Tuesday, July 2, 2013

Time is running out in NY to file a suit: File or not? (Part six of x) -Testimony of Dr Schmalzried part 4-

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.

This was a long trial and obviously, I can only summarize certain things which will answer questions I have about what transpired here

 Part One of x can be found here:  http://www.mydepuyhiprecall.com/2013/06/time-is-running-out-in-ny-to-file-suit.html.  My questions are noted in that post.

Part Two:  http://www.mydepuyhiprecall.com/2013/06/time-is-running-out-in-ny-to-file-suit_18.html

Part Three: Questioning of Dr Schmalzried Part 1 (I shortened the questions and answers for expediency. So these are not quotes unless quotes are present.)http://www.mydepuyhiprecall.com/2013/06/time-is-running-out-in-ny-to-file-suit_8989.html

Part Four:  Schmalzried (Dr S) Part 2 of his testimony.  It can be found here:  http://www.mydepuyhiprecall.com/2013/06/time-is-running-out-in-ny-to-file-suit_20.html

Part Five :  Schamalzried (Dr S) Part 3 of his testimony - here:  http://www.mydepuyhiprecall.com/2013/06/time-is-running-out-in-ny-to-file-suit_22.html

Part 4 of his testimony concludes below.

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I found a few things interesting in this part of the testimony:

1.[Lots of questioning by the attorneys  on Dr S being involved in the marketing process (messaging and market positioning.)  Sadly, this is standard practice in the field.  Nothing outrageous about the physician who invented the product  instructing the troops on the best way to position this new invention.    I can understand how this might be seen to be self serving because it is.  However, can you think of a better person who would be more informed about offering this advice about the market than the team who invented the device? After all, If you were hiring someone to make a device for you, wouldn't you assume that person knew what device to make given the issues in the market?  Is there a potential conflict of interest?  Sure.  Is this practice unique to Depuy?  No.  Were I in that situation as the head of Product Marketing, he would be the first person I would go to for any kind of strategy question re this particular product.  It is likely that person will be very familiar with the market, competitors, pluses and minuses of each device etc.  He not only invents devices, he is a consumer of them as both a designer and a surgeon with an active practice.  His extensive market knowledge is not a negative in my eyes.  Some of the following items in his testimony  are however.]

2.  In 2005 during some of the product marketing meetings,  the meeting notes reflect the following statement:  "New  Users experienced difficulty with the surgical technique" [with the  Depuy device.]  A number of metal ion issues began to be questioned."

Attorney:  So  doctors are concerned about their patients as early as 2005  about metal ions issues patients right?

Dr S:  Right

Attorney:  And the surgeon design team was aware of  these concerns right?

Dr S :  Right
........

Attorney:  Then it says :  "Toxicology review" and this is before the product was launched in the US right? [referring to the ASR xl)

Dr S: yes.

[They established that the ASR xl was launched after this September 2005 discussion.]

Attorney:  "Toxicology Review.  Surgeon team was introduced to the idea of including a toxicologist onto the ASR product team."  Do you remember that?

Dr. S: I do.

Attorney:  And there has never been a toxicologist to give you knowledgeable information or to be  a resource correct?

Dr S:  right

Attorney:  And then it [notes from the product meeting] says, "Surgeon team were introduced to the idea of including a toxicologist onto the product team who would specifically address the perceived risk of cancer due to meal ions released."

Attorney:  If you had a toxicologist present, you could have asked questions about a number of the systemic issues correct?

Attorney:  And then it says: "Although it was agreed that this would be a useful study to undertake, Dr Tom[S] had a concern.....was raised that the information needed to be contextualized to allay fears rather than feed them."...If you don't know what the answer is going to be, what is the  source of  any fear?

 Dr. S:  The lack of information is a source of fear.

Attorney:  Then it says" There would be skepticism that we would be able to generate any answers from questions that had been circulating for a significant time."  It would not have hurt to have a toxicologist on the team in 2005-2006 would it?

