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On April 17, 2015, a woman from Massachusetts filed suit against pharmaceutical giant GlaxoSmithKline. She claims that Zofran, an anti-nausea drug frequently prescribed “off-label” to treat morning sickness, caused her unborn child to develop a severe abdominal birth defect. As a result, plaintiff was forced to terminate her pregnancy. Continue reading
prREACH
May 08, 2015 /prREACH/ -- A woman living in Randolph, Massachusetts filed a lawsuit against GlaxoSmithKline on April 17, 2015. Her claim, brought against the pharmaceutical conglomerate in the United States District Court for the District of Massachusetts, Eastern Division, is now the seventh lawsuit to allege that GlaxoSmithKline’s anti-nausea drug Zofran causes severe birth defects. Her complaint was filed under case number 1:15-11627.
Plaintiff claims that she became pregnant in May of 2013 and was prescribed Zofran as a treatment for the nausea and vomiting, commonly referred to as “morning sickness,” that often accompanies early pregnancy. Five months later, her unborn child was diagnosed with “severe physical malformations, including severe and life-threatening abdominal defects.” Claimant alleges that her child’s “malformations were the direct and proximate result of prenatal exposure to Zofran.
In October of 2013, plaintiff was forced to terminate her pregnancy as a result of her child’s life-threatening defects. In her complaint, plaintiff alleges that GlaxoSmithKline has been aware of Zofran’s potential to cause birth defects for at least two decades.
In spite of this alleged knowledge, she claims that the company has actively promoted Zofran as a “safe and effective” treatment for morning sickness. In making this allegation, plaintiff echoes the US Department of Justice. In 2012, the federal government charged GlaxoSmithKline for promoting Zofran as a morning sickness treatment, in violation of US law.
While GlaxoSmithKline continues to deny allegations that it promoted Zofran for any uses other than those approved by the FDA, the fact remains that Zofran has never been approved for use during pregnancy. Nor has its manufacturer ever conducted clinical trials to determine its effects on pregnant women or their developing babies.
To the contrary, plaintiff claims that GlaxoSmithKline actively “avoided conducting [such] studies or trials because they would have hampered its marketing of Zofran and decreased profits.” She says that the company began receiving reports of birth defects associated with exposure to Zofran as early as 1992, and has received at least 200 similar reports to date. She claims that GlaxoSmithKline failed to notify the US Food & Drug Administration of a substantial number of these reports.
Further, plaintiff references three recent epidemiological studies that have sought to investigate the association between Zofran and severe congenital malformations. Her complaint summarizes several large-scale research initiatives, all of which have found an increased risk of congenital heart defects among babies exposed to Zofran’s active ingredient during the first trimester.
In light of these studies, along with the hundreds of birth defect reports, plaintiff claims that GlaxoSmithKline had both the ability and obligation to strengthen Zofran’s labeling and warn the public of the drug’s association with birth defects. According to claimant, GlaxoSmithKline failed to disclose relevant safety information to physicians and the public. Instead, she states, “GSK sales representatives specifically marketed and promoted Zofran as a Morning Sickness drug.”
If these allegations are true, any woman who was prescribed Zofran “off-label” as a morning sickness treatment and then delivered a baby with birth defects may be eligible to file suit against GlaxoSmithKline.
As this most recent complaint makes clear, women who were forced to terminate a pregnancy due to their unborn child’s severe birth defects may be entitled to pursue compensation as well.
Families interested in learning more about the on-going litigation against GlaxoSmithKline are urged to contact Monheit Law. Along with a coalition of plaintiffs’ lawyers, Monheit Law is currently offering free consultations to parents and birth defect survivors who believe they may have suffered damages as a result of prenatal exposure to Zofran. For more information, visit zofran.monheit.com.