A record setting settlement of $3 billion was signed between the Department of Justice and GlaxoSmithKline (GSK) in 2012. Among the accusations of the lawsuit, the Department of Justice alleged that GSK marketed Zofran to pregnant women suffering from morning sickness, and paid kickbacks to physicians who prescribed Zofran during early pregnancy. Despite the massive settlement, GSK continues to deny it illegally marketed Zofran, and that there is a possible link between Zofran and birth defects.
GlaxoSmithKline did admit that Zofran was never tested on pregnant women which raises many concerns. Since pregnant women and frequently excluded from drug trials, they are often denied medication. Even worse, as alleged in the Zofran litigation, pregnant women can be given untested medication that can harm a fetus. Although never tested for this use, a study published in the American Journal of Obstetrics and Gynecology reported that about 110,000 pregnant women received monthly prescriptions for Zofran by the end of 2013.
Beginning in the 90s, several large epidemiological studies were conducted on Zofran’s effects during early pregnancy. The studies have begun to reveal an association between Zofran taken during the first trimester and child birth defects, including congenital heart defects, cleft palate and cleft lip. Despite the recent studies and reports, GSK has not offered a warning that the drug is unfit for use by pregnant women. Additionally, the drug manufacturer has not asked the FDA to warn the public.
On a somewhat related note, in September 2011, the FDA did issue a warning about possible serious QT prolongation (a heart rhythm disorder) and torsade de pointes (potential of ventricular tachyarrhythmia) among women using Zofran.
If you or someone you know thinks they have been injured by Zofran contact us today for a free consultation. Our senior partner, Paul Rheingold, is available to discuss your case: (212) 684-1880