Gurley, Janssen, Topamax & Birth Defects

Gurley, Janssen, Topamax & Birth Defects: A recent case in the Superior Court of Pennsylvania ruled on an appeal related to federal preemption and awards.

The Gurley, Janssen, Topamax & Birth Defects case documents what the children of many women that took Topamax for a health concern (e.g. migraine headache, anti-epilepsy drug), during pregnancy may face today – a potential birth defect (e.g., cleft lip, cleft palate,…).

The court’s ruling: We affirm.

A brief summary of the facts include:

  • In April 2005, at age eighteen, while living in Iva, South Carolina, Appellee Haley Powell (Haley) experienced an epileptic episode that caused her to lose consciousness.
  • In May 2005, Powell’s neurologist, Dr. Bret Warner, diagnosed her as having juvenile myoclonic seizures.
  • Dr. Warner initially prescribed Keppra and Lexapro, and Haley discontinued Lexapro within a few weeks. On March 27, 2006, Dr. Warner prescribed Topamax for Haley to control her headaches and seizures, and she continued using Keppra as the main agent in treating her seizure disorder.
  • Haley continued taking Topamax through December 1, 2007.
  • Neither Dr. Warner nor Haley were aware that use of the drug during pregnancy could possibly cause birth defects such as cleft lip, cleft palate, or oral palate.
  • At the time Dr. Warner prescribed Topamax to Haley, the Food and Drug Administration (FDA) categorized it as a Pregnancy Category C drug.
  • On November 19, 2007, Haley learned that she was pregnant with her son, Brayden Gurley (Brayden). She and her husband, Michael Gurley, had conceived Brayden in late October 2007.
  • On November 21, 2007, Haley informed Dr. Warner that she was pregnant and he advised her to taper off Topamax. Haley reduced her intake and completely stopped taking the drug by December 1, 2007.
  • When Haley was twenty-seven weeks pregnant, she learned through an ultrasound that her son had a cleft lip on the right side of his mouth.
  • On July 7, 2008, Brayden Gurley was born with a right side unilateral cleft lip and gum line defects. Brayden had surgery to correct the cleft lip on October 1, 2008.

To find out more on the case, see Case No. 1:13-cv-144 – August 12, 2013.


Potentialy, the most problematic aspect of Topamax use is when it is used by women during pregnancy. Unfortunately, it appears that Topamax – when used during pregancy – may be linked to babies being born with some serious birth defects. TOPAMAX® is manufactured for by Janssen Pharmaceuticals, Inc.  Janssen is located in Titusville, New Jersey.  TOPAMAX® is a prescription medicine used to treat certain types of seizures.

The FDA published a warning in 2011 concerning the use of TOPAMAX® during pregnancy.  The FDA warning stated that if you take Topamax during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. 
These defects can begin early in pregnancy, even before you know you are pregnant. Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors. 

For more on Topamax and Birth Defects, please visit this link – Topamax & Birth Defects.


At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases. If you took Topamax and your child has suffered any potentially serious health problems, side effects or birth defects (e.g., cleft lip, cleft palate), please consider speaking with a Topamax lawsuit attorney. Our Topamax lawyers can help you determine the best course of action as these health concerns your child is experiencing may be related to the use of Topamax during pregnancy. To talk to a topamax lawyer about a topamax birth defects lawsuit, please contact our office at 1.844.329.5955.