Louisiana Mothers Claim Zofran Caused Near-Fatal Heart Defects, Zofran Lawyers Monheit Law Report
July 02, 2015 – – On June 8, 2015, two mothers from Louisiana filed a joined complaint against GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran caused their children to develop severe congenital heart defects. Filed in the US District Court for the Western District of Louisiana, their lawsuit alleges that GlaxoSmithKline unlawfully promoted Zofran as an “off label” morning sickness treatment, putting a drug with allegedly harmful effects on fetal development directly into the hands of pregnant women across the country.
To read a copy of this recent Zofran lawsuit, filed under case number 6:15-cv-01815-RFD-PJH, visit ZofranLegal.com, a website sponsored by Monheit Law. Devoted to protecting the rights of consumers and patients nationwide, Monheit Law has joined forces with an alliance of plaintiffs’ attorneys to investigate potential Zofran birth defect claims.
According to dangerous drug attorneys at Monheit Law, both plaintiffs in this lawsuit say they were prescribed Zofran to alleviate the symptoms of nausea and vomiting common during the first trimester of pregnancy. Plaintiffs note that Zofran has never been approved for use during pregnancy. In fact, the drug has only been FDA-certified as “safe and effective” for the treatment of severe nausea and vomiting among cancer patients receiving chemotherapy and radiation therapy, as well as patients undergoing surgical anesthesia.
Federal law prohibits pharmaceutical manufacturers from promoting drugs for unapproved uses. But in 2012, GlaxoSmithKline was charged by the US Department of Justice for marketing Zofran directly to physicians as a safe drug for the treatment of morning sickness. Plaintiffs in at least ten Zofran birth defect lawsuits have leveled the same allegation against the company, blaming GlaxoSmithKline’s alleged “off label” marketing for exposing their unborn children to a drug with potentially harmful effects.
The first plaintiff in case 6:15-cv-01815-RFD-PJH claims that she began taking Zofran during the first trimester of a pregnancy in early 2010. Her daughter, named L.D. in court documents, was born on July 15, 2010, plaintiff writes, and quickly diagnosed with three congenital heart defects: ventricular septal defect, atrial septal defect and intermittent tachypnea. The mother notes a series of recent epidemiological studies that have linked prenatal exposure to Zofran’s active ingredient and an increased risk for congenital heart defects. She references three studies, conducted in Sweden and Denmark, that found women who took Zofran during early pregnancy were more than twice as likely to deliver children with heart defects. Several of these studies found specific increased risks for “cardiac septal defects,” including the ventricular and atrial septal defects with which plaintiff claims her daughter L.D. was born. Plaintiff says that her daughter was forced to undergo surgery to repair her ventricular septal defect.
The second plaintiff writes that she became pregnant in 2005, and was soon prescribed Zofran as an “off label” morning sickness treatment. Her daughter V.P., born on August 9, 2005, was diagnosed with accelerated ventricular arrhythmia, the mother claims. This heart abnormality, which involves a defect in the heart’s system of electrical impulses, “nearly caused V.P. to die shortly after birth,” according to court documents. The child “required intense and regular medical monitoring and testing for the first five years of her life,” plaintiff says.
Monheit Law has been following the ongoing Zofran litigation closely, and attorneys at the firm report that at least ten individual lawsuits have now been filed against GlaxoSmithKline. Plaintiffs unanimously accuse the company of promoting Zofran for “off label” use during pregnancy, in violation of federal law. But their allegations have gone even further than those of the US Federal Government. Plaintiffs say that GlaxoSmithKline has been aware of Zofran’s potential association with increased birth defect risks for more than two decades. They cite a growing body of scientific research suggesting this link, as well as more than 200 reports of birth defects with suspected ties to Zofran exposure. GlaxoSmithKline concealed this alleged evidence, plaintiffs claim, from pregnant women and their physicians.
Joined by a coalition of lawyers devoted to advocating for the rights of parents and birth defect survivors, Monheit Law is currently providing free consultations to any family who believes that prenatal exposure to Zofran may have caused a child’s birth defect. For more information, and a case eligibility evaluation, call 1-877-620-8411.
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