Information About Zofran Problems Reported to GSK Sought in Birth Defect Lawsuits

Families who are pursuing Zofran birth defect lawsuits against GlaxoSmithKline (GSK) indicate that the drug maker is holding back important information about problems the drug may have caused when used by pregnant women, calling for a federal judge to force the pharmaceutical company to turn over adverse event reports. 

GlaxoSmithKline currently faces more than 400 product liability lawsuits that allege the company failed to adequately warn women and doctors about the potential side effects of Zofran during pregnancy, which has been linked to reports of children born with cleft palate, cleft lip, atrial septal defects, ventricular septal defects and other congenital malformations.

Given the similar questions of fact and law presented in the litigation, cases filed in U.S. District Courts nationwide have been centralized for coordinated pretrial proceedings before U.S. District Judge Dennis Saylor in the District of Massachusetts, to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses and the judicial system.

On February 23, plaintiffs filed a motion to compel (PDF), indicating that GlaxoSmithKline should be forced to turn over adverse event data from a database known as Argus, which they say includes numerous adverse event reports regarding Zofran problems received by GSK, and provide details about how the company responded to those reports.

While the litigation has been proceeding for several years, the motion indicates that the company has refused to provide requested data from the database as part of the litigation’s discovery process.

“GSK’s knowledge of adverse events related to Zofran and what GSK did or did not do with that information goes to the heart of Plaintiffs’ claims,” the motion states. “The database is the primary source, and the most comprehensive and useable source of adverse event data in GSK’s possession. It contains information from every known Zofran-related adverse event, worldwide, occurring at any time since clinical trials began, including adverse events GSK chose not to report to regulatory authorities.”

The motion indicates that recent depositions of former company employees who worked with the database suggest GSK may not have fully disclosed adverse events to the FDA and the public.

The motion requests that the Court order GlaxoSmithKline to “fully and completely” provide them with the requested information from the Argus database.

Zofran Pregnancy Risks

In the litigation, plaintiffs allege that GlaxoSmithKline knew or should have known about the Zofran pregnancy risks for years, yet failed to warn doctors or consumers against use of the drug to treat morning sickness.

As early as 2006, plaintiffs note that studies have found that Zofran crosses the placenta in significant amounts when taken by pregnant women, with Hong Kong researchers 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.

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.