Zofran Lawsuit Filed Over Chromosomal Defect Following Pregnancy Exposure

The mother of a boy born with a devastating list of a congenital malformations, including a high narrow pallet, extra digits, distended kidney, glaucoma and a urethral disorder, blames the problems on side effects of Zofran used for morning sickness during pregnancy.

According to a complaint (PDF) filed by Julie Hunter in the U.S. District Court for the Northern District of Alabama on April 1, her son has suffered chromosomal defects from Zofran exposure during the first trimester, after she was prescribed the nausea drug for morning sickness.

Talon Hunter was born on August 12, 2006, with a high narrow pallet, extra digits, distended kidney, glaucoma, and a urethral disorder. He also suffers from seizures, is nonverbal and exhibits delayed reactions. Eventually, Talon was diagnosed with a chromosomal defect, involving a duplication of the long arm of his 13th chromosome, which Hunter indicates are the cause of the myriad of health problems experienced by Talon.

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Neither of the child’s parents exhibit any chromosomal issues that could have been congenitally passed to Talon, according to the lawsuit, which alleges that exposure to Zofran caused the birth defect that will cause health issues for the rest of his life.

The case is one of a growing number of Zofran birth defect lawsuits filed in recent weeks against GlaxoSmithKline, which all raise similar allegations that the drug maker illegally marketed their anti-nausea and vomiting drug for use among pregnant women, even though that is not an approved use that has been determined to be safe or effective.

Zofran Birth Defect Concerns

Zofran (ondansetron) is only approved by the FDA for treatment of nausea and vomiting among cancer and surgery patients. However, it is commonly prescribed off-label during pregnancy, resulting in a substantial portion of the annual sales for the drug over the past decade.

Within the medical community, it is widely assumed that Zofran is safe during pregnancy. However, a number of studies have highlighted potential Zofran pregnancy risks when the medication is used in the first trimester.

As early as 2006, a study published by Hong Kong researchers confirmed that Zofran crosses the placenta in significant amounts when taken by pregnant women.

Researchers concluded that the “developmental significance of this drug exposure requires further investigation,” yet millions of women have continued to be prescribed the medication without warnings about the potential Zofran birth defect risks.

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.

Additional studies have also identified potential Zofran heart defect risks. In August 2013, a study was presented that involved data on more than 900,000 pregnancies in the Danish Medical Birth Registry, suggesting that children exposed to Zofran may be 2 to 4 times more likely to suffer a septal defect, involving holes in the heart.

More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

Despite the findings of this independent research, GlaxoSmithKline has failed to undertake a comprehensive study on the pregnancy risks or updated the warning label to inform users and the medical community about the findings, according to allegations raised in lawsuits filed by families throughout the U.S.

The Hunter family is pursuing claims against GlaxoSmithKline for violating the Alabama Extended Manufacturer’s Liability Doctrine, as well as for negligent failure to warn, breach of warranty, negligence, wantonness, and strict liability. The lawsuit seeks damages for the family’s pain and suffering and to cover all past and future medical expenses related to Hunter’s birth defects, which will lead to him requiring special medical care for life.

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