It’s almost enough to bring my high school English teacher back from the dead… me, railing on someone else’s vocabulary skills. What I’m talking about here is the new Revo pacemaker (formerly known as Enrhythm) by Medtronic, designed to allow pacemaker patients to receive MRI scans.
Last year, the United States Supreme Court decided that medical device manufacturers that had gone through the trial-by-fire of a FDA pre-market review are immune from civil action in the state courts for product liability (Riegel v. Medtronic). Just a few weeks ago, the Court threw what many considered to be a major curve-ball when they decided that comparable protections do NOT apply to pharmaceutical manufacturers (Levine v. Wyeth). What does this suggest to MRI providers (Technologists, Radiologists and Administrators)?