In a recent request to the U.S. Judicial Panel on Multidistrict Legislation (JPML), Zofran manufacturer GlaxoSmithKline requested for centralized litigation of the multiple pending Zofran lawsuits. In addition to the request for centralization litigation, the product manufacturers specified that they wanted the cases heard in the courts of the Eastern District of Pennsylvania.

A multidistrict litigation (MDL) like GlaxoSmithKline is requesting allows similar cases across the U.S. to take place in a single district court under one judge. The purpose is to conserve resources and to encourage consistent rulings across the similar issues presented in different lawsuits. If the case is not settled in an MDL, the case will be sent back for trial in the original court.

Currently, there are 33 or more Zofran lawsuits in the federal court system that have been filed by families with allegations that Zofran, a drug that was prescribed for morning sickness relief, caused birth defects in their children. At the time of GlaxoSmithKline’s request filing of the case in early July, there were only 12 cases; the number of cases has nearly tripled in a month. Experts suspect these cases may rise to the thousands over the next few years.

Plaintiffs in the litigation agree that the lawsuits should be consolidated, but they are unhappy with the location. GlaxoSmithKline’s headquarters are located in Eastern Pennsylvania, and plaintiffs argue that the trials should occur in a more centralized geographic location or closer to where the majority of cases were filed.

As the next step in the process, a hearing session for oral arguments in the Zofran birth defect lawsuits is scheduled for Oct. 1, 2015, in New York City.

Zofran Usage

Zofran (odansetron) is a medication used to prevent vomiting and nausea in individuals undergoing chemotherapy, radiation, or who experience nausea and vomiting after surgery. It has not been FDA approved for use in pregnant women; however, doctors can prescribe the medication for off-label purposes.

The lawsuits that are currently under investigation all allege that the drug manufacturer marketed Zofran as an anti-nausea drug for use in pregnant women. There are a number of studies that have proven a link between Zofran and birth defects. GlaxoSmithKline never studied Zofran’s effect on pregnant women and did not seek to obtain FDA approval for using the drug to treat nausea and morning sickness in pregnancy.

Zofran Birth Defects

The most common birth defects that have been reported from Zofran usage include:

• Heart defects
• Mouth deformities, including cleft palate
• Musculoskeletal defects

The potential dangers of Zofran were noted as far back as 2006, when a study in Hong Kong showed that Zofran does cross the placenta, and the researchers recommended further study regarding its use in pregnant women.

In 2011, a study claimed that women may have 2.37 times the risk of giving birth to a baby with a facial deformity known as cleft palate. Additional studies in 2013 and 2014 linked Zofran usage and heart birth defects.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Birth Defect Lawsuit Information

If you or someone you love was prescribed Zofran during pregnancy and had a baby born with cleft palate, musculoskeletal abnormalities, heart defect or other birth defects, you may be entitled to legal compensation. Experienced attorneys are available to provide you with a no-risk evaluation of your situation and consult with you free of charge.