A small but growing number of plaintiffs have filed Zofran birth defect lawsuits over allegations that they were not fully apprised of the health risks connected to their use of the anti-nausea drug as prescribed to treat morning sickness. As of early July, at least 12 such complaints have alleged that children have been born with such conditions as cleft lip and/or palate, heart problems, or skull malformations that can be traced to fetal exposure to Zofran.
Zofran (ondansetron) was approved by the FDA in 1991 as a treatment for nausea associated with chemotherapy, radiation, and post-surgery recovery, but was never officially approved as a morning sickness treatment.
The drug’s manufacturer (and defendant in all cases), GlaxoSmithKline (or GSK), filed a motion to consolidate all such cases in one court under one judge. Because the cases share common allegations, a streamlined discovery process and the establishment of “bellwether” (or preliminary) cases to test the waters in terms of jury reaction and encourage settlements may facilitate a speedier legal process. GSK has requested that a multidistrict litigation (or MDL) be established in the Eastern District of Pennsylvania under either Judge Cynthia Rufe or Judge Paul S. Diamond.
Safety of drug used during pregnancy at issue
Lawsuits contend that there have been indications for some time that Zofran may not be safe for use during pregnancy. A study published in 2006 by Hong Kong researchers supported the hypothesis that the drug crossed the placental barrier, opening the possibility that it could affect fetal heath and development. More recent surveys identified what appears to be a higher than average number of congenital defects in babies born to mothers who took Zofran to alleviate severe morning sickness.
Researchers emphasize that more studies need to be done to establish a direct causal link between Zofran and birth defects. A Birth Defects Research study published in 2011 suggested that an apparent 2.4-fold increase in cleft lip and/or palate incidences linked to Zofran use merits further study. A Danish Medical Birth Registry survey from 2013 found a rise in the numbers of heart defects in children born to mothers who used Zofran during pregnancy. The survey considered data related to 900,000 women.
Another survey of the FDA’s data regarding Canadian women who used Zofran while pregnant revealed a higher incidence of such birth defects or side effects as low birth weight, fetal death, kidney problems, and heart problems. The study was reported in the Toronto Star in 2014.
Zofran among drugs named in a U.S. Department of Justice settlement
In 2012, GSK agreed to pay $3 billion to the U.S. Department of Justice in order to settle multiple claims regarding fraud and other allegations related to their marketing of a number of medications, including Paxil, Wellbutrin, Advair, and others. The department reports that this settlement was the largest related to health care fraud in U.S. history at the time, and the largest dollar amount ever paid in such a context.
The settlement included both a criminal and civil portion. According to the DOJ, the civil settlement in part “resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”
Though agreeing to the settlement, GSK continues to deny any liability or wrongdoing in regard to the manufacture, distribution, or marketing of Zofran. The company denies that the drug poses risks to children in utero.
Filing a Zofran lawsuit
If you believe that your child may have suffered harm because you took Zofran to treat morning sickness during pregnancy, you may be eligible to pursue justice and monetary damages through the courts. The national product liability lawyers at Edelman, Krasin & Jaye have over 60 years of experience winning cases on behalf of the victims of big drug companies who put profit over public safety. Remember that if you or a loved one has been hurt by a defective drug or medical device, the law is on your side. Statutes of limitation set strict deadlines for when victims can file, so please call us today at 1-800-469-7429 for a free and confidential consultation.