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Janssen to Appeal Topamax Birth Defect Rulings: Report

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Philadelphia, PAWhile most are not surprised that Ortho-McNeil-Janssen Pharmaceutical Inc. (Janssen, a division of Johnson & Johnson) will appeal two recent Topamax side effects verdicts that found for the plaintiffs, industry watchers wonder if the verdicts amount to a tolling of the bell that may reverberate through the courts amidst subsequent Topamax lawsuits.

Over the interim, the reporting of combined verdicts reaching $15 million in two recent cases have succeeded in re-awakening the public conscience to a sleeper issue that has been languishing under the radar until the Topamax topiramate lawsuits got underway.

The larger of two findings for the plaintiff was handed down November 18 in Gurley v. Ortho-McNeil-Janssen Pharmaceutical, 110502251, Court of Common Pleas, Philadelphia County, Pennsylvania (In re Topamax Litigation, 110602131, Court of Common Pleas, Philadelphia County, Pennsylvania). Brayden Gurley is the five-year-old son of Haley and Michael Powell. Haley, a stay-at-home-mom from South Carolina, first began using Topamax topiramate together with an adjoining anti-epileptic drug in 2006, before becoming pregnant more than a year later, in October 2007.

Brayden was born with Topamax birth defects that will require five surgeries before his 21st birthday to correct a Topamax Cleft Lip, as well as nasal deformities.

In a statement published by Bloomberg (10/18/13), Janssen noted, “While we empathize with the plaintiff, the evidence demonstrated that Ms. Powell, and her healthcare provider, were aware of the side effect profile before beginning her treatment.”

During trial, attorneys arguing for the plaintiff claimed that Janssen knew as early as 1997 about the potential for Topamax side effects in children by way of various animal studies. Oral clefts, such as Topamax Cleft Palate, were allegedly on the radar at that time.

The US Food and Drug Administration (FDA), for its part, mandated a label change for Topamax in 2011, noting the potential for side effects stemming from a Topamax pregnancy. However, that change came too late for Powell and other plaintiffs. The Powells, before a jury awarded the family nearly $11 million, accused Janssen of operating within a culture of secrecy, and of intentionally concealing safety reports that were available in 2003 and again in 2005, or so it was alleged.

Janssen argued, in response, that birth defects such as oral clefts are a common congenital malformation in the general population with about 4,500 infants born each year in the US with an oral cleft of some kind. Janssen, in its defense, also noted that the company had petitioned the FDA as early as 2005 to allow for a label with “more robust” wording related to the potential for Topamax side effects in children. However, the company said the regulator rejected the wording.

The Powell/Gurley case is the second finding for the plaintiff in less than a month. On October 30, a jury in the same Philadelphia court awarded $4.02 million to plaintiff Virginia Czimmer to compensate for injuries suffered by Czimmer’s six-year-old son Blake (Czimmer v. Janssen Pharmaceuticals Inc., 110503459, Court of Common Pleas, Philadelphia County, Pennsylvania).

Court heard that Czimmer was prescribed Topamax for migraine headaches, one of the two primary indications for Topamax. Blake Czimmer was born with Topamax birth defects in 2007 - specifically, Topamax Cleft Lip and Topamax Cleft Palate.

While Janssen has indicated it will appeal the aforementioned verdicts, at the same time Janssen’s parent Johnson & Johnson noted in its Q3 report that $872 million has been added to an existing fund for pending litigation on a variety of fronts.

As for the Topamax file, the next Topamax lawsuit is scheduled for February 2014, with another on the docket for March. Industry watchers will be poised to see if the pendulum swings in the same direction as these two most recent cases. Bloomberg reports there are about 134 cases in the Topamax MDL consolidated in Philadelphia that have yet to begin.

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