Zofran Class Action Dangerous Drug Lawsuit
On February 16, 2015, a Zofran lawsuit was filed in the U.S. District Court
of Massachusetts. Plaintiff Tomisha LeClair filed the lawsuit individually
and on behalf of her minor daughter against GlaxoSmithKline, LLC, the
manufacturer of Zofran. Zofran was approved by the FDA in 1991 to treat
the nausea suffered by cancer patients undergoing chemotherapy and radiation
and to treat postoperative nausea. Although this is the
only approved use for Zofran, GSK marketed the drug off-label as a safe, effective
treatment for pregnant women with moderate to severe morning sickness.
According to the lawsuit, there were no studies and no clinical trials
submitted to the FDA to determine the effects of Zofran on a pregnant
woman or her unborn child. The lawsuit alleges these studies and clinical
deliberately omitted because GSK was aware of potential problems and wanted to continue
marketing Zofran for morning sickness to increase company profits.
Studies Done in the 1980’s Show Zofran Crosses Placental Barrier
GSK did, however, conduct Zofran animal studies in the 1980’s. These
studies clearly showed congenital defects and intrauterine deaths among
the babies born to the rats and rabbits. The same studies concluded Zofran
crossed the placental barrier, causing defects in the unborn mammals.
A human trial was then done—also in the 1980’s—which
showed the same results. Every sample of fetal tissue taken in the 41
pregnant patients in the study showed Zofran concentrations high enough
to cause congenital malformations. GSK failed to make this information
known to the pregnant women they were marketing the drug to or to physicians
who prescribed the drug to their pregnant patients.
GSK Does Not Disclose Reports of Birth Defects
By the year 2000, GSK had received 32 reports of birth defects associated
with Zofran, and that number is in the 100’s. Yet again, GSK neglected
to make these reports known or available to expectant mothers and their
doctors. Three recent epidemiological studies have examined the association
between prenatal exposure to Zofran and the risk of congenital heart defects
in babies. The results of the Pasternak study showed that mothers exposed
to Zofran in the early stages of pregnancy had more than a doubled risk
of having a baby with a congenital heart defect.
The results of the Andersen Study showed mothers who took Zofran in the
first trimester had a two-to-four-fold greater risk of having a baby with
a septal cardiac defect. The third study, known as the Danielson Study,
found that mothers who took Zofran during early pregnancy had a 62 percent
increased risk of having a baby with a cardiovascular defect and a two-fold
increased risk of having a baby with a septal cardiac defect.
GSK Pleads Guilty to Criminal Charges and Pays $1 Billion in Civil Settlements
GSK pled guilty three years ago to criminal charges for promoting off-label
use of several of the manufacturer’s drugs. Off-label use means
a drug is being promoted, marketed and prescribed for uses not approved
by the FDA. Zofran was one of those drugs. The complaint was lodged by
the United States, through the Department of Justice. Soon after, GSK
entered civil settlements with the United States which included more than
$1 billion in payments for marketing specific drugs illegally—Zofran
being named as one of those drugs.
In the written agreement GSK stated it promoted the sale of Zofran for
ailments other than those for which it was approved, made false, unsubstantiated
representations regarding the safety and efficacy of Zofran in the treatment
of morning sickness and illegally paid money to physicians to induce them
to prescribe Zofran to treat morning sickness.
Claims against GlaxoSmithKline
Numerous congenital defects in minor children have been discovered from
the use of Zofran in early pregnancy sine 2000.
Children have suffered from:
- heart defects, including septal or holes in the heart
- facial dysmorphia, including cleft palates
- hearing loss
- kidney malformation
Contact Our National Dangerous Drug Lawyers
It is expected that more lawsuits will be filed against GSK as time goes
on. If you took Zofran 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 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 of Zofran.
To learn more about your legal options or to schedule a free consultation call the
Philadelphia class action lawyers at Golomb & Honik today at
1-215-278-4449 or fill out our confidential
The national dangerous drug lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.
Zofran Lawsuit Charges GSK with Failure to Warn – Blog Post