Zofran Heart Birth Defect Claim - Consumer Justice Foundation

Zofran Heart Birth Defect Claim

Written by Faith Anderson on July 24, 2015

Zofran Lawsuit Filed Over Baby’s Tetralogy of Fallot Birth Defect

A new Zofran injury lawsuit has been brought against GlaxoSmithKline, alleging that side effects of Zofran, the company’s blockbuster anti-nausea medication, caused a baby boy to be born with a serious congenital birth defect called Tetralogy of Fallot. If you took Zofran while pregnant, and your child was born with Tetralogy of Fallot or another severe heart birth defect, contact an experienced Zofran attorney to discuss your options for legal recourse. You may have grounds to file a Zofran birth defect lawsuit against GlaxoSmithKline, in order to pursue financial compensation for your child’s injuries, medical expenses, and pain and suffering.

Alleged Side Effects of Zofran Use in Pregnancy

Zofran (ondansetron) is a blockbuster anti-nausea drug manufactured by GlaxoSmithKline and approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting symptoms in patients undergoing surgery or chemotherapy treatment. However, Zofran is also commonly prescribed off-label to pregnant women experiencing a severe form of morning sickness called hyperemesis gravidarum, even though the medication has never been approved for that use. At the same time, women across the country are coming forward and claiming that their use of Zofran during pregnancy caused their child to be born with severe birth defects, like cleft lip, cleft palate, Tetralogy of Fallot and other congenital malformations.

This latest Zofran lawsuit was filed on behalf of parents Jamie and Brad Bircher, in the U.S. District Court of the Southern District of Illinois, on July 21, and includes allegations that GlaxoSmithKline failed to provide consumers and healthcare professionals with adequate warnings about the potential risk of birth defects from Zofran use in pregnancy. According to the Zofran birth defect complaint, Jamie Bircher was prescribed Zofran while she was pregnant with her son in 2006, to treat nausea and vomiting associated with morning sickness, and side effects of the prescription drug caused her son to be born with Tetralogy of Fallot birth defects.

Tetralogy of Fallot Heart Birth Defects

Tetralogy of Fallot is a rare but severe heart birth defect caused by a combination of four cardiovascular malformations that are present at birth. These defects, which impact the structure of the heart, result in poorly oxygenated blood flowing from the heart and into the rest of the body. Also known as “blue baby syndrome,” Tetralogy of Fallot typically results in babies being born with blue-tinted skin, because their blood doesn’t carry enough oxygen. Treatment for Tetralogy of Fallot involves surgery to repair the malformation, but even after the defect is corrected, 90% of patients develop a leaking pulmonary valve that worsens over time and typically requires additional surgeries in adulthood.

With early diagnosis and proper treatment, babies born with Tetralogy of Fallot can sometimes go on to live relatively normal lives. However, they typically require ongoing medical care and may have restrictions on exercise. “[The] birth defects impair [the Plaintiffs’ son’s] ability to develop fully and enjoy life both at home and at school because he lives with a much higher risk of severe injuries from infections and a serious risk that the tissue lining the ventricular septal defect with detach and block his arteries, which could be fatal without emergency surgery within the hour,” the Bircher’s complaint states. “Plaintiffs have been advised by physicians that their son’s conditions is likely permanent because it has not healed in the past six years.”

Lawsuits Filed Over Alleged Zofran Birth Defects

The Bircher’s Zofran lawsuit joins a growing number of birth defect complaints filed by parents following maternal use of the anti-nausea medication in pregnancy. All of the lawsuits involve similar allegations that GlaxoSmithKline withheld information from consumers and the medical community about the potential pregnancy risks associated with Zofran. Plaintiffs involved in the litigation allege that GlaxoSmithKline knew or should have known about the potential for Zofran to cause heart defects like atrial septal defects, ventricular septal defects and Tetralogy of Fallot, yet continued to market Zofran as a morning sickness drug for pregnant women.

FDA Warnings for Zofran Users

Despite growing concerns about the alleged pregnancy risks associated with Zofran, the FDA has yet to issue a warning to consumers and healthcare professionals about the potential for Zofran to interfere with fetal development and cause Tetralogy of Fallot and other severe birth defects in babies. The FDA has, however, issued a number of warnings about side effects of Zofran possibly causing heart problems in users, indicating that Zofran use may lead to abnormal heart rhythms possibly leading to Torsades de Pointes, a type of heart rhythm problem that can result in sudden cardiac death in some people.

Contact a Reputable Zofran Birth Defect Lawyer Today

As a growing number of Zofran birth defect lawsuits continue to be filed in state and federal courts across the country, GlaxoSmithKline has requested that federal claims be consolidated for coordinated pretrial proceedings as part of a multidistrict litigation (MDL). And as Zofran birth defect attorneys continue to review cases on behalf of families who believe their children have been harmed by side effects of Zofran, it is expected that hundreds, if not thousands, of birth defect complaints will be brought against GlaxoSmithKline in the coming months and years. Contact a reputable Zofran lawyer today if you took the anti-nausea drug during pregnancy and your child was born with Tetralogy of Fallot or another serous birth defect.

Source: http://www.ncbi.nlm.nih.gov/pubmed/25450422

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