Medication spilled on a table

Zofran Birth Defect Lawsuits

Nausea medication linked to birth defects

GlaxoSmithKline (GSK), the manufacturer of anti-nausea drug Zofran, is facing numerous birth defect lawsuits in connection with Zofran. The suits allege that GSK engaged in fraudulent marketing practices to encourage pregnant woman to use Zofran, although the drug was never officially tested and approved for use during pregnancy.The lawsuits allege that Zofran creates significant risks of severe birth defects when taken by pregnant patients.

Zofran is a prescription medication officially intended to treat post-operative nausea. The FDA’s labeling of Zofran indicates that the drug was never approved for use during pregnancy. According to the U.S. Department of Justice, however, GSK allegedly “paid kickbacks to healthcare professionals to induce them to promote and prescribe” drugs such as Zofran.

These kickbacks gave doctors an incentive to prescribe Zofran as an “off-label” treatment for morning sickness and nausea in pregnant women. In spite of the lack of safety testing, Zofran was prescribed to thousands of pregnant patients. Unfortunately, many of these patients delivered infants who suffered from congenital heart defects, cleft palate, or kidney obstruction, among other defects.

The pregnant patients who received Zofran prescriptions were never warned of the drug’s birth defect risks. These patients were unaware of the kickbacks their doctors received by prescribing them off-label Zofran. They relied on the information provided by GSK regarding the drug’s safety. As a result, many pregnant women unknowingly increased the risks of severe, irreversible birth defects in their newborns.

Historic $3 billion fraud settlement

As part of the largest healthcare fraud settlement in U.S. history, GlaxoSmithKline agreed to pay close to $3 billion to settle its criminal charges and civil claims related to its fraudulent marketing practices.

According to the suit, GSK failed to report safety data for several of its most popular drugs, and engaged in fraudulent marketing practices for multiple medications, including Zofran.

GSK allegedly marketed many of its drugs for non-approved uses: it marketed Praxil to treat pediatric depression, Wellbutrin to treat weight loss, and Zofran to treat morning sickness, among other allegations. None of these drugs were officially tested or approved for the uses which GSK encouraged. These misleading and fraudulent tactics led patients to take medications which proved ineffective, or even harmful. In the case of Zofran, patients who suffered unintended consequences were unable to reverse the damage done by the drug.

Zofran birth defects

Some of the birth defects associated with Zofran include:

  • Congenital heart defects
  • Kidney obstruction
  • Cleft palate
  • Atrial septal defects (ASD)
  • Ventricular septal defects (VSD)
  • Atrioventricular Septal Defects (ASD)

If you or a loved one has suffered as a result of using Zofran, contact the Tennessee Zofran attorneys at David Randolph Smith & Associates today. Our medical device lawyers are ready to offer free advice on the next steps for your Zofran birth defects litigation.