Federal Zofran Litigation Preps for Upcoming Status Conference

Published on September 7, 2016 by Sandy Liebhard

Hundreds of federal birth defects lawsuits involving the anti-nausea medication Zofran continue to move forward in a multidistrict litigation now underway in the U.S. District Court, District of Massachusetts. Court documents indicate that the proceeding’s next Status Conference is scheduled to be convened this Friday, September 9^th, at which time the progress of the litigation will be addressed.

Just over 280 Zofran lawsuits are currently pending in the District of Massachusetts, all of which have been filed on behalf of children who allegedly suffered serious congenital abnormalities due to pre-natal exposure to the anti-nausea medication. Plaintiffs claim that GlaxoSmithKline has long concealed evidence linking the use of Zofran by pregnant women to the development of birth defects, and has failed to warn patients and doctors about this risk.

The September 9^th Status Conference is scheduled to begin at 1:30 p.m., EST. A Joint Agenda proposed by the parties indicates that a number of matters will be discussed, including:

• Update on Filings
• Update on Meet and Confers Regarding Short Form Complaints and Motions to Dismiss
• Update on ESI Protocol
• Update on Document Production and Discovery
• Update on 30(b)(6) Deposition Meet and Confer
• Parties’ Pending Proposed Discovery Plan

Zofran and Pregnancy

Zofran is an anti-nausea medication that is only approved to treat surgery patients and those undergoing certain cancer treatments. However, the medication is routinely prescribed to expectant mothers to relieve nausea and vomiting related to pregnancy, even though its effects on a developing fetus have not been well studied.

While doctors are permitted to prescribe approved medications for any purpose they deem appropriate, drug companies are barred from promoting their products for unapproved uses. In 2012, GlaxoSmithKline agreed to pay $3 billion to the federal government in order to settle allegations that it had improperly marketed a number of medications. Among other things, the company had been accused of marketing Zofran as an off-label treatment for morning sickness.

Zofran lawsuits cite a number of studies which have suggested that exposure to the drug during the early stages of pregnancy might be associated with an increased risk of birth defects. As early as 2006, research published by Hong Kong scientists confirmed that Zofran crosses the placenta when taken by pregnant women.

In November 2011, a study published in 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 treatment with Zofran. And in August 2013, a study of more than 900,000 pregnancies listed in the Danish Medical Birth Registry indicated that children exposed to Zofran in-utero may be two to four times more likely to suffer a septal heart defect.