Zofran Lawsuit Alleges Manufacturer GlaxoSmithKline Was Aware Of Drug Study Mistakes

March 02, 2016 – – ZofranLegal.com reports on a lawsuit filed against Zofran manufacturer GlaxoSmithKline in reference to the anti-nausea drug. This particular lawsuit was filed in the U.S. District Court for the District of Idaho on August 14, 2015, and was listed under case number 1:15-cv-00319-BLW. The plaintiff involved alleges that corporate giant GlaxoSmithKline had been made aware that animal studies conducted on Zofran would fail to adequately predict how expectant mothers and their fetuses may be affected if taking the drug. The plaintiff claims that GSK must have been aware that these study results were unreliable, as this is generally common knowledge, yet, following the studies, they chose to promote their drug “off-label” for uses unapproved by the U.S. Food and Drug Administration.

The FDA never approved Zofran to treat pregnant women and clinical safety trials on the drug for this intended use were never conducted. Despite this, however, after FDA approval for other uses, the manufacturer began to market Zofran as a morning sickness treatment to this consumer group. This practice, known as “off-label” marketing, leads to “off-label” prescriptions, and, according to many plaintiffs filing Zofran lawsuits, to the development of birth defects in unborn babies.

Reports show that when manufacturer GSK first submitted Zofran to the FDA pending approval, they presented results from four animal studies done on the drug, which were supposed to evaluate the drug’s overall effectiveness and potential side effects. Two of the 4 studies used lab rats and two used rabbits. Results showed, even on the animals, that the drug seemed to cause health problems when given to animals that were pregnant. Reported side effects from these studies included intrauterine death, maternal weight loss, complete litter loss, and developmental retardation in the babies.

The results bear a troublesome resemblance to what hundreds of plaintiffs involved in Zofran lawsuits currently claim. These people allege that fetal exposure to the drug through their mothers caused their children to develop serious and even fatal birth defects. The defects most commonly mentioned in lawsuits against Zofran manufacturers are: cleft lip and palate, clubfoot, tetralogy of fallot, transposition of the greater vessels, atrial septal defect and ventricular septal defect, kidney defects, and respiratory defects.

Today, lawsuits filed referencing the drug continue to increase in number, and were recently consolidated by the U.S. JPML to form multidistrict litigation No. 2657. They are being overseen by the Honorable Judge F. Dennis Saylor IV in Boston, Massachusetts and many involved believe that they will continue to grow in number as they await trial dates.

The attorneys of Monheit Law are working to ensure that all women who took Zofran while pregnant and who later gave birth to infants with defects will be provided the opportunity to fully investigate their legal rights. The mothers, children, and families affected may be entitled to legal action and substantial compensation. To help those deserving pursue justice, the attorneys of Monheit Law are currently offering complimentary legal consultations for affected parties.

To request more information on Zofran birth defect lawsuits, or to ask questions, please contact Michael Monheit, Esq. of Monheit Law 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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