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Zofran Lawsuits Increase in Federal Courts

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Though Zofran lawsuits have not yet been consolidated into one court, litigation continues to grow. Just in the last few weeks, three more cases were filed in different federal courts, each claiming that Zofran (ondansetron) manufacturers GlaxoSmithKline (GSK) failed to provide adequate warnings about the risks for birth defects.

The FDA never approved Zofran for use in pregnant women. It was approved only for the treatment of nausea and vomiting in those going through chemotherapy and radiation for cancer. Still, GSK promoted the drug to doctors and expectant moms who were suffering from morning sickness, and the promotions worked. They sold millions of dollars worth of the drug to pregnant women.

Now, many of those women seek to hold the company liable for failing to thoroughly test the drug before promoting it as a safe medication, when in fact it has been found to present risks to a fetus.

Two Moms File Zofran Lawsuits in Alabama

On June 23, 2015, two Zofran lawsuits were filed in federal court—one in the Southern District of Alabama and the other in the Northern District of Alabama, Southern Division. In the first, an Alabama mother claims she was prescribed Zofran to treat and prevent symptoms of morning sickness early in her first trimester of pregnancy with her daughter.

The child was born in 2001, and after her birth, was diagnosed with severe congenital heart defects. She had to undergo open-heart surgery to repair her heart, and had a pacemaker installed when she was four years old. She will have to live with the pacemaker for the rest of her life.

The plaintiff never suspected that Zofran could be the cause of her daughter’s birth defects until recently, as awareness of the drug’s potential side effects has increased. She claims that Zofran that GSK should be held liable for damages related to the child’s medical expenses.

The second lawsuit was filed by another Alabama mother who took Zofran in her first trimester to prevent the symptoms of morning sickness. She continued to take it as directed into her third trimester. Her son was born in 2011 with multiple congenital anomalies. He suffered from congenital heart defects, as well, for which there was no genetic cause.

The child’s mother claims she was unaware of the dangers of using Zofran during pregnancy, and that had she known, she never would have taken it. She seeks to hold GSK liable for her son’s medical expenses.

Louisiana Mom Claims GSK Was Negligent

On June 26, 2015, another mom filed a Zofran lawsuit in Louisiana. According to her complaint, she took Zofran from early in her first trimester through her third trimester to ease the symptoms of morning sickness. Her son was born in 2006.

At birth, the child was diagnosed with severe congenital heart defects, for which he had to undergo two corrective surgeries. The plaintiff claims that she had no family history of heart defects, and blames Zofran for her son’s health issues. She seeks general and compensatory damages.

Studies Link Zofran with Increased Risk of Birth Defects

A number of studies have indicated that Zofran may present risks to an unborn child. In 2006, researchers found that the drug could cross the placental barrier. In 2012, they found that treatments like Zofran were associated with a potential risk of cleft lip and palate, and in 2013, Australian researchers found it was linked with a small increased risk of birth defects. In 2014, scientists found a significant increased risk for cardiovascular defects in those infants born to mothers who had taken Zofran.

Despite these findings, GSK failed to include warnings about birth defects on their product labels.