But Zofran's label has borne the same statements in regard to pregnancy since 1993.Multiple Studies ...

1. Plaintiff Alleges Exposure To Zofran Caused Congenital
Heart Defects In Two Pregnancies
But Zofran's label has borne the same statements in regard to pregnancy since 1993.
Multiple Studies Find Increase In Birth Defects After Exposure To Zofran's Active Ingredient
Plaintiff references three separate studies conducted to investigate ondansetron's potential
association with congenital birth defects.
1.
On February 12, 2015, a woman from Minnesota
http://www.goodrx.com/zofran filed suit against GlaxoSmithKline (GSK) in the United States District
Court of the Eastern District of Pennsylvania. By the end of the first trimester, fetal organs are
almost completely developed. Click this link to speak with an experienced lawyer today.
. before her, T.F. The Pasternak study's methodology failed to account for this fact, and plaintiff
claims that "this characteristic of the [Pasternak] study led to an under-reporting of the actual risk of
prenatal Zofran exposure."
The Andersen study found that "mothers who ingested Zofran during their first-trimester of
pregnancy were more likely than mothers who did not to have a child with a congenital heart defect,
and had a two- to four-fold greater risk of having a baby with a septal cardiac defect."
The term "septal cardiac defect" refers to VSDs, AVSDs and other "hole in the heart" birth defects.

2. 3. This result was independently confirmed in human subjects by researchers in Hong Kong in 2006.
According to plaintiff, the other animal studies "revealed clinical signs of toxicity," including:
"premature births,
intrauterine fetal deaths, and
impairment of ossification (incomplete bone growth)"
Notably, the rate of intrauterine deaths observed increased as the dosage of ondansetron
administered increased.
But rather than report these results as potential signs of ondansetron's risk during fetal
development, plaintiff states that GlaxoSmithKline told the FDA that its animal studies "show[ed] no
harm to the fetus."
Plaintiff notes that animal studies are never assumed to predict similar results in human subjects. In
other words, they were meant to demonstrate whether or not exposure to Zofran could cause any
abnormalities in fetal development.
One study proved that Zofran's active ingredient could pass through the placental barrier, traveling
from a pregnant animal's blood to that of its unborn offspring. Both involve incomplete formation of
cardiac tissue and are often referred to as "holes in the heart." The complaint describes the defect
with which B.F. "The Pasternak Study"
Performed using Danish birth records filed between 2004 and 2011, the Pasternak study identified
all the pregnant women who had redeemed prescriptions for ondansetron in Denmark over that 8
year period. suffered from growth and development delays.
You can find more information on congenital heart defects here.
Was GlaxoSmithKline Aware Of Zofran's Potential Risks During Pregnancy?
Plaintiff alleges that because GlaxoSmithKline "had never once undertaken a zofran birth defects fda
single study on the effects of [Zofran] on a pregnant mother or her growing child in utero," the
company had no evidence to support claims that it was safe for pregnant women to take.
Not only that, she claims that "GSK knew that Zofran was unsafe for ingestion by expectant
mothers."
Animal Studies Revealed Evidence Of Zofran's "Toxicity"
First, she describes a series of studies conducted on pregnant rabbits and rats during the 1980s.
was born in the same words.
2. Her second child, T.F., was born the same year, and diagnosed with a congenital heart defect. In
other words, even if these studies did not show harm to animal fetuses, GlaxoSmithKline could not
have used that fact to support claims that Zofran was safe in pregnant humans.
GlaxoSmithKline Received Reports Of Birth Defects Associated With Zofran As Early As 1992

3. After reviewing the results of GSK's animal studies, plaintiff states that "at least as early as 1992,
[the company] began receiving reports of birth defects associated with the use of Zofran by pregnant
women."
She claims that GlaxoSmithKline has received over 200 such reports to date, and that many involve
birth defects like:
congenital heart defects,
orofacial anomalies (including cleft palate and cleft lip),
musculoskeletal anomalies and
kidney malformations.
Plaintiff notes that under federal law pharmaceutical companies are "free to add or strengthen -
without prior approval from the FDA - a contraindication, warning, precaution, or adverse reaction"
to a drug's labeling.
In light of the birth defect reports, she claims that GlaxoSmithKline had an "obligation" to
strengthen Zofran's warning label with information on these severe adverse events. "was unable to
breathe adequately [after birth] and required 24-hour monitoring with an electronic alarm that
would alert her parents and caregivers that her oxygen levels were dangerously low." Like B.F. was
finally forced to endure surgery, a procedure that repaired what the complaint refers to as a "hole in
her heart."
Plaintiff became pregnant again in 2006, and was prescribed Zofran to treat her morning sickness
for the second time. Much like the Andersen study, the Danielsson study concluded that ondansetron
exposure was linked to a significant increase in congenital heart defects (CHD).
The risk of delivering a baby with any CHD was found to be 62% higher for mothers prescribed
Zofran during the first trimester, and more than 200% greater in regard to cardiac septal defects.
Plaintiff does not mention two similar studies, most likely because the Pasternak, Andersen and
Danielsson studies support an association between ondansetron and congenital heart defects
specifically. To find information on this additional research, which has found an association between
Zofran's active ingredient, cleft palate and kidney malformations, click here.
Can Other Families File Zofran Birth Defect Claims?
In summary, the plaintiff in America's first Zofran birth defect lawsuit alleges that:
GlaxoSmithKline unlawfully promoted Zofran to doctors as a "safe and effective" treatment for
morning sickness
On the contrary, GlaxoSmithKline knew as early as 1992 that Zofran was associated with an
increased risk of birth defects
GlaxoSmithKline under-reported these risks to the FDA, and failed to warn the public, doctors and
pregnant women

