On Jan. 30, 2005, in Iraq, an RPG struck a chemical tank near former Marine Staff Sergeant David Payton.
The rocket ended up being a dud, said David Payton’s wife, Heather Payton, but the force of the impact damaged the tank enough that the caustic chemicals inside spilled out, burning his lungs, eyes and other parts of his body.
“He ultimately passed out,” Heather Payton said. “He couldn’t breathe in the gas, had to be drug out. He woke up on a Humvee ride to a hospital in Fallujah, and they med-evaced him to Germany, where they stabilized him and ultimately sent him to Brooke Army Medical Center in San Antonio, Texas. He was on life support for about two, two and a half weeks. I did not think he was going to make it because his injuries were so severe.”
By the grace of God, Heather Payton said, he survived. But he was never the same. He had alkali burns in his eyes, and the concussive blast of the attack gave him cataracts. Over the course of the subsequent years David Payton had multiple surgeries and treatments with multiple providers, both for the corneal damage and the cataracts. He lost his right eye to an infection in 2016.
That same year, however, the Paytons learned about a relatively new innovation in corneal transplants, which employed adult stem cells, and Dr. Edward Holland, an ophthalmologist from Cincinnati Eye Institute, or CEI, who specialized in the procedure. So, the Paytons traveled to the Edgewood campus of St. Elizabeth’s Hospital to receive treatment.
“So [David’s] had, I think, three or four corneal transplants on his left eye now, but because of the stem cell transplant that Dr. Holland did first, it saved his eye,” Heather Payton said. “So he now has usable, good vision–he’s like 20/30–in his left eye.”
Fast forward to 2023, and Holland can no longer perform the procedure in Kentucky. Or, rather, he argues that he can no longer legally obtain the materials necessary to perform the procedure.
“Because of this bill, I can go to Malaysia and do that procedure,” Holland told LINK nky, “but in the state of Kentucky I can’t do that procedure.”
The bill he’s referring to is Senate Bill 12, passed in 2021, which explicitly bans the procurement of corneal tissue from for-profit suppliers. There is currently only one for-profit eye bank in the United States, CorneaGen, based out of Seattle. Holland argues that CorneaGen is the only way he can reliably get the tissues necessary to perform the kind of transplant procedure David Payton received.
Two years and multiple lawsuits after the bill was passed, the issue is unresolved. Holland contends that the law has unfairly constrained his ability to practice the kind of medicine he specializes in. Yet, Holland’s practice is but one vector in broader tensions between for-profit and nonprofit models of healthcare, the role of investment capital in medicine and medical ethics, all of which have ramifications for not only Holland’s work in Northern Kentucky but healthcare generally in the United States and worldwide.
Eye banks in the United States and the Cincinnati Protocol
The cornea is the transparent outer layer of the eye that covers the iris and pupil. A damaged cornea can lead to blindness, and patients usually need to access donated corneal tissue if they need surgical repairs on their eyes. 184,576 corneal transplants were performed in 116 countries as of 2012, according to a 2016 study from researchers at the University Hospital of Saint-Etienne in France.
The first tissue bank for the retrieval and storage of corneal tissue was established in the 1944, and over time a network of small, community-based eye banks gradually sprung up in cities throughout the United States. Like organ donation, the tissue at these banks came from deceased donors, and all of them operated on a nonprofit model.
The head eye bank organization in the United States is called the Eye Bank Association of America. It currently has 56 member eye banks, all of which are nonprofits. CorneaGen is accredited by the Eye Bank Association of America, but they’re not members.
In 1969 a nonprofit eye bank called the Northwest Lions Eye Bank was founded in Seattle. In 2006 the eye bank rebranded itself to SightLife and by 2009, it had become the largest eye bank in the United States. In 2016 SightLife spun off a for-profit research wing called CorneaGen, which tapped into private investment capital in the hopes of using it to fund medical research as the smaller, established nonprofit banks often lacked the resources to perform long-term experimentation. Holland currently serves as the chair of CorneaGen’s medical advisory board.
