Ford & Associates has researched the birth defect allegations being brought against GlaxoSmithKline, and has added information to the firm's website for those wanting to learn more about Zofran, and potential side effects associated with the drug.
San Diego, CA (PRWEB) March 13, 2015
In wake of two February 2015 filed lawsuits: case number 1:15-cv-10429, U.S. District Court, District of Massachusetts; and case number 2:15-cv-00709PD, United States District Court of the Eastern District of Pennsylvania, Ford & Associates provides research commentary on the allegations that GlaxoSmithKline (GSK) was aware of Zofran's potential pregnancy dangers, including fetal heart defects and other congenital abnormalities, but did not warn consumers of such dangers.
“Ford & Associates has researched the birth defect allegations being brought against GSK, to which we have added pertinent information to our website in regard to recent (February 2015) lawsuits filed for those wanting to learn more about Zofran, and potential side effects associated with the drug. We are interested in talking with women who took Zofran during their pregnancy, and may have incurred injuries to themselves or their baby as a result.” - Mateo Martinez, Ford & Associates Case Manager
Zofran (ondansetran) is in a class of medications called 5-HT3 receptor antagonists, and was approved by the FDA in 1991 to treat nausea and vomiting in patients undergoing surgery or cancer treatments. However, the drug is often prescribed off-label to treat nausea and vomiting in pregnant women. Ford & Associates has learned that while Zofran's application was extended by the FDA to treat nausea in post-operative patients, the FDA never approved Zofran to treat nausea and vomiting during pregnancy.*
In addition, Ford & Associates notes that after multiple reports were received by the FDA’s Adverse Event Reporting System (FAERS) about alleged adverse Zofran side effects, in 2013, the FDA issued a warning against Zofran use during pregnancy. The FDA is continuing to research this issue to determine if any regulatory action is required.**
Two recently filed February 2015 lawsuits (case numbers 1:15-cv-10429 and 2:15-cv-00709PD) allege that GlaxoSmithKline presented no evidence of Zofran's safety for unborn children, yet marketed the drug to treat morning sickness in pregnant women without FDA approval. According to court documents, the plaintiff in case 2:15-cv-00709PD, filed February 12th in the U.S. District Court in Pennsylvania, claims her use of Zofran during two of her pregnancies allegedly resulted in both children being born with heart defects.
According to court documents, the plaintiff in case 1:15-cv-10429, filed February 16th in the U.S. District Court, District of Massachusetts, claims her daughter was allegedly born with birth defects after the plaintiff used Zofran to treat nausea during her pregnancy. Further court documents in this case claim that GlaxoSmithKline was aware of laboratory studies that allegedly linked intrauterine deaths and malformations in animals that were administered Zofran.
Ford & Associates has also learned that in 2012, GlaxoSmithKline agreed to pay $3 billion to resolve charges with the U.S. Department of Justice regarding the alleged improper marketing and failure to report safety data on a number of medications, including Zofran (case number 11-10398-RWZ: United States ex. rel Greg Thorpe, ET AL vs. GlaxoSmithKline, LLC, filed July 2012).***
*accessdata.fda.gov/drugsatfda_docs/label/2012/020007s043lbl.pdf, FDA, January 1991
**fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm351864.htm, FDA, March 2013
***justice.gov/sites/default/files/opa/legacy/2012/07/02/us-complaint.pdf, USDOJ, July 2012
About Ford & Associates Nationwide Legal Services, A.P.C.
Ford & Associates Nationwide Legal Services, A.P.C., is a San Diego based injury firm that handles each case with unparalleled dedication, competence, and skill. Your case is their case, your fight is their fight, and no stone will be left unturned until a favorable outcome has been secured as allowed by law.
If you believe that your child has suffered birth defects from Zofran use during pregnancy, you may be entitled to file a claim against GlaxoSmithKline. For more information on Zofran, and answers to Zofran lawsuit questions, contact Ford & Associates today at 1-866-242-0905 for a free, no-obligation case review.
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