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From Products Liability Law Daily, March 17, 2015

Court won’t revisit $11M Topamax® failure-to-warn verdict

By Melissa Skinner, J.D.

A verdict of over $11 million against the manufacturer of the drug Topamax® will stand in an action brought by a patient and her family who alleged that her usage of the prescription drug caused her son to be born with birth defects, the Pennsylvania Superior Court held, finding that their failure-to-warn claims were not preempted by federal law. The court also rejected the drug manufacturer’s arguments that the patient would not have heeded the warnings regarding the ingestion of the drug even if they had been available to her or her physician and additionally found that the amount of the verdict was not excessive (Gurley v. Janssen Pharmaceuticals, Inc., March 16, 2015, Platt, W.).

Background. Haley Powell was prescribed Topamax, an antiepileptic medication, by her physician after she was diagnosed with juvenile myoclonic seizures. At the time, Topamax was categorized by the Food and Drug Administration (FDA) as a Pregnancy Category C Drug, which indicated that the drug was shown to have an adverse effect on a fetus in animal reproduction studies, no adequate human studies had been executed, and pregnant women should weigh the potential benefits of the drug against the potential risks. Neither Powell nor her physician were aware of any possibilities of side effects in the form of birth defects, but when Powell became pregnant, her doctor advised her to slowly taper off her use of the drug, which she did. Powell and her husband, Michael Gurley, had a son, Brayden Gurley, who was born with a right side unilateral cleft lip and gum line defects. Although Brayden had surgery to repair some of the defects, he will need extensive treatment in the future, including potential graft surgery, extensive dental care, psychological evaluations, and rhinoplasty for his nasal deformity.

Powell, individually and as guardian of her son, along with her husband, filed suit against Janssen Pharmaceuticals, Inc. (Janssen), the manufacturer of Topamax, claiming that its failure to warn against the effects of the drug caused Brayden’s birth defects. A jury awarded Powell and Gurley a total sum of $10,955,000, which was later increased to $11,655,294.62. On appeal, Janssen argued for a judgment notwithstanding the verdict or a new trial based on the following: (1) federal law preempted the failure-to-warn claims against it because it could not have changed the pregnancy categorization of the drug unilaterally, and the FDA would not have approved additional warnings; (2) Gurley and Powell could not prove causation; and (3) the award in the amount of $10,620,000 for non-economic damages was in error.

Preemption. The court determined that the manufacturer’s arguments regarding preemption should be denied based on the record of the trial court and the precedent set by the U.S. Supreme Court in Wyeth v. Levine (S. Ct., March 4, 2009). In Wyeth, the Court found that a failure-to-warn claim was not preempted because it was possible for the drug company in that matter to comply with both state and federal law and specifically to strengthen its drug’s warnings without prior FDA approval. In the present matter, the trial court entered an order prior to the trial directing the parties not to present any evidence or arguments as to the drug manufacturer’s failure to unilaterally change the warning, and there was no evidence presented that the trial order was violated. Further, relying onWyeth, the court found that the drug manufacturer could have strengthened the warning without FDA approval. The court also determined that Janssen did not present sufficient evidence to establish that the FDA would have rejected a strengthened warning. As such, the appellate court would not reverse the trial court’s post-trial ruling denying the manufacturer’s request for judgment notwithstanding the verdict or a new trial based on the manufacturer’s preemption argument.

Causation and damages. The court also rejected the drug manufacturer’s causation and damages arguments. On causation, the appellate court confirmed that there was insufficient evidence to prove that Powell’s temporary use of her mother’s Topamax prescription instead of her own warranted a break in the causal chain for her failure-to-warn claim. In addition, there was no proper evidence of the notion that the patient’s physician would not have heeded warnings of the potential for birth defects had he known about such warnings. Finally, the court found that the trial court reviewed the verdict and found it to be proper based on the evidence. In turn, the appellate court determined that there was no basis to disturb that ruling or the amount of the jury award.

The case is No. 239 EDA 2014.

Attorneys: Kenneth Alonzo Murphy (Drinker Biddle & Reath, LLP) for Janssen Pharmaceuticals, Inc. Eric H. Weitz (Messa & Associates, PC) for Brayden Gurley.

Companies: Janssen Pharmaceuticals, Inc.

MainStory: TopStory PreemptionNews WarningsNews DrugsNews PennsylvaniaNews

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