Florida resident Robin Zgurski began taking Zofran in 2006 after her doctor prescribed it for the morning sickness that accompanied her pregnancy. When Zgurski’s son was born with a bilateral cleft lip and palate she did not connect the birth defects to her using Zofran. Then in 2012, Glaxo Klein Smith (GSK) the makers of Zofran, plead guilty to criminal charges filed by the U.S. Department of Justice.
The FDA had approved Zofran as a drug for patients experiencing nausea from radiation treatments, but they never approved it for use by pregnant women. Morning sickness is a common side effect of a normal and healthy pregnancy. GSK intentionally promoted Zofran “off-label” as a safe treatment for this condition without seeking FDA approval. As a result, many families like the Zgurskis have been affected by this illegal and irresponsible move by GSK.
Research shows that Zofran does in fact cause birth defects. While GSK has ceased any new off-label marketing their campaign has been so successful that that despite the available facts about the dangers of Zofran doctors are still prescribing it to pregnant women regularly.
Companies like GSK must do extensive research and testing prior to releasing any drug for use by the public. The FDA then needs to approve the drug for the specific use indicated to ensure it is safe as prescribed. As we see in the GSK Zofran scandal, many drug companies either conceal knowledge of known side effects from the FDA or circumvent the approval process by encouraging doctors to prescribe their drugs for non-FDA approved uses or “off-label” uses.
The recent slate of Zofran lawsuits fall under the area of the law known as “defective products.” GSK not only failed to warn the public of the dangers of taking Zofran while pregnant, but they illegally promoted and marketed the drug for this use.
Zofran (the generic form is called “ondansetron”) manipulates the brain’s serotonin levels to alleviate nausea. Pregnant women using Zofran were 50% more at risk for cardiac malformations in their unborn babies and a 30% overall risk of congenital problems.
If you were prescribed Zofran while pregnant then you must speak to an experienced Florida pharmaceutical product liability attorney as soon as possible. There is a window of only four years from the date you were harmed by a drug in order to file a lawsuit against the company manufacturing the prescription. We will help you review your legal options and take action against the company that caused harm to you and your family. Call today.