Dr S: No

Attorney:  Same for the team in 2007-2008 either?

Dr S No

Attorney:  Same for the team in 2009-2010 either?

Dr S No
 
[Questioning then turned to a  product brochure for marketing  that he (Dr.S) participated in crafting.]

" Advancing High Stability and Low Wear."

Attorney:  There is a sentence in there which states:  " The motivation for developing Artheroplasty  technology is the desire to avoid revision surgery." And then it says " when properly positioned, the  wear rate has been low for three decades."   There are footnotes included to this reference but the foot notes do not refer to any study on the ASR right?

Dr S right.

Attorney:  Then there is a page that says:  Ion comparison we looked at earlier...In 2008 did you know what these levels were?  [ Defense objected to answering this]

Attorney:  Are you aware of the benchmark data for revisions which was around 1% (the NICE guidelines?)

Dr S:  Yes

Attorney:  And that was your goal right?

Dr S : yes.

[Questioning then turned to edge wear and it was established that it occurred with 3 patients of Dr S and that Dr S was glad that the device was removed from the market when Depuy decided to remove it.  Questioning then turned to what ion levels are 'safe' and Dr  S said in a presentation to surgeons at an Academy meeting that the safe level is 2 ppb.

Attorney:  Depuy had a recommendation to monitor closely patients with 7 ppb.

Dr S:  right

Attorney:  If you see a pseudotumor (cyst), necrosis in the periprosthetic area, is that a reason to revise?

Dr S:  yes.

Attorney:  Then you say:  double digit ions are not alone, enough to warrant a revision right?

Dr S:  Yes. but I have not personally seen a case where double digit ion levels were present without seeing other abnormalities that would necessitate revision.

[ Defense began its cross and it was clear that Dr S believed the device was safe but there were tradeoffs in the design phase. In 2004-2005, Dr S printed a review article on the risk of cancer. They followed a group of patients with the McKee F. hip and found good results over a long period of time  (24 years) and concluded from that  that the risk profile was satisfactory. This discussion concluded that in a design team, you always must balance risk with benefits and he believed that the team did exactly that.

[On recross, the plaintiff established that Dr S did another study on the poly with marathon liners with no revision rates at 6 years. ]

Attorney:That would be different that having a 64% survival rate at 4.6 years correct?

Dr S: Right.

xxx

My only take away from this last round of questioning was the apparent incongruence between Dr. S's idea of what was "safe" vs Depuy's idea of what levels of ions they viewed warranted review....kind of a big gap I would say.

Is it plausible that DR S might have minimized the need for a toxicologist given the uncertainty surrounding the issue at the time?  You can answer that question for yourself.

I would have asked more questions but will reserve what those would be until I see other testimony.

The testimony is not in sequence. He seemed to have been questioned in the middle of the trial.

My conclusion from  Dr. S's testimony in all 4 parts:

The one thing I can't get over  is the  issue which I would characterize as a moral shortcoming in the actions of Dr S once he knew the hip was being removed from the market.  His behavior resulted in two actions:

(1) No mention of this eminent recall  to his colleagues and thus allowed them to  continue to use this device until it was pulled from the market. 
(2) He appeared to continue to collect commissions on the hips sold through that time frame from what I could gather through this testimony.

 A noble person would take that money  which was paid to him during the time he knew of the recall until that hip was taken off the market and fund some studies with it.  That is the least he could do! Generally, delays occur in announcing things like this  for the purpose of running down the inventory. I don't know that to be a fact here but would presume that was their goal as well. 
If one patient received those hips during that time frame, it is a tragedy.

The one thing I find disappointing from the orthopedic community and its leadership at the time, is that it appears  there was never any effort to develop a test to quantify any of the long term systemic effects of these metals despite the fact that these metals have been used for many, many years.  I wonder why.  I have spoken with a few scientists outside the orthopedic community who are working on these very tests!~  Can't wait.


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