[HSF] Litigation and DES

Mon Mar 12 17:48:14 EDT 2007

I am sorry when i said earlier on this subject that  i was only going to have a small rant.

This is a subject must bigger than a narrow legal perspective or even a larger regulatory perspective and its tie to payments. "On label" is roughly what the manufactor thinks the device was tested and approved for. "Off label" is EVERYTHING else. This means almost all of pediatric and OB is excluded. No one is going to "test" this group. The FDA is very clear that they do not, and do not want to, control "off label" for this and other reasons. However, the lawyers and ALL THE DOCTORS in the guideline and best practice business are wittingly and unwittingly throwing everything that we don't know...which is in the final analysis EVERYTHING including the stupid guidelines that we think we know...under the bus for their own small (and sometimes technically correct) agendas.

Just take the 88 year old with SOB, orthostatic presyncope, and uncertain chest pain, mild dementia, s/p CABG with patent grafts, moderate AS, unbypassed small anomalous circ to a small PL, with a reperfusion defect to PL distribution that I recently saw. He is on statins and about 25 other medicines. I told them that maybe a trial of medicine made the most sense for awhile since I was uncertain whether I could bypass the PL and was uncertain if AVR would help either. I was asked if his medicines are right ones. Who could possibly know? What study would you quote? Which specialties' set of medicines is helping, which is wasting his time and money , and which is hurting him?
One of you who knows please tell me which guideline (actionable goal if I violate) should I use? If no one knows, what the hell are we doing in the name of science, the pseudoscience of guidelines, best practice and off label, to ourselves and our patients?
tea

----- Original Message ----
From: Ben Bidstrup <benjamin.bidstrup at bigpond.com>
To: OpenHeart-L at lists.hsforum.com
Sent: Monday, March 12, 2007 2:42:23 AM
Subject: RE: [HSF] Litigation and DES

They do need to be read. Even Hal could get caught up by not reading 
the PD or Pi of something he uses regularly. It is salutary to think 
of how many devices or drugs we use off label! Do we seek consent 
from the patient or even advise them that we are doing so? I doubt it!

>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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Ben Bidstrup FRACS FRCSEd FEBCTS
Consultant Cardiothoracic Surgeon
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