Chilling reality
Body donation companies lack local oversight
Five years ago, investigators in hazmat suits removed human heads and limbs from a Phoenix company. Two years ago, the state responded with a law. But today, a thriving industry that depends on dead bodies remains unregulated in Arizona.
The funeral home industry is regulated by the state, as are hospices and health-care facilities. But not companies such as the now-defunct Biological Resource Center that accept “whole body donations” and sell them, often in parts.
The Arizona Republic identified at least four such companies operating in Phoenix and Tucson.
State Health Department officials maintain they still plan to enforce the 2year-old law that passed after the Biological Resource Center case, which involved body parts potentially diseased with blood-borne infections such as HIV and hepatitis C.
The state law says that body donation companies are not allowed to operate in Arizona without a state license.
Licensing of the companies, which are also known as nontransplant human tissue banks, could begin in 2020, the Health Department says.
Health officials say the delay is tied to technical issues with the law and a state decision to put a higher priority on combating the opioid crisis.
So right now, there’s no local oversight of Arizona businesses that accept the bodies of people after they die and then typically dismember and sell them to various entities, including pharmaceutical and medical device companies.
Often, those companies are reaching out to families at their most vulnerable moments.
“If someone says we’ll pay for expenses and cremation and your loved one’s body will go to specific places (to help cure diseases), you are pretty much going to say, ‘Sure, why not?’” said Michael Burg, whose law firm, Burg Simpson, is representing the plaintiffs in a civil lawsuit against Biological Resource Center.
It’s not just Arizona that lacks regula
tion. Few state or federal rules exist governing body donation facilities, said Sharona Hoffman, a professor of law and bioethics at Case Western Reserve University in Cleveland.
“Organ donation is very much regulated, but this particular industry is not very regulated,” Hoffman said. “In fact, when you donate your body, you never know what is actually going to happen to it. … There isn’t a good regulatory framework that requires disclosure of what they intend to do with the body, or what happened with the body. It’s sort of a free-for-all.”
Facilities don’t need to be accredited with the American Association of Tissue Banks, a 43-year-old nonprofit organization with health and safety standards for body donation entities. The group states its mission as promoting the safety and use of donated human tissue.
All four body donation companies in Arizona identified by The Republic are accredited by the national association. But the association’s function is not regulatory, said John Cover, who worked in the body donation industry in Phoenix for more than a decade and helped draft the original Arizona body donation legislation, House Bill 2307, in 2016.
“You have to be licensed to do people’s nails. Why aren’t you licensed to be a human-tissue bank?” Cover asked. “There are people out there that want to cut corners. And there are people out there that don’t feel like you should have technical expertise, and they don’t feel like you should have things a certain way — and those are the people you have to watch out for.”
‘Strapped for cash’
Phoenix resident Shawna Hinkston says her husband, retired auto mechanic Don Hinkston, decided to donate his body to Biological Resource Center in January 2013 while he was dying from complications from diabetes. Hinkston said she had no idea the company was going to cut him into pieces and then sell the parts.
In retrospect, the sales pitch was “predatory,” she said.
“He thought his body would be used by medical students, for doctors to do operations on, that type of stuff. And maybe some for transplants. That was our understanding,” said Hinkston, a 58-year-old bus driver, who is not part of the pending lawsuit against Biological Resource Center.
“We were really strapped for cash at the time and my husband wanted to be cremated,” she said. “My husband decided he would save a little money and give back at the same time. We were not given any information other than research, stuff to help the surgical arts.”
State Rep. Regina Cobb, R-Kingman, sponsored HB 2307 in Arizona and sponsored a revised body donation bill to correct some language in the original bill — HB 2497 — in 2017. Gov. Doug Ducey signed both bills into law.
Two years later, it’s still not being enforced.
“I feel this has taken too long to implement and will be looking into it further,” Cobb told The Arizona Republic in an email.
Bodies as crash-test dummies, targets in gun tests
Whole-body donation businesses often market to hospices, funeral homes and physicians who specialize in endof-life care. Their marketing materials focus on the donor’s altruism and the money they will save.
The cover of a brochure for Phoenixbased Science Care says “Pay it forward. Without paying a thing.”
The brochure of another Phoenix body donation company, Research for Life, says “You can benefit humanity. We can help. No cost whole body donation for research & medical education.”
Body-donation companies ask that people donate their body to science, and in exchange they typically will pick up that person’s body after death at no cost and later provide the family with their loved one’s cremated remains.
The bodies are then cut up, with heads, shoulders and limbs sold and sent to various entities, including medical-device companies.
The body parts that Science Care gets from donors go to medical-device companies, research organizations, universities and pharmaceutical companies, said Katrina Hernandez, Science Care’s former vice president of donor services.
Donors receive a “legacy letter” that gives a general description of how their loved ones were used, though it does not name specific research programs or companies due to “client anonymity,” said Hernandez, who recently left the company.
In the case of Biological Resource Center, prosecutors said some of the bodies ended up, without the donors’ consent, in a Department of Defense program that uses cadavers as crashtest dummies and used for fire and ballistics testing.
Crash-testing is a common use for donated bodies. Phoenix-based Science Care, which calls itself the largest bodydonation company in the world, says its consent form is clear that donor bodies could be used to test vehicle safety and could be exposed to “simulated injury, trauma, impact, crash, ballistic or blast.”
Arizona companies support unenforced law
Science Care began in 2000 when founder James Rogers spotted a need after working with seniors on end-oflife planning. The company says it is signing up an average of 100 Arizonans per week, and that 47,184 Arizona residents are currently registered donors.
