Thursday, July 4, 2013

Time is running out in NY to file a suit: File or not? (Part Seven of x) -Plaintiffs opening remarks- a remarkable summary!

I am reading the Kransky vs Depuy trial transcripts and making notes which are of interest to me in my quest to decide whether to file or not prior to the 3 year statute of limitations in NY. 

This was a long trial and obviously, I can only summarize certain things which will answer questions I have about what transpired in this trial.  Everything contained herein is a summary.  Some quotes are used  but most of this is material summarized by me based on my interpretation of the transcripts.

 Part One of x can be found here:

Part Two:

Part Three: Questioning of Dr Schmalzried Part 1 :  My summary of his testimony can be found here:

Part Four:  Schmalzried (Dr S) Part 2 of my summary of his testimony.  It can be found here:

Part Five :  Schamalzried (Dr S) Part 3 of my summary of  his testimony  here:

Part Six: Schmalzried (Dr. S) Part 4 and  my summary of his final testimony can be found here:


Part Seven of the series:  There will be 4 posts on the opening testimony which of course presents the plaintiffs and defense view of the case.  I found the first part to be very informative.  I learned things about this case I had not known previously.  Part 1 of 4 in the opening remarks by the attorneys.
Plaintiffs attorney (part 1 of 2)

1.  First interesting thing is that somehow the idea of associating cancer with the metal hips was removed from consideration from the trial by the judge?  How did that happen?    I gotta tell you, I really think the ball was dropped big time with this. The lawyers dropped the ball.

[I will post separately on what I would have asked had the cancer issue were allowed....It is likely that the attorneys spent a lot of time talking to orthopedic surgeons and oncologists who would certainly seem like the right people to talk to about this issue.  If you take that route, you will hear, " very possible but I can't prove it." [That is, that group of physicians/scientists don't have proof.  Ha!  If those attorneys switched their focus from the obvious group to another group; biochemists, I think they find quite a bit more scientific evidence for the logic of the concern about the relationship between cancer and the metals.]  As I noted, I will definitely  address this once these 4 posts on the opening remarks are complete.  I would be shocked if,  when the attorneys  surveyed the biochemists who work in the field, they were able to identify one biochemist who would defend  the claim that there is no link between cancer and the metals. I would be equally shocked if you found one who would be undecided about that relationship.]  

Then  of course, you have to find a group of biochemists who want to be involved in the suit.  Very, very,  difficult.  I learned a lot about scientists in my 3 year journey.  Many of them just don't want to be associated with taking money from one side or another.  That is, paid testimony is distasteful to many of these guys.  My answer to that is:  Don't take any money for your testimony or donate it to charity.  Then there is no conflict!  Ha!

I have one more point then I will get off of this soap box.  Science to me is the ability to impute probabilities to outcomes  based on historical work.  If the probabilities are in the statistical confidence level that are acceptable by scientists then why the heck would a court not accept those probabilities?   Is the position of the court  that we must wait and watch  the patients develop the cancers?  Cancer is one disease that takes a long time to present itself.  While I am no lawyer, I wonder if there are cases with judicial  precedents using probabilities to support a claim if the probabilities fall within the scientific standards that those probabilities establish statistically significant confidence levels that an event will occur or recur? 

I will show you one of these examples when I address this cancer issue. 

2.  Key observations in the plaintiffs case in opening remarks.
  • 33,000 Americans had this hip implanted.
  • 6K-7,000 have had revisions
  • 37%  of MoM Depuy  hips will fail in 4.5 years
  • Pinnacle hip which was on the market from Depuy was acceptable for 99% of this population. Tthe implication from the defense was there was no need for a new device.
  • Depuy knew of the likelihood of these metals shedding resulting in concerns with revisions PRIOR TO THE RELEASE OF THE PRODUCT IN THE US.
3.  A person was hired by Depuy (Magnus Fleet)  to do the failure mode analysis for the MoM prior to handing it off to the design team in 2000-2001.  Here are his answers to the Plaintiff questions paraphrased:

Attorney: Do you have any experience testing hips, metal or otherwise for failure?

Fleet:  no

Attorney: What was your experience?

Fleet:   Testing the failure mode of truck breaks

Fleet's findings from his tests:
  • risk of excessive wear debris being generated from MoM:  SMALL
  • risk of cup loosening:  SMALL
  • etc.....overall, the risk of anything going wrong was small in his testing.  Why?
What tests did he run?:   Machine simulation at only one angle and did not simulate anything else!  Further he tested only one cup size out of 12!  We all know how critical the performance of this hip was based on placement so they tested only  perfect placement.  Unfortunately, we later learned that most of the placement was far from perfect so Depuy cited the surgeon's technique as being the problem.

Time lines I found to be of interest:
  • 2001- testing of  metals to be used in the hip
  • 2003- design surgeon got the hip in 2003
  • 2004 the Depuy MoM was released in Europe, Spain and India
  • June of 2005 -
    • They began to have problems in Europe (see note below)
    • the marketing person in Ireland had heard from at least two physicians in both Spain and the middle east re problems that they concluded were technique related issues.
  • August of 2005
    • "Should we have a toxicologist on the team?"
  • June 2006
    • marketing brochure prepared by the then marketing person who eventually became the CEO of Depuy.  the concept presented in the brochure was that synovial fluid present with this hip would minimize the hip ware that might otherwise result in metal ion discharge.
    • DR Bon ended his involvement with this hip
  • 2006 they then launched the hip in the US.
*What Key information  occurred in 2006 that would have given anyone cause to consider withholding the release  of the hip to the US?

Depuy seeded opinion leaders in various places overseas to attract the hip business.  In the Netherlands, they choose an orthopedic surgeon named Dr. Bon to  begin using the hip in the hopes that his use would influence others in that market to use the hip.  He was actually also working on
study for Depuy so they trusted his opinion.  In June 2006  he announced at a Depuy study meeting that his experience with the ASR resulted in too many failures.   The notes of that meeting said:  "He will not use the ASR anymore."

Then....Depuy released the hip to the US.

I would like to hear the other side to this story but clearly, this is not good.  This gets back to my question:  What did Depuy know and when did they know it.  (I am guessing that Depuy concluded that Dr Bon's experience was placement related....The surgeons needed perfect placement at a 45 degree angle for this hip to perform optimally.)

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