Tuesday, October 27, 2009

Preemption: a blessing or a curse?

A Minnesota judge dismissed a lawsuit against Medtronic over defective defribillator leads because the FDA had approved the leads. The argument is, that if the FDA approves a product, it's approved under Federal law, which would preempt State law. See this article in Mass Device for details.

What is your opinion, is this kind of ruling "good" or "bad"? Obviously, the families of the over 100 patients who died as a result of the bad leads won't be overly joyed. On the other hand, medical device companies now find an (unlikely) ally in the FDA: if a product has inherent defects but is approved anyway, the company goes scott-free. I think there is something wrong with this picture, although I admit that sometimes it is difficult for a company to test a product exhaustively enough to prevent all failures. But then, I've been around long enough to know that companies have a tendency to stick their head in the sand with product "issues" that might affect the bottom line.

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