Rogers quickly sought out accreditation through the American Association of Tissue Banks, which previously had been focused on accrediting transplant tissue banks, Hernandez said.
Science Care became accredited with the organization in 2003, and the association created a separate set of accrediting standards for nontransplant tissue banks in 2011.
“Our founder sought this out because there was no regulation,” Hernandez said. “Science Care has really led the drive for this requirement to be accredited.”
Rogers later sold for-profit Science Care. Since 2016, the company has been owned by the Maryland-based private equity firm Northlane Capital Partners.
Science Care supports the as-yet-unenforced Arizona law, which is stricter than the American Association of Tissue Bank accreditation standards, and provides a local avenue for complaints and inspections, advocates say.
One of the biggest safeguards for consumers in the Arizona law, if it ever gets implemented, is that it subjects the facilities to unannounced inspections by the Arizona Department of Health Services, said Cover, who worked at the Phoenix body donation company Research for Life before leaving in December.
Before Research for Life, Cover worked at Science Care. Science Care last year had nearly 10,000 donations from across the country, including about 2,000 Arizonans, company officials say. Company CEO Brad O’Connell said he believes all tissue banks should be accredited by a national organization.
“I don’t really believe government is always the answer. But for this industry, promoting and supporting responsible legislation is important,” said Garland Shreves, CEO of Research for Life. “We don’t need unreasonable oversight but we need responsible oversight . ... Accreditation in and of itself, while I think it’s an important step, you still need to have licensure.”
Research for Life, which also has an office in Temecula, California, processes about 1,500 corpse donations per year, most of them from Arizona.
The two other Arizona body donation companies identified by The Arizona Republic the United Tissue Network and the Southwest Institute for Bio-Advancement — support the state law, too.
‘I’m not a body broker,’ industry insider insists
The Arizona bill was written by industry members who were looking both to separate themselves from Biological Resource Center’s illegal activities and add credibility to an industry that has been characterized in some media accounts as “body brokers.”
That label took hold in 2014 when it was revealed Biological Resource Center not only was taking bodies apart but selling them to vendors for a fee. Prosecutors were able to charge the company’s owner for fraudulent business practices — selling body parts to vendors that had not been properly screened for blood-borne diseases, and for not getting consent from some donors to send their bodies to the U.S. military for vehicle-safety testing.
“I’m not a body broker. I’m in tissue banking,” Cover said. “That term unintentionally damages those who have already donated their family and loved ones . ... Can you imagine if you donated your mother and your mother was special to you? And the next thing you are reading is ‘body brokers’ and you are thinking, ‘What have I done?’ It’s disrespectful.”
The Arizona bill wasn’t just about giving the industry credibility. The whole-body donation companies also were trying to fend off oversight by Arizona State Board of Funeral Directors and Embalmers.
“They wanted to regulate us,” Cover said. “But they also wanted to see us go away.”
Judith Stapley, who is executive director of the Arizona State Board of Funeral Directors and Embalmers, said the state board has “zero” interest in putting body donation companies out of business.
Stapley was not leading the funeral board during the Biological Resource Center case and its aftermath. But she does believe such companies need to be regulated, subject to inspections, and be more transparent with families.
Among other concerns, the companies are dealing with medical waste that needs to be disposed of safely and legally, she said.
“They should be held to a higher level of accountability,” Stapley said.
Swift, public reaction to Biological Resource Center case
The Arizona law that originated with Cobb’s two bills was part of a swift, decisive and very public reaction in Arizona to the Biological Resource Center case.
Arizona Attorney General Mark Brnovich was in court when Biological Resource Center owner Stephen Gore pleaded guilty to illegally operating an enterprise. Brnovich later told The Republic that the case showed a need for more oversight of the body donation industry.
“The thought that someone could ship body parts or body fluids without the people transporting it or without the people handling it knowing if there’s any contagious diseases or infections, or biohazards, I think it’s really problematic,” he said in February 2016, voicing support for Cobb’s legislation.
“This investigation … was initiated when you had a body company trying to ship 15 severed human heads in plastic ice coolers on a Delta cargo flight, dripping blood, and that’s how (the Department of) Customs found the shipment and that’s what began this whole process.”
Brnovich declined a request to be interviewed about the law and why it is not being enforced years later. A spokeswoman said his office is not the appropriate state agency to answer questions and referred questions to the Arizona Department of Health Services. Brnovich spokeswoman Katie Conner added that any complaints to the office are confidential.
“Our office does not have any consumer tips for people when it comes to selecting a body donation company,” Conner wrote in an email. “If a person believes they’ve been a victim of consumer fraud, they can file a complaint with our office.”
Arizona defends its delay in regulating companies
Officials with the Arizona Department of Health Services say the rulemaking process, which is necessary before the state can put the law into effect, finally is set to begin in the fall.
They blamed the delay in part on the state’s opioid crisis.
“This is really about setting the priorities for the department. That’s always a tough thing to do, but we do have it on our regulatory agenda and have had it on our regulatory agenda and we do intend to get to it this fall,” said Colby Bower, assistant director for public health licensing at the state Health Department.
“The department has been working very hard on the opioid crisis, and so getting those rules promulgated and that activity was certainly our priority.”
There will be opportunities for input from the public and from the industry, Bower said.
Reach the reporter at 602-444-8369 or Stephanie.Innes@gannett.com. Follow her on Twitter @stephanieinnes. Support local journalism. Subscribe to azcentral.com today.