Re: Product Liability Case To Be Heard Soon

From: Zachariah Newton (zbnewton@bellsouth.net)
Mon Nov 19 16:06:59 2007


Joe Baby-

Sounds like you are pedantically trying to front run the decision forthcoming from the U.S. Supreme Court.

You probably preen over LSU football team performance this season. For balance, send your BB team to Chapel Hill.

Credit given for not including "humble" before opinion.

z

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> ----- Original Message ----- From: DoctorJoe@aol.com To: Multiple recipients of list OB-GYN-L Sent: Monday, November 19, 2007 3:42 PM Subject: Re: Product Liability Case To Be Heard Soon

In a message dated 11/19/2007 2:14:42 P.M. Central Standard Time, dean@thehuffpeople.net writes: The MDA generally forbids states from imposing requirements on devices that received premarket approval from the Food and Drug Administration ("FDA"). Well, I think they're toast. The law specifically states that the states can't add to the regulation of the device unless there are some "compelling local conditions" which would make it necessary. I don't know what "local" condition exists that would allow some imposition on an angioplasty device. Maybe you think doctors in one state are more spastic than doctors in another and so ... Naw!

Further, even if there was a good argument for a local difference, the State has to formally apply for a waiver and have a hearing, etc. That (apparently) hasn't been done.

So avenues are available for reasonable State regulation -- just not done and probably not needed in this case. Federal law rules.

At least in my opinion here.

Joe P.

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