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 2-year-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 over 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.

"Am I saying none of these places are legitimate? No," Burg said. "But there have been a sufficient number of cases where misrepresentations have been made. There's a price list for everything from a head to a shoulder, like they are a side of beef. They make money, absolutely, because there's no cost in getting the bodies."

What happened at Biological Resource Center? Read more

It's not just Arizona that lacks regulation. 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."

'We were 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.

Shawna Hinkston holds a photograph of her husband, Don, who died in 2013. His body was donated to Biological Resource center for research. Tom Tingle/The Republic

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."

In Colorado, the owner of a Montrose funeral home is facing a class action lawsuit over allegations that she sold body parts without donor consent. The plaintiffs, who refer to the funeral home owner as a "body snatcher" in their complaint and who also are represented by Burg, say their loved ones were secretly dismembered and their body parts were sold.

The FBI in February 2018 confirmed it was investigating the funeral home's directors and issued a public statement asking anyone who believes a loved one was a victim to fill out a questionnaire.

In response, Colorado passed a law last summer that prohibits a person from owning more than 10 percent direct interest in a funeral establishment or crematory while also owning interest in a nontransplant body-donation company.

Anyone who doesn't follow the Colorado law faces a fine of up to $5,000 and a jail term of up to 18 months.

Arizona has a similar law in effect that prohibits a funeral home and a body-donation company from operating on the same property.

But Arizona does not have in effect other elements of the Colorado law, which requires body-donation companies to register with the state and keep records of any human tissue they handle, including tracking where the tissue goes.

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 end-of-life care. Their marketing materials focus on the donor's altruism and the money they will save.

The cover of a brochure for Phoenix-based 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 crash-test 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 body-donation 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-of-life 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."

Show caption Hide caption The consent form for Science Care says donated human tissue only can be photographed or documented in video for noncommercial scientific publication, and only if... The consent form for Science Care says donated human tissue only can be photographed or documented in video for noncommercial scientific publication, and only if the donor can't be identified in the photo or video. It specifically says bodies could be used as crash-test dummies or ballistics training and that "exposure of the donated tissue to destructive forces may be involved." Cheryl Evans/The Republic

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, which does marketing in hospices and funeral homes, accepts donations in most states and preregisters donors in nine — Arizona, Pennsylvania, Delaware, Indiana, California, Colorado, Florida, Texas and Nevada.

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.

When he lobbied for Arizona's HB 2307 in 2016, Cover called it "a landmark bill for the state of Arizona" for its effort to regulate "the Wild, Wild West of tissue banking."

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.

Science Care is already licensed by the New York Department of Health because of regulation in that state. Research for Life and the Tucson-based Southwest Institute for Bio-Advancement, another body donation company, are also licensed in New York.

"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."

Similarly, Shreves said he finds the term body broker to be a "highly offensive" label that degrades donors who gave what he calls a "gift to humanity." Shreves said he hired a lobbyist to advocate for the Arizona law.

Research for Life CEO Garland Shreves says the body donation company owes it to donors to do things in an ethical, transparent way. Cheryl Evans/The Republic

"We owe it to every donor that comes through our door to do things in an ethical, transparent way. ... It benefits all of us to make sure there are not bad players in the tissue-banking field," Shreves said.

"The reality is, these are someone's loved ones. And they place a great deal of trust in organizations like ours to do the right thing."

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

When state and federal officials raided Biological Resource Center's Phoenix location a year after her husband's death, Shawna Hinkston realized, from news reports, that her husband's body likely had been dismembered.

She was appalled.

"I cannot even describe how horrible it was. I still haven't had closure," Hinkston said. "Don was my husband; he wasn't just a piece of meat. I don't even know if the ashes I got were really him. Had I known what they were going to do to him I would have put the kibosh on that instantly — oh, heck to the no.

"It's so disturbing I don't even know what to say."

Esther Adkins, 83, a Phoenix resident, was at one time registered as a whole-body donor with Biological Resource Center, as was her husband, Billy.

