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The Johnson & Johnson subsidiary Janssen Pharmaceuticals has reached an agreement to resolve dozens of Topamax birth defect lawsuits, which allege that side effects of the epilepsy drug caused women to give birth to children suffering from cleft lips, cleft palates and other malformations.
The Topamax settlements were announced last week in Pennsylvania state court, indicating that agreements have been reached in 76 complaints brought by five different law firms. According to a report by Law360.com (subscription required), the drug maker continues to face at least 60 additional cases that are centralized in Philadelphia.
Specific details of the agreements were not disclosed by the court, and additional steps will be necessary to officially conclude most of the cases, since the claims involve minors, “Incompetent/Incapacitated Persons” or wrongful death claims.
The settlements come following three “bellwether” test trials held in the Philadelphia County Court of Common Pleas, which each resulted in a multi-million dollar damage award against Johnson & Johnson and Janssen.
In October 2013, a Philadelphia jury awarded $4 million to the family of Blake Czimmer, who was born in 2007 with numerous birth defects. That was followed by an $11 million verdict in November 2013, for the family of Brayden Powell, who was born with a cleft lip and other deformities that may require at least five surgeries to correct before he turns 21. In early March 2014, the family of a five year old boy was awarded $3 million in damages for Topamax birth defects.
Another case underway last month was settled during the trial for an undisclosed amount.
Topamax Birth Defects
Topamax (generic topiramate) 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, migraines and to promote weight loss.
Johnson & Johnson has maintained that adequate Topamax warnings were provided. However, 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.
Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.