Kransky v DePuy Orthopaedics

Transcription

1 Kransky v DePuy Orthopaedics 1

2 2

3 Ex

4 September 9, 2011 Kaplan Meier Clinical Study Ex

5 DePuy ASR Design Team Surgeons (Royalty Based) Thomas Schmalzreid, M.D. Joint Replacement Institute Los Angeles, CA Thomas Parker Vail, M.D. UCSF Medical Center San Francisco CA 5

6 Total Hip Replacement 6

7 Pinnacle Modular ASR Monoblock 7

8 The ASR XL Monoblock System Unlike any other hip implant Unique design features Never tested in people 8

9 ASR XL New and Unique Design Features Metal Head - Metal Cup (CoCr M-O-M ) 1 piece cup not modular - no liner, no screw holes Internal groove reduces amount of bearing surface Sub hemispheric cup exterior less than 180 degrees 9

10 Artificial Hip Must Be Designed To Ensure It Lasts As Long As Possible 10

11 ASR Introducer 11

12 All Hip Implants National Joint Registry of England and Wales 2012 Annual Report 5 Years After Implant Failed 2.61% Not Failed 97.39% 12

13 All Hip Implants National Joint Registry of England and Wales 2012 Annual Report ASR Hip Implant National Joint Registry of England and Wales 2012 Annual Report 5 Years After Implant 5 Years After Implant Failed 2.61% Not Failed 97.39% Not Failed 78.7% Failed 21.93% 13

14 All Hip Implants National Joint Registry of England and Wales 2012 Annual Report ASR Hip Implant DePuy s Internal Data 5 Years After Implant 4.57 Years After Implant Failed 2.61% Not Failed 97.39% Not Failed 63% Failed 37% 14

15 All Hip Implants National Joint Registry of England and Wales 2012 Annual Report ASR Hip Implant National Joint Registry of Australia 2012 Annual Report 5 Years After Implant 7 Years After Implant Not Failed 97.39% Failed 2.61% Not Failed 56% Failed 44% 15

16 Job Qualifications Magnus Flett Deposition of Magnus Flett- Page:Line 479:3 480:19 16

17 The Importance of Clinical Testing Graham Isaac Deposition of Graham Isaac - Page:Line 550:11-551:3 17

18 January 25, 2005 February 10, 2005 Ex

19 June 10, 2005 Ex

20 October 11, 2005 Ex

21 United States Launch 2006 Ex

22 United States Launch 2006 Reducing the wear rate of a hip bearing can improve long term function. By maintaining optimal clearance between a large diameter head and the cup, the ASR XL bearings produce a fluid film interface that results in a lower wear rate than previously achieved in metal on metal articulation Ex

23 United States Launch 2006 Bearing surfaces are fully separated and the load fully supported by the lubricating fluid. Ex

24 June 28, 2006 Ex

25 May 14, 2007 Ex

26 June 6, 2007 Ex

27 June 26, 2007 Ex

28 September 27, 2007 Page 1 Ex

29 September 27, 2007 Page 2 Ex

30 September 27, 2007 Page 17 Ex

31 October 8, 2007 Ex

32 January 5, 2007 Page 7 of 12 Ex

33 2008 Page 1 Page 16 Page 16 Metallosis Ex

34 April 30, 2008 Ex

35 May 2, 2008 Ex

36 May 8, 2008 Ex

37 June 24, 2008 Ex

38 July 2, 2008 Ex

39 August 15, 2008 Ex

40 August 23, 2008 ASP = Average Sales Price Page 3 Ex

41 November 7, 2008 Ex

42 December, 2008 Ex

43 December 18, 2008 Ex

44 December 19, 2008 Ex

45 March 16, 2009 Ex

46 March 16, 2009 Ex

47 September 17, 2009 Ex

48 September 17, 2009 Ex

49 May 4, 2010 Ex

50 August 24, 2010 Ex

51 Loren Bill Kransky Date of birth: 10/27/47 66 years old Husband and father of two daughters Served our country in the Vietnam War and in the U.S. Air Force Retired in

52 52

53 Mr. Kransky s ASR XL History ASR XL implanted 12/5/07 RECALL 8/24/10 ASR XL removed and rehabilitation 2/20/12 4/ months: over 4 years 53

54 Defendant Responses to Special Interrogatories Mr. Kransky s Doctors Did Nothing Wrong

55 Other Health Issues While Mr. Kransky Had the ASR XL January 2009 May 2009 August 2010 October 2010 April 2011 July 2011 August 2011 Right nephrectomy Completed four cycles of chemotherapy Radiation treatment at Mayo Clinic Received additional chemotherapy treatment Repair abdominal aortic aneurysm Left renal artery stenting Right hemispheric stroke

