A recent lawsuit filed in the U.S. District Court of the District of Massachusetts
charges GlaxcoSmithKline, the manufacturer of the drug Zofran, with failure
to warn pregnant patients of the potential risks of birth defects when
Zofran is used in the first trimester. The victim and her family is asking
for compensatory and punitive damages due to birth defects. The child,
born in 2000, has undergone thirteen major surgeries for an array of congenital
birth defects alleged to be caused by the drug Zofran.
Zofran Promoted for Off-Label Use among Pregnant Women with Morning Sickness
Zofran was approved in 1991 by the FDA
only to treat the nausea associated with chemotherapy and radiation and for
post-operative nausea experienced by some patients. Despite this, GlaxcoSmithKline
actively promoted the drug for off-label use to treat moderate to severe
morning sickness experienced by some pregnant women during the first trimester.
GSK neglected to provide information regarding animal studies done in
the 1980's which clearly showed Zofran crosses the placental barrier
and that the drug caused birth defects in animals, most especially heart defects.
Hundreds of reports of birth defects related to Zofran were also hidden
by GSK. Over the past several years, three independent studies have been
done regarding the risks of heart defects and other deformities among
babies whose mothers took Zofran during early pregnancy. Each of these
studies clearly showed a two to four times risk of congenital heart defects
among babies born to mothers who took Zofran during the first trimester.
Allegations against GSK Regarding the Use of Zofran in Pregnant Women
The current lawsuit, filed in February, 2015, states GSK was required by
law to describe any adverse reactions or safety hazards and to include
a warning as soon as reasonable evidence of hazards associated with Zofran
were discovered. The lawsuit alleges GSK knew, at least as far back as
1998, that physicians were prescribing Zofran for morning sickness. GSK
knew this because the company actively marketed and promoted Zofran for that use.
It can be reasonably assumed that GSK neglected to report potential adverse
effects of the drug when used in the first trimester of pregnancy due
to the huge financial profits the drug was bringing in. In fact, despite
evidence to the contrary, GSK placed a statement on Zofran labeling which
stated that reproduction studies had been done on pregnant rats and rabbits
which revealed "
no evidence of harm to the fetus." In Canada, however, labeling for Zofran states that safety during
not been established and that the use of Zofran in pregnancy "
The current lawsuit also charges GSK with fraudulent off-label promotion
of Zofran for the treatment of morning sickness. According to the suit,
GSK saw a lucrative business opportunity to expand the sales of Zofran,
and seized the opportunity despite available evidence showing an unreasonable
risk of harm to babies exposed to the drug prenatally. Negligence is shown
by the fact that GSK failed to "
exercise ordinary care and failed to comply with existing standards of
care in the designing, researching, manufacturing, marketing, supplying,
promoting, testing, packaging, sale, quality assurance, quality control
and distribution of Zofran."
A second lawsuit filed against GSK details nearly identical allegations.
The lawsuit was filed by Cheri Flynn in the U.S. District Court for the
Eastern District of Pennsylvania. Flynn states she gave birth to two children
who both suffered congenital heart defects. Flynn was prescribed Zofran
for morning sickness during both pregnancies. Both Flynn and LeClair's
lawsuits note that GSK paid $3 billion to settle both criminal and civil
charges in 2012. These charges resulted from GSK's unlawful promotion
and aggressive marketing of specific drugs, including the endorsement
of Zofran to treat morning sickness.
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 our 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
Call us at (215) 278-4449 to get the answers you need.