ZofranLegal.com reports on the growing concern of “off-label” marketing and prescriptions in connection with current Zofran birth defect lawsuits. Zofran, an anti-nausea drug manufactured by pharmaceutical giant GlaxoSmithKline, was approved by the U.S. Food and Drug Administration in 1991. This approval, however, does not fully align with all of the ways the drug is used today. Zofran was approved (initially in intravenous form, and later as a pill) for people suffering from nausea and vomiting episodes due to chemotherapy, radiation, and anesthesia treatments.

After this initial approval, however, GlaxoSmithKline allegedly began to market the drug in what is termed an “off-label” way to OB/Gyns for treatment of nausea associated with morning sickness. The drug had never been tested for safety on expectant mothers, yet, today, it is prescribed to over 1 million annually. The prescription of a drug “off-label” is not illegal. Unfortunately in this case, plaintiffs claim that both “off-label” marketing and prescribing occurred, and women across the nation now allege that use of Zofran while pregnant caused their babies to develop birth defects.

The defects most commonly alleged are cleft lip and palate, atrial septal defect, ventricular septal defect, transposition of the greater vessels, tetralogy of fallot, and clubfoot. Some alleged defects have been reported by plaintiffs as so severe that the infants have died. Interestingly enough, morning sickness is most frequently experienced during the first trimester, which is when most plaintiffs say they used Zofran. This also happens to be a critical time of development for the fetus’ heart, mouth, and limbs.

While lawsuits continued to mount alleging similar problems across the U.S., details of each plaintiff’s story shed new light on “off-label” marketing and prescribing practices. This was not the first time that GlaxoSmithKline had gotten themselves into hot water due to “off-label” marketing. In 2012, the company settled a lawsuit with the U.S. Department of Justice which claimed they were falsely marketing several of their drugs, including Zofran. GSK paid $3 billion and moved along, but allegedly, they have continued the “off-label” marketing practice anyway.

Today, lawsuits claiming that Zofran exposure causes an increased risk for birth defects in babies are still adding up. Several studies appear to support these claims with evidence. The attorneys at Monheit Law are currently working to help any women who were prescribed Zofran while pregnant and who subsequently gave birth to babies with defects. These women and their children may be entitled to compensation, and Monheit Law offers free consultations so that they are able to fully explore their legal rights.

For additional information on Zofran birth defects or Zofran birth defect lawsuits, please contact Michael Monheit, Esq. by calling 877-620-8411.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046