California Zofran Lawsuit Alleges GlaxoSmithKline Marketed Drug “Off Label”

  • Date: Nov 20, 2015
  • Category: Legal

GlaxoSmithKline has been accused of knowingly promoting their drug Zofran “off-label” to expectant mothers in one of the latest Zofran lawsuits, filed in California.

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Nov 20, 2015 /prREACH/ -- In one of the most recent lawsuits filed against drug manufacturer GlaxoSmithKline the plaintiff has alleged that the company promoted the drug for off-label use.

This complaint, filed in the U.S. District Court of the Central District of California under case number 5:15-cv-01780, is one of many that all allege the drug Zofran caused birth defects in a child while it was in utero. Birth defects noted in these suits include cleft lip, cleft palate, kidney defects, respiratory distress syndrome, ventricular septal defect, atrial septal defect, and clubfeet. In the majority of cases, the child underwent at least one surgery in an attempt to correct their birth defect. In many cases, multiple surgeries were required with more planned in the future.  Parents frequently claim that the birth defects have diminished their child’s quality of life.

In this particular lawsuit, the child in question was born with a cleft palate and cleft lip. Her mother was prescribed Zofran during her pregnancy to treat morning sickness. Her parents allege that, “Although the only FDA approval for this drug was for seriously ill patients, GSK marketed Zofran “off label” since at least January 1998 as an established safe and effective treatment for the very common side effect of a normal pregnancy - pregnancy-related nausea and vomiting - otherwise known as “morning sickness.” GSK further marketed Zofran during this time as a “wonder drug” for pregnant women, despite having knowledge that GSK had never once undertaken a single study establishing that this powerful drug was safe or effective for pregnant mothers and their growing children in utero.”

This isn’t the only time that GSK has faced a lawsuit that alleged they unlawfully promoted one of their products off-label. In 2012, the company agreed to a settlement in a lawsuit that had been filed by the U.S. Department of Justice. In the agreement, GSK had to pay $3 billion in fines.

Zofran lawsuits were recently consolidated into MDL 2657. The consolidated complaints will be overseen in Boston, Massachusetts by a federal judge. At this time, there have been no announcements regarding when the trials will begin.

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Michael Monheit


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