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GlaxoSmithKline is asking the U.S. District Judge presiding over all federal Zofran lawsuits to dismiss claims brought by families of children born with serious birth defects, arguing that federal regulators rejected potential warnings about the pregnancy risks associated with the anti-nausea drug.
There are currently more than 450 product liability lawsuits over Zofran pending in the federal court system, each raising similar allegations that the drug maker failed to adequately warn women and doctors about the potential side effects of Zofran during pregnancy.
The drug has been commonly prescribed “off-label” for symptoms of morning sickness, and lawsuits allege that exposure to the drug during pregnancy caused children to be born with cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other congenital malformations.
Given the similar questions of fact and law presented in the litigation, cases filed in U.S. District Courts nationwide have been centralized for coordinated pretrial proceedings before U.S. District Judge Dennis Saylor in the District of Massachusetts, to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses and the judicial system.
On July 19, GlaxoSmithKline filed a motion for summary judgment (PDF), calling for all of the failure to warn lawsuits filed by families nationwide to be dismissed. The motion claims that the FDA rejected a birth defect warning for Zofran, arguing that prevented the company from strengthen its label warnings.
“FDA controls what information should or should not be included in a drug manufacturer’s label. Here, FDA has directly considered – twice in the last three years – whether GSK’s Zofran label should advise patients and prescribers that use of Zofran during pregnancy can cause birth defects,” the motion states. “On both occasions, FDA concluded that there is insufficient scientific support for a Zofran birth defect warning.”
The motion alleges the FDA decision should preempt the failure to warn lawsuits.
Families allege that GlaxoSmithKline knew or should have known about the Zofran pregnancy risks for much longer than the last three years, yet withheld critical safety information, failed to warn doctors or consumers against use of the drug to treat morning sickness, and actively promoted the use during pregnancy, which was never approved by the FDA.
As early as 2006, plaintiffs note that studies have found that Zofran crosses the placenta in significant amounts when taken by pregnant women, with Hong Kong researchers concluding that the “developmental significance of this drug exposure requires further investigation.”
In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.
In August 2013, another study highlighted a potential risk of heart defects with Zofran, following a review of data involving more than 900,000 pregnancies in the Danish Medical Birth Registry. Researchers found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.
A study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.
If the claims survive the motion for summary judgment, GlaxoSmithKline may face hundreds of individual trials if Zofran settlements are not reached for children left with birth defects following exposure to the drug.