Zofran Lawsuits Alleging Birth Defects Bring Light To Practice Of Controversial “Off-Label” Marketing

January 28, 2016 – – ZofranLegal.com reports on a lawsuit filed against Zofran manufacturer GlaxoSmithKline which, like many others have, brings attention to the pharmaceutical giant’s “off-label” marketing practices; a controversial topic. This particular claim was filed by a mother who alleges that her use of their anti-nausea drug while pregnant caused her unborn baby to develop severe congenital birth defects while growing in the womb. The mother claims that when GSK chose to market the drug “off-label” as a morning sickness treatment for expectant mothers (without any FDA-approval for this use), they were essentially “experimenting with the lives of unsuspecting mothers-to-be and their babies.”

Unfortunately, this is not the first time that “off-label” marketing practices of GSK have been scrutinized. In 2012, the corporation was sued by the U.S. Department of Justice (DOJ) due to the marketing tactics they used in order to promote certain drugs, including Zofran. At the time, GSK settled the suit by agreeing to pay fines totaling $3 billion. Many indicate that these fines were incredibly minor to the company, who brought in much more than $3 billion that year.

Court documentation on this lawsuit notes that the plaintiff found that GSK was ordered by the U.S. Food and Drug Administration to “immediately cease distribution” of advertising or marketing tactics which “promote Zofran in a manner that is false or misleading because it lacks fair balance.” Nevertheless, after these clear FDA stipulations, GSK reportedly launched another “fraudulent marketing campaign” which alone brought them over $1 billion in sales that year.

Many plaintiffs have alleged that GSK continued their marketing campaign promoting Zofran as a treatment for morning sickness during pregnancy despite many medical reports that it was the potential cause of children being born with a variety of congenital birth defects, including cleft lip and palate, many serious heart defects, clubfoot, kidney defects, and respiratory defects.

The plaintiff who filed this particular case was prescribed Zofran in order to treat nausea episodes from morning sickness during the first trimester of her pregnancy. The first trimester is a common time for bouts of nausea, but it is also a time when the fetus does much of its initial heart, limb, and mouth tissue development. The plaintiff states that she was completely unaware that the drug was not FDA-approved or tested for safety on pregnant women and their unborn children. When the plaintiff later gave birth to a daughter, the infant girl was born with several defects, including congenital band syndrome and teratologic clubfoot.

As devastating as it is, this plaintiff is not the only parent to make these allegations. Across the United States, hundreds of other mothers and fathers have stepped forward claiming much the same. As each of their birth defect lawsuits await trial, the attorneys of Monheit Law are attempting to assist other families who may be entitled to file their own birth defect lawsuits as well. Mothers who used Zofran while pregnant and who subsequently gave birth to children with various birth defects may be entitled to substantial compensation. The attorneys at Monheit Law are currently offering free consultations to affected families.

To request additional information on Zofran birth defect lawsuits, or ask questions, please contact Michael Monheit, Esq. by calling 877-620-8411.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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