Health Care Law and Regulations week 9
Chapt24
Human Body Parts Industry
Lecture Overview
Principles and Applications
Misconduct in the Human Remains Market
General Unawareness of Corruption
Commodification of Human Materials
Medical Research and Development of Medical Products
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). .Human body parts industry. In Health care management and the law: Principles and applications (pp. 501-516). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Principles and Applications
Human material is used to develop medical devices and cosmetic products as well as in most surgeries.
Physicians and dentists use human body parts to:
Plump up lips and eliminate wrinkles
Repair bones
Replace heart valves
Treat burn victims
It is estimated that the human body parts industry in the United States generates $500 million annually in the organ procurement side of the industry alone.
Misconduct in the Human Remains Market (1 of 4)
Since the late 18th century, when dissection became an essential component of medical training, the demand for cadavers has far exceeded the supply.
Back then, the solution was the robbing of graves. Entrepreneurs could make a tidy profit digging up freshly interred bodies and delivering them, under cover of night, to medical men willing to pay handsomely for them.
In Re: Human Tissue Products Liability Litigation
Are organs and tissue from human corpses being harvested without obtaining proper consents?
Holding and Decision: Yes. While litigation is ongoing, this case demonstrates one way the courts are attempting to hold the human body parts industry accountable for illegitimate body harvesting
Misconduct in the Human Remains Market (2 of 4)
Billion Dollar Global Industry
With one harvested corpse worth $200,000 on the black market, the temptations are great and the oversight almost nonexistent.
As multidistrict litigation proceeds in the federal courts on an international human body parts operation involving Medical Tissue Services and Mastromarino, the global pervasiveness of the illegal harvesting of human body parts may be brought to light.
Some commentators think about 15% of the multibillion dollar global human body parts industry could be illegitimate or as high as $1.2 billion.
Misconduct in the Human Remains Market (3 of 4)
The Underground Market in Human Body Parts
Since his death, Alistair Cooke has become the symbol of underground market in the United States that illegally sells corpses and human body parts. Unbeknownst to his family, the bones of Cooke were cut out of his body before he was cremated and his bones were sold for $7,000.
The Cooke scandal raised concerns about the marketing and commoditization of human bodies, property rights, and the implications for medical research that are arising from publicizing this illicit sale and resale of human body parts.
Misconduct in the Human Remains Market (4 of 4)
Fraud and Negligence in the Illicit Sale of Human Body Parts
Liability for the fraudulent receipt of stolen goods is a factual issue determined by the courts after considering all relevant evidence.
The Uniform Anatomical Gift Act of 2006 (UAGA) prohibits the sale of human body parts and was adopted by the states in order to protect corpses.
Congress subsequently set a minimum standard of care for the procurement of organs and transplantable tissue when it passed the National Organ Transplant Act of 1984 (NOTA), but it does not regulate human remains.
General Unawareness of Corruption
There is no political consensus on whether:
A legalized market for buying and selling cadavers would decrease illicit transactions
More explicit rules and regulations should be adopted for the sale of human body parts
Society is so opposed to the commoditization of the human body that such a market would be incomprehensible
Graves v. Biomedical Tissue Services, Ltd
Issue: Did the tissue banks fail in their duty to obtain consents, and did they willfully disregard regulations regarding the procedures for harvesting human organs?
Holding and Decision: The issue of consent was never addressed in this part of the lawsuit. Summary judgment was granted and the complaint was dismissed without prejudice against one of the five tissue banks that had no records of receiving any human organs or tissue from the funeral home that handled the cremation; the remaining four tissue banks remain involved in this ongoing class-action litigation.
Commodification of Human Materials (1 of 11)
The human body parts industry could thrive if cadaveric human body parts could be permitted to enter an open marketplace and the sale of cadavers could be properly regulated.
Washington University v. Catalona
Issue: Once patients sign an informed consent form donating their tissue, blood, DNA, or other human body parts for research purposes to a university, who has the right of ownership?
Holding and Decision: Patients surrender all rights of ownership to direct the use and transfer of their human body parts once they consent to donate; they cannot come back later and direct a new use or ownership.
Commodification of Human Materials (2 of 11)
Limited Property Interest in Human Material
Corpses and human material have characteristics similar to property in the law. Most courts refuse to overturn traditional notions of a limited property interest in the human body.
The growth in the tissue processing market has raised concerns about the transfer of disease during orthopedic and neurosurgical operations.
In practice, the loopholes in the Uniform Anatomical Gift Act and National Organ Transplant Act mean that bones, tissue, organs, joints, limbs, heads, and even entire torsos are scarce commodities in an international marketplace where the demands of medical researchers, product developers, and physicians far exceed the supply.
Commodification of Human Materials (3 of 11)
Illegal Procurement and Sale of Human Body Parts
The first form of misconduct in this arena is the illegal procurement and sale of human body parts. The lawful as well as the unlawful procurement and sale of human body parts is a complex and confusing interplay of:
Economic opportunity
Legal loopholes
Moral limits
Scientific innovation
Commodification of Human Materials (4 of 11)
Illegal Procurement and Sale of Human Body Parts
In the absence of medical and moral clarity about the interchange of human biological material, people are left with the corrupting promise of unlimited economic opportunity in exchanging superfluous human body parts, and a legal system that is ill equipped to cope with the kind of ethical dilemmas being raised by scientific innovation.
