Thursday, June 20, 2013

Time is running out in NY to file a suit: File or not? (Part Four of x) Testimony of Dr Schmalzried part Two

I am reading the Kransky vs Depuy trial transcripts and making notes which are of interest to me in my quest to answer my questions and  thought they might also be interesting for you to review.  My objective is  to answer the question:  Should I file or not.

Part one of x can be found here:  My questions are noted in that post.

Part Two:

Part Three: Questioning of Dr Schmalzried part One (I shortened the questions and answers for expediency. So these are not quotes unless quotes are present.)

Part Four:  Schmarlzried (Dr S) part Two of his testimony (below)


There were a number of discussions about various surgeons who were having problems with the ASR and Dr S was asked to talk to them as a member of the ASR design team to discuss the issues they were having.  The implication in the questioning was if Dr S was working with the marketing folks from Depuy, how could he objectively discuss other physician's problems with the product if Dr S were working on a commission/override basis?  Is there not a  in inherent conflict of interest?

The ASR recall was in August of 2010.  When did you stop using the ASR?
  • A year before that
  • "I learned  they were going to discontinue it [The ASR] in September of 2009"
  • He learned that there was going to be a phase out. 
Did you stop using the ASR once you were advised of this?
  • Yes
  • Because I wouldn't be able to get parts if something needed replaced.
[From Connie:  I don't like all.  If I understand the comments correctly, Dr S knew in advance the hip was to be discontinued and when he was told, he personally  stopped using it but appeared to allowe other surgeons to continue using it?  This is what I mean when I say....what did he know and when did he know it and then what did he do  with the information.  Well, he did what was appeared to best for himself.  He apparently did not consider his surgeon colleagues in this news and seemed to clearly know that the parts inventory would be run down....meaning sold to other surgeons so that Depuy was not stuck was not stuck with  the parts inventory which is money of course. This is my understanding from reading this.  I am not saying it is right.  It is what I understand this testimony to imply....I wonder if he collected commission on the units sold in the inventory runoff?]

[ From Connie: The questioning then turned to the  contacts whom Dr S used  at Depuy to communicate information.  Essentially, it was clear that Dr S's contacts were for the most part, marketing folks especially re the  revisions.  Is that unusual?  No.  Generally in most of the medical companies the chain of reporting is:
  • Dr has a problem
  • Problem goes to the sales rep
  • Sales rep reports the issue to marketing
  • Marketing goes to medical affairs
  • Question is answered or event reported and the response goes right back down the line in the same manner it went up.
  • If there is a big problem, medical affairs might contact the physician directly.  I did not find this to be out of the ordinary standard of practice but I suppose the question is:  Should the communication process  work in this manner?  Should a physician report to marketing re concerns from other surgeons when their remuneration is sales commissions?  Likely not but it is the way things are least when I was in this business.]
In your practice, did you fill out a form each time you did a revision?
  • No [Connie:  but he did make the point earlier that this information did get communicated to marketing I believe.]
[The  discussion then  turned to the number of revisions Dr S did which was estimated to be 15 of 66 or 23%.  So it was estimated that the minimum revision rate in his hands was 23%.  They then proceeded to establish the reason for the revision being  aseptic loosening due to adverse tissue reaction and metallosis.

Oh, an answer to my question above:  Was he paid commissions on the runoff inventory?  The answer  appears to  yes given he was paid quarterly checks through  at least the Q1 2013.  So that means, he had to be  receiving commissions on that inventory run off so I surmise. ]

Mid day break and I will pick this up tomorrow.

Connie's comments:  Disappointing.  Dr S is a teacher and a researcher.  He has a moral and ethical  responsibility to inform his colleagues of information that he himself would want to know, notwithstanding the patient population who might have been subjected to this hip during that last year unnecessarily.  It appears to me that not only did he not step up to the  ethics required by the medical profession  but he received commissions on the devices sold before the market  and his colleagues knew of the recall ...

So at this juncture/he failed my: "What did he know, when did he know it?"  He did not seem to use  the information known to him  to do the right  thing for the general  patient population and his colleagues.  He did do the right thing for his patients though in stopping the use of these devices.

I hope I got all of this wrong.  Very disappointing indeed.  Perhaps there is redemption to come during the afternoon examination?  I hope so.  Could be that I misinterpreted all of this..... but it surely doesn't appear that way to me.

I am no expert in court room law but I am sure there is a reason why questions like this didn't get asked:
  • Did you continue to receive commissions on inventory sold after the recall was announced?
  • How did you feel when you attended orthopedic meetings knowing that the recall was in process and the medical community was not yet informed?
  • Did you have any other physicians with whom you consulted during the time you were made aware of the recall and the actual market announced recall?
  • Did this advance knowledge cause you any concern?
  • If so why?
  • etc......
I will attempt to find the exact date that the public was made aware of the recall if it was a date other than the actual recall date.

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