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A court order filed on April 2, 2014 showed that Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, settled 76 Topamax cases in Philadelphia, according to The Legal Intelligencer.  Plaintiffs claimed the drug, taken while pregnant, resulted in birth defects.  Terms of the settlement have yet to be released.

In October 2013, Janssen lost $4.02 million in a lawsuit from a woman claiming her son was injured in-vitro, blaming the company for not warning pregnant mothers of the possible risk of birth defects.

A Philadelphia jury ordered Janssen to pay $11 million in November 2013, after similar claims were filed against the company.  At the time, Janssen said it would appeal.

Another trial that started in late February 2014 was apparently settled the first day, and another case in March 2014 settled for $3 million against Johnson & Johnson, according to Law 360.

There are 59 Topamax cases still pending in the Philadelphia Court of Common Pleas. 

FDA Announces Birth Defects a Potential Side Effect from Topamax

The FDA approved the use of Topamax in 1997 to treat migraines, epilepsy, and promote weight loss.

On March 4, 2011, the FDA released a Topamax safety announcement after data showed an “increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.”

The data the FDA was referring to was from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.  It found the risk of oral clefts in infants exposed to the drug was at 1.4% compared to 0.38-0.55% in infants exposed to other similar drugs.

A cleft lip happens when the tissue that forms the lip does not completely join together.  It can occur in the middle of the lip or on one or both sides.  A cleft palate is associated with a cleft lip where the tissue on the roof of the mouth, or “palate” is open, or “split.” 

Ortho-McNeil-Janssen Pharmaceuticals, Inc. also released a statement in March 2011 announcing an update to the Topamax label.  The Company said that the previous label had “clearly outlined the risks associated with use in pregnancy.”  The statement also emphasized that Topamax should only be used when the benefits outweigh the risks.

The FDA told healthcare professionals to warn pregnant women about potential risks before giving such patients a Topamax prescription.  Again, according to the Company, the benefits should outweigh the risks.

If your child suffered birth defects as a result of using Topamax during pregnancy you could be entitled to compensation.  You should contact a Topamax attorney today.

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