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Courts Consider Zofran Lawsuit Consolidation As More Lawsuits Are Filed

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Wilmington, DEAs more Zofran lawsuits alleging infants were born with cardiac defects after exposure to Zofran are filed, the US Judicial Panel on Multidistrict Litigation (JPML) is considering whether to consolidate the lawsuits for pretrial proceedings. Lawsuits allege Zofran has been prescribed off-label to treat morning sickness after GlaxoSmithKline marketed Zofran as a treatment for pregnancy-related nausea. But plaintiffs say the cost of using Zofran has been too high.

One lawsuit recently filed by the parents of two children who were born with birth defects, alleges both children’s birth defects were linked to the use of Zofran while the mother was pregnant. Furthermore, the lawsuit alleges, GlaxoSmithKline did not carry out a single study to determine whether Zofran would affect a growing fetus or pregnant mother before it began marketing Zofran for off-label use.

“GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus,” the lawsuit alleges.
“GSK knew as early as 1992 that Zofran presented ‘unreasonable risk of harm’ to developing babies because the drug passes through the human placenta.” Despite having this information - the lawsuit claims that by 2000, GlaxoSmithKline had 32 reports of birth defects linked to Zofran - GlaxoSmithKline marketed the drug to pregnant women through 2011. Among the reported side effects were congenital heart defects, intrauterine death, stillbirth and kidney malformation.

Although it is not illegal for doctors to prescribe medications off-label, it is illegal for companies to market their drugs for uses not approved by the FDA. Zofran is approved to prevent nausea and vomiting linked to chemotherapy, radiation or surgery. In 2012, the US Department of Justice announced that GlaxoSmithKline would pay more than $1 billion to settle claims concerning the illegal marketing of Zofran and other medications.

The results, the lawsuit argues, have been devastating. Sarah Hill, plaintiff in the lawsuit, gave birth to a baby girl in 2000. That girl was born with congenital heart defects - including a malformed aorta - and died within a month of being born. A second child was born in 2003, with congenital kidney defects. In both pregnancies, Hill was prescribed Zofran. She says had she known about the unreasonable risk of harm she would never have taken the medication.

Those risks, according to the lawsuit, include 2.37 times the risk of cleft palate, twice the risk of a heart defect and 20 percent increased risk of any birth defect. However, not all studies have found a link between the use of Zofran and the risk of major birth defects. A 2013 study published in The New England Journal of Medicine (2/28/13) found no significantly increased risk of spontaneous abortion, stillbirth or major birth defects when pregnant women used Zofran.

The lawsuit is Hill v. GlaxoSmithKline, case number 1:15-cv-00637-UNA, filed in US District Court for the District of Delaware.

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