Johnson & Johnson and its subsidiary Janssen Pharmaceuticals have agreed to settle Topamax birth defect lawsuits. Plaintiffs alleged that Topamax epilepsy drug side effects birth defects including cleft lips, cleft palates and other congenital malformations.
The Topamax global settlements were announced last week in Pennsylvania state court, stating that agreements have been reached in 76 complaints. According to a report, the drug manufacturers are exposed to face at least 60 additional cases that are centralized in Philadelphia.
State Court Bellwether Trials
Three “bellwether” trials were held in the Philadelphia County Court of Common Pleas, which each resulted in a multi-million dollar damage award against Johnson & Johnson and Janssen. The plaintiff verdicts paved the way for a global settlement.
In October 2013, a jury awarded $4 million to the family of Blake Czimmer, who was born with numerous birth defects. In November 2013, a jury awarded $11 million to the family of Brayden Powell, who was born with a cleft lip and other deformities that may require five surgeries to fix. In March 2014, the family of a five year old boy was awarded $3 million for Topamax birth defects.
Another case in March was settled during the trial for a confidential sum.
Topamax Birth Defect History
Topamax was approved by the FDA in 1997, and it has been available as a generic since 2006. It is approved for the treatment of epilepsy, and migraines.
In March 2011, the FDA issued a warning about the Topamax oral cleft birth defect risk among babies born to mothers who took the drug during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.
What is Cleft Lip and Cleft Palate?
Cleft palate and cleft lip occur when parts of the lip or palate fail to completely join together. The defect results are variable, in mild cases the child is born a notched lip and in extreme defects as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating, swallowing, speech and result in the need for corrective surgery.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.