Friday, April 10, 2009
Comment on the FDA's review process for medical devices
The folks over at the PopTort Blog are reporting that "the Food and Drug Administration (FDA) is reportedly asking manufacturers of some of the oldest and most dangerous medical devices on the market (like pacemakers) to offer assurances that their products are safe." As they point out, in light of the recent study by the Center for Justice & Democracy, there is data to suggest that the FDA's review process is really not that rigorous. This contradicts the reasoning of the Supreme Court's Riegel v. Medtronic decision, which held state claims are preempted precisely because we can rely on the FDA to conduct a rigorous review process. See the full comment here.