When it comes to scrutinizing the use of new medical devices, the FDA has fallen down on the job.
Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents. Safety targets often weren’t clearly spelled out in the research submitted by device makers and important patient information was missing. . .
If you are killed or injured by a defective medical device, you can still sue the manufacturer though, right? No longer true. State products liability suits are no longer available. They have been preempted by the U.S. Supreme Court case of Riegel v. Medtronic.
These two revelations demonstrate that safety of consumers of medical devices is not the highest consideration of lawmakers.