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?

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.”

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