Zofran Birth Defect Lawsuits Highlight Practice Of Controversial âOff-Labelâ Marketing By GSK
January 12, 2016 – – ZofranLegal.com reports on the details of another lawsuit filed against GlaxoSmithKline regarding their anti-nausea drug Zofran. The suit, like many others highlights the manufacturer’s practice of “off-label” marketing. It was filed by a mother who claims that her use of the drug while pregnant caused her unborn child to develop severe congenital birth defects. The mother also alleges that by marketing the drug “off-label” as a morning sickness treatment for expectant mothers (despite the lack of FDA-approval for this use), GSK was effectively “experimenting with the lives of unsuspecting mothers-to-be and their babies.”
Pharmaceutical giant GlaxoSmithKline has been at the center of controversy because of their product marketing tactics before. In 2012, in fact, the company was sued by the United States Department of Justice regarding the marketing practices they employed to sell certain drugs. During this lawsuit as well, anti-nausea drug Zofran was named. GSK settled the suit by agreeing to pay fines totalling $3 billion.
In court documents, this particular plaintiff also notes that GSK was ordered by the FDA to “immediately cease distribution” of marketing campaigns that “promote Zofran in a manner that is false or misleading because it lacks fair balance.” Despite this warning, the manufacturer allegedly launched yet another “fraudulent marketing campaign” which brought over $1 billion in annual sales.
It was reported that GSK continued their marketing campaign for Zofran as a morning sickness treatment despite many reports from physicians that it was causing children to be born with various birth defects, including cleft lip and palate, congenital heart defects, kidney and respiratory defects, and clubfoot.
In this particular mother’s case, she took Zofran to treat her morning sickness nausea during the first trimester of her pregnancy, as her doctor had recommended. At the time, she was not made aware that the drug was not FDA-approved or tested for safety on pregnant mothers. Months later when the plaintiff gave birth, her daughter was born with multiple defects, including a congenital band syndrome and teratologic clubfoot.
Unfortunately, this plaintiff is not alone in her devastating claims. Across the nation, hundreds of other parents have stepped forward alleging the same. As their cases await trials, the attorneys at Monheit Law are working to help other families who may deserve to join the litigation as well. Mothers who were prescribed Zofran while pregnant and who later gave birth to infants with defects may be entitled to legal action and compensation. The attorneys at Monheit Law are offering complimentary consultations to all qualifying families looking to explore their legal rights.
To request additional information or ask questions, contact Michael Monheit, Esq. by calling 877-620-8411.
###
Contact ZofranLegal.com:
Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046
ReleaseID: 60007143