1 1 IN THE CIRCUIT COURT OF ST. CLAIR COUNTY 2 STATE OF ILLINOIS 3 4 TROY BUTLER, ) 5 Plaintiff, ) 6 vs. ) CASE NO. 02 L 487 7 DONALD I. SEROT, M.D. LTD., d/b/a ) 8 THE CENTER FOR ORTHOPEDICS; ) 9 DONALD I. SEROT, M.D.; RUSSELL ) 10 CURTIS, R.N.; BIOMET ORTHOPEDICS, ) 11 INC.; D.L. MERRELL CO.; and DANNY L. ) 12 MERRELL, ) 13 Defendants. ) 14 15 DEPOSITION OF DONALD H. MARKS, M.D., Ph.D. 16 17 S T I P U L A T I O N S 18 IT IS STIPULATED AND AGREED, by and 19 between the parties through their respective counsel, that the 20 deposition of DONALD H. MARKS, M.D., Ph.D. may be taken 21 before Sabrina Lewis, Commissioner, at the Plouff Law Offices, 22 1117 22nd Street South, Birmingham, Alabama, 35205, on the 23 25th day of October, 2004, beginning at approximately 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 2 1 11:45 a.m. 2 IT IS FURTHER STIPULATED AND 3 AGREED that the reading of and signature to the deposition by 4 the witness is not waived. 5 IT IS FURTHER STIPULATED AND 6 AGREED that notice of filing of the deposition by the 7 Commissioner is waived. 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 3 1 A P P E A R A N C E S 2 3 BEFORE: 4 Sabrina Lewis, 5 Commissioner 6 7 8 FOR THE PLAINTIFF: 9 Law Offices of Todd N. Hendrickson 10 Todd N. Hendrickson 11 7700 Bonhomme Avenue, Suite 510 12 Clayton, Missouri 63105 13 (314) 721-8833 14 15 FOR THE DEFENDANTS, DONALD L. SEROT, M.D. 16 and RUSSELL CURTIS, R.N.: 17 Freeark, Harvey, Mendillo, Dennis, Wuller & Cain, P.C. 18 Ted Harvey, Jr. 19 115 West Washington Street 20 P.O. Box 546 21 Belleville, Illinois 62222-0546 22 (618) 233-2686 23 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 4 1 A P P E A R A N C E S (continued) 2 3 FOR THE DEFENDANTS, D.L. MERRELL CO. and 4 DANNY L. MERRELL: 5 Moser and Marsalek, P.C. 6 Tracy L. Zuckett 7 St. Louis Place 8 200 North Broadway, Suite 700 9 St. Louis, Missouri 63102-2730 10 (314) 421-5364 11 12 FOR THE DEFENDANT, BIOMET ORTHOPEDICS, INC.: 13 Sandberg, Phoenix & von Gontard, P.C. 14 Kevin Krueger 15 One City Centre, 15th Floor 16 St. Louis, Missouri 63101 17 (314) 231-3332 18 19 ALSO PRESENT: 20 Millard Plumlee (via telephone conference call) 21 22 23 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 5 1 I N D E X 2 3 EXAMINATION BY: PAGE: 4 Mr. Krueger. . . . . . . . . . . . . . . . . . . . . . 6, 88 5 Mr. Harvey . . . . . . . . . . . . . . . . . . . . . . 83 6 Ms. Zuckett. . . . . . . . . . . . . . . . . . . . . . 88 7 8 Certificate of Reporter . . . . . . . . . . . . . . . . 91 9 10 11 12 E X H I B I T S 13 14 Defendant's Exhibit No. 1 . . . . . . . . . . . . . . 25 15 Defendant's Exhibit No. 2 . . . . . . . . . . . . . . 31 16 Defendant's Exhibit No. 3 . . . . . . . . . . . . . . 40 17 Defendant's Exhibit No. 4 . . . . . . . . . . . . . . 42 18 Defendant's Exhibit No. 5 . . . . . . . . . . . . . . 46 19 20 21 22 23 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 6 1 I, Sabrina Lewis, a Court Reporter of 2 Birmingham, Alabama, acting as Commissioner, certify that on 3 this date, as provided by Rule 30 of the Alabama Rules of Civil 4 Procedure, and the foregoing stipulation of counsel, there came 5 before me at the Plouff Law Offices, 1117 22nd Street South, 6 Birmingham, Alabama, 35205, on the 25th day of October, 2004, 7 at or about 11:45 a.m., DONALD H. MARKS, M.D., Ph.D., 8 witness in the above cause, for oral examination, whereupon the 9 following proceedings were had: 10 DONALD H. MARKS, M.D., Ph.D., 11 having first been duly sworn, was examined and testified as 12 follows: 13 EXAMINATION BY MR. KRUEGER: 14 Q. Dr. Marks, my name is Kevin Krueger, and I 15 represent Biomet in this lawsuit that's been brought by Troy 16 Butler. You have been identified by the plaintiff as an expert 17 witness in the case, and we're going to take your deposition here 18 today. 19 I assume you've been deposed before? 20 A. Yes, sir. 21 Q. And the ground rules will generally be the same. 22 If you don't hear or understand one of the questions I ask, let me 23 know, and I can repeat or rephrase it. And, of course, give all 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 7 1 verbal responses so the court reporter can take them down. 2 Could you state your full name, please. 3 A. Donald Harvey Marks. 4 Q. And your address? 5 A. 1133 Lake Ridge Drive, Hoover, Alabama. 6 Q. And your date of birth? 7 A. 6/27/49. 8 Q. And I understand you are employed at Extant 9 Medical Legal Consulting? 10 A. Well, in a sense. I mean Extant is the entity 11 through which I bill for my expert work. 12 Q. Do you have a formal position with Extant? 13 A. I'm the company president. 14 Q. How many employees does Extant have? 15 A. Two. 16 Q. And who are they? 17 A. Myself and Diane Marks, my wife. 18 Q. And who are the officers of the company? 19 A. Myself and Diane Marks. 20 Q. And what are you, and what is she? 21 A. My position is company president. 22 Q. And your wife, what positions does she hold? 23 A. I don't recall what her official corporate positions 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 8 1 are. 2 Q. Okay. 3 A. But she is also a nurse, and she handles the 4 intake and outflow of papers and the billings. 5 Q. Do you and your wife own the company? 6 A. Yes. 7 Q. What percentage of Extant's work is litigation 8 related? 9 A. It's entirely litigation. 10 Q. And I take it, then, since the work is 100 percent 11 litigation related, it would also be the income would be 100 12 percent litigation related? 13 A. The income for Extant is 100 percent litigation 14 related, yes. 15 Q. Now, of the work that Extant does, if you break it 16 down in terms of testimony or consulting on behalf of the plaintiff 17 in a case versus the defendant, what percentages are we looking 18 at there? 19 A. It's almost all plaintiff. 20 Q. Would it be in excess of 95 percent plaintiff? 21 A. Yes. 22 Q. Are you the only doctor who testifies through 23 Extant? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 9 1 A. Yes. 2 Q. So the figures for Extant would be the same as 3 the figures for you? 4 A. Yes. 5 Q. So in terms of your testimony, it would be 95 6 percent or more plaintiff? 7 A. Yes. 8 Q. Has Extant ever done any work for a medical 9 device company? 10 A. Yes. 11 Q. And who would that be? 12 A. Well, the way I interpret the question is have I 13 ever performed an expert evaluation on a medical device issue. 14 Is that the correct interpretation? 15 Q. On behalf of the medical device company. 16 A. No, I have not -- Extant has not been an expert 17 source for a medical device company. We have -- I have 18 consulted on medical device issues. 19 Q. Extant has never been employed or retained by 20 a medical device company, but you have testified on other 21 medical device cases? 22 A. Yes. 23 Q. And in those cases, you would have been 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 10 1 retained by the plaintiff? 2 A. Yes. 3 Q. Now, I was looking through the website materials 4 on Extant and the various promotional literature type stuff. And I 5 came across a Power Point-type presentation. And in there, it 6 stated, "Extant actively consults with pharmaceutical and medical 7 device manufacturers on clinical research and FDA regulatory 8 matters"; would that be correct? 9 A. Yes. I don't know if that's still on there, but -- I 10 haven't looked at the website in a long time. 11 Q. Sure. 12 A. Sure. I mean I don't -- I don't actually receive 13 any cases from the website. It's all word of mouth. So I think 14 that what it's referring to is that I also do clinical and regulatory 15 consulting which is non-litigation driven. And the billing entity I 16 use for that is Southern Clinical and Regulatory . 17 Q. Okay. 18 A. And in that company, I have done medical 19 device work for the -- in non-litigation medical device work. 20 Q. And I'm going to ask you about Southern Clinical 21 in just a little bit. Because I saw that was also listed on your CV. 22 Extant itself, though, has not done any work on behalf or been 23 retained by any medical device manufacturers? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 11 1 A. Nope, I'm not doing any work for medical device 2 manufacturers. 3 Q. Now, you mentioned that attorneys learn of your 4 services through word of mouth? 5 A. Yes. 6 Q. Does Extant do any advertising? 7 A. I have a website, but that's about it. 8 Q. Is Extant listed with or affiliated with any of the 9 services around the country that provide recommendations to 10 attorneys for expert witnesses? 11 A. Yes. 12 Q. And what services is Extant affiliated with? 13 A. I receive cases through -- I have received cases 14 in the past through AMFS in Berkley, California and Tab -- 15 T-A-B -- Expert Services. 16 Q. And where is Tab located? 17 A. In the Washington, D. C. Area. 18 MR. KRUEGER: Off the record for a second. 19 (A discussion was had off the 20 record.) 21 THE WITNESS: If you need the address for 22 Tab, let me know, and I can provide it. 23 MR. KRUEGER: We can probably find it. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 12 1 BY MR. KRUEGER: 2 Q. As far as you know, Tab is out of 3 Washington, D.C.? 4 A. Yes. I think their website is tabexperts.com. 5 Something like that. 6 Q. Do you know if Mr. Hendrickson heard of you 7 through AMFS or Tab? 8 A. I don't think he contacted me through either one. 9 Q. Your services in this case, are your services 10 being billed directly through Extant? 11 A. I think so, yes. 12 Q. And there's no expert referral service that the 13 bills are passed through? 14 A. No. 15 Q. Have you yourself ever been employed by a 16 medical device company? 17 A. I have been employed through mostly 18 pharmaceutical companies. But one company that I worked for 19 for a short amount of time in the Washington, D.C. area did 20 make both medical devices and drugs. 21 Q. Okay. What company was that? 22 A. Let me -- Perimmune. 23 Q. How do you spell that? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 13 1 A. P-E-R-I-M-M-U-N-E. 2 Q. And what medical devices would Perimmune 3 have made? 4 A. Their device was a urine test for cancer. 5 Q. And did you yourself at all work on the urine test 6 for cancer, or was that something that the company did but you 7 had no involvement with? 8 A. My involvement was the preparation of the 9 regulatory filing for the device. 10 Q. Have you ever worked for a company that 11 manufactures orthopedic medical devices? 12 A. No. 13 Q. Have you ever prepared any regulatory filings for 14 orthopedic medical devices? 15 A. No. 16 Q. Have you ever worked for the FDA? 17 A. No, I have not worked for the FDA. 18 Q. Do you have any legal training? 19 A. No. 20 Q. Didn't attend law school? 21 A. No. 22 Q. Don't hold any law license? 23 A. No. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 14 1 Q. And I take it you don't hold yourself out as able 2 to provide legal advice or what the effect of a given law would 3 be? 4 A. Definitely not. 5 Q. Because that would be practicing law without a 6 license. Yes? 7 A. Yes. 8 Q. Okay. I understand you are an M.D.? 9 A. Yes. 10 Q. And where are you licensed? 11 A. New York, Alabama, Mississippi. 12 Q. Have you ever been the subject of any license 13 suspensions? 14 A. No. 15 Q. Any disciplinary actions? 16 A. No. 17 Q. You are not an orthopedist; is that correct? 18 A. Correct. 19 Q. And my understanding is that you're an internist; 20 is that right? 21 A. Yes. 22 Q. Any particular specialty within internists? 23 A. I'm not sub-specialty certified, no. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 15 1 Q. You're not board certified in orthopedics, 2 obviously? 3 A. I am not. 4 Q. And as I understand it, you do have board 5 certification in internal medicine? 6 A. Yes. 7 Q. Have you ever implanted an orthopedic device in 8 a patient? 9 A. No. 10 Q. Have you ever performed hip replacement 11 surgery? 12 A. No. I think I have assisted on a hip case, but it 13 was a long time ago. 14 Q. How long ago would that have been? 15 A. Possibly 15 to 20 years ago. 16 Q. And where would that have been? 17 A. I would have to research that because I do recall 18 having assisted on a hip case. 19 Q. Do you recall whether a hip replacement device 20 was actually implanted during that hip case? 21 A. There was one, yes. 22 Q. And do you recall who the manufacturer of that 23 device was? