Philadephia Federal District Judge Stewart Dalzell has rejected Novartis Pharmaceutical Corp.’s claim that the Federal Food, Drug and Cosmetic Act and FDA regulations preempt state failure-to-warn tort claims.
In an opinion issued in the Perry v. Novaritis Pharma Corp., NO. 05-5350 (USDC, ED PA October 17, 2006), Judge Dalzell rejected Novartis’ claim that Novartis the failure-to-warn suit should be dismissed because the claim was preempted by FDA labeling requirements for the product, which at the time did not require a warning about the risk of cancer. Plaintiffs had claimed that use of the prescription drug Elidel for the treatment of a two-year-old’s eczema caused lymphoma.
The Judge said that "[p]reemption is unwarranted in the absence of clear evidence that state law requiring an additional warning would either compel the manufacturer to violate the terms of the FDCA or the FDA regulations, or would somehow be disruptive of the statutory and regulatory scheme. This would generally limit preemption to cases where the FDA has made a particular determination regarding a proposed warning."