Posted in Drug & Medical Devices on March 9, 2015
Zofran® and its generic equivalents have been linked to birth defects and other problems when the medication is taken during pregnancy. The manufacturer, GlaxoSmithKline, promoted the off-label use of the drug as a remedy for morning sickness in addition to its approved use as a drug for controlling nausea and vomiting after chemotherapy and surgery.
Two Recent Lawsuits Filed Alleging Birth Defects Caused by Zofran
At least two lawsuits were recently filed against GlaxoSmithKline because women who took the drug during pregnancy gave birth to children with heart problems. One mother from Minnesota charged that she had used Zofran during two pregnancies, and that both babies had been born with heart defects.
Another lawsuit, filed in Massachusetts, claimed that the baby was born with several heart abnormalities. The baby in question has undergone more than a dozen surgeries, has developmental delays and has experienced other problems. The suit also charges that GlaxoSmithKline failed to warn the mother and doctor about the potential side effects and dangers of the drug.
Legal Issues in Zofran Lawsuits
The legal allegations and issues in these lawsuits include:
- The manufacturer had a duty to ensure the safety of the drug and did not adequately determine its safety
- The manufacturer did not warn the public about potential side effects and dangers
- The manufacturer advertised and promoted Zofran as a treatment for the nausea and vomiting of morning sickness during pregnancy without the drug being approved for that use
- The manufacturer incorrectly relied on animal studies even though the research actually showed the opposite
- The manufacturer was selective in its evaluation of study results about the safety of Zofran
- The drug was defective
- The manufacturer falsely claimed that the drug was not dangerous to pregnant women
In addition to facing lawsuits about its negligence in developing, testing and marketing the drug, GlaxoSmithKline has been accused of bribing physicians to prescribe the drug for patients suffering from severe morning sickness. This is not unusual for this drug company; according to an article published in the British Medical Journal, GlaxoSmithKline has paid out almost eight billion dollars in fines and penalties since 1991 for similar practices with other drugs.
In 2012, the pharmaceutical giant consented to pay $3 billion to settle a number of charges, including that it wrongfully promoted the Zofran for unapproved uses. However, the plaintiffs allege it continued to be marketed and prescribed, despite the company’s agreement to settle. It is very likely that many more Zofran lawsuits charging the company with negligently marketing the drug for off-label uses will emerge in the coming months and years.
Zofran® is a registered trademark of GlaxoSmithKline, LLC.
Do not stop taking medications except on your doctor’s advice.
 Flynn v. GlaxoSmithKline, LLC (2:15-cv-00709), United States District Court for the Eastern District of Pennsylvania, Filed: 02/12/2015
 LeClair v. GlaxoSmithKline LLC (1:15-cv-10429), United States District Court for the District of Massachusetts, Filed: 02/16/2015.
 Escalating criminal and civil violations: pharma has corporate integrity? Not really. BMJ 2013;347:f7507 doi: http://dx.doi.org/10.1136/bmj.f7507 (Published 18 December 2013)
 GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. U.S. Department of Justice, Office of Public Affairs. Washington: Press Release, July 2, 2012. (Civil Division, Consumer Protection, 12-842).