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 16 1 A. No. 2 Q. When you say that you would have assisted on 3 that one case 15 years ago -- somewhere around 15 years ago. 4 And I understand we don't know exactly when -- 5 A. Yes. 6 Q. -- what would your role have been as assistant? 7 A. Well, my role would have been in identifying 8 surgical areas, retracting appropriate areas, suctioning, possibly 9 clamping. 10 Q. Do you know if you would have opened the 11 packaging for the hip implant device that was used? 12 A. No. 13 Q. Who would have done that? 14 A. The circulating nurse. 15 Q. You have never been the chief surgeon who 16 performed a hip replacement surgery? 17 A. No. 18 Q. Have you ever opened an orthopedic hip 19 replacement device during surgery? 20 A. No. 21 Q. What types of surgery do you perform? 22 A. I'm not a surgeon. 23 Q. So you don't perform surgery? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 17 1 A. I typically don't perform surgeries. I have 2 assisted in surgeries, but I have not been the principal surgeon. 3 Q. When would have been the last time that you 4 assisted with surgery? 5 A. Approximately 1988. 6 Q. Do you recall what type of surgery that was? 7 A. No. 8 Q. Going back to that hip surgery that you would 9 have assisted on maybe 15 years ago, do you recall where that 10 was performed? 11 A. No. 12 Q. Do you recall where you were living at the time? 13 A. Well, 15 years ago, I was living in California. 14 Q. Where at in California? 15 A. In the northern California. 16 Q. Okay. What town? 17 A. In -- pardon? 18 Q. What town? I'm sorry. 19 A. The city was Colusa, C-O-L-U-S-A. 20 Q. And at the time that you would have assisted 21 with that hip surgery, had you completed your internship and your 22 residency? 23 A. Yes. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 18 1 Q. Were you in private practice in Colusa? 2 A. Yes. 3 Q. Do you currently have an active practice with 4 patients? 5 A. Yes. 6 Q. And where are you on staff at? 7 A. I'm on staff at two hospitals. Brookwood Medical 8 Center and Cooper Green Hospital. 9 Q. And both of those are located here in 10 Birmingham? 11 A. Yes. 12 Q. What is Southern Clinical and Regulatory, LLC.? 13 A. That is the entity through which I provide clinical 14 research and regulatory support for pharmaceutical and clinical 15 device companies. 16 Q. Is that owned by you and your wife, also? 17 A. Yes. 18 Q. How many employees does it have? 19 A. Two. 20 Q. And what position -- or what do you do in 21 Southern Clinical and Regulatory? 22 A. What activities do I do? 23 Q. Yes. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 19 1 A. Well, I perform consulting on clinical research 2 issues primarily. I write clinical protocols. I write -- I have written 3 investigators's brochures. I provide site audits. I recently 4 performed an audit of a site for a clinical study. I have also 5 written regulatory filings. Last year I wrote an I & D for a vaccine. 6 And also I have written within the last two or three years two 7 510(k) applications, both of which were successful. 8 Q. The two 510(k) applications, what type of 9 products were those for? 10 A. One 510(k) was for an MRI attachment. And the 11 second was for a pump for intravenous drugs used during 12 surgery. 13 Q. Have you ever written any 510(k) applications for 14 an orthopedic medical device? 15 A. No. 16 Q. Have you ever written any labeling for an 17 orthopedic medical device? 18 A. No. 19 Q. I also, then, take it you would have never 20 submitted any labeling for an orthopedic medical device to the 21 FDA for approval? 22 A. I have not. 23 Q. Do you know what type of approval process the 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 20 1 FDA requires for the labeling of orthopedic medical devices? 2 A. Well, I have not specifically filed an orthopedic 3 device, so I'm not entirely familiar with all the details of it. But the 4 approval process for each of the types of devices including 5 orthopedic devices are outlined in the 21 C.F.R. So that would 6 be the source of looking for the detail of the information. 7 Q. Can you explain to us what an orthopedic 8 company must do to obtain FDA approval of its labeling? 9 A. Of the device or the labeling? 10 Q. The labeling. 11 A. Well, a labeling is part of the approval process 12 for the device. So the device -- normally the device would go 13 through the clinical trials, and then it would be submitted either as 14 a 510(k) or a PMA depending on the device. And then a device 15 labeling would be prepared by the company, a draft labeling, and 16 that would be submitted to the agency. And then the agency 17 would have the Division of Orthopedic Devices review the 18 labeling and then make suggested comments or changes, and 19 that information would go back to the company. There would be 20 a discussion to resolve any issues, and then the labeling would 21 be approved. 22 Q. Have you at all looked into the FDA approval 23 process for Biomet's M2a orthopedic implant labels? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 21 1 A. No. 2 Q. Would you agree that would be a public record 3 that you could access? 4 A. Yes. 5 Q. What is Emergency Technology Partners or 6 was? Is? 7 A. Emerging Technology Partners. 8 Q. Excuse me. Yes, sir. 9 A. That was an entity developed through the 10 Economic Development Partnership of Alabama to foster the 11 development of biotech companies within the state with 12 technology that was developed within the state. 13 Q. Kind of a program that the state of Alabama 14 used to promote its industry with respect to medical issues or -- 15 A. Well, it sounds like it, but it really is not exactly 16 the mechanism. What happened was that the Economic 17 Development Partnership of Alabama, or EDPA, is a 18 non-governmental independent agency which is funded by the 19 major technology and industries within the state such as the large 20 banks, the manufacturing sites that we have here including 21 automobiles and aerospace and so on and other companies, and 22 then they all contribute to the Economic Development 23 Partnership which then promotes industry within the state. And 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 22 1 that, EDPA, chartered Emerging Technology Partners to identify 2 technology inside the state which would be appropriate to 3 develop into companies that had a biotechnology basis. 4 Q. With respect to your work for Emerging 5 Technology Partners, what specifically did you do? 6 A. Well, I identified technology from the various 7 universities in Alabama that was available for licensure that 8 seemed to have economic potential. And then along with the 9 other partners in ETP, Emerging Technology Partners, we 10 chartered the company, set up the business aspects of the 11 company, located the management to come into the company, 12 identified funding for the company, assisted the company in 13 locating scientists; and then for any clinical studies that were to 14 proceed from that, I handled the development of the clinical 15 programs. And during the time I was there, we were able to start 16 two companies: a vaccine company and a gene therapy 17 company. 18 Q. Any of the technologies that you identified, any 19 of those involve orthopedic implants? 20 A. No. The nearest was the device I mentioned 21 earlier which was an external trigger for an MRI scanner. 22 Q. Have you ever designed an orthopedic implant 23 that was sold out in the market? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 23 1 A. Have I ever devised one? 2 Q. Designed. 3 A. No. 4 Q. Have you ever designed the packaging or 5 labeling for an orthopedic implant sold on the market? 6 A. No. 7 Q. Have you ever conducted any formal studies of 8 the types of packaging labeling or warnings provided with 9 orthopedic implants? 10 A. No. 11 Q. Ever construct any formal studies regarding the 12 effects of an orthopedic implant's packaging, labeling, or 13 warnings? 14 A. No. 15 Q. Would you agree that if one were to study the 16 effects of the orthopedic implant's warnings, packaging, or 17 labeling, the proper people to study would be orthopedic 18 surgeons, those who actually receive those materials? 19 A. Well, they certainly would be involved in the 20 overall team. But usually the development of a device and the 21 development of labeling is a team effort which involves the end 22 user -- in this case orthopedic surgeons -- but it would also 23 involve regulatory affairs experts, legal experts, individuals from 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 24 1 marketing, and other miscellaneous end users that would be 2 involved in the utilization of the product. 3 Q. With respect to orthopedic implants, would there 4 be any other end users other than orthopedic surgeons? 5 A. Well, certainly orthopedic surgeons are the 6 ultimate end user. But individuals involved in receiving the 7 packaging, interpreting the information on the packaging, and 8 handling the packaging within the operating room environment 9 might also be appropriate to consult with. 10 Q. And as I understand it, you have never 11 conducted any studies of the effects of the materials -- the 12 warnings, the labeling, the product brochures, packaging -- on 13 any of those end users? 14 A. That's correct. 15 Q. Are you aware of any such studies out there in 16 the medical literature? 17 A. Concerning any medical device? 18 Q. No, concerning orthopedic implants. 19 A. Am I aware of an article in the medical literature 20 concerning orthopedic implant labeling? 21 Q. Concerning the effects of orthopedic labeling, 22 packaging, warnings on end users. 23 A. I have looked -- I have actually performed a 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 25 1 search for that on the NLM database -- National Library of 2 Medicine -- and didn't find anything. So I'm not aware of any, but 3 I did look. 4 Q. You brought your CV with you here today? 5 A. Yes. 6 Q. And we'll mark that as Defendant's Exhibit 1. 7 (Defendant's Exhibit No. 1 was 8 marked for identification.) 9 BY MR. KRUEGER: 10 Q. Is Defendant's Exhibit 1 a copy of your current 11 CV? 12 A. Yes. 13 Q. Any additions or deletions that need to be made 14 to it? 15 A. No. 16 Q. On here, under the "FDA Experiences, you have 17 noted, "Preparation of PMA's and 510(k)'s for in vitro diagnostic 18 devices." Anything other than what we've discussed already 19 included within that category? 20 A. No. 21 Q. So none of that would involve anything related to 22 orthopedic implants? 23 A. No. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 26 1 Q. Have you ever had any contact with the FDA 2 relative to orthopedic implants? 3 A. No. 4 Q. Now, as I understand your background -- and 5 this is purely based upon reviewing your CV -- it seems to be 6 more related to microbiology and the interaction of 7 pharmacological agents; am I correct? 8 A. Yes. 9 Q. That type of background would be more 10 pharmaceutical related as opposed to something such as 11 orthopedic implants; is that correct? 12 A. Yes. 13 Q. I noted that you hold two patents, one involving 14 vaccination and one involving immunization? 15 A. Well, actually, I now own three patents, and 16 they're all involving vaccinations or immunization. 17 Q. None of those are related to orthopedic 18 implants? 19 A. No. 20 Q. Even related to medical devices? 21 A. No. Well, the vaccination system involves both 22 the evector for the vaccine, which is another virus, and a method 23 of application, which involves a medical device. But it is not an 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 27 1 orthopedic medical device. 2 Q. You've also listed a number of publications, 3 abstracts, and research reports on your CV. 4 A. Yes. 5 Q. Any of those related to the packaging, labeling, 6 or warnings regarding orthopedic implants? 7 A. No. 8 Q. Any related to orthopedic implants generally as 9 apart from the packaging, warnings, or labeling? 10 A. No. 11 Q. Any even related to medical devices generally? 12 A. I have not had any publications on medical 13 devices. 