Phoenix resident Shawna Hinkston, whose husband, Don, donated his body to Biological Resource Center I cannot even describe how horrible it was. ... Don was my husband; he wasn't just a piece of meat. I don't even know if the ashes I got were really him. Quote icon

Billy Adkins died at age 89 in 2018, after Biological Resource Center closed. He was cremated and did not donate his body to any other entity, his wife said.

She had no idea when she signed up as a donor that body donation companies would take bodies apart and sell them, and she would not have agreed had she known, she said. Like her husband, she wants to be cremated.

"We thought the bodies would be used for maybe studying the heart, the liver and the eyes, and the rest would be cremated, " said Adkins, who is not a plaintiff in the pending lawsuit against Biological Resource Center. "It makes you wonder who you can trust."

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 body donation companies

Officials with the Arizona Department of Health Services say the rule-making process, which is necessary before the state can put the law into effect, finally is set to begin in the fall.

Colby Bower, assistant director for public health licensing at the state Health Department Cheryl Evans/The Republic

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. The last step will be getting approval from the Governor's Regulatory Review Council.

Ducey spokesman Patrick Ptak referred questions about enforcing the law to the Arizona Department of Health Services, which sets its own priorities when it comes to rulemaking unless a law specifies otherwise.

What does the new law require?

Under the state law, body donation companies are automatically licensed if they have accreditation through the American Association of Tissue Banks, which means all four body donation companies operating in Arizona that were identified by The Republic automatically would get a license. Those that aren't would need to go through a separate licensing process.

The law says licenses must be renewed every two years for a fee. It requires the companies to have a licensed physician as a medical director and also to employ a director who has a minimum education of a bachelor's degree in a "related science" from an accredited university.

The law also calls for the use and maintenance of donor consent forms, an identification system for bodies and body parts, and the documentation and disclosure of the disease status of human tissue samples.

While Cover says it seems like the department has been "dragging its feet" on implementing the law, state health officials say that's not true.

"The bill in 2016 had some inherent flaws in it, and so in 2017 those flaws were fixed," Bower said. "Then there were some national standards from the accrediting bodies that were being updated, and we wanted to wait for that to get done. We wanted to pass rules that were congruent with national standards. "

Once body donation companies have to be licensed by the state, consumers will be able to check whether a facility is licensed on the Health Department's website, and any state actions against a particular facility would be public.

Congress has made a couple of recent efforts at legislation, with no success.

A bill introduced by U.S. Rep. Paul Gosar, R-Ariz., in 2014 in reaction to the Biological Resource Center case would have added federal regulation to the labeling, transporting and licensing of human tissues by body donation programs.

Another federal bill to regulate the body donation industry — HR 1835 — was introduced this year by U.S. Reps. Bobby Rush, D-Ill., and Gus M. Bilirakis, R-Fla. The bipartisan Consensual Donation and Research Integrity Act of 2019 would create a registration and tracking system for bodies and body parts donated for research and guarantee "respectful disposition." The bill was referred to the House Committee on Energy and Commerce on March 18. No hearings have taken place.

For now, any oversight or regulation of body donation businesses is really up to states, said Arthur Caplan, a professor of bioethics at New York University who helped draft the National Organ Transplant Act.

"All matters pertaining to death, from defining when it happens, to the responsibility of the disposal of the body for family or friends or for state if there aren't any, to organ donation and tissue donation, are state issues," Caplan said. "The only federal role, really, is to distribute organs for transplant."

No one is inspecting the body donation industry in Arizona In 2016, HB 2307, which requires regulation of the body donation industry, was signed into law. The bill was revised in 2017 but never implemented. Arizona Republic

Arizona law exempts medical schools

Two medical schools in Arizona have whole-body donation programs, and both are specifically exempted from the state law requiring licensing of nontransplant tissue programs.

The University of Arizona College of Medicine-Tucson's willed body donation program has been in existence since 1967 and processes about 150 body donations per year, which are used for instruction at the medical school.

