[HSF] Litigation and DES

[A]

Thank you these labels are over twenty pages each. Boy they get you in the
fine print don't you 

-----Original Message-----
From: openheart-l-bounces at lists.hsforum.com
[mailto:openheart-l-bounces at lists.hsforum.com] On Behalf Of Ben Bidstrup
Sent: Sunday, March 11, 2007 10:52 PM
To: OpenHeart-L at lists.hsforum.com
Subject: RE: [HSF] Litigation and DES

The FDA approval for DES is for specific lesions as tested during the 
'studies.' If you look at the product labelling it has NOT been 
tested in small or large arteries, residual thrombus etc. Have a look 
at the Product Labelling at 
http://www.cordislabeling.com/eLab/index.jsp

So over 50% of use of 'off label.' Makes for excellent sales, but the 
risk falls back onto the implanting cardiologist although we know 
that they are not discouraged from use in those circumstances.

Hmmmmm

>Please enlighten me what do you mean by using DES off label? Thanks
>
>Ahmed
>
>-----Original Message-----
>From: openheart-l-bounces at lists.hsforum.com
>[mailto:openheart-l-bounces at lists.hsforum.com] On Behalf Of msekela at aol.com
>Sent: Sunday, March 11, 2007 7:34 PM
>To: OpenHeart-L at lists.hsforum.com
>Subject: Re: [HSF] Litigation and DES
>
>Hal,
>      We, who have had to deal with this vulture trial lawyer mentality,
knew
>this was coming. These cases will likely not have much real merit, but will
>change practice patterns. I, for one am weary of medicine being dictated by
>issues not germane to the care and benefit of our patients!
>      I'm certain some in the cardiac surgical community will actually be
>pleased by this turn of events and I'm also certain that manufacturers of
>these devices will try to place blame on physicians who were doing what
they
>considered best for their patients.(after telling them "off the record"
that
>they should use them in Off label situations)
>      This business isn't as fun as it was 15 years ago!               Mike
>
>-----Original Message-----
>From: Hgrmd at aol.com
>To: OpenHeart-L at lists.hsforum.com
>Sent: Sun, 11 Mar 2007 2:13 PM
>Subject: [HSF] Litigation and DES
>
>
>HSF'ers,
>   Well, while I was writing the last post, I saw it for the first  time.
A
>commercial on the History Channel was asking, "Have you, or anyone  you
>know,
>had a drug coated cardiac stent and suffered blood clots?"  Look  out!  I
>was
>having lunch today with a cardiologist at the hospital, and the  DES
subject
>
>came up.  He predicted that the manufacturers would blame the
>interventional
>cardiologist for any cases where the stents were used off label,  which, as
>we
>know, if most of them.
>Hal 
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-- 
Ben Bidstrup FRACS FRCSEd FEBCTS
Consultant Cardiothoracic Surgeon
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