Have there been any lawsuits filed against the manufacturer of Zofran related to birth defects in children?

Have there been any lawsuits filed against the manufacturer of Zofran related to birth defects in children? After an extensive investigation, the United States Department of Justice filed civil and criminal actions against GlaxoSmithKline in 2012. Among other things, the allegations claimed that the company was illegally promoting the drug for uses that were not FDA-approved such as alleviating nausea in pregnant women. Also, the DOJ alleged that the GlaxoSmithKline had set up an illegal kickback system to doctors, hospitals, and other healthcare providers to market and distribute Zofran. After settling with federal and state authorities, GlaxoSmithKline agreed to pay nearly $3 billion for its fraudulent activities.

In the wake of the notoriety brought upon GlaxoSmithKline and Zofran following the DOJ investigation, lawsuits against them have started to emerge including the following:

  • LeClair vs. GlaxoSmithKline: This Massachusetts case was filed in February of 2015; however, the actual underlying pregnancy was in 2000. The mother took Zofran while pregnant to treat nausea and morning sickness in the first three months of her pregnancy. Unfortunately, her child was born with several defects. Specifically, the child had one of the most common defects associated with Zofran, Atrial Septal Defect (“hole in the heart”). Her child also developed others including hearing problems, webbed toes, and low-set ears. The lawsuit alleged that after receiving hundreds of reports of defects and after major studies had proffered evidence of the risk of the same defects, GlaxoSmithKline concealed these dangers and continued to market and distribute Zofran. To read the complaint, click here.
  • Flynn vs. GlaxoSmithKline: This Minnesota lawsuit also came to the surface in February of 2015. It involved a mother who took Zofran during two of her pregnancies, one in 2004 and one in 2006. The first was born with congenital heart defect and the “hole in the heart.” This child also suffered from extreme growth and development issues. The child born in 2006 also had a heart defect and experienced growth issues but also suffered from oxygen deprivation. The latter required around-the-clock care. Like the LeClair case, Flynn claimed that GlaxoSmithKline concealed the dangers of Zofran while distributing it for years. To read the complaint, click here.

In the last ten years, there have been other cases involving Zofran. All in all, across these settlements and awards, approximately 36% of plaintiffs received nothing, 36% received something between one hundred thousand dollars ($100,000.00) and five hundred thousand dollars ($500,000.00), and 28% received more than five million dollars ($5,000,000.00). However, after the recent DOJ investigation, there are probably going to be a lot more cases against GlaxoSmithKline regarding Zofran.

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