Kat Alvarado, the UA program director, is licensed through the Arizona Board of Funeral Directors and Embalmers, which is required for the job. She previously worked as a funeral director.

The UA program also provides cadavers to the UA College of Medicine-Phoenix, Arizona State University and Northern Arizona University. Like all aspects of the university, the UA program is governed by the Arizona Board of Regents.

Midwestern University in Glendale, which is a private nonprofit university accredited by the Higher Learning Commission, has had a body donation program since 2016 and has already processed 116 donations.

"There is no official agency that regulates university body donation programs themselves," said Heather Smith, an associate anatomy professor who directs Midwestern's program. "We report to our university administration and board of trustees, and adhere to all laws for medical education and the laws of the Arizona Board of Funeral Directors and Embalmers."

The Midwestern program's assistant director and manager of donor relations are licensed through the funeral board.

Leaders of both university programs say donating one's body for medical education is different from body donation through a for-profit business like Science Care or Research for Life.

"We are nonprofit, run by the state of Arizona and we are whole-body donation for medical education. We are not selling parts to private physicians or doing research," Alvarado said.

Still, medical school body donation programs in the United States have not been immune from scandal.

In 2004, UCLA temporarily suspended its body donation program after one of its employees was involved in the illegal sale of cadavers. The former director of the program later pleaded guilty to conspiring to steal body parts worth more than a million dollars between 1999 and 2004, the Los Angeles Times reported.

In 2016, the dean of the George Washington University's School of Medicine and Health Sciences released a statement that said its body donation program would be suspending donations in the wake of mismanagement that included the inability to identify some donor bodies.

Enrollment in the UA program must be completed while the donor is still alive. The Midwestern program allows a person's next-of-kin or power of attorney to enroll the donor after death, although program leaders recommend preregistration.

There are 700 people registered with Midwestern's program, ranging from people in their 20s on up to the elderly. The program sends out an annual newsletter to those enrolled, which gives enrollees specific examples about how the cadavers are used and always includes at least one student voice.

"It's strictly for education. We are nonprofit and the gift is directly to the students," said April Cornejo, manager of donor relations for the Midwestern program.

Another difference from the nonuniversity companies is that the donors will stay at Midwestern. They aren't sent out to any other programs or entities, said James Edmundson, the program's assistant director.

"I think that's reassuring for the family, to know mom is here on campus and when the studies are done she'll be cremated and returned," he said.

Your body will be dismembered and sold in pieces

Shreves, of Research for Life, who hired a lobbyist to advocate for the state law and helped initiate the bill, said he wants to see it take effect but understands the delay. The law is complicated and still needs tweaks, he said.

He'd still like to see university programs included in the oversight, he said.

"There are no sacred cows. I think everyone ... should have oversight," Shreves said. "Not by their own eyes, but by an independent body. That's what transparency is all about."

Caplan, the New York University bioethicist, says accreditation is some assurance for consumers. But he'd also like to see companies being more upfront about exactly how the bodies are used.

"Just saying we're going to dismember your body and send it around makes it sound like the use of body parts is going to be for teaching at a dental convention, which is not the only place these things get used," he said.

And since companies are asking people for a "donation" of their body, there's an implication that it's a gift. The fact that the gift is being sold needs to be clear to the public, he said.

Shreves and others in the industry dispute the word "sell" when it comes to their business activity.

"It may be semantics, but we are not selling them. We are charging a fee," Shreves said. "Nothing can be done unless we recover fees — that's just the sad reality."

Science Care is compensated for the procurement, shipping, recovery and storage of the human tissue, said Hernandez, explaining why Science Care doesn't consider what it does to be selling human tissue, either.

"It's not illegal to pay for body parts. Our legal group says it's not. But we're not in the business to sell body parts," she said. "We're in the business of having successful research, education and training take place."

Reach the reporter at Stephanie.Innes@gannett.com or at 602-444-8369. Follow her on Twitter @stephanieinnes

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