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Birth Defects Believed to Result from Nausea Drug Lead to $100 Million Lawsuit

Birth

A drug that was frequently prescribed for nausea during pregnancy has led to a flurry of lawsuits. In Alabama, a major lawsuit was recently filed against drug manufacturer GlaxoSmithKline (GSK) for birth defects believed to be caused by the drug Ondansetron, (sold under the brand name Zofran). The drug was approved by the Food and Drug Administration (FDA) as a treatment for nausea resulting from chemotherapy, radiation therapy, and surgical anesthesia, but became a commonly-prescribed treatment for nausea associated with pregnancy. This was an off-label use of Zofran. “Off-label” uses occur when a doctor prescribes a drug for a use not specifically approved by the FDA. Off-label prescribing is not regulated by the FDA, but it is against federal regulation for a drug manufacturer to advertise a drug for an off-label use.

In 2012, the US Department of Justice filed multiple civil and criminal charges against GSK, asserting, among other things, that the company promoted a number of its products, including Zofran, for off-label uses. The Justice Department alleged that GSK had promoted Zofran for pregnancy-related nausea, offered illicit pay to health care professionals to promote Zofran, and made false statements regarding Zofran’s safety as a treatment for morning sickness. GSK never admitted wrongdoing regarding its promotion of Zofran, but did settle these claims with the Justice Department for $3 billion for three of the criminal charges lodged against it. GSK continues to claim that it did not promote Zofran for off-label uses. Research conducted on the nausea drug, however, shows that it poses a risk to fetal development. One peer-reviewed study published in the medical journal Reproductive Toxicology found that use of Ondansetron as a remedy for pregnancy-induced nausea carried with it an increased risk for malformation of a fetus’ heart, especially the cardiac septum dividing the heart’s ventricles.

One Chilton County, Alabama, family has filed a lawsuit against GSK for $100 million in damages on behalf of their son. The Harris family’s lawsuit claims that their son, Talon, suffered from a number of severe defects at birth and is now a nonverbal special needs child with a malformed palate who suffers from seizures. The Harris family alleges that these issues are related to a chromosomal defect for which neither parent carries the genetic marker, and which are similar to birth defects that have occurred in other children whose mothers took Zofran.

If you or a loved one took Zofran during your pregnancy and believe that your child suffered birth defects as a result, contact the skilled, compassionate Mobile attorneys at J. Allan Brown, LLC, for a no-cost consultation on your possible claims. Our attorneys will help you to recover the damages to which you are entitled for your suffering and the suffering of your child.

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Law Office of J. Allan Brown, LLC, is located in Mobile, AL and serves clients in and around Mobile, Bucks, Satsuma, Eight Mile, Semmes, Spanish Fort, Citronelle, Theodore, Saraland, Montrose, Irvington, Saint Elmo, Wilmer, Point Clear, Grand Bay, Chunchula, Fairhope, Creola, Bayou La Batre, Axis, Coden, Bay Minette, Silverhill, Baldwin County and Mobile County.
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