14 Q. Have you brought your file with you here today 15 on this case? 16 A. Yes. 17 Q. Can I take a look at it. 18 A. Yes, sir. 19 Q. Sir, your file contains a copy of a letter from 20 Mr. Hendrickson dated May 20th, 2004 in which Mr. Hendrickson 21 encloses Dr. Serot's chart; Memorial Hospital admission of 22 8/14/01 complete; Memorial Hospital admission of 10/6/01 23 (selected); Dr. Serot's deposition; and Danny Merrell's deposition. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 28 1 Mr. Hendrickson also enclosed a check in the amount for $1,500 2 for the first five hours of your work. Then he notes, "Please 3 contact me to discuss this matter prior to drafting any report." 4 Is this the only letter that you have received 5 from Mr. Hendrickson in this case? 6 A. I think so. 7 Q. The five sets of materials listed in this letter, are 8 they all the materials that you received from Mr. Hendrickson in 9 this case? 10 A. Well, I think also, there's a deposition there by 11 your right hand -- 12 Q. Yes. 13 A. Which may not be listed on that letter. 14 Q. And this would be the deposition of Troy Butler? 15 A. Yes. 16 Q. Any other depositions that you've received in the 17 case? 18 A. No. 19 Q. Any other medical records that you've received 20 in the case? 21 A. No. 22 Q. Did you receive copies of the depositions of any 23 of the various Biomet employees who have been deposed in this 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 29 1 case? 2 A. I have the deposition of Danny Merrell, and that's 3 it. 4 Q. And do you understand that Danny Merrell is not 5 an employee of Biomet? 6 A. He is a representative -- a device rep. 7 Q. Independent sales rep? 8 A. Yes. 9 Q. Okay. Did you receive the deposition of 10 T. L. Weiss? 11 A. No. 12 Q. Did you receive the deposition of David 13 Montgomery? 14 A. No. 15 Q. How about the deposition of Rex White? 16 A. No. 17 Q. Did you receive from Mr. Hendrickson any of the 18 various documents which Biomet has produced in this case? 19 A. No, I only received the documents you have in 20 front of you. 21 Q. Prior to today, did you ever look at what's sitting 22 in front of us which is labeled as Plaintiff's Exhibits 2 and 3, 23 deposition date July 8th, '03, which consists of Biomet packaging 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 30 1 for the M2a hip components? 2 A. Can I see that stack? 3 Q. Sure. 4 MR. HENDRICKSON: I sent you a copy. I don't 5 remember if it was in that packaging or not. 6 BY THE WITNESS: 7 A. Seems to me that I received the packaging, but I 8 did not see those boxes before today. 9 BY MR. KRUEGER: 10 Q. I didn't see the packaging contained within your 11 file. Do you know where that would be? 12 A. Pardon? 13 Q. Do you know where that would be? 14 A. No. I'm looking for it. But I think I have seen a 15 picture of some of the key parts, but I don't know where they are 16 offhand. But at any rate, to answer your specific question, I have 17 not seen those boxes before today. 18 Q. And this is probably a question I should have 19 asked sooner. Is this what you brought with you here today your 20 entire file in this matter? 21 A. Yes. 22 Q. Anything taken out of the file or deleted from the 23 file after it was reviewed? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 31 1 A. No. 2 Q. So any materials that you would have received in 3 the case should be contained within your file contents? 4 A. Yes. 5 MR. KRUEGER: What I'd like to do is go ahead 6 and label the file as Defendant's Exhibit 2. And sometime, we're 7 going to want to get a copy of everything here. And I don't know 8 whether it matters to you if the court reporter takes it and gets it 9 back or -- 10 THE WITNESS: Doesn't matter to me. 11 MR. KRUEGER: Okay. 12 (Defendant's Exhibit No. 2 was 13 marked for identification.) 14 BY MR. KRUEGER: 15 Q. Doctor, I am also finding in your file two 16 groupings of documents that appear to be pages that you printed 17 off of a Biomet website; is that correct? 18 A. Yes. 19 Q. And did you also actually print those off, or were 20 those provided to you? 21 A. These -- I think I printed these off myself. 22 Q. Okay. This first one, as I was looking through it, 23 it appears to be, first of all, "Driven By Engine..." -- I assume 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 32 1 that's "Engineers"? 2 A. Yes. 3 Q. Okay. And it applies towards the Biomet M2a 4 Taper? 5 A. Yes. 6 Q. There's a general description of what it is, 7 "Indications", "Contraindications", "Effects", "Sterility". And then I 8 saw at the end it said, "Authorized representative, Biomet Merck, 9 Ltd., Waterton Industrial Estates, Bridgend, South Wales". Do 10 you know if that's what's generally used in Wales or in the U.S.? 11 A. It should be information that would be 12 available -- this is available on the website, but it would be 13 available -- I think it might more specifically be available to their 14 English representatives. Or at least identifying an English 15 representative. 16 Q. Okay. 17 A. It doesn't specifically say it does not apply to 18 American product. 19 Q. Right. 20 A. In fact on the first page, there's an address in the 21 U.S. 22 Q. Sure. 23 A. And then at the bottom of the first page, in the 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 33 1 lower left, it says, "Enter your state...for contacting a Biomet rep 2 near you." 3 Q. Okay. 4 A. So it does again apply to the U.S. 5 Q. The other material you have here is two sets of 6 what appear to be -- or three sets, excuse me. Make that four. 7 Four sets of information relative to the M2a Taper, metal on 8 metal articulation, same general type of information that you 9 would have pulled up off the website? 10 A. Yes. 11 Q. And with respect to product literature, 12 information, warnings, that would have been -- the material that 13 you pulled off the website would have been the only material that 14 you reviewed in this case relative to the orthopedic implants at 15 issue? 16 A. Yes. 17 MR. HENDRICKSON: Other than the stuff that 18 you said that you had seen. 19 THE WITNESS: Right. Other than the 20 documents that were referred to a few minutes ago that I couldn't 21 lay my hands on which are the package descriptions and other 22 materials which I don't see in there but I do have. So even 23 though I said that these were the complete files, obviously, there 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 34 1 is a small part of the file which is still not here which would be the 2 description of the packaging. 3 BY MR. KRUEGER: 4 Q. Doctor, that small part of the file that's still not 5 here, is that something that after the deposition when you go 6 back to your office or home you can locate and then furnish to 7 Mr. Hendrickson who can furnish it to us? 8 A. Definitely. And I apologize for not bringing it, 9 because I thought I brought everything that I have; and obviously, 10 I don't have a small section of the material that I have. 11 MR. HENDRICKSON: Off the record. 12 (A discussion was had off the 13 record.) 14 BY MR. KRUEGER: 15 Q. Doctor, are you aware of anything else than the 16 product labeling that may be contained within your small section 17 of that file which is not here today? 18 A. No. 19 Q. Doctor, in what we call Expert Endorsement, 20 what the plaintiffs filed identifying you as an expert, with respect 21 to you, the endorsement reads -- it gives your name. It gives 22 your address. Then it says, "Is expected to testify as to 23 causation of plaintiff's injuries, inadequacy of Biomet implant 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 35 1 labeling and identification of implant components, negligent of 2 manufacturer's representative in providing implants to surgeon, 3 surgeon's negligence in implanting mismatched components and 4 inadequacy of Biomet product literature and components 5 identification. Further, Dr. Marks may testify as to the general 6 practice and requirements regarding training and education for 7 manufacturers's representatives who will sell or market implants." 8 Any other areas that you intend to express 9 opinions about in this case? 10 A. I don't think so. 11 Q. And I have looked at the report that you 12 previously furnished to Mr. Hendrickson. And as I looked at the 13 report, I did not see anything in the report about the general 14 practice and requirements regarding training and education for 15 manufacturers's representatives who will sell or market implants. 16 Given that that's not in your report, am I correct that you no 17 longer intend to testify about that at trial? 18 A. Yes, that is my understanding is that I have not 19 specifically been asked to address those areas. 20 Q. The first contact in this case as I understand it 21 would have been on May 20th, 2004, correct? That was the date 22 of the first letter. 23 A. Well, that's the date of the first letter. The 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 36 1 original contact by phone would have been sometime 2 immediately before then. 3 Q. It would have been in the same time frame? 4 A. Yes. 5 Q. And that contact would have been made by 6 Mr. Hendrickson? 7 A. Yes. 8 Q. Do you recall what was discussed during that 9 initial telephone conversation? 10 A. Yes. He gave me a brief discussion of the case 11 and asked me if I would be able to give an opinion on this. And I 12 said that I might be able to, and I gave him an outline of the kinds 13 of materials that I would need to see in order to be able to give 14 an opinion. 15 Q. First of all, do you recall how the brief description 16 of the case -- what the brief description of the case was that 17 Mr. Hendrickson gave you? 18 A. I don't recall the details of the conversation. And 19 I don't have records of that conversation. 20 Q. The outline of the types of materials that you 21 would need to be furnished, does that still exist? 22 A. There was no written conversation log. 23 Q. Okay. Did you just generally orally tell him the 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 37 1 type of materials that you would need to see? 2 A. Yes. 3 Q. Do you recall what you would have told him? 4 A. I wanted to see the operating log, any packaging 5 materials, and interviews with the principals involved in the case. 6 Q. Obviously, Mr. Hendrickson's office and you 7 have had telephone conversations relative to the scheduling of 8 this deposition? 9 A. Yes. 10 Q. Other than those telephone conversations and 11 the first telephone conversation that we just discussed, have you 12 had any other telephone conversations with Mr. Hendrickson or 13 anyone from his office? 14 A. Yes. 15 Q. When would those have occurred? 16 A. I spoke with Mr. Hendrickson on, I think, either 17 Friday or Saturday for a brief amount of time to go over the 18 general conduct of the deposition and what -- to be sure that I 19 had supplied all the papers that you were requesting and to be 20 sure that we would have the meeting site coordinated. 21 Q. Any other conversations between shortly before 22 May 20th, 2004 and either Friday or Saturday of the last week? 23 A. I don't think so. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 38 1 Q. Did you and Mr. Hendrickson have any 2 telephone conversations relative to your report in this matter? 3 A. Yes. I sent him a copy of my report. And he had 4 asked me to address certain questions. And so I tried to address 5 those in my report. And I think that for the most part, I did. I 6 think there were some issues that subsequently were no longer 7 issues in the case that were settled in some way. And in fact, I 8 think there was actually one that is in the copy of the report that 9 you have that is one or two points which are no longer at issue. 10 And I did not remove them from that report because I didn't 11 update the report. 12 Q. Now, how many conversations would you have -- 13 telephone conversations would you have had with 14 Mr. Hendrickson besides the one last week and the first one? 15 A. Perhaps two or three. 16 Q. And would those two or three conversations 17 have been with respect to the report itself? 18 A. Yes. 19 Q. Anything else discussed during those 20 conversations that you can recall? 21 A. I can't recall what other things would there be to 22 discuss. 23 Q. Have you exchanged e-mails with 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 39 1 Mr. Hendrickson? 