Zofran Lawsuit Alleges Failure to Warn of Risk of Cleft Lip, Other Birth Defects

Parents have filed a Zofran lawsuit against GlaxoSmithKline on behalf of their son.  The lawsuit was filed in Arkansas.  The plaintiffs claim that the mother using Zofran while pregnant led to a partial cleft lip for their son.  Specifically, the plaintiffs claim that their son’s exposure to this anti-nausea medication during the early stages of pregnancy led to his birth defect.  This is just the latest in a growing number of Zofran birth defects lawsuits that have been filed against GlaxoSmithKline.  The claim was filed in federal court and seeks several different forms of damages.

Statement of Facts

According to the complaint that was filed to initiate the case, a link to which can be found here, the mother was prescribed Zofran for her nausea during the early stages of her pregnancy in September of 2011.  The complaint also alleges that GlaxoSmithKline marketed Zofran for morning sickness despite the fact that the medication was never approved for this use by the FDA.  In June of 2012, the mother gave birth to a son who was born with a partial cleft lip.

Three months later, the son underwent surgery to correct the problem.  While the surgery was deemed a success, the minor child has a permanent scar in that location.  His lip is also red and inflamed, and the bottom of the child’s lip is not symmetrical.  This problem also led to several different developmental delays, according to the complaint.  The child is thereby forced to visit several different types of therapists to aid in his development.

Causes of Action

The plaintiffs assert several different causes of action in their complaint.  These legal causes of action, which form the basis of a lawsuit in terms of why a defendant should be held liable, include:

  1. Negligence – Failure to Exercise Reasonable Care
  2. Negligence Per Se
  3. Products Liability
  4. Fraudulent Misrepresentation
  5. Fraudulent Concealment
  6. Negligent Misrepresentation
  7. Breach of Express Warranty
  8. Breach of Implied Warranty of Merchantability and Fitness for a Particular Purpose
  9. Negligent Infliction of Emotional Distress


The crux of this Zofran lawsuit is that using Zofran during the early stages of pregnancy exposed the child to harm, and that harm manifested itself by way of the partial cleft lip.  In addition, GlaxoSmithKline allegedly marketed Zofran as safe for use for symptoms of morning sickness when it had not been approved for this use.

Damages Sought

The plaintiffs are seeking the following forms of recovery:

  1. General damages in excess of the jurisdictional minimum
  2. Pain and suffering damages
  3. Medical, incidental and hospital expenses
  4. Financial losses incurred for the care of the minor child
  5. A full refund for the cost of purchasing Zofran
  6. Pre-judgment and post-judgment interest
  7. Attorneys’ fees and court-related costs
  8. Any other form of relief the court deems proper
  9. Punitive damages


Punitive damages are sought when the plaintiff believes that the defendant acted either intentionally or so egregiously that such damages are warranted.  Punitive damages are awarded as a form of punishment for these types of defendants.

Zofran Lawsuits and Your Legal Rights

If you or someone you love has suffered as a result of using this medication, contact the Zofran birth defects lawyers at Parilman & Associates today to schedule a free initial consultation.  You can either email the firm or call 800-800-DRUG.