Zofran Lawsuit Filing Procedure for Birth Defect Claims Streamlined in MDL

While a growing number of families throughout the U.S. continue to file Zofran lawsuits, alleging that use of the anti-nausea drug during pregnancy caused children to develop severe birth defects, the U.S. District Judge presiding over the litigation has established a new procedure for bringing cases through a Master and Short-Form Complaint, which will outline the common allegations raised in the claims. 

GlaxoSmithKline currently faces at least 260 cases pending throughout the federal court system, each involving allegations that children were born with congenital defects or malformations due to side effects of Zofran use during pregnancy.

As Zofran birth defect lawyers continue to review and file additional cases in the coming months and years, it is possible that more than 1,000 claims may eventually be filed by families nationwide.

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Given the similar allegations and questions of law raised in the complaints, the Zofran birth defect cases are all centralized for pretrial proceedings in the federal court system before U.S. District Judge Dennis Saylor in the District of Massachusetts, as part of a federal MDL, or multidistrict litigation.

In an MDL order (PDF) issued on May 18, Judge Saylor indicated that a Master Complaint will be filed on behalf of all plaintiffs by May 31, and that GlaxoSmithKline will file a Master Answer that responds to all of the allegations by June 21.

With the creation of these master pleadings, plaintiffs will be able to bring a case in the MDL by filing an abbreviated Short Form Complaint, outlining the specific claims and allegations they are adopting.

“The Master Complaints and Master Answers will have legal effect in a particular matter only when an individual plaintiff files a Short Form Complaint adopting by reference all or part of the applicable Master Complaint,” Judge Saylor said. “Once an individual plaintiff files a Short Form Complaint, the Short Form Complaint, together with the applicable Master Complaint, will be legally operative and binding as to that plaintiff as if that plaintiff filed an individual complaint, or amended complaint if a complaint is already on file.”

Within 30 days after the Court approves the new forms, each plaintiff with a pending case will be required to file a Short Form Complaint, and all new claims transferred into the MDL will file the same form. This will provide uniformity to the allegations raised throughout the litigation.

Zofran Pregnancy Risks

Zofran (ondansetron) is a prescription medication approved for treatment of nausea and vomiting among chemotherapy and surgical patients. However, following aggressive marketing by GlaxoSmithKline, it has been widely used off-label among pregnant women for treatment of morning sickness.

Most of the pending complaints allege that the drug maker engaged in illegal marketing of the drug for use during pregnancy, while withholding information about the potential birth defect risks it may pose for unborn children.

As early as 2006, studies have highlighted potential Zofran pregnancy risks, according to the lawsuits. Hong Kong researchers found that Zofran crosses the placenta in significant amounts when taken by pregnant women, concluding that the “developmental significance of this drug exposure requires further investigation.”

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.

In August 2013, another study highlighted a potential risk of heart defects with Zofran, following a review of data involving more than 900,000 pregnancies in the Danish Medical Birth Registry. Researchers found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.

More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

As part of the coordinated pretrial proceedings before Judge Saylor, it is expected that a small group of Zofran claims will be selected for a “bellwether” program, which will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Following pretrial proceedings and any bellwether trials, if the parties fail to reach Zofran settlements for children left with birth defects following exposure to the drug, GlaxoSmithKline may face hundreds of individual trials in U.S. District Courts throughout the country over the failure warn women and the medical community about the potential risk of birth defects linked to the anti-nausea drug.


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