The Pennsylvania Superior Court last month upheld an $11 million verdict returned against a Johnson & Johnson unit on behalf of a boy who was born with a cleft palate and other defects after his mother took epilepsy drug Topamax during her pregnancy. A three-judge panel rejected Janssen Pharmaceuticals Inc.’s arguments that claims the company failed to warn the public of the drug’s risks could not stand because it would have needed permission from the U.S. Food and Drug Administration (FDA) to change the label.
The court relied on the U.S. Supreme Court’s 2009 decision in Wyeth vs. Levine to conclude that Janssen could have made changes to the warning on Topamax, even without the FDA approving the move. Senior Judge William Platt drew a direct line between the two cases in his opinion, saying:
Specifically, the FDA’s Changes Being Effected (CBE) regulation permitted a brand-name drug manufacturer like Wyeth ‘to unilaterally strengthen its warning’ without prior FDA approval. Therefore, federal regulations allowed Wyeth to strengthen its label to comply with its state law duty to provide an adequate warning.
A Philadelphia jury ruled in favor of Plaintiff Brayden Gurley and his parents in November 2013, concluding that mother Hayley Powell was not properly informed about the risk of birth defects connected to use of the drug. The company challenged the ruling, asserting that the family’s failure to warn claim — the sole issue at the trial — was preempted by federal law. Janssen, in its appeal, contended that the Plaintiffs said at trial that the company should have unilaterally changed the categorization of the drug. It added that since this was a designation solely within the FDA’s control, the change was preempted.
The company’s lawyers argued that Janssen could not have charged the drug to a [Category] D drug. They claimed Janssen would have needed prior FDA approval to make that change with respect to a pregnancy category. Apparently, the Superior Court was not swayed by this argument, with Judge Platt calling it a “red herring” in the opinion. Judge Platt wrote:
Prior to trial, the court entered an order specifically prohibiting appellees from presenting any argument or evidence that Appellant could have unilaterally changed the Topamax pregnancy category without FDA-approval. Appellees maintain that they fully adhered to the court’s order during trial.
At the same time the court heard the Powell case, the court also reviewed a second Topamax jury verdict, in which a $4 million verdict was returned against Janssen over another birth defect. That appeal remains pending. Only 17 Topamax cases remain pending in the Philadelphia Court of Common Pleas mass tort program, down from approximately 30 in October.
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