Identification of Generic Zofran Lawsuits Sought by GSK in Birth Defect Litigation

With a growing number of families nationwide pursuing Zofran birth defect lawsuits, GlaxoSmithKline is calling for plaintiffs to establish whether they used the brand name drug or a generic equivalent of the anti-nausea medication.

GlaxoSmithKline currently faces at least 225 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.

Given the similar allegations raised in the complaints, the litigation is 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 a motion (PDF) filed on February 22, the drug maker is asking the court to enter an Order regarding product identification, suggesting that cases should be dismissed where children suffered injuries due to the mother’s use of generic Zofran.

The motion was discussed at a status conference yesterday, with the drug maker indicating that product identification is a “fundamental and threshold question” in the litigation.

“Requiring disclosure of product information now — information that Plaintiffs should already possess — is the most sensible and fair way to proceed with initial discovery in this litigation,” according to the motion filed by GlaxoSmithKline. “It will allow for a meaningful and fair assessment of the viability (or lack thereof) of the cases before time and money are expended on cases and claims that can and should be dismissed at an early stage.”

In a docket entry issued yesterday, Judge Saylor indicated that a deadline for plaintiffs to respond to the motion has been set for March 8.

The request comes only a few weeks after Judge Saylor denied a request by the drug maker to have all Zofran pregnancy warning lawsuits dismissed, rejecting an argument by GlaxoSmithKline that the cases should be pre-empted because the FDA would have rejected any label update proposed by plaintiffs. Judge Saylor found that the motion was premature, as no discovery has been conducted by the parties.

GlaxoSmithKline now indicates that a lack of product identification at this early stage of the litigation unfairly impacts their ability to prepare for future discovery and dispositive motions in the case, suggesting that a significant number of plaintiffs likely used generic products sold by other companies since 2006.

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. Many plaintiffs 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 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.

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.