Zofran Wrongful Death Suit - Consumer Justice Foundation

Zofran Wrongful Death Suit

Written by Faith Anderson on June 21, 2015
zofran birth defect fears

Newborn’s Death Blamed on Zofran Heart Defects in Product Liability Lawsuit

A wrongful death lawsuit has been filed against GlaxoSmithKline by the family of a newborn baby girl who died of heart birth defects allegedly caused by her exposure to the anti-nausea drug Zofran during pregnancy. The Zofran birth defect lawsuit was filed by Patrick and Valerie Reagan in the U.S. District Court for the Northern District of Ohio on June 10, following the 2006 death of the Reagan’s three-day-old daughter, Molly. If you took Zofran while pregnant, and your child was born with a heart defect or another potentially life-threatening birth defect, consult a reputable Zofran lawyer to discuss the possibility of filing a drug injury claim against GlaxoSmithKline.

Zofran Uses

Zofran (ondansetron) is a prescription drug manufactured by GlaxoSmithKline and approved to treat nausea and vomiting symptoms among patients undergoing surgery or chemotherapy. Zofran functions by blocking one of the body’s natural substances – serotonin – that causes vomiting, which may be beneficial for patients who vomited as a side effect of chemotherapy or radiation, or for those who grew sick after taking post-operative medications to help with pain or other surgical complications. In some cases, Zofran is also prescribed to pregnant women as an off-label treatment for a severe form of morning sickness called hyperemesis gravidarum, despite the fact that the FDA has not approved the drug for this use.

Birth Defects Allegedly Linked to Zofran

Unfortunately, mounting evidence has suggested that Zofran use among pregnant women may cause severe and possibly life-threatening birth defects in babies exposed to the powerful medication in utero. Mounting research has linked Zofran use in pregnant women to congenital malformations, including:

  • Cleft lip
  • Cleft palate
  • Heart murmur
  • Heart defects
  • Atrial septal defect
  • Ventricular septal defect
  • Mouth deformities
  • Kidney malformations
  • Fetal growth restriction
  • Musculoskeletal malformations
  • Fetal death

According to the Reagan family’s wrongful death suit, Valerie was prescribed the anti-nausea drug Zofran off-label by her physician because she was experiencing morning sickness during her pregnancy. About nine days before Valerie gave birth to her daughter, Molly, the baby’s heart rate began to decelerate, and, when she was born on March 17, 2006, the newborn was diagnosed with a right ventricular heart defect. Molly Reagan was immediately placed in an intensive care unit for treatment, and she died just three days later. It was only recently that Valerie and Patrick Reagan became aware that their daughter’s fatal heart birth defect may have been caused by her exposure to Zofran in pregnancy.

Studies Highlighting Zofran Pregnancy Risks

Other former Zofran users are also now becoming aware of the potential pregnancy risks of Zofran, and a growing number of studies are examining the increased risk of heart malformations and other birth defects tied to the anti-nausea drug. According to one study published by researchers from Hong Kong as early as 2006, Zofran is capable of crossing the placenta when taken by pregnant women and interfering with the development of an unborn baby. Another study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology in November 2011 found that pregnant women who take Zofran for morning sickness may face a 2.37-times increased risk of giving birth to babies with a cleft palate birth defect.

Additional research has identified a potential connection between Zofran use in pregnancy and an increased risk of heart birth defects, like Molly Reagan’s deadly ventricular heart malformation. In August 2013, a study conducted using data on more than 900,000 pregnancies in the Danish Medical Birth Registry found that babies exposed to Zofran in utero may be two to four times more likely to develop an atrial or ventricular septal defect, a malformation characterized by a hole in the wall separating the left and right sides of the heart. More recently, an October 2014 study published in the journal Reproductive Toxicoloy found a “statistically significant” increased risk for certain heart defects when Zofran is taken in early pregnancy.

Lawsuits Filed Over Zofran Birth Defects

This latest wrongful death lawsuit joins a growing number of Zofran birth defect cases filed against GlaxoSmithKline recently, on behalf of families throughout the United States who believe their children have been harmed by the anti-nausea medication. All of the Zofran lawsuits involve similar allegations that GlaxoSmithKline knew or should have known about the pregnancy risks associated with its medication, yet failed to provide the public with adequate warnings about these risks. One of the most recent Zofran claims was filed by an Arkansas woman whose baby was born with a cleft lip birth defect after being exposed to Zofran during pregnancy.

Contact a Zofran Lawyer for Legal Help

Despite numerous studies highlighting the alleged link between maternal use of Zofran and birth defects in babies, the FDA has yet to issue an official warning about the potential for Zofran to cross the placenta and interfere with fetal development. This is particularly alarming, considering the fact that approximately one million women take Zofran or its generic counterpart every year. If you believe your child has been adversely affected by birth defects from Zofran, contact an experienced Zofran attorney today for legal help. You may have grounds to file a product liability lawsuit against GlaxoSmithKline, in order to pursue financial compensation for your child’s injuries, medical expenses, and pain and suffering.

Posted Under: Birth Defects, Dangerous Drugs, Drugs During Pregnancy, Heart Defects, Legal, News, Zofran
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