A Michigan couple has filed a new Zofran lawsuit, after one of their children died as a result of heart defects allegedly related to the mother’s use of the medication. The complaint also claims that the couple’s surviving twin continues to suffer as a result of Zofran-related birth defects.
According to the June 8th filing in the U.S. District Court, District of Massachusetts, the couple’s twins were born in 2014. Beginning in her first semester and continuing throughout her pregnancy, their mother took a generic bioequivalent of the drug Zofran to treat severe morning sickness.
The children were delivered via C-section. Sadly, one did not survive the procedure and was stillborn. That baby suffered from multiple heart birth defects, as well as other abnormalities impacted the kidneys, liver, pancreas and adrenal glands. The surviving twin was diagnosed with an anterior muscular ventricle septal defect and other heart problems, and may require future surgeries and medical treatment, as well as monitoring.
The parents allege that prenatal exposure to Zofran was the direct and proximate cause of the babies’ abnormalities. The complaint further claims that GlaxoSmithKline has long-concealed reports and studies linking Zofran to birth defects
“In the 1980s and 1990s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses,” the lawsuit indicates. “A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta barrier and exposed fetuses to substantial concentrations. GSK did not disclose this material information to pregnant women or their physicians.”
Plaintiffs also allege that Glaxo has wrongly marketed Zofran as a safe and effective treatment for pregnancy-related nausea and vomiting, even though the drug has never been approved for this use. In fact, the lawsuit points out that the company has never conducted a single test to ensure its safety for pregnant women.
Court documents indicate that 250 similar Zofran lawsuits are now pending in the District of Massachusetts, where all federally-filed birth defects claims involving the medication have been centralized for coordinated pretrial proceedings. However, some legal experts believe that the litigation may eventually involve thousands of cases, considering the widespread use of Zofran as an off-label remedy for morning sickness