2 A. Only concerning the forwarding electronically of 3 the initial report and his e-mail concerning the location of the 4 deposition today and the times. 5 Q. Would you still have copies of those e-mails? 6 A. I might. 7 Q. When you get the small section of the file 8 together, could you also search for those e-mails and include 9 those with the section of the file and furnish them to 10 Mr. Hendrickson so he can supply them to us? 11 A. Certainly. 12 Q. Earlier just where we began talking about the 13 report, you had mentioned that you outlined for Mr. Hendrickson 14 the type of materials that you needed. And then you mentioned 15 something else, and I'm trying to remember what that was. 16 A. Well, when I say outlined, what I did was I gave 17 him verbally a listing of the types of documents I would need and 18 any depositions or discussions with pertinent parties. 19 Break for a second? 20 MR. KRUEGER: Sure. 21 (A discussion was had off the 22 record.) 23 BY MR. KRUEGER: 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 40 1 Q. Your billings thus far in the case, anything other 2 than the $1,500 that Mr. Hendrickson originally sent you? 3 A. I brought with me a record of my billing. I have 4 the initial review, the supplemental charge for revisions, phone 5 calls, and e-mail -- which I will look for for you. 6 Q. Okay. Thank you. 7 A. The preparation for the deposition today, and the 8 deposition time itself. 9 MR. KRUEGER: Okay. Can we just have these 10 billings marked as Defendant's Exhibit 3. I'll go ahead and do 11 that. 12 (Defendant's Exhibit No. 3 was 13 marked for identification.) 14 BY MR. KRUEGER: 15 Q. Defendant's Exhibit 3 are the billings you just 16 referred to? 17 A. Yes. 18 Q. Are there any other billings on the case? 19 A. No. 20 Can I ask for a short question here, 21 Mr. Hendrickson? 22 MR. KRUEGER: Sure. 23 (A discussion was had off the 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 41 1 record.) 2 MR. HARVEY: What's the total, Kevin? 3 MR. HENDRICKSON: He's got a revision. 4 MR. KRUEGER: Okay. $5,400. 5 BY MR. KRUEGER: 6 Q. Go ahead. 7 A. Yes. In preparation for the report, I consulted a 8 number of orthopedic surgery textbooks to familiarize myself -- 9 refamiliarize myself with the orthopedic surgery procedures 10 involved and the types of implants. And I did not bring with the 11 names of those textbooks; but if you like, I could supply those to 12 you. 13 Q. Get those for us. 14 A. Would it be okay if I supply you with the front 15 page which lists the name, the date, and the edition? 16 Q. Sure. That's fine. I assume they're textbooks 17 that are generally available? 18 A. Yes, they're standard textbooks. 19 Q. What are your rates in the case? 20 A. My rate for all cases is $300 per hour for all work 21 except deposition and trial, which is $400 an hour. 22 Q. Is there any work that you intend to do before 23 trial? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 42 1 A. No. Except that if there is a trial, I will need a 2 few hours to review the materials once again before I went in. 3 But other than that, no. 4 Q. Do you have what is called or what we lawyers 5 call a standard federal Rule 26 disclosure? It's the listing of 6 testimony over the past four years. 7 A. Yes. 8 Q. And did you bring that with you here today? 9 A. Yes. 10 MR. KRUEGER: Okay. We'll go ahead and 11 mark this as Defendant's Exhibit 4. 12 (Defendant's Exhibit No. 4 was 13 marked for identification.) 14 BY MR. KRUEGER: 15 Q. Defendant's Exhibit 4 lists the dates and case 16 names of your deposition and trial testimony? 17 A. Yes, sir. 18 Q. It also lists on here some presentations that you 19 have given? 20 A. Yes. 21 Q. And you've given some presentations, I see, to 22 ATLA? 23 A. Yes. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 43 1 Q. And what is ATLA? 2 A. American Trial Lawyers Association. 3 Q. Is it your understanding that ATLA is generally a 4 group of attorneys representing plaintiffs? 5 A. Yes, sir. 6 Q. Have you ever been retained by Mr. Hendrickson 7 in another case? 8 A. Not that I know of. 9 Q. Have you ever been retained on any cases 10 involving Dr. Serot? 11 A. No. 12 Q. Have you ever spoken with the plaintiff, Troy 13 Butler? 14 A. No. 15 Q. Ever speak with any of Mr. Butler's treating 16 physicians? 17 A. I have not. If this does progress, if the case 18 progresses to a trial, I have asked Mr. Hendrickson if I could have 19 the opportunity to speak with Mr. Butler. And I also may speak 20 with other individuals. But at this point, I have not. 21 Q. You have not spoken with any of his treating 22 physicians? 23 A. No. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 44 1 Q. And you have not reviewed any of his treating 2 physicians's depositions, with the exception of Dr. Serot? 3 A. Correct. 4 Q. You have not spoken with Danny Merrell? 5 A. No. 6 Q. Have you spoken with T. L. Weiss? 7 A. No. 8 Q. Have you spoken with anyone from Biomet? 9 A. No. 10 Q. Speak with any distributors or independent sales 11 reps for Biomet? 12 A. I have not. 13 Q. Spoken with anyone at Memorial Hospital? 14 A. Where? 15 Q. Memorial Hospital. 16 A. No. 17 Q. Have you consulted with any of the other experts 18 that are retained in this case by the plaintiff? 19 A. No. 20 Q. Rely on anyone else's opinions in forming your 21 opinions on this case? 22 A. I have not. 23 Q. Other than the parties that I have just identified, 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 45 1 anyone else that you have consulted with on this case other than 2 Mr. Hendrickson? 3 A. No. 4 Q. Do you or anyone in your immediate family have 5 any hip replacements? 6 A. No. 7 Q. Have you reviewed Mr. Butler's x-rays? 8 A. Yes. 9 Q. When did you review those? 10 A. This morning. 11 Q. You have not examined Mr. Butler, obviously? 12 A. Not yet. 13 Q. Is that something you intend to do? 14 A. If this case progresses to trial, then I would 15 expect to be able to examine him sometime before my 16 deposition. 17 Q. And what would be the purpose of your 18 examination? 19 A. Well, to reconfirm my medical history with 20 Mr. Butler which I might able to do by phone but I prefer to do in 21 person, and then also to examine his range of motion in his leg. 22 Q. Other than the telephone conversation that you 23 had with Mr. Hendrickson last Friday or Saturday and the review 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 46 1 of your file materials, anything else that you did in preparation for 2 today's deposition? 3 A. Review of the documents, review of the 4 orthopedic surgery, textbooks that I mentioned earlier. I have 5 some regulations from the FDA website which I reviewed. 6 Q. Okay. 7 A. And I think that's it. 8 Q. The regulations from the FDA website that you 9 reviewed, what regulations would those be? 10 A. Those are the ones cited in my report. 11 Q. And is that a copy of your report that you have in 12 front of you? 13 A. It is. 14 MR. KRUEGER: We'll mark that as Defendant's 15 Exhibit 5, please. 16 (Defendant's Exhibit No. 5 was 17 marked for identification.) 18 BY MR. KRUEGER: 19 Q. Now, Doctor, in your report, you have cited to the 20 operative report by Dr. Serot, correct? 21 A. Yes. 22 Q. And in that operative report of 8/14/01, Dr. Serot 23 states that a 32-millimeter liner and a 14 Biomet femoral 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 47 1 component with a standard 32-millimeter femoral head were 2 used during the surgery of 8/14/01; is that correct? 3 A. Yes. 4 Q. Do you agree that Dr. Serot's operative report is 5 in error and that actually a 28-millimeter liner and a 32-millimeter 6 head were implanted in Mr. Butler on 8/14/01? 7 A. Yes. 8 Q. Do you agree that if Dr. Serot had looked at the 9 component sticker that was on the outside of the box that the 10 components were contained within, he would have seen that he 11 had a 32-millimeter head and a 28-millimeter liner? 12 MR. HARVEY: Let me object to that question on 13 the basis that it may not have been the right size component in 14 the box. Subject to that objection, you may answer. 15 BY MR. KRUEGER: 16 Q. Go ahead. 17 A. What am I supposed to do now? 18 Q. Do you agree that if Dr. Serot had bothered to 19 look at the box, he would have seen on the outside of the box 20 that he had a 28-millimeter liner and a 32-millimeter head? 21 MR. HARVEY: Same objection. 22 BY THE WITNESS: 23 A. If Dr. Serot would have looked at these boxes 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 48 1 that I'm holding in my hands, Exhibits 2 and 3, he would have 2 seen that one box is labeled 28-millimeter Taper liner, and one 3 box is labeled 32-millimeter head. That's not to say what the 4 contents of the boxes were but that this is the labeling on the 5 outside of the box. 6 BY MR. KRUEGER: 7 Q. Okay. 8 A. Yes. 9 Q. And these boxes are boxes that were 10 reproduced after this event. Assuming that these boxes are 11 identical to the boxes that would have accompanied Mr. Butler's 12 implants, would your answer be the same? 13 A. Well, if I'm willing to assume that these are the 14 same. 15 Q. Okay. So if indeed these are the same, if 16 Dr. Serot had looked at them, he would have seen on the outside 17 label that he had a 28-millimeter liner and a 32-millimeter head? 18 A. Right. That is what the boxes state. 19 Unfortunately, the liner label doesn't say use with a 28-millimeter 20 head. And the neck -- the head, 32-millimeter head does not say 21 use only with a 32-millimeter liner. But that's -- 22 Q. Doctor, I understand you are not an orthopedic 23 surgeon. But wouldn't you agree that a properly trained and 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 49 1 practicing orthopedic surgeon would know that you should use a 2 28-millimeter liner with a 28-millimeter head and a 32-millimeter 3 liner with a 32-millimeter head? 4 A. I would presume that if the orthopedic surgeon -- 5 yes, the orthopedic surgeon would typically use the matching 6 sizes for the head and the liner if the orthopedic surgeon had the 7 opportunity to ascertain that information. 8 Q. And you didn't see anything in Dr. Serot's 9 deposition testimony that indicated to you that he did not know 10 that he should use a 28-millimeter liner with a 28-millimeter head 11 and the same with respect to the 32-millimeter sizes? 12 A. Could you repeat your question? I didn't 13 understand it. There was a double negative. 14 Q. Sure. Did you see anything in Dr. Serot's 15 deposition indicating to you that he did not know that he should -- 16 did you see anything in his deposition that indicated to you that 17 he didn't know that he should use a 28-millimeter head with a 18 28-millimeter liner? 19 A. No. 20 Q. The same with respect to the 32-millimeter sizes. 21 A. Yes, sir. 22 Q. Okay. Now, Doctor, is it your understanding that 23 inside the box, there is a wrap provided around the components? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 50 1 A. Yes, sir. 2 Q. And do you understand that there is another 3 label provided on that wrap? 4 A. Yes. 5 Q. And in fact, does that wrap also identify the size 6 of the components? 7 A. Yes. 8 Q. The label on the wrap. And again, if Dr. Serot 9 had bothered to look at these labels on the inside of the box that 10 is on the wrap going around the components, would he also 11 realize that he had two different-sized components? 12 MR. HARVEY: Again, same objection. 13 Depending on what size components are in the box. 14 MR. HENDRICKSON: I'm going to ask if Biomet 15 is willing to stipulate that Danny Merrell would have known the 16 same exact thing. But... 17 MR. KRUEGER: It's my deposition, not yours. 18 Go ahead. 19 BY THE WITNESS: 20 A. Could you repeat the question. 21 BY MR. KRUEGER: 22 Q. Sure. 23 A. I'm sorry. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 51 1 Q. Would you agree that if Dr. Serot had looked at 2 these labels, the second set of labels inside the packaging, he 3 would have seen that he had a 28-millimeter head and a 4 32-millimeter liner. Opposite. Excuse me. A 28-millimeter liner 5 and a 32-millimeter head. 6 MR. HARVEY: I'm going to add to my objection 7 that it hasn't been established that these are the same labels that 8 were in the operating room at that time. 9 BY THE WITNESS: 10 A. My understanding is that the liner and the head 11 were handed to Dr. Serot outside of the packaging, so he did not 12 have an opportunity to observe the packaging. But had he been 13 able to observe the packaging before it was opened, he would 14 have -- assuming that this is the same packaging, he would have 15 seen the same material on the packaging. 