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Zofran Lawsuit

birth injury lawyerProduct liability attorneys at Eisbrouch Marsh are currently evaluating potential claims linking Zofran and birth defects. We have been speaking with mothers who believe that their children’s suffering occurred because they took a drug their doctors said was safe. It is difficult to imagine that drug manufacturers would promote a drug for pregnant women with little evidence to support its safety regarding the development of the fetus. Though the FDA has approved Zofran for use in radiation therapy, chemotherapy, and surgery patients, the agency has not done so for morning sickness.

The link between Zofran and birth defects

Zofran is a 5-HT3 receptor antagonist that prevents nausea and vomiting in cancer chemotherapy, radiation treatment and surgery patients. However, since the removal of Bendectin from the market, doctors have increasingly prescribed Zofran (ondansetron) and its generic equivalents to pregnant patients with morning sickness.

Until fairly recently, limited studies had been reassuring:

  • A Motherisk study of 176 women found no increase in major malformations compared to women taking other drugs, but the sample size was admittedly small.
  • Another study looked at 2,000 women from the Danish birth registry exposed to the drug between 2004 and 2011 and found there was no increase in adverse fetal outcomes like stillbirth, preterm delivery or low birth weight.

However, other research has caused some concern about risk of fetal injury from Zofran exposure:

  • Another look at the Danish registry with a sample size of nearly 900,000 women from 1997 to 2010 detected a twofold increase in congenital heart defects with Zofran use in the first trimester; furthermore, the risk of birth defects like cleft palate, kidney failure, webbed toes, and facial deformities was 30 percent higher among women taking the drug.
  • A 2012 study from the Center for Birth Defects Research and Prevention identified a twofold increased risk for cleft palate among mothers taking ondansetron.
  • In May 2013, the FDA has issued an updated warning regarding the increased risk for Serotonin Syndrome in patients taking 5-HT3 receptor antagonists, including Zofran, and said they would be looking into the “potential safety issue” to see if further action should be taken.

Zofran lawsuits emerging

The first Zofran lawsuits have been filed in courts across the nation, including one report of a Massachusetts mother who took Zofran for morning sickness and gave birth to a baby with numerous congenital defects. According to the lawsuit, echocardiograms showed that the baby “suffered from an atrial septal defect, right ventricular hypertension and aortic arch hypoplasia,” which required 10 surgeries. Furthermore, the baby was diagnosed with hearing loss, light sensitivity, webbed toes, facial dysmorphia, and inguinal hernia, which the lawsuit claims further diminished her quality of life. Had the mother known of the risks associated with the product, she would have never taken the drug, she said.

According to the lawsuit, drug manufacturer GlaxoSmithKline failed to conduct appropriate safety testing before recommending the drug to pregnant women, “using expectant mothers and their unborn babies as human guinea pigs.”

$3 billion settlement

According to the Department of Justice, in 2012, GlaxoSmithKline agreed “to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false reporting practices.” This settlement pertained to a variety of medications produced and marketed by the GSK. Though the manufacturer has never admitted wrongdoing with respect to its any of its marketing tactics regarding Zofran, at the time it was announced the global resolution marked “the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”

 So far, no settlements or jury awards have been made public with regard to birth defects cases filed by individual plaintiffs.

What Eisbrouch Marsh lawyers can do for you

The burden of proof is ultimately what makes or breaks a case. It is not enough to simply say, “I took Zofran during my pregnancy and I have a child with birth defects.” You will need to dispel counterarguments that another factor may have caused the birth defect and prove that the drug manufacturer negligently or willfully failed to inform medical practitioners and consumers of product risks that were either known or should have been known.

Having a Zofran lawyer will help you build a strong case with:

  • All the necessary documentation,
  • Assembly of medical journal research,
  • Access to internal company memos secured through the courts, and
  • A team of medical experts willing to testify on a plaintiff’s behalf.

Eisbrouch Marsh attorneys have over 25 years of experience winning settlements and jury awards for our personal injury clients. Medical malpractice and birth injuries are among our specialties, and we have a substantial roster of respected medical experts on hand to testify on your behalf.