GlaxoSmithKline Files for Consolidation of Zofran Lawsuits

Pittsburgh, PAGlaxoSmithKline has reportedly filed for consolidation of Zofran lawsuits in Pennsylvania. Zofran side effects lawsuits allege women who took the medication to treat morning sickness gave birth to infants with birth defects. Lawsuits are still being filed against GlaxoSmithKline alleging the company failed to warn about the risks associated with taking the medication while pregnant.

According to Reuters (7/7/15), GlaxoSmithKline filed a motion before the US Judicial Panel on Multidistrict Litigation to consolidate around 12 lawsuits for pretrial proceedings. Consolidation is generally approved to prevent duplication of discovery when the lawsuits filed all share similar material questions of fact. GlaxoSmithKline has requested the cases be transferred to Pennsylvania federal court, which is where the headquarters of the drugmaker’s US operations are located.

Zofran is an anti-nausea medication approved to treat patients who are post-operative or undergoing specific cancer treatments. Although it is not approved for use in pregnant women, it is frequently prescribed off-label to treat nausea associated with pregnancy. Women who have filed lawsuits against GlaxoSmithKline allege they were not adequately warned about the potential risk of side effects associated with the medication.

In 2012, GlaxoSmithKline agreed to pay $3 billion to resolve allegations that it illegally marketed some of its drugs, including Zofran, for off-label use. While it is not illegal for doctors to prescribe medications off-label, it is illegal to market them for such uses.

There are reportedly 12 Zofran lawsuits filed against GlaxoSmithKline; although it is possible that more lawsuits will be filed. One lawsuit (Coughlin and Swann v. GlaxoSmithKline, case number 15-1815, in the US District Court for the Western District of Louisiana) alleges that GlaxoSmithKline knew of 32 reports of birth defects linked to Zofran by 2000, and has received further reports since. The lawsuit also alleges GlaxoSmithKline marketed Zofran as safe for pregnancy-related nausea and vomiting despite never conducting a study regarding Zofran use in pregnant women.

Some studies have been conducted regarding the risk of Zofran side effects. Those studies have found conflicting results. A 2014 Canadian study by The Toronto Star (6/25/14) reportedly found at least 20 women who used ondansetron (the generic of Zofran) and had babies who experienced side effects. Those effects included infant death, low birth weight, heart murmur and atrial septal defect. Other studies, however, have found no birth defect risk associated with Zofran.