16 BY MR. KRUEGER: 17 Q. Now, it's your understanding that Dr. Serot did 18 not look at the packaging; is that correct? 19 A. It's my understanding that -- and also my 20 experience, limited as it is from operating room procedures, is 21 that many times medical devices are removed from the 22 packaging and passed through at least one person before they 23 enter the sterile field. So having the device enter the sterile field 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 52 1 outside of its identified packaging is not totally unusual for an 2 operating room procedure. 3 Q. So anything that would have been contained on 4 the packaging would be irrelevant at least with respect to 5 Dr. Serot, correct, because he didn't look at it? 6 A. It wasn't irrelevant to him. I would just say he 7 didn't look -- he didn't have the opportunity to look at it because 8 operating room procedures -- I was not there. But my 9 understanding is -- and it's consistent with my own experience is 10 that medical devices are removed from their carton and passed 11 through several hands before they enter the sterile field in order 12 to keep the sterile field sterile because the packaging itself is not 13 sterile. The contents of the package are sterile. And therefore, 14 someone who is not sterilized has to remove the packaging and 15 in a sterile or a non-contaminating manner allow the sterile 16 material to pass into an operative field. 17 Q. I realize that. But my question more directly is 18 with respect to Dr. Serot and his actions in implanting these 19 particular mismatched components, the packaging would have 20 been irrelevant because he didn't see it? 21 MR. HARVEY: I'm going to object. He just 22 answered the question. 23 BY THE WITNESS: 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 53 1 A. Yeah, I agree. I mean it's not irrelevant. It's just 2 that he didn't, which is not atypical from a surgical procedure, 3 have the opportunity to view the material. Usually material is 4 verified by the operating room staff, and they are -- who are 5 trained in a particular material, whether it is a surgical device 6 such as a suture or a catheter or a clamp or some implantable 7 material. In this case, I don't think anyone had the opportunity to 8 do that because the company rep passed the material to the 9 surgical field. 10 BY MR. KRUEGER: 11 Q. Were any of the nurses involved with respect to 12 the packaging? 13 A. Were any of the nurses involved with packaging? 14 Q. From Memorial Hospital with respect to opening 15 the packaging? 16 A. My understanding is that the rep for this device 17 handed the device to the operating room staff and it was 18 introduced into the field but that he supplied the materials. 19 Q. Okay. And what is your understanding with 20 respect to exactly what the rep opened? 21 A. The rep opened the box. 22 Q. Okay. And this packaging inside the box, was 23 that opened by the rep? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 54 1 A. No, I don't recall the details of his deposition on 2 that part. 3 Q. Okay. Do you recall the details of the 4 depositions of any of the nurses who have been deposed in this 5 case? 6 A. Yes, but I would have to refresh myself with it 7 before I replied to you. I only have deposition -- well, the only 8 depositions I looked at were Dr. Serot, Danny Merrell, and the 9 patient. 10 Q. So you didn't review any of the depositions of the 11 nurses? 12 A. No, I didn't review any of the nurses's depos. 13 Q. Now, do you recall whether the labels -- let me 14 back up for a second. 15 Beyond the two labels that we've just 16 identified, isn't it correct that there would have been also four 17 additional labels provided with the product? 18 A. Well, what label are you referring to? There is 19 the package insert that came with that and then I think this label. 20 Q. Correct. 21 A. Right. And this is the label that gets placed on 22 the operative record. 23 Q. Right. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 55 1 A. Right. 2 Q. What is your understanding of how many labels 3 are provided to be placed on the operative record? 4 A. There are two labels placed on the operative 5 record. 6 Q. And where do you get that understanding from? 7 A. Well, it's standard procedure in the operating 8 room that there are at least two different places where the 9 material -- the actual material used is recorded. And the labeling 10 is supplied as a sticker as it is here so it can be removed directly 11 and placed on the record as the device is used so that a true 12 record of what is used is recorded. 13 Q. So am I correct that it is your understanding that 14 with respect to these particular components, there would have 15 been four labels provided with respect to each component: the 16 one on the outside of the box, the one on the outside of the 17 packaging contained within the box, and then the two separate 18 labels to go in the medical record? 19 A. Yes. 20 Q. Now, is it your understanding that the Memorial 21 Hospital nurses would have placed those two labels that we've 22 just referred to that were inside the packaging in the medical 23 record? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 56 1 A. Yes. 2 Q. Do you agree that if those nurses had looked at 3 those labels, they would have seen that they had mismatched 4 components: a 28-millimeter head -- or liner and a 32-millimeter 5 head? 6 A. Well, yeah, yes, if several -- several of the facts 7 of the case have to be operative in order for that to occur. For 8 example, the labeling of the box and of the packaging for the 9 device and the stickers all have to be true and factual 10 representations of what the actual device was. In other words, 11 there couldn't have been a mismatch between the device and the 12 labeling and the packaging for the device. 13 Secondly, there couldn't have been any 14 mismatching between the outside labeling of the box and the 15 inside labeling of the material so that you would have a 16 32-millimeter liner, for example, or a 32-millimeter head and have 17 the actual labeling material indicate otherwise. But assuming 18 everything is 100 percent concordant, that would be correct. 19 Q. Doctor, are you aware of any evidence in this 20 case of mislabeling? 21 MR. HENDRICKSON: Well, let's correct. You 22 mean where the labels -- 23 MR. HARVEY: Define it. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 57 1 MR. HENDRICKSON: Yeah. Let's define 2 mislabeling. 3 MR. KRUEGER: Sure. 4 MR. HENDRICKSON: That the labels on the 5 packaging didn't match other labels in the packaging or didn't 6 match the implant? 7 MR. KRUEGER: Correct. 8 MR. HENDRICKSON: Okay. 9 BY THE WITNESS: 10 A. Right. You're not referring to improper labeling 11 or my opinion as concerning inadequate labeling. But in terms of 12 mislabeling, I'm not aware of any specific demonstration that any 13 mislabeling occurred. I was just raising that as an alternative 14 hypothesis. 15 BY MR. KRUEGER: 16 Q. In fact, the labels that are contained in 17 Mr. Butler's medical record reflect the mismatched sizes that 18 were implanted in him on August 14th, '01? 19 A. Right. The prosthesis log indicated a 20 28-millimeter liner and a 32-millimeter head. 21 Q. Now, Doctor, in your report, you state that 22 Dr. Serot testified in his deposition he was not familiar with 23 hospital policy regarding handling of components at the time of 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 58 1 the 8/14/01 surgery, correct? 2 A. Right. 3 Q. Would you agree that as an orthopedic surgeon 4 on staff at Memorial Hospital, it was Dr. Serot's duty to be familiar 5 with any hospital policies regarding handling of components? 6 MR. HARVEY: I'm going to object to that 7 characterization. I don't think this witness is in a position to say 8 what Dr. Serot should have known about the hospital policy. But 9 as I recall his deposition, he testified that it had changed so many 10 times that he didn't know what it is on exactly that date. But 11 subject to that objection, you can answer. 12 BY THE WITNESS: 13 A. Right. So in answer to that, in answer to that, 14 that actually occurred to me at the time I was reading it. And it 15 occurred to me that he might have been replying out of context 16 because it would be difficult for me to imagine how Dr. Serot 17 would not be familiar with hospital policy regarding the handling 18 of components at the time of Mr. Butler's surgery. 19 BY MR. KRUEGER: 20 Q. You also state in your report that it was not 21 Dr. Serot's policy at the time of Mr. Butler's surgery to visually 22 confirm the correct size of implants handed to him. Don't you 23 agree that good medical practice necessitates that an orthopedic 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 59 1 surgeon confirm the correct size of implants that are handed to 2 him before implanting them in the patient? 3 MR. HARVEY: I'm going to object to this 4 witness's ability to answer that question based on his experience. 5 BY THE WITNESS: 6 A. Would you repeat your question. 7 MR. KRUEGER: Sure. In your report -- and Ted 8 will have the same objection with respect to foundation, I'm sure. 9 BY MR. KRUEGER: 10 Q. In your report, you say that it was not Dr. Serot's 11 policy at the time of Mr. Butler's surgery to visually confirm the 12 correct size of the implants handed to him. Wouldn't you agree 13 that good medical practice necessitates that an orthopedic 14 surgeon confirm the size of the implants handed to him before 15 implanting them in the patient? 16 MR. HARVEY: Same objection. 17 BY THE WITNESS: 18 A. Okay. In my report I stated that Dr. Serot stated 19 that it was not his policy -- he stated that it was not his policy to 20 visually confirm the correct size of implants handed to him. I 21 think he was relying on the operating room staff to have reviewed 22 the labeling of the device since it might be possible to not judge 23 accurately the number of millimeters of a device. And the 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 60 1 standard would be for the operating room staff to confirm the size 2 of the material since they were actually in contact with the labeled 3 material and not Dr. Serot. So that's how I interpreted 4 Dr. Serot's -- 5 BY MR. KRUEGER: 6 Q. Doctor, I wasn't asking you about the standard 7 with respect to the operating staff. My question was specific 8 relative to the standard for the orthopedic surgeon and whether 9 he should confirm them prior to implant. 10 MR. HARVEY: Again, I'm going to object. I 11 think you're arguing with the witness. He's just answered that -- I 12 gather his answer is that he was relying on the representative 13 and the other staff to do that for him. 14 BY THE WITNESS: 15 A. Right. That basically was my response was that 16 he would do that because one would not want to be -- to rely 17 solely on a visual determination of the number of millimeters in a 18 head diameter or a liner diameter but to rely specifically on the 19 labeling. So even though Dr. Serot may have looked at the 20 material, he would have, I think, relied on confirmation of the 21 correct size of the implants by the staff that introduced the 22 material into the operating room field. 23 MR. HENDRICKSON: I think that his question is 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 61 1 shouldn't Dr. Serot also be looking and confirming visually the 2 information on the box. I think you're thinking he's talking 3 about -- you're talking about being able to compare the sizes to 4 the actual components. He's asking shouldn't Dr. Serot visually 5 confirm the box labeling; in other words, have a nurse show him 6 the label before he implants. 