As a Dallas personal injury attorney and a Texas medical doctor, I have seen my fair share of birth defects. Recently, my attention was drawn to Zofran and the parents who blame the anti-nausea medication for a whole slew of Zofran birth defects in their children.
According to Julie Hunter, her son has chromosomal defects from her use of Zofran during the first trimester. Hunter took the medication for morning sickness. Hunter filed her claim in the U.S. District Court for the Northern District of Alabama.
Hunter’s son, Talon, has a high narrow palate, extra fingers, enlarged kidney, glaucoma, and a urethral abnormality. He has seizures, is nonverbal and exhibits delayed reactions.
Talon was diagnosed with a chromosomal defect, involving a duplication of the long arm of his 13th chromosome, which according to experts are the cause of the birth defects.
There are several Zofran birth defect lawsuits filed recently against the drug manufacturer, GlaxoSmithKline, (GSK).
The lawsuits share similar allegations, that GSK illegally pushed their anti-nausea and vomiting drug for use among pregnant women, off-label. In other words, Zofran is not approved by the FDA for use among pregnant women.
Alarm About Zofran Birth Defects
The FDA has approved Zofran (ondansetron) for treatment of nausea and vomiting for cancer and surgery patients.
Many medical studies have indicated potential Zofran birth defect risks when the drug is used in the first trimester.
In 2006, a Hong Kong study noted that Zofran crosses the placenta in significant amounts when taken by pregnant women.
Zofran Cleft Lip, Cleft Palate
In 2011, in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology indicated that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use.
Cleft palate causes children to have a serious facial deformity, when development of the fetus is affected during the first trimester.
Zofran Heart Defects
In 2013, a study by the Danish Medical Birth Registry, indicated that children exposed to Zofran may be 2 to 4 times more likely to suffer a septal defect, or holes in the heart.
In 2014, a study in the medical journal Reproductive Toxicology noted that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.
GlaxoSmithKline: No Warning Label Change
According to the lawsuits, GSK has not researched or investigated the risks or updated the warning label to warn pregnant women and the doctors about the birth defect risks.
GSK Zofran Settlement for Illegal Marketing
Doctors are allowed to prescribe Zofran for morning sickness for their pregnant women patients. But, it is illegal for GSK to promote such off-label use, since the commpany has not demonstrated that it is effective among pregnant women or safe for unborn babies during pregnancy.
In 2012, GSK paid $3 billion to settle a criminal investigation involving the off-label promotion for pregnancy use of Zofran, as well as other illegal drug marketing and withholding safety data from U.S. regulators. GSK allegedly offered and paid illegal kickbacks to doctors to encourage them to prescribe Zofran to pregnant women.
The U.S. Department of Justice noted that the settlement is the “largest health-care fraud settlement in U.S. history.”
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.