Zofran Lawsuit Alleges Zofran Exposure Caused Atrial Septal Congenital Birth Defect In Infant

January 08, 2016 – – ZofranLegal.com reports on a recent lawsuit filed by plaintiffs in Louisiana which alleges that exposure to Zofran through the mother while developing in utero caused a baby to develop severe congenital birth defects. The lawsuit has been consolidated with many others alleging much the same in a multidistrict litigation in Boston, Massachusetts (MDL No. 2657). All cases in the MDL are being overseen by Judge F. Dennis Saylor IV.

Details of the complaint explain that the plaintiff was prescribed Zofran during her first trimester of pregnancy, in order to treat nausea associated with morning sickness. While the first trimester is a time when many mothers experience morning sickness, it is also a time when the fetus does much of its initial heart tissue development. Months later when the plaintiff’s son was born, he was diagnosed with several congenital heart defects: atrial septal defect and partial anomalous pulmonary venous return. The infant required two corrective surgeries for these defects.

The plaintiff states that Zofran manufacturer and pharmaceutical giant GlaxoSmithKline is responsible for the formation of these defects in her son. The anti-nausea drug has been linked by many across the nation to a variety of birth defects, including respiratory distress, clubfoot, tetralogy of fallot, transposition of the greater vessels, atrial septal defect, ventricular septal defect, kidney defects, and cleft lip and palate. Lawsuits filed by some parents indicate that the defects were fatal, while others required numerous surgeries.

Zofran was approved by the U.S. Food and Drug Administration in 1991, but, interestingly enough, it was never FDA-approved for expectant mothers or tested for safety on this consumer group. Instead, the FDA specifically approved Zofran to treat nausea and vomiting in patients who had recently undergone chemotherapy, radiation, or anesthesia procedures.

After GlaxoSmithKline gained this initial approval, however, the company began to market Zofran as a morning sickness treatment to OB/Gyns and pregnant women across the U.S. This practice is termed “off-label” marketing, and it led to the “off-label” prescribing of Zofran to an estimated 1 million women in one year’s time.

The plaintiff in this particular case discusses this “off-label” marketing practice, stating that GSK marketed the drug in this way since 1998. She notes that if she had been made aware of this or better aware of the birth defect risks which she now connects with the drug, she would have chosen an alternative treatment.

The attorneys at Monheit Law are currently working to ensure that all affected mothers have the opportunity to investigate their legal rights. Women who used Zofran while pregnant and later gave birth to an infant with congenital defects may be entitled to legal action and compensation. These women and their families are now offered free legal consultations at Monheit Law.

To request additional information, or to ask questions, contact Michael Monheit, Esq., lead attorney at Monheit Law 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

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