“GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs,” the complaint charged.
Harsh words, indeed. Harsh, but understandable given the fact that Zofran never carried approval by the US Food and Drug Administration (FDA) for treating morning sickness and nausea associated with pregnancy. In fact, Zofran was never tested for that indication.
And while doctors have always had the legal and medical authority to prescribe medications to patients off-label, the Zofran file can be likened to opening the barn door to expose an entire herd to sudden freedom.
Arellanes’s complaint noted that Zofran eventually became the most prescribed drug for morning sickness in the US.
How could that be, given that Zofran was originally approved for use in cancer patients experiencing the extreme nausea associated with the aftereffects of chemotherapy?
There is no question that Zofran is effective in tamping down extreme nausea. However, it was never approved for use within the context pf pregnancy. It was never tested as such, a fact that GSK has verified when admitting that the safety profiles of Zofran use in pregnant women are not known - or at least, were not known at the time Zofran was approved.
How then, could Zofran wind up becoming the most prescribed antinausea medication within the context of pregnancy in the US?
GSK’s alleged promotion of Zofran off-label for morning sickness may have something to do with it.
It should be noted that only doctors, based on their medical training and their intimate knowledge of the health profiles of their patients, have the authority to prescribe off-label. Manufacturers do not, and in fact the practice is illegal. And yet, the US Department of Justice (DOJ) accused GSK of illegally promoting to doctors the advantages of Zofran for morning sickness from 2002 through 2004. GSK, in fact, was cited by the DOJ for promotion of several drugs off-label within a similar period.
The UK-based manufacturer eventually, in 2012, settled those allegations through the payment of a $3 billion fine while not required to admit any wrongdoing. One wonders how many millions GSK made on the sale of Zofran for morning sickness during that time.
In so doing, however, while admitting the absence of safety profiles of Zofran use for pregnancy - and having been accused by the DOJ of promoting Zofran off-label for such a purpose - GSK has been accused by plaintiffs of being in receipt of more than 200 complaints of birth defects associated with Zofran, while failing to make any attempt to update the product warning label.
Plaintiff Arellanes makes just such an allegation in Melisa Arellanes v. GlaxoSmithKline LLC, case number 2:15-cv-05544, in the US District Court for the Central District of California.
READ MORE ZOFRAN BIRTH DEFECT LEGAL NEWS
The label currently, as well as the point of time at which Arellanes was prescribed Zofran, states that studies of Zofran, or ondansetron, in pregnant rats and rabbits “revealed no evidence of…harm to the fetus.” But it also cautions that data for pregnant women is lacking and that as a result, “this drug should be used during pregnancy only if clearly needed.”
The Zofran birth defects allegations made by Arellanes mirrors those of other lawsuits. GSK, meanwhile, has petitioned the Judicial Panel on Multidistrict Litigation that current and forthcoming lawsuits should be consolidated in the Eastern District of Pennsylvania. The motion is expected to be considered in October.