FDA is not responsible . . .

If the FDA approves it, you would think it must be safe.

Not so.

If new legislation passes, consumers will be permitted to sue the manufacturer of medical devices and possibly drug manufacturers as well.

A year ago today, the Supreme Court ruled that federal law bars lawsuits “challenging the safety or effectiveness of a medical device,” as long as the device is marketed in a form approved by the FDA.

The ruling, in a case called Riegel v. Medtronic, relied heavily on a federal law that regulates medical devices; now, some key congressional players are looking to change the law, this morning’sNew York Times reports.

Democrats Henry Waxman and Frank Pallone plan to introduce a House bill that would allow injured patients to sue device makers. In the Senate, Democrats Ted Kennedy and and Patrick Leahy plan to reintroduce a similar bill they rolled out last year.

So if a medical device doesn’t work (even if FDA approved), or you have an adverse reaction, the company that manufactured the device is fair game.

If this law passes look for the cost of medical devices to go up, fewer new devices will come on the market, and (of course) health insurance premiums will rise.

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