7 BY THE WITNESS: 8 A. Is that so? 9 BY MR. KRUEGER: 10 Q. That's one of the questions, yes. 11 A. Okay. Well, I have already answered that the 12 outside box and the inside liner box were not directly in the 13 operative field. And the way an operating room is usually set up, 14 particularly with an -- this looks like it's going to be a long answer, 15 but it won't. 16 The way an operating room field is set up, 17 particularly in orthopedic surgery, these are very messy cases. 18 There's a lot of blood. There's a lot of bloody towels. There's a 19 lot of medical equipment. There are a lot of staff circulating 20 around. There's suction going on. There might be transfusions 21 going on. There's medical monitoring equipment. It's a very 22 busy operative field. Dr. Serot may not have had access near to 23 a place where he could have viewed these boxes and may have 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 62 1 been relying solely on the operating room staff where he said, 2 "I'm going to use 32 liner, 32 head," and that's what he assumed 3 that he told his staff and his staff put in the field. 4 BY MR. KRUEGER: 5 Q. And is that based upon your experience 6 performing hip replacement surgery? 7 A. I have not performed hip replacement surgery. 8 It's my experience in the operating room. 9 Q. Doctor, do you agree that Dr. Serot should have 10 orally confirmed with those present in the operating room the size 11 of the components? 12 MR. HARVEY: Same objection as before. 13 BY THE WITNESS: 14 A. I really cannot comment on what Dr. Serot's -- 15 orthopedic surgeons in Dr. Serot's medical community, surgical 16 community, have as a standard for confirming their devices. 17 Whether they do it verbally, they order it, they confirm it visually, I 18 don't know. 19 Can I have a break for a minute? 20 MR. KRUEGER: Sure. 21 (Recess taken.) 22 BY MR. KRUEGER: 23 Q. Okay. Doctor, I had asked you some questions 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 63 1 about if Dr. Serot had looked at the labeling on the inside of the 2 package here that's contained on this bubble wrap type thing. 3 And you had referred to you weren't sure that Dr. Serot even had 4 the opportunity to and that that was usually the hospital staff or 5 the sales rep, what have you. 6 A. Yes. 7 Q. I want to go back to that for just a second. And I 8 have -- I understand what you've said about the hospital staff and 9 whether he would have had the ability to look at it, what have 10 you. But strictly speaking, if Dr. Serot had indeed looked at these 11 labels on these bubble wraps, would he not have seen that he 12 had a 28-millimeter liner and a 23-millimeter head? 13 MR. HENDRICKSON: 32. 14 MR. KRUEGER: 32. 15 BY THE WITNESS: 16 A. Yes. 17 MR. HARVEY: Objection. Asked and answered. 18 BY MR. KRUEGER: 19 Q. Doctor, would you also agree -- I know you're not 20 a surgeon, but would you agree that in the operating room, the 21 surgeon has the authority to look at anything he wants to look at? 22 A. Yes. 23 Q. And would you also agree that the surgeon has 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 64 1 the authority to tell anyone in the operating room to confirm orally 2 the sizes of the implants? 3 A. Yes. 4 Q. Now, Doctor, moving to the specifics of the 5 labeling, based on my review of the report, it's my understanding 6 that you think there is something wrong with the labeling. Could 7 you tell me what you believe is wrong with the labeling? 8 A. Well, as I mention on page 4 of my report, in the 9 last paragraph, I say, "From a review of the above regulations," 10 which are the 21 C.F.R. regulations I cited, "It is clear that the 11 Biomet hip replacement was not supplied with adequate 12 directions for use and that the directions supplied did not contain 13 adequate warnings against unsafe methods of administration or 14 application in such manner or form as were necessary for the 15 protection of users such as Mr. Butler." 16 Then I specifically say that, "The Biomet 17 implants were labeled in such a way that there is no effective 18 warning or notice regarding the use of mismatched size 19 components. The 28-millimeter Taper liner..." -- which I'm 20 holding up as the inside of Exhibit -- 2? 21 MR. HENDRICKSON: Yeah. From 7/8/03. 22 BY THE WITNESS: 23 A. -- says "28-millimeter ID," or internal diameter, 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 65 1 "M2a Taper liner." And then it also says, "Size 41-millimeter OD 2 Taper," which is not -- which is not really the main issue that 3 they're trying to identify. They're trying to identify the 4 28-millimeter nature of the internal diameter. And then it says, 5 "Use 11-163660/66 M2a modular heads only." It doesn't 6 specifically say, "Use a 28-millimeter modular head only." 7 So, "This labeling is insufficient in that it 8 fails to identify the matching product by size rather than the more 9 confusing product number," which I just referred to. "Further, on 10 the sample provided by the defendant Biomet, this labeling 11 appears at a point on the outer package where the printed 12 information could be obliterated when the package is opened and 13 is difficult to read prior to opening because it appears on a fold 14 section where the label wraps over the side of the package." And 15 this is what I'm holding up in my left hand. And everyone can see 16 that. 17 "The label use directions provide 18 insufficient information and are not prominently placed to draw 19 attention to this critical information." Then I say, "Further, there 20 is no corresponding use directions on the modular head 21 component," which is Exhibit 3. "Presumably, printed information 22 on that component would make reference to only a single product 23 number rather than the confusing range utilized on the liner." 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 66 1 BY MR. KRUEGER: 2 Q. Tell me if I'm correct. As I understand your 3 criticisms, number one, you say that the labeling is insufficient as 4 it fails to identify the matching sizes? 5 A. Right. It fails -- the labeling fails to say on the 6 neck -- on the head that it should only be used with a 7 32-millimeter liner. And the liner is deficient in that it does not 8 specifically say, "should be used with a 32-millimeter head." 9 Q. And then the other aspect of your opinions is you 10 believe that the labeling is insufficient because the labeling 11 provided on the outside of the box is obliterated when the box is 12 opened? 13 A. Yes. 14 Q. Okay. And would that be basically what your 15 criticisms of the labeling are? 16 A. Yes. In number five of my conclusion, I say, 17 "Identification and description of matching components and types 18 were inadequate in that the information was not clearly set forth, 19 it did not contain information as to matching sizes, and the 20 information was not prominently displayed." Those are the three 21 components. "Further, the information that is displayed is placed 22 in a location which is difficult to read and will be obliterated upon 23 opening of the package," which are four and five. And then on 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 67 1 number six of my conclusion, I say, "Further, the package 2 contains no prominent warnings of any danger associated with 3 use of other than the properly sized components and does not 4 adequately identify the matching component sizes," which are 5 points six and seven. So there are actually seven separate 6 criticisms of the packaging. 7 Q. The packaging? 8 A. Packaging and label, I mean. 9 Q. Where are you getting the seven from? 10 A. May I write on Exhibit 5? 11 Q. Sure. Here, I'll give you a piece of paper. 12 MR. HENDRICKSON: No, he's going to put 13 numbers where -- kind of bullet points. 14 MR. KRUEGER: Okay. Okay. That's fine. 15 BY MR. KRUEGER: 16 Q. Doctor, with respect to the labeling, am I correct 17 that you don't believe Dr. Serot even looked at the labeling? 18 A. I don't know whether Dr. Serot looked at the 19 label or not. I don't think that he had -- in this particular case, in 20 this particular operation, I don't think he had the opportunity 21 because the packaging was opened by the rep before Dr. Serot 22 could see the labeling or -- before he could see the labeling. 23 Q. Okay. Generally with respect to orthopedic 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 68 1 surgeons, do you agree that they should know that they should 2 not put mismatched components in an implant? 3 A. Yes. 4 Q. And do you agree that they know that if they do 5 put mismatched components in, it can cause injury to the 6 patient? 7 A. Yes. 8 Q. With respect to the information that you're critical 9 of with respect to Biomet, the seven points that you've just 10 identified in your report, have you designed any alternative 11 labeling? 12 A. No. I have not been asked to do so. 13 Q. Have you at all tested any alternative labeling 14 with any orthopedic surgeons to see what their perceptions would 15 be and if their perceptions would be any different than the 16 labeling currently provided? 17 A. No, I have not. 18 Q. Have you conducted any such testing of 19 alternative labeling with respect to nurses -- operating room 20 nurses, circulating room nurses? 21 A. No. 22 Q. Have you conducted any such testing with 23 respect to orthopedic implant sales reps? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 69 1 A. No. 2 Q. So as I understand it, you have not done any 3 type of testing with any group of individuals with respect to 4 whether the things you criticize in those seven points, if those are 5 changed, whether or not anyone's actions with respect to the 6 labeling would change? 7 A. No, I have not been asked to do that type of 8 testing. 9 Q. Okay. Now, you mentioned that you're critical of 10 the labeling as it's placed -- or the package labeling as it's placed 11 in a position where when you open it, it's going to be obliterated 12 on the outside box? 13 A. Well, that is a criticism I raise, yes. 14 Q. Would you agree that even though that is 15 obliterated, when you get inside the box, you have another label 16 that has the sizes on them? 17 A. Yes. 18 Q. And this additional label which is on the bubble 19 wrap, when you open it, that label is not obliterated? 20 A. Correct. 21 Q. And additionally, as I understand your testimony, 22 there are two more labels that are going to be contained within 23 the box with the sizes on them? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 70 1 A. Yes. 2 Q. And these labels wouldn't be obliterated? 3 A. No. 4 Q. Would you agree that an orthopedic surgeon 5 performing 50 to 100 hip replacement surgeries a year should 6 know that the size of a head component must match the size of a 7 liner component? 8 MR. HARVEY: I'm going to object to asked and 9 answered. You have already asked Dr. Serot the same question. 10 MR. KRUEGER: You can answer. 11 BY THE WITNESS: 12 A. Well, as you know, I'm not an orthopedic 13 surgeon; so it's unfair for me to comment on what an orthopedic 14 surgeon should or should not know. But I would imagine that the 15 answer to your question would be yes. 16 BY MR. KRUEGER: 17 Q. Doctor, in your report you state that, "The 18 plaintiff's medical complications developed as a result of adverse 19 complications from the mismatched use of Biomet head and 20 liner." 21 A. Yes. 22 Q. What specific complications are you referring to? 23 A. The poor mechanical stability of the replacement 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 71 1 joint which eventually resulted in the fracture of the femur. 2 Q. Anything else? 3 A. No. 4 Q. Doctor, what, if any, surgical orthopedic 5 background do you have for that opinion? 6 A. My opinion is based on the mismatched 7 components that were identified during the second surgery and 8 the mechanical nature of the fracture which was along the line of 9 the implant and the mechanical instability of the components. 10 Q. Well, that wasn't necessarily my question. My 11 question is what orthopedic background do you have in your 12 training, in your experience that qualifies you to render an opinion 13 as to the mechanism for a fracture? 14 A. Well, although I'm not an orthopedic surgeon, I 15 am a physician, and I'm trained in anatomy and physiology and 16 structure of bones and the nature of fractures. And having seen 17 a number of fractures myself, I am opining that is the most likely 18 cause of the fracture. 