Zofran, an anti-nausea medication made by GlaxoSmithKline (GSK), has been linked to birth defects in babies born to mothers who take the drug during pregnancy. Many of these problems occur in the kidneys, organs that produce urine and filter wastes from the blood.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a kidney defect after the mother took Zofran (ondansetron) while pregnant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Zofran and our lawyers can help.
Update: New Jersey Mother Alleges Daughter’s Kidney Defects from Zofran
August 3, 2016 – A woman from Hainesport, New Jersey, has filed a lawsuit alleging that her use of Zofran during pregnancy caused her daughter to be born with kidney defects including hydronephrosis, as well as an atrial septal defect (ASD) and a ventricular septal defect (VSD). Subsequent testing has failed to detect a genetic anomaly, and Plaintiff claims her family has no history of birth defects. The complaint was originally filed in the U.S. District Court of New Jersey in March, but later transferred to the Zofran multidistrict litigation (MDL) in Boston, where nearly 300 similar cases have been consolidated for pretrial handling.
What’s the Problem?
Expecting mothers do all they can to ensure their children are born healthy. However, the anti-nausea drug Zofran (generic: ondansetron) has often been prescribed “off-label” to pregnant women for the treatment of morning sickness. Unfortunately, when used for this purpose, Zofran may cause kidney defects and other serious congenital abnormalities.
Zofran Birth Defect Studies
In June 2014, a study published in the Toronto Star reported that Zofran could cause birth defects when taken by pregnant women. The study identified at least 20 Canadian women who had children with congenital defects after they took Zofran in pregnancy. Four of the babies weighed 4.5 lbs or less, and in 6 cases the defect was classified as fetal growth restriction. Other problems identified by the researchers included congenital kidney defects.
Kidney Defect Overview
Certain abnormalities may occur in the development of the kidneys or urinary tract in babies whose mothers use Zofran during pregnancy. In some cases, 1 or both kidneys may not develop correctly. In others, an abnormality may occur that blocks the outflow of urine, causing it to back up into the kidneys. This is called hydronephrosis, and causes the kidneys to appear enlarged on the ultrasound test.
Another common kidney-related birth defect is called reflux. This condition occurs when a mechanism near where the ureter joins the bladder does not work, causing urine to wash back up into the kidneys.
Australian Study Finds Increase In Kidney Defects
In Nov. 2013, a study was published in the journal BioMed Research International called “Off-Label Use of Ondansetron in Pregnancy in Western Australia”. The researchers looked at all birth records filed in Western Australia from 2002 to 2005. They then determined how many women had been prescribed Zofran through Australia’s Pharmaceutical Benefits Scheme (PBS), a federal program like Medicare in the U.S.
Of 96,968 live births, only 251 pregnant women were prescribed Zofran during that three year period. The study’s authors noted that Zofran users were typically of higher socioeconomic status, and thus could afford private health insurance. Since the research only included who were women enrolled in a public healthcare program, they suspect that “more pregnant women were diagnosed ondansetron as a private prescription.”
For the study, researchers compared the birth outcomes of women who took Zofran during pregnancy to those who had not. They found a “20% increased risk of a major birth defect amongst children exposed to ondansetron in the first trimester,” while acknowledging a relatively small sample size (251 live births) that prevented their findings from being more accurate. While “the study was too small to assess risks of individual birth defects,” the researchers also found a 7-fold increased risk for kidney defects associated with Zofran.
Kentucky Family Blames Zofran for Daughter’s Death from Kidney, Heart Defects
August 5, 2015 – A lawsuit filed today in the Pike County Circuit Court for the Commonwealth of Kentucky alleges that a woman’s use of Zofran during pregnancy caused her daughter to be born with catastrophic kidney and heart defects that led to her death at the age of 3 months. The complaint is the first to allege post-birth exposure to Zofran, since the family’s pediatrician allegedly prescribed the baby girl Zofran for vomiting the day before she died. Click here to learn more.
Zofran Kidney Defects Lawsuit Filed in North Dakota
A product liability lawsuit has been filed against GSK on behalf of a couple from Bismarck, North Dakota, who allege their son was born with severe kidney defects after the mother took Zofran for morning sickness during pregnancy. According to the complaint, the boy was born with only 1 kidney, malformation of the vas deferens, unspecified kidney damage, and absence of “connective kidney tissue,” which makes a kidney transplant impossible. Click here to read the article.
Texas Mom Claims Zofran Caused Death of One Daughter, Kidney Defects in Another
A Texas couple has filed a lawsuit against GSK alleging that the mother’s use of Zofran during pregnancy caused the death of their first daughter due to heart defects and severe kidney defects in their second. The plaintiffs are seeking damages in excess of $75,000 from GSK, as well as a label change regarding the risks involved with using Zofran during pregnancy. Click here to learn more.
Alabama Mother Sues GSK for Son’s Kidney Defects
A lawsuit filed July 26 in U.S. District Court Northern District of Alabama Southern Division alleges that a woman’s use of Zofran during pregnancy caused her son to be born in 2014 with hypoplastic left heart syndrome (HLHS) and an unspecified kidney defect. The baby’s doctor says there is no known genetic cause or family history for either condition, and the complaint alleges that Zofran is the direct cause of the boy’s defects. Click here to learn more.
North Dakota Couple Blames Zofran for Son’s Missing Kidney, Vas Deferens
A family from Bismarck, North Dakota has filed a lawsuit alleging that prenatal exposure to Zofran caused their son to be born without one kidney or a vas deferens, the tube that connects the testes with the urethra. According to the complaint, the boy’s lack of vas deference means he may never achieve normal sexual function, and the missing kidney has caused a “serious threat” to his “health and enjoyment of life.” Click here to learn more.
Do I Have a Zofran Kidney Defect Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently accepting new kidney defects cases in all 50 states.
Free Confidential Case Evaluation: Again, if your child or other loved one was born with a kidney defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.