Cryolife, Inc.'s Unsafe Procedures Kill and Harm Innocent Victims |
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Industry |
This year over 750,000 surgical operations will use implanted cadaver tissue. In many instances, the use of cadaver tissue circumvents the need to use the patient’s own tissue. Within three years it’s estimated over 2 million operations in the United States will use implanted cadaver tissue. This compares with only 350,000 surgeries 12 years ago, and 650,000 surgeries 3 years ago.
Because of the newly emerging nature of the industry, there exists little federal and state regulation. The FDA has been dragging their feet for over five years formulating the regulations. This foot dragging was actually criticized by an oversight federal agency. |
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| Virtually, no state regulations apply to the tissue industry. While California and New York have laws regarding inspections, only a handful of inspections have occurred. According to Congressional testimony this year, over 100 tissue banks have never been regulated by any state or federal agency. |
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| Against the backdrop of virtually no oversight or regulation, huge profits are being made. |
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Profits |
| Cadaver tissue sales amounted to $500 million in 2000. It’s estimated that in the year 2003, sales will top $1 billion and, according to a CryoLife projection, the industry will enjoy $20 billion in sales by the year 2007. |
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| CryoLife, Inc. is the industry leader with current sales of almost 100 million dollars. That’s more than an 800% increase over the last six years. Currently, the company has nearly 30 million dollars cash or securities on hand and pays its CEO nearly one million dollars. |
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The Price of Profit |
| CryoLife has been able to accumulate staggering sales figures and profit by conducting its business in dangerously unsafe manners. They can do so because of a lack of regulation. While there exists a voluntary association of tissue banks, which has minimal guidelines, CryoLife refuses to join this association, American Association of Tissue Banks. |
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Brian’s Tragedy: |
| Brian was just 23 years old when he underwent elective knee surgery. Both he and his surgeon believed the cadaver tissue implanted in his body was safe. The proven facts indicate that the tissue had been left unrefrigerated for at least 19 hours and was dangerously infected. |
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| Brian died a painful death several days later from a form of clostridium sordelli. The CDC determined the cause of death to be the infected cadaver tissue. |
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| Brian, unfortunately, was not the first victim. A stockbroker in San Francisco was seriously injured by an infected cadaver in 1998, as was a truck driver in Santa Cruz, California in 2000. Further, an Illinois man, who received a part of the infected cadaver that was implanted into Brian, also suffered serious and debilitating injury. |
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No Safeguards: |
| Amazingly, the unrefrigerated cadaver which caused Brian’s death was not tested by CryoLife when received. CryoLife made no attempt to sterilize the tissue before distribution. Further, after it was known the cadaver was contaminated, it was not discarded. Lastly, at no time has CryoLife reported the contamination to any federal agency or the end-use doctor. Sadly, these acts are not isolated to Brian. This is the manner CryoLife conducts its business. |
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Reforms Needed: |
| The Keenan Law Firm has undertaken a several month survey of government regulators, academicians, and members of both the for-profit and non-profit tissue industry for the purpose of developing meaningful reforms that would safeguard the industry. |
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| There is no question that the tissue industry is necessary and important for the advancement of quality of life, however, it need not proceed in such a dangerous manner. All agree that if proper reforms are instituted, the tissue industry will be safe and will pose no unnecessary risks and dangers to incident surgical victims. |
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| The specific reforms are as follows: |
- REJECT HIGH RISK CADAVERS
- Diseased Cadavers i.e. cancer, meningitis
- Over 70 years old
- Cadavers un-refrigerated over 10 hours
- TESTING OF TISSUE WHEN CADAVER IS RECEIVED
- STERILIZE TISSUE BEFORE DISTRIBUTION
- DISCARD CADAVER IF ANY CONTAMINATION FOUND
- MANDATORY REPORTING OF CONTAMINATION TO:
- Federal Agencies
- End User Doctor
- CERTIFICATION OF CADAVER HARVESTING PERSONNEL
- Uniform Basic Qualifications
- Uniform Training
- MANDATORY ANNUAL PROCEDURE/INVENTORY AUDIT
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