“CorneaGen became a for-profit eye bank to raise money for innovation,” Holland said, adding that CorneaGen currently supplies about 25% of all corneas in the United States.
CorneaGen’s research and the procedures that Holland perform piggy-back off of research first developed in Japan. Holland’s work, which he’s done in partnership with the University of Cincinnati, St. Elizabeth Healthcare and Cincinnati Children’s Hospital, employs adult stem cells to repopulate the cellular structure of an injured eye, making it more amenable to donated tissue. When combined with other interventions, Holland said, this curtails the likelihood of an auto-immune response in the patient and significantly reduces the amount of tissue needed for each procedure compared to earlier forms of transplantation. The different interventions Holland and his partners have developed have even come to be called the Cincinnati Protocol.
“Right now it takes one donor eye to fix one cornea,” Holland said. “With this technology of cell therapy, one donor eye could potentially take care of 1,000 patients.”
Testimonies from Holland’s patients suggest that the procedure isn’t widely available. The Paytons and others both went through multiple corneal procedures before even finding out about Holland’s work. The patients LINK nky spoke with also lived outside of the state of Kentucky and had to travel to get the work done.
The cells and tissue necessary for this protocol, Holland argues, cannot be sourced from most eye banks.
“There’s only two eye banks in the United States that do it,” Holland said. “Minnesota Lions Eye Bank, where I used to be, and CorneaGen. I can’t get that tissue from Lexington. I can’t get it from Louisville. I can’t get it from Cincinnati.”
As mentioned before, CorneaGen is the only for-profit eye bank in the country. The fact that they’re the only one is key to understanding the legal battle that ensued.
Statutes and suits
Senate Bill 12 passed out of the general assembly on March 11, 2021. Gov. Andy Beshear signed the bill into law about a week later on March 19.
The bill augments earlier statutes that restrict the sale and transfer of body parts generally. The text of the bill does not mention CorneaGen by name, but it states that a “for-profit entity shall not engage, directly or indirectly, in the procurement, transfer, or distribution of any human eye, cornea, eye tissue, corneal tissue, or portions of eyes.”
Any one who violates the law can land themselves in jail for up to five years and incur a fine of up to $50,000. It also stipulates that non-profits can charge “a reasonable amount” for operations typically associated with organ donation and transplant. What constitutes a reasonable amount is not elicited in the statute.
Legislative committee hearings prior to the bill’s passage heard testimony from Dr. Woodford Van Meter, a professor emeritus in ophthalmology at the University of Kentucky. Van Meter is retired today, but he formerly served as the chair of the Eye Bank Association of America, a position that Holland has also held. Additionally, Van Meter managed the merger of the University of Kentucky Eye Bank and the University of Louisville Eye Bank into what would become the Kentucky Lions Eye Bank. The eye bank would later separate from the Lions Eye Bank system and go independent, rebranding itself as the Eye Bank of Kentucky.
At a hearing of the Kentucky House Health and Family Service Committee on March 4, 2021, Van Meter spoke out in favor of Senate Bill 12, saying it was necessary to “protect the not-for-profit model of eye donation from for-profit entities that are aggressively marketing their services and are a threat to not-for-profit eye banks.”
Van Meter argued that an incursion of the for-profit model into eye donations could undermine public trust in the system.
“The idea of profiting from the selfless act of a cornea donation is an affront to the morals and standards of everyday people,” Van Meter testified.
Unlike the statute, Van Meter specifically called out CorneaGen at the committee hearing, indicating that they were the only for-profit provider in the country.
“We would like to keep for-profit eye banks like CorneaGen out of Kentucky,” Van Meter said.
