GlaxoSmithKline Urges MDL Court to Dismiss Zofran Failure to Warn Claims Early in Birth Defect Litigation

With a growing number of Zofran lawsuits continuing to be filed on behalf of children born with severe birth defects after exposure to the nausea drug before they were born, GlaxoSmithKline is asking a federal judge to dismiss the failure-to-warn claims early in the litigation.

Just four months ago, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings in the federal court system, centralizing all lawsuits filed over the drug maker’s failure to warn about the risk of birth defects from Zofran side effects before U.S. District Judge Dennis Saylor in the District of Massachusetts.

There are already more than 200 complaints pending in the federal MDL, or multidistrict litigation, involving children born with congenital heart defects, cleft palate, cleft lip and other malformations allegedly caused by us of Zofran during the first trimester of pregnancy.

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The MDL proceedings remain in the early stages, with discovery into common issues that apply to all claims just getting underway. In addition, as Zofran injury lawyers continue to review and file claims for families throughout the U.S., it is ultimately expected that several thousands cases will pending in the MDL by the end of this year

Motion to Dismiss All Zofran Claims

During a status conference scheduled for tomorrow, Judge Saylor is expected to review whether it is appropriate to address a motion to dismiss filed by GlaxoSmithKline last month, and if the drug maker’s argument that state law failure to warn claims presented in each of the complaints should be pre-empted by federal law is “ripe for determination” at this early stage.

According to the Omnibus Motion to Dismiss (PDF) filed on December 11, GlaxoSmithKline indicates that all Zofran lawsuits in the MDL should be dismissed because there is sufficient evidence in the public record to establish that the FDA would have rejected any warning label update the plaintiffs claim should have been provided to women and the medical community.

The drug maker indicates that the FDA has previously rejected a citizens’ petition to have the Zofran pregnancy category on the warning label changed, which called for a stronger indication that the drug puts unborn fetuses at risk.

Plaintiffs have opposed the motion, arguing that the issue is not “ripe” at this time, since discovery in the cases has barely begun.

“Defendant GlaxoSmithKline, LLC’s (“GSK’s”) request to dismiss all cases at the initial pleading stage is unripe, unprecedented and violates established federal law,” the plaintiffs said in a response (PDF) filed January 5 . “GSK has not cited a single case in which a court has addressed the so-called “clear evidence” preemption exception at the pleading stage, and Plaintiffs’ research has disclosed no case in which a court upheld a clear evidence affirmative defense prior to any discovery. Indeed, every case cited by GSK addressing the issue did so based on a summary judgment or trial record.”

According to a proposed agenda (PDF) for the status conference scheduled for January 14, the parties indicate they will review the motion with Judge Saylor and whether it is ripe for consideration. The parties also expect to review the status of new case filings and to provide the court with an update on the early discovery in the litigation.

Zofran Pregnancy Risks

Each of the lawsuits stems from use of Zofran by pregnant women to treat morning sickness. However, the drug has never been approved by the FDA for this purpose, and is only indicated for treatment of nausea and vomiting among cancer patients and following surgery.

Plaintiffs argue that GlaxoSmithKline has illegally promoted Zofran “off-label” for pregnancy-related nausea, even though the drug maker has never conducted studies or submitted data to establish that it is safe or effective for pregnant women or their unborn children.

The lawsuits also allege that the pregnancy category on Zofran was misleading and fails to adequately warn about the risks associated with use of the drug, leading to the false impression that Zofran is safe for pregnant women.

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, if GlaxoSmithKline’s motion is rejected, 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.


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