The Tissue Industry

• 750,000 Operations 2002

• 2 million 2005 (est)

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Profits

• 500 million 2002 Industry

• 100 million 2002 Cryolife

Profits

• 500 million 2002 Industry

• 100 million 2002 Cryolife

• 1 billion estimated 2 years Industry

Profits

• 500 million 2002 Industry

• 100 million 2002 Cryolife

• 1 billion estimated 2 years• 300% ↑ in last 6 years Cryolife

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.

Profits

• 500 million 2002 Industry

• 100 million 2002 Cryolife

• 1 billion estimated 2 years

• 300% ↑ in last 6 years Cryolife

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• Forbes Magazine “200 Best Small Companies”

• $30 million cash on hand

• CEO’s compensation ↑ 335% in 6 years.

Price of Profit

• Dangerous safety practices

• No state, federal regulation

• Cryolife not even a member of AATB

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Brian’s Tragedy

• 12/22/77 – 11/11/01

Brian’s Tragedy

• 12/22/77 – 11/11/01• Elective Knee Surgery 11/7/01

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

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Reckless Conduct

1. FAILED TO REJECT HIGH RISK CADAVERS a) Diseased Cadavers i.e. cancer, meningitis b) Over 70 years old c) Cadavers un-refrigerated over 10 hours

2. FAILED TO TEST TISSUE WHEN CADAVER IS RECEIVED 3. FAILED TO STERILIZE TISSUE BEFORE DISTRIBUTION 4. FAILED TO DISCARD CADAVER IF ANY CONTAMINATION FOUND 5. FAILED TO REPORT CONTAMINATION TO:

a) Federal Agencies b) End User Doctor

6. FAILED TO HAVE CERTIFICATION OF CADAVER HARVESTING PERSONNEL

a) Uniform Basic Qualifications b) Uniform Training

7. 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.

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 Reforms1. REJECT HIGH RISK CADAVERS

a) Diseased Cadavers i.e. cancer, meningitis b) Over 70 years old c) Cadavers un-refrigerated over 10 hours

2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED a) Cryolife does not b) AATB acredited tissue banks do

Cryolife does not

AATB accredited tissue banks do

Needed Reforms1. REJECT HIGH RISK CADAVERS

a) Diseased Cadavers i.e. cancer, meningitis b) Over 70 years old c) Cadavers un-refrigerated over 10 hours

2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED a) Cryolife does not b) AATB acredited tissue banks do

3. STERILIZE TISSUE BEFORE DISTRIBUTION

a) Cryolife says it can't be done

b) Other companies do

CryoLife Says It Can’t Be Done

Other Companies Do

Needed Reforms1. REJECT HIGH RISK CADAVERS

a) Diseased Cadavers i.e. cancer, meningitis b) Over 70 years old c) Cadavers un-refrigerated over 10 hours

2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED a) Cryolife does not b) AATB acredited tissue banks do

3. STERILIZE TISSUE BEFORE DISTRIBUTION

a) Cryolife says it can't be done

b) Other companies do4. DISCARD CADAVER IF ANY CONTAMINATION FOUND

.

5. MANDATORY REPORTING OF CONTAMINATION TO:

a) Federal Agencies

b) End User Doctor6. CERTIFICATION OF CADAVER HARVESTING PERSONNEL

a) Uniform Basic Qualifications

b) Uniform Training

Rao Senate Testimony

CryoLife Help Wanted

Needed Reforms1. REJECT HIGH RISK CADAVERS

a) Diseased Cadavers i.e. cancer, meningitis b) Over 70 years old c) Cadavers un-refrigerated over 10 hours

2. TESTING OF TISSUE WHEN CADAVER IS RECEIVED a) Cryolife does not b) AATB acredited tissue banks do

3. STERILIZE TISSUE BEFORE DISTRIBUTION

a) Cryolife says it can't be done

b) Other companies do4. DISCARD CADAVER IF ANY CONTAMINATION FOUND

5. MANDATORY REPORTING OF CONTAMINATION TO:

a) Federal Agencies

b) End User Doctor

6. CERTIFICATION OF CADAVER HARVESTING PERSONNEL

a) Uniform Basic Qualifications

b) Uniform Training7. MANDATORY ANNUAL PROCEDURE/INVENTORY AUDIT .

Proposed Regulations for Good Tissue Practices

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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