19 Q. If an orthopedic surgeon were to render a 20 different opinion as to the mechanism of this fracture, would you 21 defer to that orthopedic surgeon? 22 A. I might, depending on the orthopedic surgeon's 23 relationship to the case and interest in the case and the device. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 72 1 It depends. But in general, of course. 2 Q. And would you agree that generally, questions of 3 mechanisms of fractures are resolved by orthopedic surgeons. 4 That's why one goes to an orthopedic surgeon for treatment of a 5 fracture? 6 A. Well, sure. I mean I would not treat a fracture of 7 the femur. But I made my opinion in this case based on the 8 foundations that I outlined to you a few minutes ago, which were 9 the nature of the materials used in the hip replacement, the 10 mismatch of the materials, and the inherent mechanical instability 11 of such a combination as can be seen by trying to place the parts 12 together that are on the table here and also the nature of the 13 location of the fracture that is immediately around the displaced 14 device. 15 Q. Do you know what type of fracture Mr. Butler 16 sustained? 17 A. He had a comminuted fracture of the right femur 18 with right total hip in place. 19 Q. And in orthopedic terms, do you know how that 20 fracture is classified? 21 A. No. 22 Q. Do you know the type of forces that would be 23 necessary to produce that fracture? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 73 1 A. Well, in general, that's a large bone, and it's a 2 very sturdy bone. So in general in a normal individual, it would 3 be a considerable force since that is not a normal site for 4 fracture. But on the other hand, the patient, Mr. Butler, had an 5 unstable hip because of the mismatch of the device liner and the 6 head. He also had the artificial head implanted into the neck of 7 the femur and into the proximal shaft of the femur so that it was 8 in some way stronger but in other ways mechanically unstable. 9 So the forces in this case are much less than what would be 10 required in a normal young individual. 11 Q. Doctor, you had mentioned you looked at 12 Mr. Butler's x-rays today? 13 A. Yes. 14 Q. Why did you look at those? 15 A. Because I had asked them to see them before 16 the deposition. And I asked Mr. Hendrickson to bring them with. 17 Q. And why did you want to see the x-rays? 18 A. I wanted to confirm the location of the fracture 19 and the appearance of the implant head in the hip. 20 Q. So did you look at x-rays of Mr. Butler's hip prior 21 to the femoral fracture? 22 A. Yes. 23 Q. And did you form any opinions as a result of 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 74 1 looking at those x-rays? 2 A. Well, I'm not a radiologist; and I'm not pretending 3 to be one or representing myself as being a radiologist. 4 However, I could see that the hip was in the area of the 5 acetabulum, and it didn't look that it was -- it didn't look as it was 6 as firmly in place as it did during the revision when a smaller 7 head was used with the same liner. 8 Q. Could you tell if the head was properly seated in 9 the liner? 10 A. Well, it was hard for me as a non-radiologist to 11 absolutely say that with 100 percent certainty, but it looked like it 12 didn't -- it was not properly seated. 13 Q. Doctor, I realize you're not an orthopedic 14 surgeon, but do you know what the term trial reduction means? 15 A. I don't recall that term. 16 Q. Okay. Now, Doctor, you state in your report that, 17 "The Biomet representative is not adequately familiar with the 18 Biomet product information and identification of differences 19 between similar products." 20 A. What page are you reading from? 21 Q. I'm not even sure. 22 MS. ZUCKETT: 5. 23 BY MR. KRUEGER: 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 75 1 Q. 5. Point number 7 on page 5. 2 MR. HENDRICKSON: We're about one hour 3 from close. 4 THE WITNESS: Thank you. 5 MR. KRUEGER: Does that include breaks? 6 MR. HENDRICKSON: Yeah, I'm including. 7 BY THE WITNESS: 8 A. I did say that, yes. 9 BY MR. KRUEGER: 10 Q. Okay. Doctor, what information are you aware of 11 that Biomet provides its distributors regarding its products? 12 A. Well, I have not at this point referenced or 13 researched the types of training materials supplied by Biomet 14 representatives with the product information. But it seems 15 evident that there it was a problem with the training in that 16 apparently the Biomet representative supplied a mismatched 17 head and liner. 18 Q. So you're taking the supply of a mismatched 19 head and component as evidence of training, correct? 20 A. It is evident that there -- that -- only that the 21 representative was inadequately familiar with the product 22 information and identification of differences between similar 23 products. To what extent this represented a problem on the part 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 76 1 of the rep that was not characteristic of all reps and to what 2 extent it represented a problem with training or identification or 3 labeling of materials by the company, I can't say at this point. 4 Q. That's because you don't know what training or 5 materials that rep received? 6 A. Exactly. 7 Q. Now, in your report, you state that Mr. Merrell 8 placed himself in the operating room as an authority figure. What 9 do you mean by that? 10 A. Well, the representative of the device is in the 11 operating room representing in some way the company and the 12 product. So he or she would be expected to be more familiar 13 with the product than almost anyone else in terms of its 14 identification -- at least in terms of its identification. 15 Q. And is that what you mean by the term 16 "authority" there? 17 A. Yes, because he was authoritarian in that he was 18 the person perceived as directly representing the device and the 19 manufacturer. 20 Q. And did Mr. Merrell have the ability to control the 21 actions of anyone else there in the operating room? 22 A. Apparently he did because he in some manner 23 supplied mismatched devices. And that controlled the 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 77 1 implantation of the mismatched devices. So he did control 2 indirectly the actions of a lot of people and the surgical 3 consequences of the patient. 4 Q. I guess I'm not following you when you say his 5 alleged supply of mismatched components controlled others's 6 actions. Could you be more specific in that regard? 7 A. Sure. He supplied the mismatched heads. How 8 this exactly occurred, I don't think any of us know at this point. 9 But through his actions, a set of mismatched components was 10 introduced into the operating field. As a result of that, 11 mismatched components were surgically implanted into the 12 patient. So his action controlled the outcome, which was the 13 implantation of the mismatched components. 14 Q. Did he have the ability to tell anyone specifically 15 what to do or not to do in that operating room? 16 A. Well, he didn't have the authority to tell anyone 17 what to do or not to do. But on the other hand, as an 18 authoritative figure, he represented the company. He had the 19 aura or the impersonation of having the authority and knowledge 20 of the company and supplier that he was representing. 21 Q. You agree that he did not have the authority to 22 tell Dr. Serot to accept the components without confirming their 23 size? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 78 1 A. He did not have such authority. 2 Q. He did not have the authority to tell the Memorial 3 nurses to attach the labels to the medical record without checking 4 the sizes? 5 MR. HENDRICKSON: Objection. That's 6 assuming facts that are not in evidence. Go ahead and answer. 7 BY THE WITNESS: 8 A. I don't think he had the authority to do that, no. 9 BY MR. KRUEGER: 10 Q. Doctor, you stated that Mr. Merrell placed 11 himself in the OR as a Biomet company rep. How did he do 12 that? 13 A. Well, the hip prostheses were products that he 14 was representing. So he is the representative for the product 15 that he is representing. 16 Q. Are you aware that Mr. Merrell was in the 17 operating room, if he was in the operating room, at the specific 18 request of Dr. Serot? 19 A. I don't recall whose specific request he was there 20 in and to what nature there was a specific request and what the 21 specific request consisted of. 22 Q. Now, as I think I established before, you don't 23 have any legal training, correct? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 79 1 A. No. 2 Q. I gather you're not qualified to render an opinion 3 relative to what we call the agency issues in this case? 4 A. I don't know what you're talking about. 5 MR. HENDRICKSON: That answers your 6 question. 7 MR. KRUEGER: That answers the question. 8 BY MR. KRUEGER: 9 Q. Now, in your report you state that Biomet product 10 literature and part identification were not in compliance with 11 various FDA regulations. And you cite to some regulations there 12 in your report. Those are the regulations you're referring to? 13 A. Yes. 14 Q. Do you know whether the FDA reviewed and 15 approved Biomet's product literature and part identification? 16 A. Yes. 17 Q. Do you have any information that the FDA did 18 not approve the labeling and product information as it was at the 19 time of Mr. Butler's initial surgery? 20 A. No. 21 Q. Are you aware of any FDA warning labels to 22 Biomet or warning letters to Biomet concerning the labeling or 23 product information? 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 80 1 A. No. 2 Q. Have you looked at Biomet's 510(k) relative to 3 these products? 4 A. Not yet. 5 Q. Is that something you intend to do? 6 A. If the case progresses to trial, then I intend to 7 request access to that file. 8 Q. For what purpose would you want access to that 9 file? 10 A. To review the regulatory history of the device to 11 learn if there were any problems with the device and if there were 12 any discussions, prolonged discussions about the labeling or 13 whether there were other problems like this that may have 14 occurred in other cases either with this device or with another 15 Biomet device. 16 MR. KRUEGER: Todd, if he does look at the 17 510(k), I'm probably going to want another deposition. 18 MR. HENDRICKSON: Okay. 19 MR. KRUEGER: Just if he looks at it, let us 20 know. 21 BY MR. KRUEGER: 22 Q. Have you made any comparisons between the 23 Biomet product literature, warnings, and product identification 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 81 1 information and the information supplied by any other orthopedic 2 implant manufacturers? 3 A. No. 4 Q. Would you agree that that type of material would 5 generally be available out there for review? 6 A. Yes, it will be. 7 Q. Have you looked at the package inserts for these 8 implants? 9 A. I don't think so. I have looked at the labeling but 10 not the package insert. 11 Q. Would you agree that the surgeon is generally 12 under the obligation to familiarize himself or herself with the 13 material contained within the package inserts? 14 A. Yes. 15 Q. And would you agree that the surgeon should go 16 ahead and heed any warnings or other complication information 17 that may be contained within the package insert? 18 A. Yes. 19 Q. You don't have any information as to what 20 specific information is contained within the product or the 21 package insert for this particular material? 22 A. Not yet. Not -- if the case progresses, I intend to 23 be familiar with that. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 82 1 Q. And why would you want to be familiar with that? 2 A. To see if there's any additional labeling or 3 information about labeling or use or cautions or warnings or 4 directions concerning mismatching of products. 5 MR. KRUEGER: Todd, that's going to be the 6 same as with the 510(k). If he looks at it, let me know. 7 BY MR. KRUEGER: 8 Q. Am I correct that you do not have any opinions 9 relative to Mr. Butler's future medical condition? 10 A. Not at this point, I do not. 11 Q. When you add that "at this point" on there, do 12 you intend to do more work later on that may cause you to 13 develop opinions concerning Mr. Butler's future medical 14 condition? 