On February 16, 2015, a Boston mother filed the first birth defect lawsuit against GlaxoSmithKline, initiating a litigation that has since grown to at least ten individual claims. Families accuse the pharmaceutical giant of concealing evidence that its anti-nausea drug Zofran increases the risk of major birth defects, while unlawfully promoting the drug for use during pregnancy.
Jul 02, 2015 /prREACH/ -- To date, at least 10 plaintiffs have sued GlaxoSmithKline, claiming compensation for child birth defects that they believe were caused by the potent anti-nausea drug Zofran. Parents accuse GlaxoSmithKline of concealing evidence of Zofran’s risks for more than two decades, while simultaneously promoting the drug as a “safe” product for pregnant women.
In February of 2015, a mother from Boston filed what many experts believe to be one of the first Zofran-related birth defect claims. Her complaint, filed in the US District Court of the District of Massachusetts, introduced many of the allegations that would be echoed in subsequent suits. Court documents filed under case number 1:15-cv-10429 paint a portrait of wanton negligence fueled by rampant corporate greed.
If the mother’s allegations are true, it’s possible that any parent who was prescribed Zofran as a morning sickness treatment and then delivered a child with major birth defects may be eligible to file a claim. Plaintiff claims that she began taking Zofran in her first trimester to “alleviate the symptoms of morning sickness.” Her daughter, named A.S. in the complaint, was born in 2000 and subsequently diagnosed with “numerous [...] congenital defects,” plaintiff writes.
Congenital heart defects came to the fore in this first lawsuit, and have remained at the center of the Zofran litigation. Plaintiff writes that her daughter was diagnosed with three heart abnormalities after birth: atrial septal defect, right ventricular hypertension and aortic arch hypoplasia. Plaintiff notes that atrial septal defect, a defect in which barriers that normally separate heart chambers fail to form properly, has been linked to Zofran in recent epidemiological studies. One conducted by researchers in Denmark, who reviewed more than 900,000 birth records, found that women who had taken Zofran during the first trimester were more than twice as likely to deliver babies with an atrial septal defect.
Plaintiff claims that her daughter has also been diagnosed with “facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingu[inal] hernia, and webbed toes.” Over the course of twelve years, plaintiff writes, her daughter has been forced to undergo ten surgeries. Plaintiff notes that Zofran is only approved as a treatment for nausea and vomiting in chemotherapy and radiotherapy patients, as well as surgical patients undergoing anesthesia. She cites federal laws prohibiting pharmaceutical manufacturers from promoting their products for unapproved uses.
But according to prosecutors at the US Department of Justice, who themselves filed suit against GlaxoSmithKline in 2012, the company actively promoted Zofran as a “safe and effective” morning sickness treatment. Plaintiff contends that “GSK [promoted Zofran as safe during pregnancy] despite having knowledge that such representations were utterly false, as GSK had never once undertaken a single study on the effects of this powerful drug on a pregnant mother or her growing child in utero.”
In fact, plaintiff claims that GlaxoSmithKline marketed Zofran for use during pregnancy despite receiving mounting evidence that the drug “presents an unreasonable risk of harm to babies.” She cites early evidence, obtained in the 1980s during pre-clinical trials involving animal subjects, that Zofran readily crosses the placental barrier. This fact was confirmed in human subjects in 2006, by researchers who found substantial amounts of Zofran had transferred from maternal blood to fetal tissue. Plaintiff says that as early as 1992, GlaxoSmithKline began receiving reports of birth defects with suspected ties to Zofran. She claims that the company has received more than 200 such reports to date.
The mother then turns to the epidemiological studies, referenced above, that have found statistically significant increased risks for major birth defects among babies exposed to Zofran prenatally. In the face of what plaintiff calls “reasonable evidence associating Zofran use with the increased risk of birth defects,” she accuses GlaxoSmithKline of concealing this vital safety information from the US Food & Drug Administration, health community and patients everywhere. Plaintiff claims that GlaxoSmithKline had an obligation to revise Zofran’s labeling with warnings of these alleged risks, but says that the company has failed to fulfill that duty.
Led by Michael Monheit, Esq., Monheit Law has joined an alliance of plaintiffs’ attorneys to investigate potential Zofran birth defect claims. The lawyers are currently providing free consultations and case eligibility evaluations. For more information, call 1-877-620-8411.