Research shows approximately 75 percent of all pregnant women suffer some degree of nausea during gestation. It’s sometimes referred to as “morning sickness,” though symptoms can occur at all times of the day. In some cases, the symptoms are severe, sometimes even resulting in hospitalization.
Several years ago, doctors began prescribing a drug touted as safe for both mother and child. It’s called Zofran, and it was previously developed as a powerful anti-nausea drug for cancer patients enduring chemotherapy. Its prescribed use for pregnant women is an off-label use that was not approved by federal regulators.
Now, it’s being alleged that use of Zofran during pregnancy can cause a host of birth defects, including heart defects and other serious congenital abnormalities. At least four lawsuits have been filed so far against drug manufacturer Glaxo Klein Smith.
One of those is a woman from California who alleges her son was diagnosed with a serious heart birth defect after she consumed Zofran, prescribed by her OBGYN, during the first trimester of pregnancy. Her now 5-year-old son has been diagnosed with supraventricular tachycardia. In her complaint, she alleges this condition was proximately caused by her prenatal exposure to the anti-nausea drug.
In another case out of Pennsylvania, a woman who took the drug as prescribed by her doctor during both of her pregnancies (in 2004 and 2006) gave birth to two children with serious heart defects.
In Massachusetts, a mother alleges her little girl was born with a number of birth defects, including heart problems, after she consumed the drug while pregnant.
And finally in a product liability case in Alabama, a woman alleges her son, born in 2006, is considered special needs after he was diagnosed with a number of congenital defects she says were caused by her consumption of Zofran during pregnancy. Among the conditions he suffers: A high, narrow pallet, extra digits, a distended kidney, ureteral disorder, seizures and his inability to be verbal. She says neither she nor her husband have the chromosomal issues that would have been passed on to the child to cause these defects (reportedly stemming from duplication of the long arm of his 13th chromosome). The lawsuit alleges the drug was unreasonably dangerous and as a result, her son will suffer health issues the rest of his life. She seeks compensatory damages on claims of negligence, negligent failure to warn, breach of warranty, strict liability and the Extended Manufacturer’s Liability Doctrine recognized in Alabama.
This is the same company that paid $3 billion to settle allegations from the U.S. Department of Justice regarding the off-label marketing of a number of medications.
Zofran isn’t the only drug that is alleged to cause problems for unborn children. Recently in Pennsylvania, a state superior court upheld an $11.6 million verdict favoring a couple who alleged their son was born with numerous birth defects as a result of the mother’s use of prescribed epilepsy drug Topomax during gestation.
The company that makes the drug, Janssen Pharmaceuticals Inc. (a subsidiary of Johnson & Johnson) appealed, arguing it could not on its own change the warning rating from the FDA. AT the time, it was rated as a “Category C” drug, meaning there were indications of adverse effects on unborn children, but no well-controlled studies to prove it. The appeals court upheld the jury’s finding that the company failed to adequately warn pregnant women of the potential risk of birth defects.
Our experienced defective drug lawyers in Florida are available to answer your questions regarding the adverse effects of prescribed drugs during pregnancy.
If you have been injured, contact the Hollander Law Firm at (888) 751-7770 for a free and confidential consultation. There is no fee unless we win.
Mom Claims Anti-Nausea Drug Caused Defects, April 7, 2015, By Tracey Dalzell Walsh, Courthouse News
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