When corpses are cremated, it eliminates the possibility of police, coroners, or other investigatory agencies finding out what drugs were in the body at the time of death.
Often morticians replace the stolen human body parts with pieces of plastic or metal pipe as was done to with the body of Alistair Cooke, in order to cover the damage for open casket funerals.
Commodification of Human Materials (5 of 11)
Illegal Sale of Cadavers Through University Willed Body Programs
The second, more complicated, form of misconduct involves the trade in corpses from university willed body programs. Donors will their corpses to science, expecting that their cadavers (as most do) will be delivered to the anatomy laboratories of medical schools, and that, in being dissected, they will help train the next generation of physicians.
Louisiana State University, Tulane University, and the University of California at Los Angeles (UCLA) were all implicated in the underground traffic of cadavers. They were caught selling human body parts to brokers and suppliers who then resold them to independent buyers.
For years, military researchers bought corpses through this market to use in research involving explosive devices.
Commodification of Human Materials (6 of 11)
Illegal Sale of Cadavers Through University Willed Body Programs
Gudo v. Administrators of the Tulane Education Fund
Tulane University sold cadavers to the U.S. military to be used in explosives testing
Issue: Can donated cadavers be used in a manner not authorized by the surviving family members?
Holding and Decision: Yes. The statutory definition of what encompasses an action for the unauthorized desecration and mutilation of a cadaver is broad enough to cover cadavers being blown up in landmine experiments.
Commodification of Human Materials (7 of 11)
Sale and Transplantation of Contaminated Body Tissue
Cases of contaminated tissue are rare, but they are making headlines more often. Tissue from one contaminated donor can go to dozens of patients.
The UAGA bans the sale of transplant tissue and the FDA forbids the transplanting of cancerous tissue. The FDA Center for Biologics Evaluation and Research has a regulatory framework for human tissue and cellular and tissue based products that is designed to prevent the introduction, transmission, or spread of communicable diseases by tissue products.
Commodification of Human Materials (8 of 11)
Sale and Transplantation of Contaminated Body Tissue
Commercial human tissue recovery firms are required to screen and test donors for relevant communicable diseases and to ensure that tissues are processed in a way that prevents communicable disease contamination and cross contamination.
The reality is that the regulations governing donor screening and record keeping practices are seldom enforced:
Death certificates maintained by human tissue recovery firms often do not match state death certificates regarding the cause of death
Donors are not always screened for risk factors or clinical evidence of disease agents and diseases
Human tissues are often recovered in a manner that causes contamination
Commodification of Human Materials (9 of 11)
Laundering of Corpses
When corpses have been sold and resold, it is unclear when the charge of receipt of stolen human body parts may be dropped, or if such charges should ever be dropped.
The legal principle of caveat emptor states that buyers must be aware that what they purchase may be accompanied with legal baggage, but the principle of good faith also excuses those who, even with due diligence, claim ignorance to the stolen nature of their purchase.
Commodification of Human Materials (10 of 11)
Criminal and Civil RICO Liabilities
The RICO legislation, originally passed to control organized crime, may create both criminal and civil liabilities against individual health care providers and medical research corporations involved in the underground human body parts industry.
Hypothetically, it could be argued that RICO prohibits using two or more racketeering acts to accomplish:
Acquiring legitimate human body parts that were stolen from donated cadavers
Maintaining human tissue processing organizations and medical research organizations through acceptance of stolen human body parts
Operating a human body parts business with resold human body parts that never should have been commoditized
Commodification of Human Materials (11 of 11)
A two-step process could be used to prove that individuals and corporations violated RICO, whether it would be a criminal prosecution or a civil lawsuit.
First, it would have to be shown that two or more racketeering acts were committed, which would be any of a list of specified criminal acts, including fraud, sales and receipt of stolen property, and theft.
Second, it must be shown that the racketeering acts were used to accomplish one or more of the aforementioned three purposes.
Medical Research and Development of Medical Products (1 of 2)
Several class action lawsuits are focusing on those that deal in cadavers and human body parts:
Body brokers who supply human materials to the medical products industry
Medical research centers that accept the human body parts from the brokers
Tissue banks and other health care providers who act as middlemen
Tissue processing industry that processes tissue and body parts for sale
Hospitals that do business with all these players
There is no oversight of hospitals involved in the human body parts industry; it remains to be seen what, if any, sanctions will be imposed on hospitals involved in the Human Tissue Products Liability Litigation case.
Medical Research and Development of Medical Products (2 of 2)
Although cadavers are bought and sold as commodities, this commodity market is used for the benefit of the living.
Cadavers and human body parts, though they may be illegally bought and sold, are often ultimately used in medical research.
As new medical products are continually developed, more and more human tissues are being stored and distributed for therapeutic and research purposes in a hidden market with few regulations and great opportunities for financial gain.