Topamax Attorney: Oral Clefts Can Require Many Surgeries

Los Angeles, CAInfants who are exposed to reported Topamax side effects, such as cleft lip and cleft palate, require surgery to fix the Topamax birth defect, but often one surgery is not enough. In fact, it might surprise people that infants born with cleft lip and cleft palate can require years of treatment that involve many different specialists and disciplines. For that reason, some attorneys, such as Nicole Maldonado, attorney at Baum, Hedlund, Aristei & Goldman, are investigating a possible Topamax lawsuit, alleging patients were not adequately warned about the risks to the fetus.

"When people think of cleft lip or cleft palate, they tend to think that one craniofacial surgery takes care of the defect, but it generally doesn't," Maldonado says. "With the more severe cases, it can take a number of surgeries. A typical treatment plan for these children involves ear, nose and throat specialists, dentists, pediatric oral surgeons, speech and feeding teams, orthodontists, and even therapists during the adolescent years to help these kids cope with the social stigma often associated with oral cleft defects."

Treatment may not just involve one surgery that takes place when the child is young. Instead, some children can spend their entire childhood facing various treatments for oral clefts. In the meantime, they face the insecurity that can come from being born with a birth defect such as cleft lip and cleft palate.

"Depending on the severity of the defect, a treatment plan for oral clefts can take up to 18 years, with different disciplines involved. By the time the child's jawbone has grown and developed, it could be 18 years for treatment to be complete. In that time, the child may also have to go through speech therapy and deal with insecurities. This can have a significant impact on the child."

So far, no lawsuits have been filed against the maker of Topamax alleging that the drug is linked to oral clefts. Concerns have arisen from a recent announcement from the US Food and Drug Administration (FDA) that the drug was being moved from Pregnancy Category C to Pregnancy Category D, which indicates that there are now studies involving human fetuses that indicate there is a potential risk to infants.

Although no lawsuits have been filed, attorneys are investigating possible claims against the maker of Topamax. Any such claims would likely allege that the drug company failed to adequately warn about the risk of oral clefts in infants exposed to Topamax prior to birth.

"The biggest concern right now is consumer awareness. We need consumers, especially women of child-bearing ages, to realize that the label has been changed for preventative purposes," Maldonado says. "There are e-mails that go out and doctors are informed, but it takes a while for the process to work."