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The Dark Side of the Tissue Industry: A Look into Cryolife's Operations and Safety Concerns

This article explores the troubling practices of Cryolife in the tissue industry, revealing grave safety concerns surrounding cadaver tissue harvesting and distribution. With over 500 million in profits reported in 2002, Cryolife has faced allegations of reckless conduct, including failed safety protocols and misrepresentation of facts. The tragic case of Brian, who died due to contaminated tissue, highlights urgent need for industry reforms. This exposé calls for regulation and accountability in order to protect patients and prevent future tragedies within the sector.

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The Dark Side of the Tissue Industry: A Look into Cryolife's Operations and Safety Concerns

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

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

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

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

  5. 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.

  6. 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. .

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

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

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

  10. 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 .

  11. 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 .

  12. 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.

  13. 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. .

  14. 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. .

  15. 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

  16. Cryolife does not

  17. AATB accredited tissue banks do

  18. 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

  19. CryoLife Says It Can’t Be Done

  20. Other Companies Do

  21. 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 .

  22. Rao Senate Testimony

  23. CryoLife Help Wanted

  24. 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

  25. Proposed Regulations for Good Tissue Practices

  26. 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 .

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