GSK spokeswoman Marti Skold Jordan said that “In recognition of the fact that prescription medicines have inherent risks, a manufacturer is not to be subject to liability when someone experiences a side effect when the medicine is accompanied by appropriate labelling,” according to The National Law Journal (Aug. 13, 2015). Who is that someone Jordan is referring to? And what does Jordan mean by appropriate labeling - when the anti-nausea drug is prescribed off-label to pregnant women?
The Zofran website clearly states that Zofran “is not for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery.” It also says that “Zofran is not expected to harm an unborn baby.” How can GSK make such a statement when it has never once “undertaken a single study on the effects of this powerful drug on a pregnant mother or growing child in utero, according to a number of Zofran lawsuits. GSK doesn’t dispute this fact. It has never conducted clinical trials to investigate Zofran’s effects during pregnancy, but in its defense, what drug company would conduct studies on pregnant women? It would be unethical, to say the least. About as unethical as promoting the drug to pregnant women.
GSK’s marketing of its anti-nausea drug is sickening. The company continues to market Zofran to doctors as a morning sickness treatment despite the fact that it paid close to $150 million a decade ago to settle the Justice Department’s fraud charges and in 2012 paid a whopping $3 billion to resolve a civil and criminal investigation involving its off-label marketing of pharmaceutical drugs. Marketing Zofran off-label must be a profitable business and a business that takes profits over birth defects.
Recent Zofran birth defects lawsuits
Since the first Zofran case was filed in February 2015 by a Boston resident, parents nationwide have filed lawsuits against GSK for marketing its anti-nausea medication off-label to pregnant women who were suffering from morning sickness and severe nausea.
July 21, 2015:
An Illinois couple filed a Zofran lawsuit in the U.S. District Court for the Southern District of Illinois, alleging that the mother’s intake of Zofran during pregnancy caused their son to suffer a congenital heart defect called “Tetralogy of Fallot,” which is a combination of four heart defects. The couple claims that GSK failed to provide adequate warnings about Zofran’s potential to cause birth defects. The mother took Zofran to prevent symptoms of morning sickness during her pregnancy, despite the fact that it was never approved by the FDA for such treatment. GSK promoted Zofran to doctors as an effective off-label solution for morning sickness.
July 24, 2015:
A Zofran lawsuit was filed in Louisiana, alleging GSK knew that Zofran was unsafe for pregnant women based on receiving over 200 adverse events by the year 2000. The mother of the child stated that if GSK had warned her of birth defects, she would not have taken the risk and her son would not have been born with an atrial septal defect that required two surgeries and possibly more in the future.
August 6, 2015:
READ MORE ZOFRAN BIRTH DEFECT LEGAL NEWS
August 10, 2015:
A New Jersey couple filed suit alleging that Zofran caused their child to be born with a severely clubbed foot, according to The Legal Examiner. The plaintiff’s son has reportedly not been able to learn to walk correctly despite treatments.
The above lawsuits, along with almost two dozen more lawsuits filed nationwide all claim that Zofran caused the birth defect. Parents are claiming negligence, failure to warn of the risks of fetal exposure to Zofran, fraudulent misrepresentation and concealment, and other allegations against GSK, including promoting the drug off-label without warnings.