56 Defendant Responses to Special Interrogatories Mr. Kransky Did Not Cause His Injuries

57 Defendant Responses to Special Interrogatories Defendants Agree Mr. Kransky Was a Proper Patient for the ASR XL

58 Post ASR XL Hip Implant Complaints Dec. 5, 2007 May 2, 2008 Oct. 26, 2009 Nov. 27, 2009 Jan. 27, 2011 Early May, 2011 June 15, 2011 Oct. 19, 2011 Jan. 23, 2012 Dr. Wendt performs hip replacement surgery on Mr. Kransky implants ASR XL Mr. Kransky sees primary care physician, Thomas Trotsky, M.D. - left hip pain Mr. Kransky sees Dr. Trotsky - left hip pain mostly at night and sometimes when walking Mr. Kransky sees Dr. Trotsky - legs giving way when walking Mr. Kransky sees Dr. Trotsky - left hip is popping and grinding Mr. Kransky sees Dr. Trotsky - falling - has pain in left hip Mr. Kransky referred to Dr. Daniel Brooke - orthopaedic surgeon Mr. Kransky sees Jeffrey Hansen, M.D. - orthopaedic surgeon Mr. Kransky returns to Dr. Hansen pre op evaluation Feb. 20, 2012 Mr. Kransky undergoes revision surgery - hospitalized until March 13,

59 Thomas Trotsky, M.D. Unless ASR XL Hip Was Removed, Bill Was Dying QuickTime and a Photo - JPEG decompressor are needed to see this picture. Deposition of Dr. Trotsky Page:Line 166:1-14 Thomas Trotsky, M.D. - Bill Kransky s Primary Internal Medicine Doctor 59

60 Mr. Kransky s Pre operative Cobalt And Chromium Levels Date Chromium Cobalt 9/01/ ug/l (serum) 53.6 ug/l (serum or plasma) 27.5 ug/l (serum) 9/19/ ug/l (serum) 109 ug/l (serum) 10/19/11 No Chromium Draw 47 mgc/l (serum or plasma) Recall notice suggests over 7 ppb is concerning and should be monitored closely Current recommendation is to monitor patients with levels over 2 ppb 60

61 Mr. Kransky Revision Surgery Feb 20, 2012 Ex

62 Metallosis Mr. Kransky Revision Surgery Feb. 20, 2012 DePuy Brochure Page 16 Ex Ex

63 Revision Not Due To Infection Pre-op surgical evaluation did not indicate infection Prior to surgery, Dr. Hansen did not believe there was infection Intra-operative culture Negative Post operatively Dr. Hansen did not believe condition caused by infection Only positive culture was from hematoma that developed post operatively

64 Surgeon Dr. Hansen Deposition of Dr. Hansen Page:Line 331:23-332:17 64

65 Defendant Responses to Special Interrogatories Mr. Kransky s Doctors Treated Him Appropriately

66 Dr. Dennis Bobyn Masters and Ph.D in Biomaterials and Biomechanics Director, Orthopaedic Retrieval and Research Laboratory, Montreal General Hospital Has examined explanted hip implants for more than 30 years Authored / Co-Authored Peer-Reviewed Scientific Articles on Metal-on-Metal Hips Elite Member of Editorial Board, Journal of Arthroplasty 66

67 Dr. Bobyn s Opinions The ASR hip implant has design defects that cause it to fail at a much greater rate than other hip implants Any perceived benefits of the ASR were greatly outweighed by the risks of the implant Mr. Kransky s ASR XL hip implant was defective, causing it to fail, shedding significant amounts of cobalt and chromium into Mr. Kransky s body 67

68 Kransky Rim Max/Min

69 All Hip Implants National Joint Registry of England and Wales 2012 Annual Report ASR Hip Implant Dr. Peter Wendt s Experience 5 Years After Implant Failed 2.61% Not Failed 97.39% Not Failed 81.6% Failed 18.4% 69

70 All Hip Implants National Joint Registry of England and Wales 2012 Annual Report ASR Hip Implant Dr. Craig Swensen s Experience 5 Years After Implant Failed 2.61% Not Failed 97.39% Not Failed 65% Failed 35% 70

71 Mr. Kransky s ASR XL History ASR XL implanted 12/5/07 RECALL 8/24/10 ASR XL removed and rehabilitation 2/20/12 4/ months: over 4 years 71

72 72