About the Litigation
ZOFRAN, a Prescription for Birth Defects
Zofran, generically known as Ondansetron Hydrochloride, was first introduced to the American market in 1991 by GlaxoSmithKline (GSK). Zofran was originally approved by the Federal Drug Administration (FDA) to treat nausea and vomiting associated with cancer patients undergoing chemotherapy and/or radiotherapy treatments as well as patients with post-surgery nausea.
Despite only being approved by the FDA for these purposes, GSK began marketing Zofran “off label” as a safe and effective treatment for pregnancy-related nausea and vomiting, otherwise known as “morning sickness.”
GSK never performed studies on the negative side effects that Zofran could cause to a growing child in the womb. Unlike other FDA approved anti-nausea prescription drugs for pregnant women, Zofran was never part of any clinical trials to test its safety on growing babies in the womb before it was marketed to pregnant women for their nausea.
In short, GSK did not seek or obtain FDA approval to market Zofran to treat pregnancy nausea and did not perform tests to find out if Zofran was safe to use during pregnancy.
Evidence suggests GSK knew that Zofran was unsafe for ingestion by expectant mothers. In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths, and malformations in offspring. Testing further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed that ingested Zofran readily crossed the human placenta barrier and potentially exposed fetuses to increased risk of congenital malformations. GSK did not disclose this information to pregnant women or their physicians.
Over time, GSK received mounting evidence of birth defects associated with Zofran. GSK never disclosed this evidence to pregnant women or their physicians. Recently, scientists have conducted large-scale epidemiological studies that have demonstrated an elevated risk of developing birth defects such as those suffered in these cases.
In 2012, GSK pled guilty to criminal charges lodged by the United States of America, through the Department of Justice, for its “off-label” promotion of its drugs for uses never approved by the FDA.
Around the same time, GSK also agreed to civil settlements that included more than $1 billion in payments to the federal government for its illegal marketing of various drugs, including Zofran specifically. GSK’s written agreement with the government reports that GSK:
“promoted the sale and use of Zofran for a variety of conditions other than
those for which its use was approved as safe and effective by the FDA
(including hyperemesis and pregnancy-related nausea)”
“made and/or disseminated unsubstantiated and false representations
about the safety and efficacy of Zofran concerning the uses described
in subsection (a) [hyperemesis and pregnancy-related nausea]”
“offered and paid illegal remuneration to health care professionals to
induce them to promote and prescribe Zofran”
GlaxoSmithKline’s (GSK's) conduct has caused irreversible life-long consequences and suffering to innocent newborns and their families.
Click on the PDF to view GSK's legal settlement agreement to payout over $1 BILLION in damages.
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