Zofran Hypospadias

Several reports and studies have linked pre-natal exposure to Zofran to hypospadias, a urethral abnormality that affects baby boys. A growing number of Zofran lawsuit filings claim that the drug’s manufacturer concealed its association with this and other birth defects.

Zofran Legal Investigation

Bernstein Liebhard LLP is now offer free legal reviews to families throughout the U.S. whose child may have been born with a Zofran-related birth defect. If your baby boy was diagnosed with hypospadias, and his mother was treated with Zofran in the first trimester of pregnancy, please call (888) 994-5118 to learn more about your legal rights.

What is Hypospadias?

Hypospadias is a congenital abnormality in which the opening of the urethra is not located at the tip of the penis. Hypospadias may occur as one of three types:

  • Subcoronal: The urethral opening is located somewhere near the head of the penis.
  • Midshaft: The opening of the urethra is located along the shaft of the penis.
  • Penoscrotal: The opening is located where the penis and scrotum meet.

It is estimated that each year about 5 of every 1,000 infant boys born in the U.S. have hypospadias.

The cause of hypospadias is not known. However, some risk factors have been identified:

  • Age and weight: Women 35 or older and who were considered obese are more likely to have a baby with hypospadias.
  • Fertility treatments: Hypospadias is more common in boys whose mother used assisted reproductive technology to become pregnant.
  • Certain hormones: The use of certain hormones just before or during pregnancy appears to increase the risk of having baby with hypospadias.

Hypospadias Treatment

Children with untreated hypospadias may have difficulty learning how to go to the toilet properly. In adulthood, they may experience issues with sexual function. In most cases, a boy with hypospadias will undergo surgery to correct the defect between the ages of ages of 3–18 months. Sometimes, the surgery will take place in stages. Because the foreskin might be needed to correct the defect, a baby boy with hypospadias should not be circumcised.

Zofran and Hypospadias

The urethra develops during the first trimester of gestation. Millions of expectant mothers have been prescribed Zofran during this same time period to treat nausea and vomiting associated with pregnancy. Recently, reports have suggested that use of Zofran in the first trimester increases the risk that a baby will be born with a major birth defect, including hypospadias.

  • 2004: An analysis of data on 176 women who took Zofran during the first trimester of pregnancy found that six gave birth to a child with a major birth defect. Three of these babies were born with mild-to-moderate hypospadias. However, the sampling was too small to conclude that Zofran increased the risk of the hypospadias, even though rate of the condition was higher than what is seen in the general population.

Zofran Litigation

More and more families are filing Zofran lawsuits on behalf of children who allegedly suffered birth defects following first-trimester exposure to the drug. These plaintiffs claim that GlaxoSmithKline received numerous reports of birth defects potentially associated with Zofran, but withheld this information from the public and medical community. The company is also accused of aggressively marketing Zofran as an appropriate treatment for morning sickness, even thought the medication has never been approved for this purposes. Read More

October 2015: Dozens of Zofran lawsuits have been centralized in the U.S. District Court, District of Massachusetts, for the purposes of coordinated pretrial proceedings. By November 2015, more than 100 such cases had been filed in the proceeding. Read More

Should I File a Zofran Lawsuit?

You may be able to file a Zofran lawsuit if your child was born with hypospadias following pre-natal exposure to the anti-nausea drug. To learn if you qualify, please contact Bernstein Liebhard LLP today by calling (888) 994-5118.

  1. CDC (2015) “Fact About Hypospadias” http://www.cdc.gov/ncbddd/birthdefects/hypospadias.html
  2. BJOG (2004) “The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study.” http://www.ncbi.nlm.nih.gov/pubmed/15327608
Last Modified: December 11, 2015

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