Coronavirus Update: To New & Existing Clients Learn More ›

NOTICE: Rosenfeld Injury Lawyers LLC is no longer accepting these type of cases. This page is strictly for informational purposes. We appreciate your cooperation and understanding by not contacting our office on these cases. We are actively investigating and prosecuting cases involving Valsartan cancers. For information on Valsartan lawsuits, look here.
Super Lawyers
Illinois State Bar Association
Justia Lawyer Rating
Million Dollar Advocates Forum
Avvo Rating
BBB Accredited Business

If I Took Zofran During my Pregnancy and my Child was Born With Birth Defects, can I File a Legal Claim or Lawsuit to Recover Compensation for Their Injuries?

If I took Zofran during my pregnancy and my child was born with birth defects, can I file a legal claim or lawsuit to recover compensation for their injuries? Generally, if you or your loved one has been harmed while taking Zofran, your case will have a couple of common claims. Here are the two most recurring themes in Zofran litigation:

1) Failure to warn: In the medical context, pharmaceutical companies must disclose any adverse reactions that taking the drug might cause. They must warn patients of any adverse experiences that other patients have had while taking the drug. If the drug is used in interstate commerce for reasons for which it was not approved, manufacturers have the special obligation to provide instructions in accord with these unapproved uses. Finally, if there is a lack of evidence supporting the use of the drug for the reason it is being prescribed, that must be noted. All of these must be prominently and conspicuously displayed in the label on the medication. Federal law provides for this in the following sections:

  • "Describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur." 21 C.F.R. § 201.57(e)
  • "To include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." Id. § 201.57(e)
  • "If a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put." Id. § 201.128

Obviously, many plaintiffs are claiming that GlaxoSmithKline violated the law through these provisions.

2) Off-Label Promotion of Zofran: The essence of this claim repeatedly made by plaintiffs in Zofran litigation begins with the fact that it was never FDA-approved for the treatment of nausea, morning sickness, or other problems pregnant women experience. Instead, it was approved largely for the application to chemotherapy patients. In the face of the risks posed to women who take Zofran, GlaxoSmithKline continued to market its use to this segment of patients. In fact, it ignored FDA mandates to stop doing so as early as the 1990s. In 1999, the FDA told GlaxoSmithKline to "Immediately cease distribution of this and other similar promotional materials for Zofran that contain the same or similar claims without balancing risk information."

For additional information see the following pages:

250M + Recovered for Our Clients
No Fee Guarantee We Never Charge a Fee Unless We Win
Available 24/7 Available 24-Hours per Day When You Need Us
Client Reviews
Jonathan Rosenfeld was professionally objective, timely, and knowledgeable. Also, his advice was extremely effective regarding my case. In addition, Jonathan was understanding and patient pertaining to any of my questions or concerns. I was very happy with the end result and I highly recommend Jonathan Rosenfeld. Michonne Proulx
Extremely impressed with this law firm. They took control of a bad motorcycle crash that left my uncle seriously injured. Without any guarantee of a financial recovery, they went out and hired accident investigators and engineers to help prove how the accident happened. I am grateful that they worked on a contingency fee basis as there was no way we could have paid for these services on our own. Ethan Armstrong
This lawyer really helped me get compensation for my motorcycle accident case. I know there is no way that I could have gotten anywhere near the amount that Mr. Rosenfeld was able to get to settle my case. Thank you. Daniel Kaim
Jonathan helped my family heal and get compensation after our child was suffered a life threatening injury at daycare. He was sympathetic and in constant contact with us letting us know all he knew every step of the way. We were so blessed to find Jonathan! Giulia
Jonathan did a great job helping my family navigate through a lengthy lawsuit involving my grandmother's death in a nursing home. Through every step of the case, Jonathan kept my family informed of the progression of the case. Although our case eventually settled at a mediation, I really was impressed at how well prepared Jonathan was to take the case to trial. Lisa