Judge Finds No Conflict in Negligence Claim, Denies Preemption Defense

PHILADELPHIA - A federal judge has denied a drug manufacturer's preemption defense in a pediatric Elidel case, stating that because the FDA had not made a finding linking the eczema drug and plaintiff's specific injury, a state law requiring the manufacturer to provide an additional warning would not create a conflict with FDA regulation. Perry, et al. v. Novartis Pharmaceuticals Corp., et al., No. 05-5350 (E.D. Pa.).

Judge Stewart Dalzell of the U.S. District Court for the Eastern District of Pennsylvania added in an Oct. 16 opinion that, 'given the recent concerns about the effectiveness of the FDA's safety monitoring …