James S. Cohen, a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office, was quoted in a November 30, 2009, article published in FDA News' Devices & Diagnostics Letter. The article, titled "Drug-Eluting Stents Protected by Preemption, Judge Rules," discussed a recent decision in a Louisiana federal court, which extends federal preemption to drug-device combination products when the device part is the primary mode of action.

As noted in the article, "Citing the preemption provision in the Federal Food, Drug and Cosmetic Act (FDCA), Louisiana Judge Tom Stagg dismissed a case against Boston Scientific involving its Class III Taxus drug-eluting stent."

Cohen weighed in on the ruling saying, "The district court's decision in this case is a significant one for the device industry because it expressly extends the principle of federal preemption to a drug-device combination product for which the 'primary mode of action' is that of a Class III device."

The article went on to explain that "Combination products have been considered a gray area because PMA-approved devices are protected by preemption but drugs aren't. The U.S. Supreme Court upheld device preemption in Riegel v. Medtronic last year. But earlier this year, it ruled in Wyeth v. Levine that FDA regulations do not shield drugs from state tort suits."

"The fact that drug-eluting stents are regulated by CDRH helped establish the combination products as predominantly devices," Cohen said.