The Tissue Industry

2. The Tissue Industry • 750,000 Operations 2002 • 2 million 2005 (est) .

3. Profits • 500 million 2002 Industry • 100 million 2002 Cryolife

5. Profits • 500 million 2002 Industry • 100 million 2002 Cryolife • 1 billion estimated 2 years Industry

7. Profits • 500 million 2002 Industry • 100 million 2002 Cryolife • 1 billion estimated 2 years • 300% ↑ in last 6 years Cryolife

9. Profits • 500 million 2002 Industry • 100 million 2002 Cryolife • 1 billion estimated 2 years • 300% ↑ in last 6 years Cryolife • Forbes Magazine “200 Best Small Companies” • $30 million cash on hand • CEO’s compensation ↑ 335% in 6 years.

11. Profits • 500 million 2002 Industry • 100 million 2002 Cryolife • 1 billion estimated 2 years • 300% ↑ in last 6 years Cryolife • Forbes Magazine “200 Best Small Companies” • $30 million cash on hand • CEO’s compensation ↑ 335% in 6 years. .

12. Price of Profit • Dangerous safety practices • No state, federal regulation • Cryolife not even a member of AATB .

13. Brian’s Tragedy • 12/22/77 – 11/11/01

18. Brian’s Tragedy • 12/22/77 – 11/11/01 • Elective Knee Surgery 11/7/01

22. Brian’s Tragedy • 12/22/77 – 11/11/01 • Elective Knee Surgery 11/7/01 • Death three days later • Death 11/11/01 • CDC determined rotten cadaver tissue .

24. Reckless Conduct • FAILED TO REJECT HIGH RISK CADAVERS • Diseased Cadavers i.e. cancer, meningitis • Over 70 years old • Cadavers un-refrigerated over 10 hours • FAILED TO TEST TISSUE WHEN CADAVER IS RECEIVED • FAILED TO STERILIZE TISSUE BEFORE DISTRIBUTION • FAILED TO DISCARD CADAVER IF ANY CONTAMINATION FOUND • FAILED TO REPORT CONTAMINATION TO: • Federal Agencies • End User Doctor • FAILED TO HAVE CERTIFICATION OF CADAVER HARVESTING PERSONNEL • Uniform Basic Qualifications • Uniform Training • FAILED TO HAVE MANDATORY ANNUAL PROCEDURE/INVENTORY AUDIT .

25. The Smoking Guns • Written proof of 19 hour delay in processing cadaver • Cryolife Refuses To Accept Recommendations and Institute Reform • CDC Proves Cryolife Is Responsible For Brian's Death and Recommends Changes • 2002: FDA to Cryolife: "You Must Change" * • Cryolife's Reponse to the FDA warning letter: "Never Received a Warning Letter Before" • Proof that Cryolife Misrepresents the Facts * • Massive Cryolife Recalls: 96 Recalls in 152 Weeks • Cryolife Products 100 Times more dangerous than products like Baycol, Propulsid, Rezulin, Duract, Lotronex, Posicor, Raxar and Rotashield, all pulled from the market by the FDA.

27. The Smoking Guns • Written proof of 19 hour delay in processing cadaver • Cryolife Refuses To Accept Recommendations and Institute Reform • CDC Proves Cryolife Is Responsible For Brian's Death and Recommends Changes • 2002: FDA to Cryolife: "You Must Change" * • Cryolife's Reponse to the FDA warning letter: "Never Received a Warning Letter Before" • Proof that Cryolife Misrepresents the Facts * • Massive Cryolife Recalls: 96 Recalls in 152 Weeks • Cryolife Products 100 Times more dangerous than products like Baycol, Propulsid, Rezulin, Duract, Lotronex, Posicor, Raxar and Rotashield, all pulled from the market by the FDA. • Cryolife stated infection rate is a lie and Brian's case proves it in 3 steps. .

28. Cryolife stated infection rate is a lie and Brian's case proves it in 3 steps. • Cryolife admits 10 tissues were distributed from the cadaver which supplied Brian's tissue. 2 were contaminated, Brian dies, a 17 year old Illinois teen is permanently injured. • CDC seizes 19 tissues from the same cadaver and finds contamination in 2 tissues. • 4 of 29 tissues are contaminated, 13.7% not the 0.002% claimed by Cryolife. .

29. Needed Reforms 1. REJECT HIGH RISK CADAVERS • Diseased Cadavers i.e. cancer, meningitis • Over 70 years old • Cadavers un-refrigerated over 10 hours 2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED • Cryolife does not • AATB acredited tissue banks do

30. Cryolife does not

31. AATB accredited tissue banks do

32. Needed Reforms 1. REJECT HIGH RISK CADAVERS • Diseased Cadavers i.e. cancer, meningitis • Over 70 years old • Cadavers un-refrigerated over 10 hours 2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED • Cryolife does not • AATB acredited tissue banks do 3. STERILIZE TISSUE BEFORE DISTRIBUTION • Cryolife says it can't be done • Other companies do

33. CryoLife Says It Can’t Be Done

34. Other Companies Do

35. Needed Reforms 1. REJECT HIGH RISK CADAVERS • Diseased Cadavers i.e. cancer, meningitis • Over 70 years old • Cadavers un-refrigerated over 10 hours 2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED • Cryolife does not • AATB acredited tissue banks do 3. STERILIZE TISSUE BEFORE DISTRIBUTION • Cryolife says it can't be done • Other companies do 4. DISCARD CADAVER IF ANY CONTAMINATION FOUND 5. MANDATORY REPORTING OF CONTAMINATION TO: • Federal Agencies • End User Doctor 6. CERTIFICATION OF CADAVER HARVESTING PERSONNEL • Uniform Basic Qualifications • Uniform Training .

36. Rao Senate Testimony

37. CryoLife Help Wanted

38. Needed Reforms 1. REJECT HIGH RISK CADAVERS • Diseased Cadavers i.e. cancer, meningitis • Over 70 years old • Cadavers un-refrigerated over 10 hours 2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED • Cryolife does not • AATB acredited tissue banks do 3. STERILIZE TISSUE BEFORE DISTRIBUTION • Cryolife says it can't be done • Other companies do 4. DISCARD CADAVER IF ANY CONTAMINATION FOUND 5. MANDATORY REPORTING OF CONTAMINATION TO: • Federal Agencies • End User Doctor 6. CERTIFICATION OF CADAVER HARVESTING PERSONNEL • Uniform Basic Qualifications • Uniform Training . 7. MANDATORY ANNUAL PROCEDURE/INVENTORY AUDIT

39. Proposed Regulations for Good Tissue Practices

40. Other Cases • Montgomery v. Cryolife, Inc., United States District Court, Eastern District Tennessee, Case # 3:2002cv00029  • Dayton v. Cryolife, Inc., United States District Court, Eastern District Tennessee, Case # 3:2002cv00305  • Karnes v. Cryolife, Inc., United States District Court, Eastern District Tennessee, Case # 3:2002cv00330.  • Minvielle v. Cryolife, Inc., Superior Court, Santa Cruz County, California, Case # CV143210  • James v. Cryolife, Inc., Superior Court, San Francisco County, California, Case # CGC-99-301160 .