PJC Blog
|
 |  |  |  |  |  |  Email Post |
Comments (1)
Let's not preempt innovation
November 4, 2008 at 10:15 am by Dan
Yesterday 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.
read more...
Tags: healthcare FDA medical_device innovation
Comments (1)
Yesterday 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.
read more...
Tags: healthcare FDA medical_device innovation
| | | | | | Email Post |
Comments (1)