Southern Med Law Discusses Studies Cited in Numerous Zofran Lawsuit Claims That Link the Anti-Nausea Drug to Serious Birth Defects, Including Heart Defects, Oral Clefts
Court records indicate that numerous Zofran lawsuit claims have been filed in recent months that allege use of the anti-nausea medication during pregnancy can increase the risk that a baby will be born with a serious birth defect. According to Southern Med Law, these allegations are backed by several recent studies that link the drug to serious birth defects, including heart defects and oral clefts.
Zofran (ondansetron) is indicated to treat nausea and vomiting related to surgery, chemotherapy and radiation therapy. Despite the fact that the anti-nausea drug, Zofran has never been approved to treat morning sickness in expectant mothers, a recent analysis indicated that more than 1 million women annually have been prescribed some form of ondansetron off-label to treat nausea and vomiting related to pregnancy.
Court records indicate that one of the first Zofran lawsuits involving birth defect allegations was filed on February 16, 2015 in the U.S. District Court, District of Massachusetts. Among other things, the complaint claims that as early as the 1980s, GlaxoSmithKline had evidence from four animal studies that indicated that the active ingredient in Zofran could cross the placental barrier. The plaintiff asserts that the company should have taken further steps to investigate Zofran’s effects on a developing pregnancy based on these findings. (Case 1:15-cv-10429)
Like other Zofran lawsuits, this complaint cites recent epidemiological studies investigating the drug’s potential association with birth defects. In August 2013, for example, scientists using data from a Danish health registry concluded that women who took Zofran during the first trimester of pregnancy were 30% more likely to have a baby with a major birth defect. Swedish researchers supported these results, finding that babies exposed to Zofran were 1.62 times more likely to be born with congenital heart defects.
(ajog.org/article/S0002-9378%2814%2900853-9/fulltext, American Journal of Obstetrics and Gynecology, August 17, 2014)
[ncbi.nlm.nih.gov/pubmed/25450422, Reproductive Toxicology, December 2014]
“The findings presented in this and other Zofran lawsuits are compelling, and do indicate that there is cause for concern. Expectant mothers who might be considering Zofran to control morning sickness should understand that the drug has not been well-studied in pregnancy. Furthermore, they should be fully apprised of its potential risk before beginning treatment,” Dr. François Blaudeau, the founder of Southern Med Law. As both a practicing gynecologist and attorney, Dr. Blaudeau, possesses a unique perspective regarding the medical and legal questions relating to Zofran birth defect claims.
Southern Med Law is currently evaluating potential Zofran lawsuits on behalf of families who believe their child was born with a birth defect due to this medication. To learn more about the litigation involving Zofran and birth defects, please contact the Firm as soon as possible to learn more about your legal rights. You can arrange for a free, no obligation Zofran lawsuit review by calling Southern Med Law today, at 205-547-5525.
About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
Southern Institute for Medical and Legal Affairs
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Birmingham, AL 35203
Phone: (205) 547-5525
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