A mother in Arkansas filed suit against GlaxoSmithKline on September 14,
2015, alleging that the drug company’s anti-nausea drug, Zofran,
was responsible for her child’s congenital birth defects. The Arkansas
mother joins more than sixty other parents who are currently seeking damages
in similar Zofran claims. All the current Zofran claims allege GSK concealed
evidence of the link to Zofran birth defects to doctors and patients.
Although this latest plaintiff resides in Cabot, AR, she has chosen to
file her Zofran lawsuit in the U.S. District Court for the Eastern District
of Louisiana. A Boston MDL is also currently in the works.
The story of this Arkansas mother appears to be all-too-familiar, as the
allegations against GSK continue to mount. Zofran is a powerful anti-nausea
drug, which has been prescribed for off label use to mothers in their
first trimester to combat severe morning sickness. The Arkansas mother
claims she was prescribed Zofran, then her baby was born in 2007 with
a cleft palate, apnea, respiratory distress syndrome and bilateral clubfeet.
The child, now eight years old, has undergone two surgical procedures
and it is expected he will undergo more surgeries in the future. The drug
was never intended for “morning sickness” in pregnant women.
Dangers of Zofran and Studies Associated with Zofran
Cleft palate, which is essentially a hole in the roof of the infant’s
mouth, has been identified as an injury in at least a dozen Zofran lawsuits
and was linked to Zofran use by a Boston University study reported in
2012. The Boston study concluded infants exposed to Zofran during the
first trimester were more than twice as likely to be born with a cleft
palate. Two large European studies reported in 2013 and 2014, found significant
evidence that Zofran, when taken in the first trimester, increased the
risk of congenital heart defects, including ventricular septal defect,
atrial septal defect and atrioventricular septal defects.
A more recent investigation by the Toronto Star, reviewed medical records
from Canadian mothers who submitted adverse event reports to the U.S.
FDA. It was discovered in this investigation that at least 20 Canadian
women who were treated for morning sickness with Zofran, delivered babies
with various birth defects. The Star also reported two cases of infant
death after Zofran exposure, however those deaths have not been definitively
tied to the drug.
Did GSK Illegally Promote Zofran for Off-Label Use?
Zofran was approved in 1991 as an anti-nausea drug, primarily to treat
patients undergoing chemotherapy or radiation treatment for cancer. Zofran
has never been approved by the FDA for use as a “morning sickness”
treatment among pregnant women. There have, however, been allegations
against GSK for years that the company promoted the drug for off-label
use. In 2012, the U.S. Justice Department filed a lawsuit against GSK,
alleging the pharmaceutical giant had unlawfully marketed Zofran directly
to OB/GYNs. GSK pled guilty to federal charges of fraud and illegal promotion
of several drugs, including Zofran, paying out a staggering $3 billion
as part of the settlement.
Was GSK Aware of the Potential Dangers of Zofran to Pregnant Women?
Certain court documents appear to indicate GSK was aware—as early
as 1992—Zofran could present unreasonable harm to fetuses, as the
drug was known to pass through the placenta. Despite this knowledge, GSK
continued to promote Zofran for off-label use among pregnant women with
severe “morning sickness.” In addition to alleging GSK concealed
evidence of the dangers associated with Zofran, there are additional allegations
that GSK failed to warn the public about potentially dangerous side effects,
failed to determine safety risks prior to selling Zofran, promoted Zofran
as being a safe treatment for morning sickness, misrepresented animal
studies which showed signs of abnormal bone growth and toxicity, and produced
a defective drug.
As many as 80 percent of all pregnant women suffer some form of nausea
or vomiting during the first trimester. In addition to cleft palate and
heart defects, lawsuits have alleged cleft lip, club foot, kidney malformations
and skull deformations
Contact Our National Dangerous Drug Lawyers
If you took Zofran during pregnancy and your baby was born with a congenital
defect, it is important to speak one of the experienced national dangerous
drug attorneys at Golomb & Honik, P.C. immediately. Our lawyers can
answer all your questions regarding the current Zofran litigation and
determine if you are eligible to file a lawsuit against the manufacturers
To learn more about your legal options or to schedule a free consultation call the
Philadelphia class action lawyers at Golomb & Honik, P.C. today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential
The national dangerous drug lawyers at Golomb & Honik, P.C. have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.