Zofran Birth Defect Lawsuit Points To “Andersen Study” Results

November 12, 2015 – – ZofranLegal.com reports on one of the most recently filed lawsuits against Zofran, claiming as many others have, that use of the drug during pregnancy causes an increased risk for birth defects. The suit was filed against Zofran manufacturer GlaxoSmithKline in the U.S. District Court of the Eastern District of Louisiana and is case number 2:15-cv-04399-SM-DEK. Additional allegations in the complaints state that GlaxoSmithKline was aware of the risk associated with their drug and yet failed to inform expectant mothers across the nation of its potential birth defect side effects.

In this case, the mother uses information from a study named “The Andersen Study” to support her argument. Results from this study seem to indicate that use of Zofran during pregnancy may result in an increased risk of the development of birth defects in the unborn child.

Although many expectant mothers in the United States use Zofran as an anti-nausea medication to combat morning sickness, it was never approved for this use or tested for safety on pregnant women by the U.S. Food and Drug Administration. The drug was actually approved by the FDA to treat people suffering from nausea and vomiting due to having undergone chemotherapy, radiation, or anesthesia. Shortly after this approval, however, plaintiffs allege that GlaxoSmithKline decided to market the drug to pregnant mothers and Ob/Gyns in order to increase their profit. Today, many women are prescribed the drug by their Ob/Gyns, and use the medicine without even realizing that this use is considered “off-label.”

Since the start of this “off-label” marketing and prescribing, GSK has allegedly been sent more than 200 reports from medical doctors across the country who indicated that mothers using Zofran were giving birth to children with a range of defects. Additionally, several epidemiological studies have investigated the link between fetal exposure to Zofran while in utero, and the development of birth defects. The “Andersen Study,” specifically cited by this case, found that mothers who used the drug during their first trimester (when morning sickness is most common), were, in fact, more likely to give birth to a baby with congenital heart defects.

As allegations against Zofran began to mount, more than 60 families stepped forward filing birth defect-related lawsuits, each alleging that Zofran had caused their children’s defects. Their complaints list a range of defects, but most commonly note kidney defects, clubfoot, cleft lip and palate, respiratory distress syndrome, atrial septal defect and ventricular septal defect, and transposition of the major vessels.

In some of the lawsuits filed, the children born with defects ultimately died. Others had to undergo multiple surgeries. The United States Judicial Panel on Multidistrict Litigation recently consolidated the suits into MDL number 2657, which is being overseen in Boston by the Honorable Judge F. Dennis Saylor. As these cases await trial, it is expected that others will continue to be filed.

The attorneys at Monheit Law are currently working to ensure that anyone who was prescribed Zofran during pregnancy and who subsequently gave birth to a child with defects is able to explore their legal rights. These individuals may be entitled to compensation. At this time, Monheit Law is offering free consultations to those involved.

For additional information on Zofran birth defects, or to ask questions, contact Attorney Michael Monheit 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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