Women are filing lawsuits against Janssen Pharmaceuticals, a unit of Johnson & Johnson, over their anti-epileptic medication Topamax. One such lawsuit is being heard in a Pennsylvania court, and involves the plaintiff, April Czimmer, whose son was born with oral defects.
Czimmer accuses Janssen of not warning users of Topamax birth defects risks prior to a 2011 order from the U.S. Food and Drug Administration (FDA).
The FDA sent out a safety announcement in March 2011 about the risk of oral clefts in children born to women using Topamax. They cited recent findings from human studies that strengthened the case of children developing oral defects when exposed to Topamax in the womb. As a result, the FDA categorized Topamax as a Pregnancy Category D drug.
Though the plaintiff’s primary argument in the Pennsylvania case involves Janssen’s lack of warning, the presiding judge in the case, Judge Arnold New, removed these claims from the litigation along with defective drug allegations. In addition, per Judge New’s approval, Janssen will not be targeted with punitive damages.
Instead, the trial’s updated focus involves company negligence, misleading marketing, and dishonest business practices.
Czimmer v. Janssen Pharmaceuticals Inc. is being heard in the Court of Common Pleas in Philadelphia County, Pennsylvania.
When pharmaceutical companies knowingly endanger lives through a lack of warning, Carey Danis & Lowe defective pharmaceutical attorneys strongly believe it is important to hold them accountable. In the case of Janssen, which many claim were aware of the birth defects risk well before the FDA safety alert in 2011, withholding such information is deceitful and compromises patient safety.
Carey Danis & Lowe assists individuals who claim that their child’s birth defects are due to Topamax exposure in the womb. Often, these women accuse Janssen of a failure to warn, misleading marketing, and company negligence. Though the Pennsylvania case has ruled out the failure to warn accusation, this is does not mean that every court hearing Topamax birth defects lawsuits will follow suit.
If your child was born with an oral defect after being exposed to Topamax in the womb, you and your child may be eligible for compensation. Discuss your Topamax case with a Carey Danis & Lowe Topamax attorney in a free legal consultation.
Share your story with Carey Danis & Lowe by calling 800.721.2519, or by completing a confidential personal injury claim form.References: Pharmaceutical litigation, Topamax