the drug “off-label” as a morning sickness treatment for expectant mothers. It was never tested for safety on these women or their unborn children before being promoted in this fashion.

Because of this marketing decision by GSK, the drug was subsequently prescribed “off-label” to an estimated 1 million pregnant women within one year’s time. Plaintiffs allege that GSK had potentially received hundreds of reports of children being born with defects after their mothers took Zofran, and yet neglected to warn the public about this potential side effect. The drug is generally prescribed in the first trimester, when morning sickness most often occurs, however, this is also a time when the fetus does much of its initial heart, mouth, and limb tissue development--a critical time in the growth process.

This Boston news story shares details of one plaintiff’s specific case, discussing a mother who took the drug while pregnant with her daughter. When the daughter was born, doctors quickly noticed that she was struggling to get air. After a quick medical evaluation, they discovered that she suffered from a congenital birth defect and would require life support and a feeding tube. They informed the mother that in order for her infant daughter to survive, she would require open heart surgery.

This is not the first time that pharmaceutical giant GlaxoSmithKline has stirred up public controversy over their marketing practices. In 2012, the company paid a $3 billion settlement with the United States Department of Justice because the DOJ stated that they were using “unlawful promotion” for their products and had shown “failure to report safety data” of several drugs, including Zofran.

The attorneys at Monheit Law are attempting to ensure that all pregnant women who were given Zofran and who subsequently gave birth to children with defects will be given the opportunity to investigate their legal rights fully. The mothers, fathers, and children involved may be entitled to significant compensation. At this time, Monheit Law is offering complimentary consultations for affected individuals.

To request additional information, or to ask questions, contact Attorney Michael Monheit by calling 877-620-8411.



Michael Monheit
1368 Barrowdale Road, Rydal, PA 19046

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