The Risks Involved In Tissue Implantation

The human tissue trade is a multi-million dollar per year industry in which a single human body yields enough tissue for the tissue brokers to pocket $250,000. While many skilled doctors throughout the world perform miracles with the tissue obtained from these brokers, the dark side of the human tissue trade has recently come to light.

There is little oversight from the Food and Drug Administration (“FDA”), which only requires that the person harvesting the tissue “register” with the FDA. No testing for qualifications nor the knowledge or resources to properly screen the tissue is required. Over the last several years, this lax oversight by the federal government has permitted a few opportunistic and unscrupulous tissue brokers to pass along tissue that did not meet FDA requirements and was not fit for implantation. This was documented in the CNBC special “How Much Is Your Dead Body Worth?”

It happened in a Montgomery, Alabama hospital when an elderly woman received an allograft for a back fusion surgery in 2006. It was unknown to the patient that the donor from whom the allograft was obtained died of cancer, a condition which made that donor ineligible under FDA requirements. The donor’s death certificate, obtained from the individual who harvested the tissue under contract with the tissue broker, had been falsified to show the donor died of coronary artery disease. It was also discovered that the donor was an I.V. drug user, another condition rendering the donor’s tissue ineligible for implantation. These facts were not discovered until several years after implantation.

The tissue broker was, at the very least, negligent in failing to obtain a certified death certificate of the donor before selling the donor’s ineligible tissue to numerous hospitals for implantation. Moreover, the broker’s failure conduct its own investigation into the donor’s eligibility by obtaining medical records and interviewing family members of the donor was also negligence. Moreover, the broker’s selling this tissue with full knowledge that it had not been properly screened makes the issue of wantonness a jury question. The firm of Allred & Allred, P.C. serves as co-counsel in a suit against the tissue broker as well as the hospital who provided the defective tissue in an Alabama state court but the case has yet to be tried.