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New Allegations in Zofran Lawsuit Hurled at Manufacturer

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Randolph, MAWith every new lawsuit that stems from an allegation that GlaxoSmithKline’s Zofran causes Zofran birth defects, we are reminded of charges levied against the manufacturer by the US Department of Justice (DOJ) in 2012 which, among other things, accused GlaxoSmithKline (GSK) of promoting Zofran and other drugs off-label.

Specifically, for morning sickness - or at least, that was the allegation. While doctors have the legal, medical and moral authority to prescribe drugs for indications to which they were not approved by the US Food and Drug Administration (FDA), it is illegal for manufacturers to promote them as such.

Zofran was approved only for post-operative nausea, and not to resolve morning sickness in pregnant women. GSK, in fact, in relation to an investigative report appearing in The Toronto Star in June of last year, noted that
“the safety of ondansetron (Zofran) for use in human pregnancy has not been established…”

And yet there was GSK, in 2012, facing an allegation from the DOJ, which noted the $3 billion settlement agreement between the DOJ and GSK “further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women,” according to an official news release by the DOJ (7/2/12). The hit to GSK was $3 billion to resolve the foregoing and other charges - at the time the largest pharmaceutical settlement in US history.

Aside from the $3 billion slap on the wrist, GSK carries on marketing its pharmaceutical portfolio and developing new drugs. However, what remains are the alleged victims of Zofran birth defects who are left with lasting collateral damage.

One of the most recent Zofran birth defects lawsuits was filed April 17 in US District Court, Texarkana Division of Texas (case No. 5:15-34), by a plaintiff who claims she gave birth to a child with “numerous birth defects” after having been prescribed Zofran for nausea and vomiting early in her pregnancy.

The birth defects allegedly linked to prenatal Zofran side effects include, according to the lawsuit, “heart murmur, fluid on the brain [hydrocephaly], thickened arteries and multiple developmental delays.” The plaintiff’s son, now nine months of age, faces a “long road of multiple surgeries” to correct the alleged Zofran birth defects.

A handful of other Zofran lawsuits have been filed, according to Monheit Law. Plaintiffs claim that GSK illegally promoted Zofran as a “safe and effective” treatment for morning sickness, a use that never secured FDA approval and a use that has never been adequately studied - an admission made by GSK itself in June 2014 in concert with the investigation by The Toronto Star.

The Texas case, meanwhile, doesn’t stop there. New and disturbing allegations have been brought forth in the Zofran lawsuit, according to Monheit Law. “Between 1992 and 2011, [GlaxoSmithKline] avoided conducting studies or trials because they would have hampered its marketing of Zofran and decreased profits,” the lawsuit alleges. The defendant, according to court records associated with the lawsuit, began “receiving reports of birth defects associated with the use of Zofran by pregnant women” as early as 1992. The plaintiff further alleges that GSK “has received more than 200” such reports to date, but further alleges that “the number of events actually reported to GSK was only a small fraction of the actual incidents.”

The latest Zofran lawsuit, and the seventh such lawsuit in the US, was also filed April 17, this time in US District Court, Eastern Division of Massachusetts (Case No. 1:15-11627). In this Zofran side effects lawsuit, the plaintiff, who hails from Randolph, claims to have been prescribed Zofran to mitigate the effects of morning sickness early in her pregnancy. Soon afterwards, according to the complaint, a routine examination revealed evidence of “severe and life-threatening defects, including a severe abdominal malformation.” The plaintiff was left with no other choice but to terminate her pregnancy on October 16, 2013.

The Toronto Star in its June 2014 investigative report noted that doctors who are prescribing Zofran to their patients off-label may not possess the best information needed to adequately guide their decisions.


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