Friday, February 22, 2008

With Victory Comes Responsibility

The Medical Device Community has been handed a victory by the Supreme Court with their decision in Riegel vs. Medtronic . Without going into too much detail, I will summarize the essence of the article by stating that The Supreme Court ruled in favor of Medtronic in a case where faulty wiring on an implanted medical device Medtronic manufactured failed, and the reason they ruled in favor of Medtronic is due to the fact that the FDA approved of the design.

As the writers of the blog Drug and Device Law very eloquently point out, this now means that medical device manufacturers and the FDA must now step up to the plate and prove to the world in general, that patients are best served by backing off with litigation and letting the professionals do their jobs. Please allow me a little poetic license.

What it all boils down to is this:
  • Medical Device Manufacturers Must Now Take An Even Greater Integrity Based Approach To Insuring Safety Of Medical Devices
  • The FDA Must Step Up Their Efforts In Insuring Devices Are Safe

If the Medical Device Community and the FDA fail to deliver from this point forward, Congress will inevitably be granted the power to step in and "fix" the problem. This is rarely a good thing.

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