15 MR. HENDRICKSON: I don't think we've 16 identified him for that purpose. 17 MR. KRUEGER: Okay. 18 BY MR. KRUEGER: 19 Q. Likewise, would you have no opinion relative to 20 the feasibility of a future hip implant replacement for Mr. Butler? 21 MR. HENDRICKSON: Again, we haven't 22 identified him for that purpose. 23 BY MR. KRUEGER: 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 83 1 Q. Aside from the labeling issues that we have 2 talked about here, am I correct that you have no criticisms 3 concerning the design or the manufacture of these particular 4 implants? 5 A. That's correct. 6 Q. And am I correct that you also do not have any 7 opinions concerning the inventory practices or reordering 8 procedures for Biomet or its distributors? 9 A. That's correct. 10 Q. Have we discussed all of your opinions relative 11 to Biomet's labeling and product warnings? 12 A. Well, yes, if you include all of my opinions as 13 stated on my report, 1 through 10, yes. 14 MR. KRUEGER: I may have some other 15 questions. I'm going to need to make a phone call at some point 16 and then come back. But why don't we go on to Mr. Harvey or 17 Tracy. 18 MS. ZUCKETT: Why don't you go ahead. 19 MR. HARVEY: Okay. Doctor, I introduced 20 myself earlier. My name is Ted Harvey. I represent Dr. Serot, 21 the orthopedic surgeon in this case. I only have a few questions 22 for you. 23 EXAMINATION BY MR. HARVEY: 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 84 1 Q. Would it be your opinion based upon a 2 reasonable degree of medical certainty that implant surgery is a 3 team effort? 4 A. Yes. 5 Q. And that all the members of the team have to do 6 their assigned duties in order to accomplish a reasonable result; 7 is that right? 8 THE WITNESS: Excuse me. 9 (A discussion was had off the 10 record.) 11 BY THE WITNESS: 12 A. Okay. Would you repeat your last question for 13 me, sir. 14 (Whereupon, the record was 15 read back as follows: 16 "QUESTION: Would it be your opinion 17 based upon a reasonable degree of medical certainty 18 that implant surgery is a team effort? 19 "ANSWER: Yes. 20 "QUESTION: And that all the members of 21 the team have to do their assigned duties in order to 22 accomplish a reasonable result; is that right?") 23 BY THE WITNESS: 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 85 1 A. Yes. 2 BY MR. HARVEY: 3 Q. Doctor, do you have an opinion based upon a 4 reasonable degree of medical certainty as to whether it is 5 reasonable for the doctor to rely on the Biomet representative to 6 bring the proper-sized components into the operating field? 7 MS. ZUCKETT: Objection, foundation. 8 MR. KRUEGER: Same. 9 BY THE WITNESS: 10 A. Well, my experience from being involved in 11 surgeries and my training in medical school, which also included 12 surgical procedures to some extent, is that when a device is 13 brought into the operating field, the request is made that the 14 device be brought into the operating field but that the participants 15 in the surgical team have to verify that the correct device is 16 brought in. 17 BY MR. HARVEY: 18 Q. Doctor, I don't think you answered my question. 19 I'll ask it again. Do you have an opinion based upon a 20 reasonable degree of medical certainty whether it is reasonable 21 for the doctor to rely on the Biomet representative to bring the 22 proper-sized components into the operating field? 23 MS. ZUCKETT: Same objection to foundation. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 86 1 MR. KRUEGER: Same objection; foundation 2 plus asked and answered. 3 MS. ZUCKETT: Join. 4 BY THE WITNESS: 5 A. I don't see how the response I gave you was 6 inadequate. I mean as I stated, the assumption is that the 7 device -- that a device ordered, whether it's an orthopedic device 8 or a valve for a heart, is the correct device that's ordered. But I 9 don't think any device is used unless there's some verification 10 that the correct device is brought in. So I think that it would not 11 be prudent to rely solely upon the Biomet representative to make 12 a determination of what is the correct device to be brought into 13 the operating room. 14 BY MR. HARVEY: 15 Q. Would you agree that the Biomet representative 16 had the obligation in this case to bring the proper-sized 17 components into the operating field? 18 A. Well, I think that the Biomet rep, from my 19 understanding of all the different actions that transpired in this 20 case, would be expected to bring in a device, but I don't think 21 anyone who is present at the surgery recognized the Biomet rep 22 as having any training that was specific to surgical procedures. 23 And so even though he brought in a device, no one would be -- to 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 87 1 my experience accept solely the Biomet rep's selection of a 2 device as the ultimate identification of the correct device. 3 Q. Do you know what his function was in the OR 4 that day? 5 A. I really -- I'm at a loss other than that he was 6 there to observe the placement of the device and possibly to give 7 some technical information if some information were asked. But 8 he was not there as a participating member of the surgical team. 9 Q. Do you know if he is there solely to bring the 10 proper-sized components into the operating field? 11 A. Well, I think that goes back to my previous 12 question which is that if his only function was to come in as a 13 deliverer of specific devices, that still would not exclude other 14 members of the operating team of confirming the device he 15 brought in was the correct one. 16 Q. Do you know where the devices are kept at 17 Memorial Hospital from which the representative would take them 18 into the operating field? 19 A. No. Devices for operating procedures are 20 usually stored in the OR storage area. And I don't know for a fact 21 that that's what occurred at this hospital. 22 Q. You haven't read any of the nurses's depositions, 23 so you don't know how the components were delivered to the 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 88 1 nurses before they were delivered to Dr. Serot; is that right? 2 A. No, I don't. I have not read the nurses's depos 3 yet. 4 MR. HARVEY: That's all the questions I have, 5 Doctor. Thanks. 6 EXAMINATION BY MS. ZUCKETT: 7 Q. Doctor, I just want to ask you. You have never 8 been a sales representative for a medical device company; is 9 that correct? 10 A. That's correct. 11 MS. ZUCKETT: That's the only question I have. 12 MR. KRUEGER: Before we adjourn, I need to 13 call Perky real quick. 14 (Recess taken.) 15 FURTHER EXAMINATION BY MR. KRUEGER: 16 Q. Doctor, earlier I had asked you some questions 17 about what Dr. Serot would have observed on the labeling. And 18 you had commented that you weren't sure that Dr. Serot would 19 have had the opportunity to observe anything on the labeling, 20 given everything that was going on in the operating room. 21 Would you not agree that the surgeon does 22 have the authority as the, quote, captain of the ship of the 23 surgery to suspend the surgery completely or halt it for a given 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 89 1 amount of time until he's able to actually confirm that he has the 2 right size components? 3 MR. HARVEY: I'm going to object to the phrase 4 captain of the ship because I think that misstates what the law is. 5 MR. KRUEGER: Subject to that. 6 BY THE WITNESS: 7 A. Well, I think that part of what you said is true and 8 part of what you said is a misconception or a misconstruing of the 9 circumstances in that, for example, if a surgeon asks for a 10 particular type of suture -- which is a medical device -- the suture 11 is taken from the stock, the package is opened and the suture is 12 dropped down onto the operative field in some manner; and then 13 that material is attached to a clamp or passed to the surgeon or 14 whoever is using it. There's no verification of the outside of the 15 packaging done at that point other than by the staff who opens 16 the package. So there are many things that are brought into the 17 operative field that the surgeon, even though the surgeon is the 18 captain of the ship, does not directly verify. So the actual 19 identification of the material that's brought in at the request of the 20 surgeon, whether it be a hip implant or a suture, the verification 21 of that material is left to the ancillary persons in the operating 22 room who depend on the accuracy and the legibility and clarity of 23 the labeling that the material is provided with. 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 90 1 BY MR. KRUEGER: 2 Q. Well, Doctor, I understand what your answer is. 3 But if the surgeon wanted to verify for himself that he had the 4 proper size components, doesn't he have the authority to go 5 ahead and stop that surgery until he's satisfied that he does have 6 the proper size components? 7 A. Yes. 8 MR. KRUEGER: That's all the questions I have. 9 MR. HENDRICKSON: All right. 10 MR. HARVEY: I have no more questions, 11 Doctor. 12 MR. HENDRICKSON: We will read and sign. 13 MR. KRUEGER: I would like copies of all the 14 exhibits attached. 15 (The deposition was concluded.) 16 17 18 19 20 21 22 23 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 91 1 C E R T I F I C A T E 2 3 STATE OF ALABAMA ) 4 JEFFERSON COUNTY ) 5 6 I, Sabrina Lewis, Court Reporter, Notary Public, State 7 at Large, do hereby certify that I recorded by means of stenotype 8 the foregoing proceedings at the time and place stated in the 9 caption hereof; that later, under my supervision, the proceedings 10 were transcribed by means of computer-aided transcription, and 11 the foregoing represents a full, true, and correct transcript of the 12 proceedings on said occasion. 13 I further certify that I am neither of counsel nor of kin 14 to any parties of said cause, nor am I in any manner interested in 15 the result thereof. 16 17 _____________________________ 18 Sabrina Lewis, Commissioner 19 20 21 22 23 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 92 ERRATA SHEET PLEASE LIST ANY CORRECTIONS BELOW PLEASE DO NOT WRITE ON THE TRANSCRIPT PAGE NO. LINE NO. CORRECTION 1.______________________________________________________________ 2.______________________________________________________________ 3.______________________________________________________________ 4.______________________________________________________________ 5.______________________________________________________________ 6.______________________________________________________________ 7.______________________________________________________________ 8.______________________________________________________________ 9.______________________________________________________________ 10._____________________________________________________________ 11._____________________________________________________________ 12._____________________________________________________________ 13._____________________________________________________________ 14._____________________________________________________________ 15._____________________________________________________________ 16._____________________________________________________________ 17._____________________________________________________________ 18._____________________________________________________________ 19._____________________________________________________________ 20._____________________________________________________________ 21._____________________________________________________________ 22._____________________________________________________________ 23._____________________________________________________________ 24._____________________________________________________________ 25._____________________________________________________________ 301 Title Building / 300 21st Street North Birmingham, Alabama 35203 93 DEPONENT'S CERTIFICATE I, DONALD H. MARKS, M.D., PhD., the witness herein, have read the transcript of my testimony and the same is true and correct, to the best of my knowledge. Any corrections and/or additions, if any, are listed separately. ______________________________________ DONALD H. MARKS, M.D., PhD. Dated: 301 Title Building / 300 21st Street North Birmingham, Alabama 35203