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Medical Device Safety Act of 2009

Preemption is typically a bad thing (big business and their lawyers typically disagree with me on this). In a nutshell, preemption is the ability to one set of laws to override another set. Typically, the context is that the federal law says ‘A,’ a state’s laws say ‘B,’ and so ‘A’ wins. Of course, the way our country was set up, we encouraged states to experiment with their own laws.
Applied to the medical arena, many medical device manufacturers believe they should be immune from lawsuits for defective devices (devices may be defective for any number of reasons—they may have been designed incorrectly, the manufacturing process may have had errors, or they may come with improper warnings). Sadly, the Supreme Court agreed that the law allowed that conclusion in Riegel v. Medtronic, Inc.


Fortunately, lawmakers are working to change that. Medical device companies make plenty of money, and they have survived and created medical devices despite the occasional lawsuit. They should be held responsible for bad products just like any other manufacturer. Therefore, the Senate is considering a bill, the Medical Device Safety Act of 2009 (click here for full text—it’s short) that will bring things back into balance and allow victims of defective devices to recover for injuries. Some of the stories of people who have suffered at the hands of the current interpretation of the law are heartbreaking. We’ve spoken with a number of people who had Medtronic pacemakers (which suffer from defective “Sprint Fidelis” lead wires), who have been repeatedly shocked by a device that was supposed to save their life. And, because of the risks of surgery, many cannot have the device replaced—so they have no guarantee that it will not inappropriately shock them again, and no guarantee that it will work when they need it to.

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