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Last week, in
Dunn v. Genzyme,[1] the Massachusetts Supreme Judicial Court (SJC) provided clarification as to the pleading standard that applies to state product liability claims against medical device manufacturers. Under
Riegel v. Medtronic,[2] such claims survive federal preemption under the Medical Device Amendments (MDA) of the Food, Drug, and Cosmetic Act, so long as the state claims parallel (and do not supplement or conflict with) federal law.
But courts have reached conflicting results as to whether the alleged “parallel” violation of federal law must be pleaded with specificity. Some courts require detailed pleading where they will dismiss a complaint unless the plaintiff “allege[s] that the defendant violated a particular federal specification relating to the device at issue.”[3] Other courts are more lenient, where they do not require that plaintiffs “specify the precise defect or specific federal regulatory requirements that were allegedly viol ....

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