On July 15, 2022, Holland and CorneaGen sued, arguing that Senate Bill 12 violated the Kentucky Constitution on two grounds: that it arbitrarily discriminated against CorneaGen for no legitimate government purpose, which is prohibited by the Constitution’s second and third sections, and that it served as a form a special legislation under the Constitution’s fifty-ninth and sixtieth sections–essentially, that it unfairly singled out CorneaGen as the only existing for-profit eye bank.
“Plaintiffs argue that there is no rational basis to single out one discrete form of organ or tissue donation (corneal transplants) to ban for-profit entities, and that such a classification violates equal protection and constitutes special legislation,” trial court documents read. “Plaintiffs argue that if such a ban is a valid exercise of police power, rather than an attempt to create a monopoly for the existing non-profit eye bank, the ban would apply to all organ and tissue donations, not just corneal tissue.”
The Franklin Circuit Court, a trail court, agreed with the plaintiffs and declared the law unconstitutional at the end of December 2022.
The Kentucky Attorney General’s Office, which at the time was under the tutelage of Daniel Cameron, counter-sued in 2023, escalating the case to the Kentucky Court of Appeals.
The Attorney General argued that the law was “not special legislation as it only referred to for-profit entities rather than specifically named for-profit entities,” according to documents from the appeals court. “The Attorney General reasoned that the fact that the law only applied to two entities upon passage in 2021 was not a feature of the law, but rather a feature of market conditions in Kentucky at that time.”
The Attorney General’s office expounded upon this reasoning by saying that “a statute is only considered special legislation if its language specifically refers by name to a particular individual, object or locale.”
The Court of Appeals did not find this convincing and published its opinion upholding the trail court’s judgement in February of this year, by which time the leadership of the Attorney General’s office had passed to Russell Coleman.
Following the appeals court’s decision, the Attorney General’s office appealed again, this time requesting a discretionary review from the Kentucky Supreme Court. Its request cited recent case law it viewed as affirming its original arguments.
“Under the Court of Appeals’ logic,” the Attorney General’s review request reads, “the legislature cannot pass class-based legislation if at the time the class consists of only a few companies or individuals. This imposes a meaningful limitation on the General Assembly’s power to remedy a perceived issue promptly–before it becomes more of a widespread problem.”
Holland and his lawyers responded in April. Now, the Supreme Court can choose to review the case or to deny the review request, which would solidify the appeals court’s ruling.
First Do No Harm: medical ethics, business models and investment capital
“I wouldn’t have gotten to see my three-month old daughter again without Dr. Holland and what he’s doing,” said David Tegtmeier, another one of Holland’s patients.
Tegtmeier was the victim of a chemical accident in 2018. He didn’t share the exact circumstances of the accident, but it left him completely blind.
“I was completely blind, and my eyelids, everything were completely melted away by a chemical,” David Tegtmeier said.
David Tegtmeier and his wife Danielle Tegtmeier state outright that the only reason David was able to get functional vision back was due to Holland’s interventions.
“Dr. Holland is the only doctor that we truly trust David for his care,” Danielle Tegtmeier said. “We’ve been a patient of Dr. Holland for over five years now and had many many surgeries with Dr. Holland, stem cells being one of them, and then corneas to follow. David now has some sight out of one eye, and we just started the process over again for stem cells on his bad eye to try to regain vision.”
The debate about CorneaGen has less to do with efficacy of Holland’s procedure and more to do with what CorneaGen’s business model might portend for accepted practices around tissue donation, which historically have been considered selfless gifts rather than products.
A 2019 article in the academic journal Clinical Ophthalmology, which attempted to offer a “fact-based” and “non-biased approached to the topic” expressed the dilemma succinctly: “Some argue that the for-profit connection fundamentally alters the relationship between the physician, eye bank and donor by rendering the gift of the tissue as a commodity.”
Kevin Corcoran, the current CEO of the Eye Bank of America, affirmed the point of view that eye tissue is first and foremost a gift.
“The association’s position on this is that donated tissue, donated ocular tissue that’s given by donors after they’ve died, is an altruistic gift,” Corcoran said.
