Examination 1 - direct exam of doctor and expert witness in medical device product liability case
BY MR. TRINLEY:
Q. Will you please state your full name for the record for us, please?
A. Alan M. Litsky.
Q. How do you spell your last name?
Q. Dr. Litsky, what is your business or profession?
A. I'm Associate Professor in Orthopaedics and Biomedical Engineering at Ohio State University.
Q. In addition to being an Associate Professor at Ohio State, are you the Director of any laboratory at Ohio State University?
A. I am a Director of the Orthopaedics Materials Laboratory.
Q. What is the function of the Orthopaedics Materials Laboratory and what are your duties as Director?
A. It's a research and teaching laboratory investigating all sorts of questions in artificial bio-materials, being orthopaedic and dental type materials. And my role as Director is to coordinate the research that's going on there and to supervise the mostly graduate students and residents who are working in the laboratory.
Q. What are the - in general can you tell us what the - what bio-materials are and specifically what type of bio-materials you're testing and researching in your laboratory at Ohio State University?
A. Sure. Bio-materials are the materials of which the body is constructed. My area is hard tissue bio-materials, so we're dealing with bones, ligaments, cartilage, teeth and the supporting structures and also the materials that are used to repair or supplement injury or damage to those tissues, metals, polymers, a little bit of ceramics that are used for fixing fractures or total joint replacements or tooth implants or those kinds of things.
Q. Have you been asked by us in behalf of Mr. Mele in this case to study the case, study all relevant documents and to render opinions in this case?
Q. Have you formed opinions in this case?
Q. Have the opinions that you've formed in this case all been formed to a reasonable degree of medical and/or a scientific certainty?
A. The same level of certainty that I use in my research.
Q. Before we go into detail with respect to your background, you are a medical doctor, sir?
Q. And as well as having a degree, a medical degree, you are a doctor of engineering as well; is that correct?
A. Yes, Material Science and Engineering.
Q. Broadly speaking before we get into the details on your opinions, what are the broad areas of opinions that you have in this case?
A. The unreasonable dangerousness of the cable, the similar situation with the cutter and the abrasive osteolysis that it caused in Mr. Mele's case.
Q. When you speak of abrasive osteolysis in Mr. Mele's case, to what are you referring specifically?
A. Essentially a sandpaper type of effect where the cable enlarged the holes that were drilled in his bone to secure the device.
Q. In terms of the unreasonable danger of the products here, do you also have opinions with respect to two types of osteolysis?
A. There was - yes, I do. I do as well.
Q. And what are the two types of osteolysis involved here?
A. Well, there's the abrasive osteolysis. It's a mechanical factor. And the other is the biological endosteal osteolysis.
THE COURT: Excuse me, Mr. Trinley. Hang on a second, please. You drop your voice at the end of the sentence. Can you try to keep it up so I can hear you, please?
THE WITNESS: Sure.
THE COURT: Go ahead.
BY MR. TRINLEY:
Q. Is there a nickname for the abrasive osteolysis named after some Italian or French orthopaedic surgeon?
A. I don't know where the name came from, but it's called the gigli effect and it's - there is a gigli saw that essentially works essentially the same way. It's like almost a barbed wire type thing. And the cable operates the same way, so that's how that nickname was derived.
Q. Does this case and your opinions also involve third-body wear?
A. Yes, it does.
Q. Would you explain to the Jury what third-body wear is? And in the course of explaining that, tell us what body number one is, body number two so that we can distinguish that from the so-called -
A. Well, when two bodies move against each other - in this case a joint where you've got a ball and socket - those are the first two bodies and they would wear to some extent.
If you put something in between a third body which isn't a part of the joint itself, that's what's referred to as third-body wear, sand in a gear box or a pebble in your shoe, that kind of situation where it vastly increases the wear which vastly increases the stresses.
Q. Have you during the course of the case approved a number of so-called Rule 213(g) Disclosures which have outlined your opinions and given the reasons for your opinions?
A. Yes, I have.
Q. Do you have copies of those with you today?
A. Yes, I do.
Q. To the extent you need those to refresh your recollection, we'll go through a certain procedure, an appropriate procedure at the time.
Let me though hand you two copies,
Plaintiff's Exhibit 19/B, which are your disclosures from December 29 of last year, and Plaintiff's Exhibit 19/C, which are your testing disclosures filed on or about January 12, ′01.
A. Okay, I have those with me.
Q. You do?
Q. Okay. And just so that you know the numbers that I'm referring to, I'll put 19/B -
(WHEREUPON, the court reporter's stenograph equipment failed and the testimony of said continued unreported by a court reporter) (Exit the Jury at 4:00 p.m.)