The Zofran Birth Defects Lawsuit Contends That Drug Manufacturer GlaxoSmithKline Failed To Perform Tests on Humans Before Marketing The Drug As Safe For Treating Morning Sickness in Pregnant Women Reports Wright & Schulte LLC
As Zofran side-effect lawsuit claims continue to assert that use of the drug during pregnancy causes congenital birth defects, Wright & Schulte LLC noticed a recent Zofran complaint was filed on behalf of a mother whose two children suffered severe injuries allegedly due to prenatal exposure to the drug. The mother was prescribed Zofran in her first trimester of pregnancy to treat morning sickness and gave birth in 2004 and in 2006 to children with congenital heart defects, according to the complaint. The oldest child had to undergo surgery in 2011 to repair a hole in the heart and the youngest child was not able to breathe adequately at birth due to dangerously low oxygen levels and required 24-hour monitoring, the complaint said. The Zofran lawsuit purports that the growth and development of both children were stifled due to their condition. Until recently, the mother did not suspect the nausea medication as the cause of her childrens’ condition, according to the Zofran complaint which was filed in U.S. District Court, Eastern District of Pennsylvania. (2:15-cv-00709-PD)
“The complaint asserts that had the mother known the truth about Zofran, which was hidden by its manufacturer, GlaxoSmithKline, she would not have taken Zofran during pregnancy,” says Wright & Schulte LLC. “According to the complaint, the family had no previous history of birth defects and genetic screenings did not identify any genetic anomalies. The lawsuit clearly outlines the devastating effects that Zofran allegedly have on pregnant women and their children.”
The harmful drug side-effect attorneys at Wright & Schulte LLC offer free, no-obligation Zofran lawsuit evaluations to families whose children suffered birth defects, such as heart defects, cleft lip and cleft palate, due to taking Zofran during pregnancy. To speak with one of the firm’s attorneys, call 1-800-399-0795 or visit yourlegalhelp.com for more information on this and other harmful drugs.
According to the Zofran birth defects lawsuit, the U.S. Food and Drug Administration approved Zofran in 1991 to treat nausea induced by chemotherapy and radiation. However, GlaxoSmithKline promoted the off-label use of the drug as a “safe and effective” treatment for morning sickness, which is pregnancy-related vomiting and nausea. The lawsuit contends that GlaxoSmithKline knew that its representations of the drug were “utterly false” because the company had not done a single study on Zofran effects on a pregnant woman or her baby. The Zofran complaint purports that GlaxoSmithKline did not conduct studies because the research would have hindered the company from marketing the drug and profits would have decreased due to Zofran’s association with serious birth defects, such as cleft palate and cardiac malformations. The court document further purports that the company’s conduct “was tantamount to using expectant mothers and their unborn children as human guinea pigs.”
The court document further claims that GlaxoSmithKline knew in the 1980s that Zofran was not safe for pregnant mothers after studies the company conducted on animals revealed toxicity, malformaties in offspring and intrauterine deaths. The studies also found that Zofran’s active ingredient can pass through the placental barrier of pregnant mammals to fetuses, the complaint said. A later study conducted on humans confirmed these findings since Zofran was found to cross the human placenta and fetuses were exposed to the drug in “substantial concentrations.” According to the Zofran complaint, GlaxoSmithKline began receiving reports in 1992 of birth defects associated with the anti-nausea medication and had received at least 32 reports by 2000. Since that time, the company has received more than 200 such reports but the company did not reveal this information to pregnant women or their physicians, the complaint says.
According to the Zofran complaint, GlaxoSmithKline pleaded guilty to criminal charges lodged by the U.S. Department of Justice (DOJ) for off-label promotion of its drugs, including Zofran. The drug maker agreed to pay $3 billion to resolve the DOJ’s civil and criminal complaints against the company, which included offering kickbacks to health care professionals who promoted and prescribed Zofran, the complaint says.
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Zofran lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.