November 4, 2008 at 10:15 am by DanYesterday the Supreme Court heard arguments in a case involving a woman
who was given a pharmaceutical treatment that resulted in a significant
adverse event. While I spend less time thinking about drugs than
medical devices, the case, its coverage in the media and a discussion
at the most recent Dartmouth Device Development Symposium (3D) got me
thinking about another Supreme Court case decided earlier in the year,
Riegel v. Medtronic, which has significant implications for innovation in the device industry.
The essence of the
Riegel decision
was that a company cannot be sued in state court for harm caused by a
medical device provided that it was approved under a PMA process and
was manufactured and marketed under FDA guidelines. In other words, the
Court held that challenges to the safety and efficacy of such devices
are "preempted." The decision was 8-1 (on a court not terribly well
known for 8-1 decisions). So why would someone concerned with the
prospects for medical device innovation still be thinking about this
case? As it turns out, members of congress are apparently drafting
legislation that would preempt preemption—and limit medical device
innovation.
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