United Kingdom: GlaxosmithKline is facing 220 lawsuits for its anti nausea drug Zofran . Consumed by pregnant mothers, the drug has allegedly produced birth defects in infants born to them. In multi district litigation the plaintiffs have alleged that GlaxoSmithkline has been illegally promoting off label use of Zofran resulting in the harm. Cases for pretrial proceeding have continued to grow ever since multi district litigation has been announced.
A US judge has declined GlaxoSmithKlines request to dismiss the petition emphasising that affected families should be given adequate time to develop their cases and that the companies request was too early in the day.
The Affected families argued that they were not in the no of whether GSK had provided the US Food and Drug Administration with evidence about birth defects related to Zofran, they were aware that the drug labels did not give any information about the potential side effects.
Calling the failure to warn claim a pre empt by federal law , the drug company has asked for a dismissal.
“If – as plaintiffs allege – GSK was in exclusive possession of information not previously submitted to the FDA indicating the need for a new or strengthened warning, that information would presumably be included in a CBE request,” Judge Saylor wrote “That information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it.”
According to a web portal the drug Zofran has been recommended off label to treat nausea associated with pregnancy. Though prescribing off label drugs is not illegal marketing of the same is.
GSK maintains that in 2012 when it settled lawsuits related to illegal promotion of drugs by the company- including Zofran, it was basically to avoid the expense of litigation.
The multi district litigation now sits at 223 lawsuits, up from 211 as of January 15, 2016. In addition to lawsuits filed in the United States, a class-action lawsuit has also been filed in Canada.
Jon and Clara Rickman one of the plaintiff couple allege that there son Nicholas was born with congenital heart defects linked to the mother’s use of generic Zofran. The couple’s baby went through his first heart surgery five days after his birth.
Another allegation made by the victims is that since the drug is prescribed off label it has never been tested in pregnant women for the safety of their foetuses.