Zofran Lawsuit Plaintiff Claims Drug Exposure Caused Atrial Septal Birth Defect In Infant

February 09, 2016 – – ZofranLegal.com reports on a lawsuit filed by parents from Louisiana who claim that exposure to Zofran while growing in the womb caused an unborn baby to develop severe congenital heart defects. The lawsuit was consolidated with hundreds of others containing similar allegations to form multidistrict litigation number 2657 in Boston, Massachusetts. This consolidation was done by the U.S. Judicial Panel on Multidistrict Litigation. The MDL cases are being overseen by the Honorable Judge F. Dennis Saylor IV.

A closer look at details in court documents which discuss this specific complaint shows that the plaintiff was prescribed Zofran in her first trimester of pregnancy to help ease nausea episodes she was experiencing. The first trimester is a time when many mothers battle morning sickness, however, more critically, it is a time when the fetus completes much of its first heart tissue development, and undergoes periods of rapid cell division. After using the drug during her first trimester, the plaintiff later gave birth to a son who was diagnosed with multiple congenital heart defects: atrial septal defect and partial anomalous pulmonary venous return. He required two corrective surgeries to help his heart work properly.

The plaintiff alleges that corporate giant and Zofran manufacturer GlaxoSmithKline is ultimately responsible for the development of these defects in her infant. Zofran has been linked to a variety of birth defects by parents across the nation, including respiratory distress, clubfoot, tetralogy of fallot, atrial septal defect, ventricular septal defect, transposition of the greater vessels, kidney defects, and cleft palate and lip. Several plaintiff’s lawsuits claim wrongful death, as their infant’s birth defects were so severe they were fatal.

In 1991, the U.S. Food and Drug Administration approved Zofran, although, surprisingly to some, the drug was never FDA-approved to treat pregnant women, or tested for safety on these women and their unborn babies. The FDA’s approval was specifically for the treatment of nausea and vomiting in patients who had recently undergone chemotherapy, radiation, or anesthesia.

After the FDA approval was given, however, GlaxoSmithKline began to market Zofran as a morning sickness treatment to OB/Gyns and the general public. This is called “off-label” marketing, and, in this case, it led to the “off-label” prescribing of Zofran to an estimated 1 million pregnant women within just one year. This “off-label” marketing is frequently discussed by plaintiffs and is a common point of contention and controversy. In this lawsuit, the plaintiff involved also discusses “off-label” marketing, and states that GSK has marketed the drug in this way dating back to 1998.

At this time, the attorneys at Monheit Law are working to help ensure that all mothers and children affected by Zofran will have the opportunity to fully investigate their legal rights. Women who took Zofran while pregnant and who subsequently gave birth to babies with congenital defects may be entitled to substantial compensation. Those involved are now offered free legal consultations at Monheit Law.

To request more information or ask questions, please 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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