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Zofran Lawsuit Alleges Death of One Child, Permanent Birth Defects in Another

462411351A Zofran heart defect lawsuit recently filed in U.S. District Court in Delaware alleges use of Zofran to treat morning sickness during pregnancy resulted in severe birth defects in two of the plaintiff’s children. The first child died of her defects less than a month after her birth, while the second child is suffering with permanent kidney defects. The plaintiff further claims that had she been aware of the risks associated with Zofran, she would not have exposed her unborn children to such dangers.

Zofran injury lawsuits growing

The lawsuit, which was filed in the District of Delaware on July 24, 2015, joins a growing number of similar complaints against Zofran manufacturer GlaxoSmithKline. Plaintiffs are alleging that prescribing this drug off-label to treat morning sickness during pregnancy has resulted in a host of congenital birth defects in their children. Plaintiffs are further stating that the risks of taking Zofran during pregnancy have not been disclosed by the company, even though studies have indicated the drug could lead to severe defects while babies are still in utero.

The plaintiff in this lawsuit claims she became pregnant around November 2000. When she began to suffer with morning sickness, her physicians prescribed Zofran to treat the nausea and vomiting. The plaintiff began taking the drug in January 2001, while still in her first trimester of her pregnancy.

When the plaintiff went in for diagnostic testing at around 20 weeks of pregnancy, she was told her unborn child had “severe and life-threatening” heart defects. When the child was born, she was immediately taken to another hospital, where she was placed on a ventilator in the NICU unit. The child died on August 2, 2000, less than one month after her birth.

More birth defects in second pregnancy

The plaintiff became pregnant again in 2002, and once again she was prescribed Zofran for morning sickness. When this child was delivered on February 18, 2003, she suffered from vomiting, reflux and the inability to retain necessary nutrition. This child also required an extended hospital stay and continues to suffer the effects of congenital kidney defects to this day.

In her drug injury lawsuit, the plaintiff claims she could not have known about the potential risks associated with Zofran when she took the drug during both of her pregnancies. The plaintiff attributes this to the fact that GlaxoSmithKline “misrepresented” the safety of their drug to the medical community and the general public. Despite the fact that the company actively marketed this drug for use in pregnant women, no studies had demonstrated the drug’s safety for pregnant women or their unborn children.

Zofran MDL under consideration

With the increasing number of similar lawsuits filed, coordination of litigation is now under consideration by the U.S. Judicial Panel for Multidistrict Litigation. If an MDL is established, this case and other federal lawsuits may be centralized in a single location for the purpose of streamlining early court proceedings. MDLs are used to create a more efficient legal process by eliminating duplicate discovery and conflicting rulings.

Like others that have filed complaints alleging a causal link between Zofran and birth defects, this plaintiff is seeking compensatory, punitive and general damages from GlaxoSmithKline for medical, hospital and funeral expenses, as well as non-economic losses.

  1. U.S. National Library of Medicine, Use of Ondansetron during Pregnancy and Congenital Malformations in the Infant,

  2. The Toronto Star, Birth Defects Blamed on Unapproved Morning Sickness Treatment,

  3. Fertility Centers of New England, FDA Warns against Zofran Use during Pregnancy,