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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 violated.”[4]

United statesMassachusetts supreme judicial courtStryker corpCourt decisionFord motor coArrow intl incMedical device amendmentsCosmetic actஒன்றுபட்டது மாநிலங்களில்மாசசூசெட்ஸ் உச்ச நீதித்துறை நீதிமன்றம்ஸ்ட்ரைக்கர் கார்ப்நீதிமன்றம் முடிவுஃபோர்ட் மோட்டார் இணைஅம்பு இந்தில் இன்க்மருத்துவ சாதனம் திருத்தங்கள்ஒப்பனை நாடகம்