Zofran Lawyers Appointed to Leadership Roles in MDL for Birth Defect Lawsuits

A small group of plaintiffs lawyers have been appointed to serve in key leadership positions in the federal Zofran birth defect lawsuits, including three attorneys who will serve as co-lead counsel on behalf of all plaintiffs and two attorneys who will serve as liaison counsel.

There are currently at least 112 complaints pending in the federal court system, which each involve similar allegations that side effects of Zofran use during pregnancy caused children to suffer severe and debilitating birth defects and malformations, such as cleft palate, cleft lip, heart defects or other health problems.

Given the nearly identical claims presented in the complaints against GlaxoSmithKline, the Zofran cases are centralized for coordinated pretrial proceedings before U.S. District Dennis Saylor in the District of Massachusetts, as part of a federal multidistrict litigation (MDL).

As Zofran lawyers continue to review and file birth defect cases on behalf of families throughout the U.S., it is ultimately expected that several thousand lawsuits will be transferred into the MDL for coordinated management, which is designed to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

In an order (PDF) issued on November 18, Judge Saylor appointed Kimberly D. Barone Baden, Elizabeth Graham and Tobias Millrood to serve as Co-Lead Counsel in the Zofran litigation, who will generally be responsible for coordinating the activities of all plaintiffs’ attorneys during the MDL proceedings, charged with taking certain actions that will benefit all families who are pursuing claims.

Judge Saylor also appointed attorneys Robert K. Jenner and Kimberly A. Dougherty to serve as plaintiffs’ Liaison Counsel, with the responsibility for coordinating efforts between the federal litigation and similar Zofran lawsuits pending in various state courts nationwide.

A larger group of Zofran attorneys will be appointed at later date to serve on a Plaintiffs’ Steering Committee (PSC), which will coordinate and conduct various pretrial discovery, and take other actions during hearings, settlement negotiations and any bellwether or test trials that may be held in the MDL.

Zofran Pregnancy Risks

Zofran is only approved by the FDA for treatment of nausea and vomiting among cancer patients and following surgery. However, it has been widely used “off-label” for pregnancy-related morning sickness, even though GlaxoSmithKline has never submitted data to establish it is safe or effective.

As early as 2006, studies have highlighted potential Zofran pregnancy risks, with Hong Kong researchers finding that Zofran crosses the placenta in significant amounts when taken by pregnant women. At that time, researchers concluded that the “developmental significance of this drug exposure requires further investigation,” yet millions of women have continued to be prescribed the medication without warnings about the potential Zofran birth defect risks.

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 cases 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.

If the parties fail to reach Zofran settlements following pretrail proceedings and any bellwether test trials, 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.