But as court documents note, Zofran’s pregnancy-related labeling information has zofran lawsuit lawyer remained unchanged since 1993. They cite more than 200 accounts of birth defects with suspected ties to Zofran, reports that GlaxoSmithKline allegedly received but failed to report to the FDA.
Many of these parents also refer to several epidemiological studies in which researchers have investigated Zofran’s possible effects on unborn children. The government claimed that GlaxoSmithKline had promoted Zofran to doctors as “safe and effective” during early pregnancy. A team in Australia found that exposure to Zofran’s active ingredient was associated with a six-fold increase in the rate of kidney defects.
As for this evidence of Zofran’s potential to increase the risk of major birth defects, plaintiffs say GlaxoSmithKline has remained silent. Families say that the company has received mounting evidence of Zofran’s potential to cause birth defects, but has done nothing to warn the public or physicians.
Zofran is a powerful nausea medication, approved by the US Food Drug Administration to treat three specific forms of nausea and vomiting. In fact, this practice, referred to as “off-label” prescription, is common and completely unregulated by the FDA. More information can be found at Zofran.Monheit.com.
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Contact ZofranLegal.com:
Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046
. Researchers in Denmark and Sweden have found a link between Zofran and congenital heart defects, while scientists at Harvard University observed increased risks of cleft palate. Monheit Law is currently offering free case evaluations. Estimates have placed the number of prescriptions written for Zofran to treat morning sickness at over 1 million per year.
Doctors are not prohibited from prescribing drugs for unapproved uses.
In the first months of 2015, at least 7 parents have filed lawsuits against GlaxoSmithKline, the manufacturer of a drug they say causes birth defects.
All 7 mothers gave birth to children with major birth defects after taking Zofran to alleviate the symptoms of morning sickness during early pregnancy. GlaxoSmithKline has never sought Zofran’s approval for use as a morning sickness treatment, and has never conducted the trials involving pregnant women that would be necessary for such approval.
Despite having no evidence of Zofran’s safety during pregnancy, physicians have been prescribing it to alleviate the symptoms of morning sickness for more than two decades. Now they claim that GlaxoSmithKline has been aware of the alleged risk Zofran presents during pregnancy for over two decades. Parents claim that the company was both obligated and able to revise Zofran’s warning label and notify the public and medical community of the drug’s association with birth defects. Based on clinical data submitted by GlaxoSmithKline, the FDA has found Zofran safe and effective in controlling nausea that can follow chemotherapy, radiotherapy and surgical anesthesia. Because the company had never studied Zofran’s effects in pregnant women, federal prosecutors said that any claims as to its safety or efficacy as a morning sickness treatment were necessarily “unsubstantiated and / or false representations.”
While the company has always denied these allegations, new Zofran birth defect lawsuits insist that GlaxoSmithKline promoted the drug for off-label use during pregnancy.
In her complaint, filed in the Superior Court for the State of California, County of Alameda, the plaintiff in case RG15761042 alleges that “GSK knowingly avoided conducting [studies to investigate Zofran’s effects in pregnancy] because they would have hampered its marketing of Zofran and decreased profits.” Some of these parents have gone so far as to say that GlaxoSmithKline’s alleged conduct “was tantamount to using expectant mothers and their unborn children as human guinea pigs.”
Contrary to Zofran’s safety in pregnancy, plaintiffs say GlaxoSmithKline has actually received evidence that exposure to the drug can increase the risk for birth defects. If the allegations in these lawsuits are true, many other families may be eligible to file Zofran birth defect lawsuits. Drug manufacturers, on the other hand, are barred by federal law from promoting their products off-label.
In 2012, the federal government saw the culmination of an investigation into GlaxoSmithKline’s marketing practices that had begun in 1997. To date, four studies have found that women prescribed Zofran’s active ingredient in early pregnancy are at a significantly increased risk of delivering babies with major birth defects. The Justice Department filed both civil and criminal charges against the company, including allegations that GlaxoSmithKline had promoted several drugs directly to members of the health community for off-label use.
One of the drugs named was Zofran. Rather than discourage the http://www.druglib.com/druginfo/zofran/indications_dosage/ drug’s use in pregnant women, plaintiffs say that GlaxoSmithKline chose to promote it as a treatment for morning sickness.
Joined by an alliance of plaintiffs’ attorneys, Monheit Law is investigating the claims of parents who believe that prenatal exposure to Zofran may have caused their child’s birth defects
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