For one mother who took Zofran during pregnancy to treat morning sickness, the birth of her daughter was incredibly distressing. Immediately after birth, a doctor noticed her newborn daughter was born with a club foot. Surgery was needed to help correct the birth defect. This devastating experience was shared by hundreds of other women that took Zofran for nausea and vomiting during pregnancy. Zofran is now known to cause birth defects when taken by pregnant mothers. Some of the birth defects linked to Zofran include congenital heart defects, cleft lip, cleft palate, and club feet among others.
Although Zofran was never approved for use in pregnant women, it is widely prescribed off-label to treat morning sickness. The rise in Zofran’s popularity in treating morning sickness comes, in part, from the manufacturer’s illegal marketing of the drug.
In 2012, Zofran’s manufacturer, GlaxoSmithKline (GSK), paid $3 billion to resolve fraud allegations and failure to report safety data. The allegations stated that GSK illegally promoted Zofran for the off-label treatment of morning sickness and paid kickbacks to doctors who prescribed it.
But the resolution of fraud allegations did not help mothers who gave birth to babies with birth defects caused by Zofran. Hundreds of women have filed lawsuits against the GSK for failing to warn them of the risks associated with taking Zofran during pregnancy. More than 270 lawsuits are currently pending in a multidistrict litigation against the company.
But plaintiffs in the Zofran litigation received quite a shock recently when lawyers for GSK proposed a sequenced discovery plan. During the discovery phase of a lawsuit, both parties are allowed to demand evidence from each other, and GSK’s sequenced discovery plan suggests the order in which the discovery should take place.
GSK is demanding the discovery focuses on two major questions first: (1) whether Zofran actually causes the specific birth defects alleged by plaintiffs and (2) whether GSK withheld relevant safety information from the FDA.
In a rebuttal to GSK, plaintiffs refused the sequenced discovery plan because it fails to address GSK’s liability in illegally promoting Zofran to doctors and patients for uses not approved by the FDA. Plaintiffs believe GSK is attempting to circumvent any liability for its marketing of Zofran.
Although disagreement over the proposed discovery plan will bring the litigation to a screeching halt, plaintiffs are unwavering in their desire to hold GSK responsible.