GlaxoSmithKline (GSK) is once again in the headlines after numerous Zofran birth defects lawsuits were consolidated in a Massachusetts court. According to reports, the U.S. District Court of Massachusetts will now consolidate into MDL No. 2657, with all pending or future lawsuits being centralized therein. Consolidation into MDL helps to expedite complex cases, including product liability lawsuits. The MDL process assists with discovery, and places the lawsuit before a single judge.
Zofran Birth Defects Lawsuit Information
The continuing MDL No. 2657 lawsuit stems from numerous product liability lawsuits being filed against GSK in relation to the popular anti-nausea medication, Zofran. It is alleged that GSK misrepresented Zofran to prescribing physicians, leading many physicians to prescribe the medication to pregnant women who commonly suffer from nausea. Further allegations claim that GSK did not provide a proper safety profile, which directly resulted in congenital birth defects. Currently, lawsuits claim that infants have suffered from serious birth defects, including heart defects.
Traditionally, Zofran was FDA approved for cancer patients and seriously ill patients, though it is noted that GSK began marketing the drug as an effective aid for morning sickness. Reports indicate that no studies were conducted to determine the safety of Zofran to pregnant mothers or infants. Additionally, the FDA never approved use of Zofran as an “off-label” morning sickness medication. In 2012, GSK made headlines for this very reason, and was subject to criminal charges and civil sanctions totaling over $1 billion in settlement payouts.
In 2013, the FDA released a formal announcement listing Zofran as a “potential safety issue”, but had not gathered enough evidence at the time to form a causal relationship between Zofran and alleged birth defects. Still, the FDA categorized Zofran as a Category B drug, meaning that it had not been proven safe for use during pregnancy. Unfortunately, many physicians continued to prescribe Zofran during pregnancy.
Zofran Birth Defects
Zofran use during pregnancy has been shown to increase the risk of several serious birth defects, including:
- Congenital heart defects
- Cleft palate
- Fetal growth restriction (also called intrauterine growth restriction, or IUGR)
- Kidney malformation
- Spontaneous miscarriage
How to Get Help for Birth Defects Lawsuits
Anyone who has experienced an injury, loss, or other harm after using Zofran during pregnancy should be diligent in exploring his or her rights. Birth defects can be devastating and present lifelong complications and financial responsibilities. To find out more, and determine your legal rights, contact a personal injury attorney today to see if you qualify to participate in MDL No. 2657.