Thursday, April 9, 2009

The New England Journal of Medicine's Opinion on Medical Device Safety

THE SUPREME COURT'S RULING IN RIEGEL - NOT BASED ON WHAT IS BEST FOR THE HEALTH OF THE PUBLIC.

The attached statement by The New England Journal of Medicine says it all and explains their view on what needs to be done.

The Medical Device Safety Act of 2009



2 comments:

  1. To beat my favorite horse, even the dissent in Levine did not come near to supporting the 2006 preemption preamble and the way preemption, in general, has been argued by most of its advocates.

    Writing the dissent in Levine, Justice Alito concluded:

    "To be sure, state tort suits can peacefully coexist with the FDA's labeling regime, and they have done so for decades. But this case is far from peaceful coexistence."

    The operative language is clearly "this case"--the particular history of FDA's review of the risk in question. As we've discussed, this is not what is "on the label," but how whatever _got_ on the label.

    Of course, it is also true that the same Supreme Court voted 8-1 in favor of Medtronic in the Riegel case. This was premised on the explicit preemption language of the Device Act, and the way that has gotten interpreted to include state tort law, as has been discussed here.

    Change that language and, presumably, those whose vote was based on it (probably Thomas, Kennedy, Stevens, and (maybe) Breyer), and you have a different Supreme Court result.

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  2. Should have included Souter....

    For those who don't know the great Souter story, someone at Logan airport once mistook him for Justice Breyer. He was asked what was the best thing about serving on the Supreme Court.

    S's answer: "Serving with David Souter."

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