Zofran Birth Defect Lawsuits Allege Heart Defects

Zofran Birth Defect Lawsuits Allege Heart Defects

Posted By Golomb & Honik, P.C. || 29-Oct-2015

In July 2015, two women filed lawsuits against the pharmaceutical giant GlaxoSmithKline. The lawsuits allege that their babies were born with congenital heart defects after the women took the medication Zofran during their pregnancies. They claim GlaxoSmithKline knowingly marketed this dangerous drug to OBGYNs though the drug was never approved for use in pregnancy.


The mothers, both residents of Ohio took Zofran during their first trimester of pregnancy in the mid-to-late 1990s; to help them combat the pregnancy-induced nausea and vomiting. Zofran, however, was never tested on pregnant women and was only approved in 1991 as a remedy for nausea and vomiting associated with chemotherapy.

The first Plaintiff claims that her daughter was born on July 3, 1999 and initially confined to the NICU with lung problems. For two years, her breathing problems did not improve – until she was finally diagnosed with a severe heart defect, known as an atrial septal defect. The defect had irreparably damaged the little girl's lungs and she would now require extensive open-heart surgery. Her heart defect is now repaired, but her breathing difficulties have continued because of the lung tissue damage.

The second Plaintiff claims that her daughter was born in 1999 with a ventricular septal defect that was not identified until she was four years old. This defect forced the heart to strain harder to deliver oxygen and vital nutrients to the body's organs and tissues. To date, the birth defect has not been resolved, nor has it closed on its own.

Zofran Manufacturers Purposefully Hid Risks from Public

Plaintiffs claim that Zofran manufacturers purposefully hid the risks associated with Zofran, while simultaneously promoting this drug to obstetricians and gynecologists. They told the OBGYN community that it was a safe morning sickness treatment, despite never being tested on pregnant women. This unapproved promotion was a direct violation of federal law.

According to lawsuits, Zofran manufacturers concealed numerous warning signs that their drug was associated with major birth defects. They even failed to submit a number of birth defect reports to the FDA. Two studies in particular have been referenced in lawsuits. Both studies have found increased risk for "hole in the heart" defects, such as atrial septal defects and ventricular septal defects, when mothers use Zofran during pregnancy – especially during the first trimester.

Sadly, they are not alone – at least 34 other Plaintiffs have filed Zofran lawsuits across the country claiming that Zofran causes birth defects.

Contact Our National Dangerous Drug Lawyers

If you took Zofran during pregnancy and your baby was born with a congenital defect, it is important to speak one of the experienced national dangerous drug attorneys at Golomb & Honik immediately. Our lawyers can answer all your questions regarding the current Zofran litigation and determine if you are eligible to file a lawsuit against the manufacturers of Zofran.

To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

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