4. Whether or not these allegations are true is a matter that will be decided in this, and at least six
other, cases that have now been filed against GlaxoSmithKline. These tests were intended to study
Zofran's potential "teratological" effects. In her complaint, claimant notes that:
"at or around the same time, GSK also entered civil settlements with United States that included
more than $1 billion in payments to the federal government for its illegal marketing of various
drugs, including Zofran specifically."
While GlaxoSmithKline has always denied that it promoted Zofran as a safe and effective treatment
for morning sickness, plaintiff alleges that the company did, conduct she calls "tantamount to using
expectant mothers and their unborn children as human guinea pigs."
Two Children Born With Congenital Heart Defects, Developmental Delays
Plaintiff's child, B.F., was born in 2004 "with a congenital heart defect." According to the complaint,
the child's birth defect "prevented her from thriving physically and developmentally. Her complaint,
filed under case number 2:15-cv-00709, was the first in an ongoing litigation surrounding the
company's anti-nausea drug Zofran. "The Danielsson Study"
Using birth records from Sweden, a team of Swedish researchers investigated more than 1.5 million
births from 1998 to 2012. Comparing these Zofran-exposed pregnancies to unexposed ones, the
researchers reported in their supplemental materials that women who took ondansetron were:
41% more likely to have a baby with ventricular septal defect (VSD),
22% more likely to have babies with any cardiac septal defect and
"greater than four-times more likely to have offspring with atrioventricular septal defect" (AVSD).
VSD and AVSD are two of the most common congenital heart defects. The risk of developing a birth
defect drops considerably afterwards. Only this time, researchers expanded their data set to include
all pregnancies in Denmark from 1997 to 2010.
Notably, the Anderson study eliminated from consideration pregnant women who had taken
ondansetron after the first trimester. To date, seven other claims have been brought against
GlaxoSmithKline.
In this article, we'll outline the allegations made in this first Zofran birth defect lawsuit.
In 2004, plaintiff was prescribed Zofran to alleviate the symptoms of nausea and vomiting that
commonly accompany early pregnancy.
Her complaint notes that Zofran was never approved for use in pregnant women. The complaint
states that T.F. Zofran's active ingredient, ondansetron, has only been FDA approved for the
treatment of severe nausea and vomiting in three circumstances:
patients undergoing chemotherapy as a cancer treatment
patients undergoing radiotherapy, another cancer treatment
patients undergoing surgical anesthesia

5. Plaintiff Says GSK Unlawfully Marketed Zofran As Safe Treatment For Morning Sickness
Despite the fact that Zofran's manufacturer has never conducted clinical trials to test the drug's
safety or efficacy during pregnancy, plaintiff alleges that GlaxoSmithKline "marketed Zofran 'off-
label' as a safe and effective treatment" for morning sickness.
Under US law, pharmaceutical manufacturers are not allowed to promote drugs for any uses that
have not been FDA approved. We have joined together with a multi-state coalition of plaintiffs'
attorneys to investigate Zofran birth defect claims. We're here to review your case eligibility 24 / 7,
7 days a week. Indeed, plaintiff references a series of federal charges filed against GlaxoSmithKline
in 2012, many of which involved "off-label" promotion. "The Andersen Study"
The Anderson study was conducted immediately after the Pasternak study, and also investigated
Danish birth records. But if they are, any mother who was prescribed Zofran as a morning sickness
treatment during the first trimester and then delivered a child with birth defects may be eligible to
bring a claim for compensation against the pharmaceutical manufacturer.
If you would to like learn more about the on-going Zofran litigation, contact Monheit Law for a free
consultation. As a result of her condition, B.T.'s growth metrics were below the fifth percentile
compared with other children her age." B.T