Van Meter spoke with LINK nky about the topic, and, much like his 2021 testimony, argued that the introduction of the profit motive could undercut public trust in they eye banking system, something he said is reflected in the Eye Bank Association of America’s historical operating principles.
“The fear was that someone would be less likely to donate grandma’s cornea if they thought that it was going to a for-profit operation where investors would have to be paid,” Van Meter said.
As evidence, Corcoran pointed to a survey among racial minority populations in 2021, commissioned by Donate Life America, a national non-profit that aims to increase the number of organ donors. The survey showed that just over half of the 1,800 Black, Hispanic and Asian cited the fear that someone would might money off their donation as a barrier to becoming a donor.
The effect of money and investment capital on eye banking is something that looms large throughout the discussion. The Clinical Ophthalmology article, for example, posits a hypothetical scenario in which CorneaGen goes public.
“CorneaGen may eventually be a publicly traded company and subsequently will have a responsibility to their shareholders to maximize revenue,” the article’s authors state.
Van Meter compared the effects of investment capital in eye banking to reforms around names and likeness in college sports and recent developments in sports betting. Yes, some people are benefiting from the changes, he argued, but it’s not clear the effect on sports as a whole has been positive.
“We’re not too far away from having about 24 college football games, and maybe 50 college basketball teams, the way the money is going,” Van Meter said, “and then you’re going to have huge split between the haves and the have-nots, which, I guess, will benefit the haves. It’s not going to necessarily benefit most college students.”
Van Meter also pointed to laws and principals set down by the World Health Organization declaring that the buying and selling of human organs and tissue should be banned. Likewise, he pointed to the so-called Barcelona Principles, which arose out of an international conference of eye banks in 2018 that affirmed, among other things, the commitment to the altruistic donation model.
Van Meter also noted that universities throughout the United States–like this study from Harvard, for instance–were engaging research similar to Holland’s, meaning that the procedure may in time become more widely available and less reliant on singular institutions like CorneaGen.
“CorneaGen is not doing anything that no other banks are doing,” Van Meter said.
To the charge that human tissue and organ donations should be completely divested of the profit motive, Holland retorts that many established organ donation processing centers often employ for-profit business models.
“Throughout the United States, about half of tissue supplied for tissue, transplantation–skin grafts, bone grafts, cartilage, things like that–comes from a for-profit, including the state of Kentucky,” Holland told LINK nky.
Corcoran affirmed this, saying that bone grafts and organ parts often need to go through intensive processing procedures before they’re ready for surgery. But since eye tissue often doesn’t require that sort of processing–it’s more of a direct donation to a patient–the altruistic nature of the gift should be preserved.
“There’s a difference between eye banking and tissue banking, like Achilles tendons or skin or muscle or bone, because those the products that they produce out of the donated tissue or bone are significantly different,” Corcoran said. “They’re very heavily processed. They are terminally sterilized in most cases. So, there’s a lot more work and processing that goes into handling other tissues than there are with corneas. Corneas are defined as being minimally manipulated, which means that the tissue that is transplanted is substantially the same as the tissue that was recovered. When you are making that sort of direct transfer from a donor to a recipient, our feeling is that that is an altruistic gift and a nonprofit organization is the more appropriate venue for handling those tissues.”
For the Tegtmeiers and Paytons, the issue of for-profit versus non-profit is irrelevant, as long as they get the treatment they need.
“To me it doesn’t matter because me seeing the world and seeing my family’s faces again is far more important than an issue of which company is getting the money,” David Tegtmeier said.
The Tegtmeiers have actually named their their second child, a son named Holland, after Dr. Holland for the work he’s done.
“They should listen to a doctor who is trying to help his patients be able to see, and this is what they need,” Heather Payton said. “It shouldn’t factor one way or the other whether it’s a [for] profit or non-profit.”
There is no timeline or deadline by which the state Supreme Court needs to make a decision.