New Zofran Birth Defect Lawsuit Alleges Zofran Caused Two Children’s Heart Defects

Zofranlegal.com has reported that a family in Minnesota has filed a lawsuit against GlaxoSmithKline, alleging that both of their sons were born with cardiac defects as a result of their mother taking Zofran during her pregnancies.

Zofran, an anti-nausea drug, was promoted “off-label” by GlaxoSmithKline for use in pregnant women to treat morning sickness. The FDA had approved Zofran in 1991 to treat nausea in patients receiving chemotherapy and radiation treatments and also in patients experincing nausea after surgery, but had never approved the drug for use in pregnant women. The drug was labeled a Category B drug, which indicated that not enough human clinical trials had been performed to determine the safety of the drug for use in pregnant women.

The lawsuit, filed in the United States District Court of the Eastern District of Pennsylvania, alleges that “As a direct and proximate result of GSK’s conduct, the plaintiffs have suffered and incurred harm including severe and permanent pain and suffering, mental anguish, medical expenses, and other economic and noneconomic damages, and will require more constant and continuous medical monitoring and treatment than had they not been exposed to Zofran.” The mother, in this case, was prescribed Zofran during the first trimester of both of her pregnancies. Her first son was born in 2004 and her second son was born in 2006. Both children were born prematurely and both were diagnosed with congenital heart defects after their birth.

By 2000, GSK had been notified of 32 cases of birth defects in children born to women who had been prescribed Zofran, but did not inform the medical community or the public of this knowledge. The most common birth defects reported are an atrial septal defect, ventricular septal defect, heart murmurs, cleft palate, cleft lip, and renal defects. While the FDA has not released an official warning regarding Zofran birth defects, there have been multiple studies performed which suggest there is an increased risk when pregnant mothers are prescribed the drug.

In 2012, GSK settled a lawsuit with the U.S. Justice Department which alleged that GSK had promoted several medications, including Zofran, for “off-label” use. In the settlement GSK agreed to pay a total sum of three billion dollars.

For more information regarding this press release contact Michael Monheit, Esquire of ZofranLegal.com at 877-620-8411.