By Emily Cox
The judge presiding over all federal Zofran birth defect lawsuits has struck down the drug maker’s attempt to have certain fraud-based claims dismissed, ruling that plaintiff allegations were sufficient to proceed on the basis that pregnancy warnings for the anti-nausea drug were false and misleading.
Judge Dennis Saylor filed the memorandum and order Monday in the District of Massachusetts. The order denied Zofran maker GlaxoSmithKline’s (GSK) motion to dismiss plaintiffs’ fraud claims. Judge Saylor acknowledged that the plaintiffs’ didn’t have grounds to claim fraud based on the drug maker’s marketing and advertising. He also noted that there were no allegations that specific GSK representatives had made false statements to prescribing physicians. Regardless, he found that fraud allegations based on product labeling satisfied federal rules’ mandates.
“Here, the master complaints allege generally that plaintiffs and their physicians relied on the misrepresentation in the label in prescribing and ingesting Zofran and/or ondansetron,” wrote Judge Saylor. “In this context, at least, that is sufficient. Pharmaceutical product labeling is highly regulated, and its very purpose is to advise prescribing physicians, who may reasonably rely on the representations in such labeling. Whether a particular physician did, in fact, rely on the representations in the labeling is of course a question of fact that cannot be resolved on the pleadings.”
Zofran Birth Defect Risk
Zofran is an anti-nausea medication. It works by inhibiting the body’s serotonin signaling. However, serotonin signaling regulates processes that are critical to normal embryonic development. Consequently, it has been linked to reports of children born with cleft palate and lip. It can also cause atrial septal defects, ventricular septal defects, and other birth defects.
According to at least 364 lawsuits, GSK knew and concealed the birth defect risk for decades. These complaints allege that GSK discovered the birth defect risk during pre-clinical studies in the 1980s. These studies showed that Zofran crosses the placental barrier during mammalian pregnancy, exposing the fetus to the drug. This exposure revealed clinical signs of toxicity. This led to intrauterine fetal deaths, stillbirths, congenital heart defects, craniofacial defections, incomplete bone growth, and other birth defects. Subsequent research has confirmed that Zofran also crosses this barrier during human pregnancy.
Allegedly, from 1992 to the present, there have been reports of Zofran birth defect risks that GSK was aware of.
Despite mounting scientific evidence that Zofran could cause harm to unborn children, GSK allegedly launched marketing scheme in 1997 to promote Zofran to obstetrics and gynecology doctors and patients as a safe and effective treatment for pregnancy-related nausea and vomiting. As a result of its aggressive marketing campaign, Zofran became the most frequently prescribed drug for treating pregnancy-related nausea and vomiting in the United States by 2002. However, GSK never warned of the substantial risk the drug posed to unborn children.
Zofran Birth Defect Study Statistics
In November 2011, Birth Defects Research Part A: Clinical and Molecular Teratology published a cleft palate study. It showed Zofran may increase the risk for cleft palate by 2.37 times.
A 2013 review of 900,000 pregnancies’ data in the Danish Medical Birth Registry concluded that children were two to four times more likely to suffer a septal defect, involving holes in the heart, if their mothers had taken Zofran during pregnancy.
Reproductive Toxicology published a study in October 2014 that found that there was a 62 percent increase in risk for certain heart defects with early pregnancy Zofran use.