Have you or a loved one given birth to a child with birth defects after taking Zofran?

We can help! Call (702) 444-4444

Medication/Drug: Zofran (ondansetron Hydrochloride)

Use

Anti-nausea medication prescribed to pregnant women for morning sickness. This was an off-label use of this medication that is manufactured by GlaxoSmithKline. Zofran was originally approved for the treatment of nausea and vomiting caused by chemotherapy and radiation therapy.

Related Injuries

• Birth defects including:
  • Skull deformities
  • Cleft lip and palates
  • Heart malformations
  • Heart murmurs
  • Fetal death

What are the potential side effects on the unborn child?

Unfortunately, we know now that this product can have significant adverse effect on the unborn. Just since the beginning of 2015, several lawsuits have been brought against GSK after babies were born with (among other birth defects):

• Congenital heart malformations-including atrial and ventricular septal defect (hole in heart)
• Orofacial Clefts-lip and palate clefts require surgery to repair in most cases
  Craniosynostosis (skull deformities)
• Heart murmurs
• Others

In 2012 the U.S. Department of Justice (DOJ) and GSK settled a case where the DOJ had accused GSK of promoting off-label use of Zofran, in spite of the FDA not finding the drug safe for the fetus. GSK pleaded guilty and paid the federal government $3 billion in the “largest healthcare fraud settlement in U.S. history.”

FDA has not stopped Zofran from being prescribed!

Even with the known potential risks of Zofran to pregnant women, the FDA has not stopped it from being prescribed. Doctors are still legally allowed to prescribe the medication as they see fit. It is a doctor’s legal duty to inform all pregnant women of the risks associated with Zofran before prescribing it.

Additional information regarding the Zofran lawsuit

The product Zofran was developed and distributed by GlaxoSmithKline (GSK) and approved by the U.S. Food and Drug Administration (FDA) in 1991, only for treatment of nausea due to chemotherapy, or surgery. This product was never approved for use by pregnant women. Since its introduction, this product has been a top selling drug for GSK ranking as high 20th most used prescription in the U.S. at one time.

In 2006 after generating $1.3 billion during just the first 9 months of the year, the patent on this product expired allowing the introduction of numerous generic versions of the drug by several generic drug makers. In preparation for the patent expiration, an attempt was made in the early 2000’s to bolster the sales of this preparation.

GSK began marketing this product to a new target audience for which the product had never been approved. GSK “suggested” to OB/GYN’s that this prescription drug would be a great fit for women suffering from morning sickness during the first trimester of pregnancy, without regard for the fact that the product had never been approved by the FDA for use by pregnant women. Beyond that, GSK offered a portion of the purchase price to physicians who prescribed the medication, as a “thank you”, effectively bribing doctors to prescribe the drug.

As early as 1992, court documents showed that GSK knew that Zofran presented an “unreasonable risk of harm” to the unborn, since it was known that the drug was passed through the placenta to the developing baby. In spite of this, GSK marketed the product to this new target audience and promoted the drug as a safe treatment for morning sickness.

Have you or a loved one taken Zofran during a pregnancy? You may be entitled to compensation.

Call (702) 444-4444

Nevada Zofran Lawsuits

If you were prescribed the drug Zofran while pregnant, and your child was born with birth defects, we want to hear from you. Please call the Richard Harris Personal Injury Law Firm at 702-444-4444 to discuss your potential case.

Call us if you took or have taken Zofran during a pregnancy. Call us so we can help you.

(702) 444-4444