GlaxoSmithKline Files A Motion To Dismiss Zofran Lawsuits

courtroom where Zofran lawsuit will be tried
GlaxoSmithKline has filed a motion requesting that Judge Saylor dismiss Zofran lawsuits. Last month, on December 11th, 2015, GlaxoSmithKline (GSK) filed a motion in the United States District Court for the District of Massachusetts regarding all claims involved in Zofran MDL 2657.

The Motion

GSK, the manufacturer of the drug Zofran, has requested that all federally filed lawsuits regarding the drug be dismissed because they believe that there is enough evidence to show that the U.S. Food and Drug Administration (FDA) wouldn’t have allowed the creation of a warning label that the plaintiffs claim would have informed the public and medical community of certain risks associated with the drug. They noted that the FDA has already denied a citizens’ petition to have the warning label changed to include that the drug may cause birth defects.

The Plaintiff’s Response

Plaintiffs filed a response on January 5th, 2016, stating that “Defendant GlaxoSmithKline, LLC’s request to dismiss all cases at the initial pleadings stage is unripe, unprecedented and violates established federal law.”

A status conference was set for January 14th, where both parties reviewed the motion with Judge F. Dennis Saylor. A determination has yet to be announced.

Zofran Lawsuits

The decision to file this motion by GSK is hardly surprising. Over 200 lawsuits have been filed against the company, each one alleging that the drug Zofran caused a birth defect in an unborn child.

Zofran is one of the most popular drugs prescribed to expectant mothers as a treatment for morning sickness. The drug was first approved by the FDA in 1991, but what patients weren’t aware of was that the drug was not approved for pregnant women. Zofran was approved for the treatment of nausea and vomiting but only in patients undergoing anesthesia, radiation, and chemotherapy.

GSK marketed the drug “off-label”, however, and indicated to the medical community and the public that the drug was “safe” and “effective” as a treatment for morning sickness. But shortly after the company began this marketing campaign, they allegedly received multiple reports indicating that woman who took Zofran during pregnancy had given birth to children with birth defects.

Today, the birth defects noted in the complaints include cleft lip, cleft palate, atrial septal defect, ventricular septal defect, transposition of the greater vessels, respiratory distress syndrome, and kidney defects. Every child who suffers from one of these defects has required ongoing medical care and most have had to undergo at least one surgical procedure. In some cases, the family claims that the birth defect resulted in the child’s death.

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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