Federal Judge Deals Pharma a Setback

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."

He went on to say that "[i]n this case, a state law requirement to provide an additional warning would not force Novartis to choose between violating state and federal law. At the time Elidel was prescribed for Andreas Perry, the FDA had made no finding regarding a link between use of topical calcineurin inhibitors and increased cancer risk in children16 and no statute or regulation prevented Novartis from adding the warning. Because federal law was effectively silent on whether such a warning was warranted, state law was not barred from requiring it. … Requiring Novartis to add a warning to the Elidel label would not disturb the balance of the regulatory scheme since FDA regulations make specific accommodation for adding a warning in the situation the Perrys allege."