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An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
Margarita Rubin
ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …
An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
Margarita Rubin
ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …
An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin
Margarita Rubin
ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …