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
- 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
- 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
- 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.
- 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.
- 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
- 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
- Wear rates were lower than conventional poly and a larger diameter ball to increase range of motion
- He spent time researching a group of about 270 patients who had the hips in over a period of 10-20 years.
- Elevated levels of metal ions could occur
- I don't think it was known or understood and continues to be studied to this day.
- "The fundamental variables related to the bearing diameter, the lubrication, the radial clearance and the composition of the metal."
- There was a surgical design team and if we needed a toxicologist we could get one as a consult
- 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.
- greater than 2 parts per billion (2ppb)...the ion level alone is not a trigger for me to take action
- low wear
- It was international
- I have received about $20 Million some of it related to the Depuy ASR.
My take away after reviewing 25% of his testimony:
- Competent guy
- Very familiar with the landscape of materials and implications thereof
- Understands the tradeoffs made in product design
- So far, I find this fellow to be credible and conscientious.