What is the Latest Status Update on Zofran Litigation for Congenital Malformations or Birth Defects?



Hundreds of product liability lawsuits are being pursued by families throughout the United States, as result of birth defects allegedly caused by side effects of Zofran exposure during pregnancy.

While consolidated pretrial proceedings were established in the federal court system in October 2015, the Zofran birth defect litigation remains in the early stages, and it is widely expected that hundreds of additional cases may be brought on behalf of children injured due to GlaxoSmithKline’s failure to warn about this risk.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for all Zofran complaints filed in U.S. District Courts throughout the U.S., centralizing the cases before U.S. District Judge Dennis Saylor in the District of Massachusetts to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.

Throughout 2016, discovery into common issues in the lawsuits has been underway, and it is expected that case-specific discovery on the link between Zofran and birth defects suffered by children born with specific injuries will continue throughout 2017.

Although much progress has been made in the litigation, it will likely be several years before the first Zofran trials reach a jury or birth defect settlements are negotiated with GlaxoSmithKline.

Allegations Raised in Zofran Birth Defect Lawsuits

The Zofran litigation emerged after a series of studies linking Zofran with pregnancy risks, including a risk that children may be born with congenital heart defects, cleft palate, cleft lip or other health issues.

Although it appears that GlaxoSmithKline knew or should have known about the potential link between Zofran and birth defects for years, information about the risk was withheld from consumers and the medication community, preventing pregnant women from switching to an alternative treatment for morning sickness in the early stages of pregnancy.

GlaxoSmithKline introduced Zofran in 1991 for treatment of nausea in cancer patients. However, the medication has been illegally marketed for use as a morning sickness treatment for pregnant women. As a result, many doctors and consumers assume it is safe for pregnant women. However, several studies have suggested that use of Zofran during the first trimester may expose children to a risk of severe and potentially life-threatening injury.

The Zofran cases raises allegations that GlaxoSmithKline placed their desire for profits before consumer safety, withholding information to generate off-label sales, which account for the vast majority of all Zofran prescriptions each year.

Find Out If You Have a Zofran Birth Defects Case

The Zofran birth defects lawyers at Saiontz & Kirk, P.A. provide free consultations and case evaluations for pregnant women diagnosed with birth defects, to help determine what the legal options are and whether financial compensation may be available. Financial compensation may be available for:

  • Zofran Heart Defects
  • Zofran Oral Cleft Defects

Given the substantial discovery and work that remains to be done in the litigation, including the review of what will likely be millions of pages of internal GlaxoSmithKline documents on the development and marketing of Zofran, and a substantial number of depositions of common fact witnesses with information relevant to all cases, the Zofran birth defects litigation is likely to be on-going for several years. However, each case does have a deadline or statute of limitations, which requires that a Zofran lawsuit be filed within a certain amount of time.

If it is suspected that you, a friend or family member may be eligible to participate in the litigation, it is important to review your case as early as possible.


Austin Kirk

Last Updated November 15, 2016
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