Tuesday, June 18, 2013

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

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:  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 One (I shortened the questions and answers for expediency. So these are not quotes unless quotes are present.)

Plaintiff's counsel went first and covered Dr. Schamlzreid's background:
  •  Co Inventor of the Depuy hip along with others on the "surgeon design team."
    • joined the ASR design team in 2001
  • Researcher
  • Publisher (160 or so peer reviewed  journal articles)
  • School:  UCLA, Harvard etc
  • Prominent joint surgeon primarily hips.
  • Compensation:  royalties on the sale of the hips
What were the limitations of the hips in 2001?:
  • small diameter balls that limited the range of motion
  • wear resistance of the material (When you rub two materials together, materials can come off.  Wear turns into debris.)
  • sometimes balls came out of the sockets.  Smaller heads were used to minimize the volumetric wear debris
Were you involved in the research of the cross linked poly?
  • In the late 80's and early 90's, he was involved in the research but not the development
  • He provided input to the engineers to what the wear resistance should be
  • Essentially, he was pretty familiar with all of the hips developed around that time.
How did you test these devices you worked on at that time?
  • Monitored patients for wear and positioning over time with this microprocessor chip placed on the ankle of the patient and then we would  x-ray the joints.
In the early 2000's, what kind of poly was available and with what type of ball?
  • cross linked poly which with a larger ball would become brittle and break
  • also, wear particles (tiny) would cause a tissue reaction called osteolysis
  • This was commonly known to surgeons like himself in the early 2000's
Were you involved and aware of the metal on metal devices and when?
  • Outside of the US, MoM became available in the late 60's early 70's
  • In the US, they became available in the mid 70's
What was your experience with the MoM hips in the late 80's?
  • Wear rates were lower than conventional poly and a larger diameter ball to increase range of motion
What research had you done on the MoM hips prior to joining the ASR design team in 2001
  • He spent time researching a group of about 270 patients who had the hips in over a period of 10-20 years.
Were you aware of the metal ions surrounding the MoM hips prior to joining the design team in 2001?
  • yes.
What was your understanding of the metal ions in 2001?
  • Elevated levels of metal ions could occur
How about the significance of metal ions in the early 2000's?
  • I don't think it was known or understood and continues to be studied to this day.
Was reducing wear a goal of the design team?
  • yes.
"What type of literature existed as of 2001" re MoM?
  • "The fundamental variables related to the bearing diameter, the lubrication, the radial clearance and the composition of the metal."
"Did you have a toxicologist on the design team?"
  • "No"
"Why not?"
  • There was a surgical design team and if we needed a toxicologist we could get one as a consult
Have you been involved in looking at systemic effects of MoM products?
  • Yes.
Have you published on that?
  • Yes
Tell us about that
  • In the late 90's early 2000's one of the questions was,  was there a higher risk of cancer with MoM hips? So we looked at the world literature and found there was no difference between cancer rates in MoM vs a metal plastic total hip... there were only a few cases in the whole literature.
What metal ion level causes you to follow your patients more closely?
  • greater than 2 parts per billion  (2ppb)...the ion level alone is not a trigger for me to take action
What was the goal of the design team?
  • low wear
Who was on the surgeon design team?
  • It was international
  • engineers
  • Surgeons
How have you been compensated by Depuy over the various projects you have been involved with?
  • I have received about $20 Million some of it related to the Depuy ASR.
Break.....I will resume on Schmarlzried's testimoney  tomorrow...

My take away after reviewing 25% of his testimony:
  1. Competent guy
  2. Very familiar with the landscape of materials and implications thereof
  3. Understands the tradeoffs made in product  design
  4. So far, I find this fellow to be credible and conscientious.
stay tuned....

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