The Tissue Industry

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The Tissue Industry

• 750,000 Operations 2002
• 2 million 2005 (est)

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Profits

• 500 million 2002 Industry
• 100 million 2002 Cryolife

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Profits

• 500 million 2002 Industry
• 100 million 2002 Cryolife

• 1 billion estimated 2 years Industry

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Profits

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

• 300 ? in last 6 years Cryolife

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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
• CEOs compensation ? 335 in 6 years.

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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
• CEOs compensation ? 335 in 6 years.

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Price of Profit

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

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Brians Tragedy

• 12/22/77 11/11/01

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Brians Tragedy

• 12/22/77 11/11/01

• Elective Knee Surgery 11/7/01

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Brians 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

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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

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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.

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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.

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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.

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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

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Cryolife does not
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AATB accredited tissue banks do
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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

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CryoLife Says It Cant Be Done
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Other Companies Do
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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

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Rao Senate Testimony
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CryoLife Help Wanted
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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

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7. MANDATORY ANNUAL PROCEDURE/INVENTORY AUDIT
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Proposed Regulations for Good Tissue Practices
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Other Cases

• Montgomery v. Cryolife, Inc., United States
  District Court, Eastern District Tennessee, Case
  32002cv00029 
• Dayton v. Cryolife, Inc., United States District
  Court, Eastern District Tennessee, Case
  32002cv00305 
• Karnes v. Cryolife, Inc., United States District
  Court, Eastern District Tennessee, Case
  32002cv00330. 
• 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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