Saturday, June 22, 2013

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

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:  Schmalzried (Dr S) part Two of his testimony

Part Five :  Schamalzried (Dr S) part three of his testimony below -summary- (I am taking only snippets of the conversation that I find to be problematic in the examination.  This was a long trial and obviously, I can only summarize certain things which will answer questions I have about what transpired here.

The first topic of the afternoon was  re a paper Dr. S co-authored in 2005.  The plaintiff's counsel asked about footnote 11 in that report which was paper by a tribologist, Dr Bobyn.  Dr. Bobyn's paper stated a few things:
  • "Little is known about the distribution of metal and ions."
Is that true Dr S?  
  • Yes
Was that statement true when the design team recommended the hip be released for humans?
  • Yes.
The next sentence says: "the significance of the systemic distribution [of those ions] was not known[at the time].  Dr. Ss is  that a true statement?
  • Yes.
And was that a true statement when the device was released to humans?
  • Yes
Do you think patients had a right to know this?
  • They certainly do have a right to know.
You were working with the marketing department [at depuy] right?
  • Yes
Had you put these statements in a marketing brochure, these statements would have been true correct?
  •  Yes
Had someone from Depuy wanted to put this in a brochure, would you have objected?
  • No
What does systemic mean: 
  • Ions travel through the blood and particles travel through the lymph system or your immune system.
And as a part of this metal degrades, it gives off ions right?
  • Yes
Now you also write: "there is a also a concern about the potential for malignant generation secondary to prolonged exposure to these elements'?

  • yes
Are these ions Cr and Co?
  • Yes but mostly Chromium
[Then a discussion  ensued about whether you would use the word "these" to discuss only one element....  that is, did the reference to "these" include or exclude cobalt?  This line of questioning  didn't lead anywhere but raised a doubt about whether there are issues with Co as well as Cr.]

[A discussion about edge ware came up and the lawyer wanted to know whether  the design team was aware of that at the time. ]
  •  No.  No one was talking about that on the design team.

So no one on the design team mentioned that  Mr. John Fisher in Leeds England was working on edgeware in his paper in 2000?
  • Not that I recall
Wasn't it your responsibility as a member of the design team to make sure you released a product that was at least as safe as what was on the market then?
  • That was  our  goal.
It was your obligation wasn't it?
  •    No (he said he didn't understand the legal implication of this.)
Weren't you obligated to put a bearing on the market that was as good as anything Depuy had on the market at the time?
  • I don't recall anyone telling me that
Do you have a 23% revision rate with the Pinnacle hip?
  • No.
Do you have a 23% revision rate with any hip in your practices?
  • No.
[It was  stated that the goal of the surgical team to have the wear rate better than any other MoM device and they had some testing done to show it was low.  However, they only tested one head size at a perfect angle and the lawyer asked if that test was designed by the surgeons.  Dr S didn't recall.  The attorney then asked if Dr S was advised that the test conducted on the wear was not going to be done on the worst case scenario as would be customary in a situation like this.  Dr S didn't recall.  Dr S did concede that when releasing a product on the market, there would be a variability of use and placement.]

It says in the 2004 paper that metals may react differently than poly, in  the normal immune response and that it is recognized that the Cr and Co particles have greater potential or cytotoxicity than poly particles and the cell may incapable of the same inflammatory response [microphages come and "eat" the offending particles]

True when you wrote it? 
  • yes
True when they released it to humans?
  • Yes.
Did everyone on the design team understand that when you got too much debris in the local area, you can have cells dying?
  • yes.
Low to moderate metal particles stimulate the  release cytokines right?
  • yes
And then it says, cytotoxins such as Il1 and Il6  can lead to osteolysis and aseptic loosening correct?
  • Yes
Then it says at higher concentrations however, Cr and Co particles have been found to be cytotoxic   and then there are many citation following  meaning many people were aware of this  right?
  • yes
Altering the phagocytic activity of the macrophages leading to cell death right?
  • Yes.
One of the citations goes back to 1975.  Does that sound right?
  • I'd have to check.
Now if you go the end of the page under cancer risk, did you write Cr and Co metals have been known to induce cancer in animal models?
  • Yes.
And you then stated you found no link between cancer and humans
  • yes
Weren't you concerned that you should not be putting this in people until you could assure yourself that they were safe?
  • I wouldn't say it like that..

end of  3 of 4 parts for Dr S's testimony.

Well, as per my summary at the end of part two, I have not seen anything redeeming about this testimony either.  In fact, the comments seem to become more and more problematic as far as I am concerned.  The key take away from this testimony from my perspective is again, gets back to the "What did he know?"  When did he know it?"  "What did he do about what he knew?"

He  clearly knew and  the whole design team knew the uncertainties surrounding both the ion levels and the systemic risks including  but not limited to  cancer.  Given that Depuy had the Pinnacle hip on the market at that time and it seemed to have a good track record at the time, I am not clearly seeing the reason the ASR was developed.

I recall that the ASR might have been undertaken originally to address the competition in the market with the Birmingham resurfacing product in England  but the so called "Alpha project" was killed. Depuy never came to market with a resurfacing product.  There is some information gap here from my perspective.  Perhaps it's here but I missed it?  Maybe it will come up later.

The  4th and final part of this testimony will be addressed next and then I will move on to other witnesses.

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