Litigation Update: FDA Denies Request to Add Birth Defect Warning to Zofran’s Label

Litigation Update: FDA Denies Request to Add Birth Defect Warning to Zofran’s Label

The FDA has notified Novartis that it has rejected their request to add a birth defect warning to Zofran’s label. Plaintiffs claim that Zofran, a drug used to treat nausea for cancer and surgery patients, was also promoted by GlaxoSmithKline – the original developer of the drug – as an off-label treatment for morning sickness without specifying any fetal harm risks or lacking any evidence of its safety on pregnant women.

Novartis acquired Zofran from GlaxoSmithKline in 2015. The MDL, which has been overseen by U.S. District Judge F. Dennis Saylor since 2015, is comprised of more than 400 lawsuits. It is worth noting that Zofran was one of many drugs for which GSK paid $3 billion in 2012 to settle claims with the DOJ for marketing pharmaceuticals for off-label purposes.

This was not the first time that the FDA rejected a request to modify Zofran’s label and GSK will be leaning on that issue at their upcoming hearing. GSK argues that since the FDA declined their request to change Zofran’s label, the company had no ability to include the risks on their label; this is what plaintiffs claim should have occurred, and in GSK’s view, the failure-to-warn lawsuits are thus preempted by federal law. The label warnings did change in Europe a few years back after regulators there learned of some additional studies.

Back in 2019, plaintiffs claimed that GSK hid information from the FDA, which could have made a difference in the agency’s decision. GSK claims that the FDA had access to all the information and even after the agency reviewed other studies as well, they were still not satisfied that drug causes birth defects.

READ  Recall of Potentially Fatal Airbags Widens to BMW, Honda, Audi, Toyota and More

A bellwether case scheduled for May has been delayed due to the Covid-19 pandemic.

Click on this link for information on Verus’ Mass Tort Services. To contact us, fill out this form or email us at and we will reply immediately.


Director of Marketing
609-466-0427 ext. 1030

In her role as Director of Marketing for Verus, Veronica is responsible for promoting the company’s services through branding, communication and business development tactics. As a member of the Leadership Team, Veronica is involved in working in the planning and execution of the company’s strategic plan. More.

Published at Tue, 17 Nov 2020 16:44:38 +0000

Spread the love

Author: Edward Lott

Edward Lott, Ph.D., M.B.A. is President and Managing Partner of Allentown-based ForLawFirmsOnly Marketing, Inc., a client acquisition company that offers attorneys signed client cases.Ed has been a digital entrepreneur since 1994, having discovered very early the opportunities the Internet offered. After having spent over two decades helping small business owners, Ed joined the staff of ForLawFirmsOnly Marketing as President and Managing Partner, where he is expanding the agency's cutting-edge services.A true marketing futurist, Ed's vast experience working directly with attorneys has given him a unique perspective on law firm marketing not found in many other digital marketing agencies. Ed has reshaped the offerings of ForLawFirmsOnly to focus on growing law firms through a holistic approach to digital marketing evident in the reformulated lead generation processes now in place. He is taking that same holistic approach for small businesses, helping them grow their bottom line.Want to learn more about ForLawFirmsOnly Marketing, our client acquistion services or lead generation programs, or just talk to Ed about his visions for helping your business grow? Call him at 855-943-8736.

Copyright ©2021 Medical Injury Help, ForLawFirmsOnly Marketing, Inc. All Rights Reserved