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$10.9 Million Verdict Revived Against Topamax Maker Janssen Pharmaceutical

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The National Trial LawyersA Pennsylvania appeals court affirmed the $10.9 million verdict against Johnson & Johnson’s Janssen Pharmaceuticals involving the anti-seizure drug Topamax that caused birth defects.

Topamax is an antiepileptic medication used to treat epilepsy and migraines. Janssen Pharmaceuticals attempt to upset the plaintiff’s jury verdict failed after the appeals court affirmed the lower court’s ruling.

Topamax was prescribed to plaintiff Hayley Powell after she had an epileptic episode. Hayley took Topamax from 2005 to 2007, and discontinued use of the drug two months into her pregnancy. The record showed that Hayley nor her physician knew Topamax would cause defects such as cleft lip.

Hayley’s son was born with a cleft lip and a gum line defect that required surgery; he receives speech therapy and has regular visits with plastic surgeons.

Inadequate Warnings

On appeal, Janssen argued the plaintiff’s failure to warn claim was preempted by federal law because Janssen could not change warning labels without FDA approval.

But pre-trial the defendants requested any mention of their ability to change labels be excluded from trial; the plaintiffs abided by this exclusion.

Following Supreme Court precedent, this court agreed that a drug manufacturer may unilaterally “strengthen its warning labels” without FDA approval under the FDA’s Changes Bring Effected regulation.

This was the holding in Wyeth v. Levine, where a patient developed gangrene and her right hand was amputated after receiving an injection of Phenegram. 555 U.S. 555 (2009). Further, the defendants argued because the company was unsuccessful with changes to a package insert with the FDA for Topamax, this label change would yield the same result.

The judges rejected both arguments for a lack of evidentiary support.

Challenge Causation Element

Janssen continued to challenge the suit by attacking the plaintiff’s evidence supporting proximate cause element. Janssen attempted to argue there was insufficient evidence to show the physician would not have prescribed Topamax if the labels were different.

Janssen’s argument also failed under this point. The plaintiff’s and the physician’s testimony clearly showed that both parties were unaware of the potential birth defects. The physician believed that Hayley would have continued taking the drug on a daily basis had he not instructed her to discontinue the prescription.

The family’s jury award was affirmed and the court believed there were no errors sufficient to overturn the lower courts ruling.

This case is Brayden & Michael Gurley and Hayley Powell v. Janssen Pharmaceuticals, Case No 239 EDA 2014, Pennsylvania Superior Court.

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READER COMMENTS

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This med was given to me for headaches. Terrible side effects. I told doctors many times I'm having bad side effects. I was told stay on it, the good outweigh the bad. & if I don't take it. They won't see me anymore. 21 days into the medicine. I shot myself under the chin. Because of this drug. I was not told about the 31% of male between 41 & 49 who committed suicide on it. All within the first 30 days on the medicine. I was 46 when I shot myself. This drug caused it. I can't believe this medicine is even on the market. When 51% of people say it's a very dangerous medication. Now after 10 surgeries. I still can't talk or eat normal. This drug completely ruined mine,and my family life. It's terrible. And the makers & doctors should be ashamed and punished for prescribing this medicine. This is the worst drug that ruined way to many people's lives. It makes me cry every time I think about it. Every day I do. And every day I'm reminded of it and really will never be the same. Or happy again. I was a very outgoing, happy and productive person. Now I'm nothing. A nobody,lost my friends and many family. Because they are afraid of me, & have no use or desire anymore. To see me now. All because of this damn drug.

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