Posterior Urethral Valves (PUV) are obstructive membranes that develop in the urethra, which functions by draining urine from the bladder. These valves can obstruct or block the outflow of urine, which leads the ureters and kidneys to become progressively dilated, resulting in damage. PUV cannot be prevented. It develops in the early stages of fetal development and abnormally affects male infants. Reports of the incidence of PUV vary as widely as 1 in 2,000 to as much as 1 in 25,000 according to Nature.com.
Background
PUV is the most common cause of congenital bladder outlet obstruction and is responsible for 17% of pediatric end-stage kidney disease. PUV can be diagnosed in an ultrasound, x-ray, blood sample, or a cystoscopy. Long-term complications can be prevented or minimized in some patients. Yet many patients suffer ongoing bladder dysfunction and progressive kidney injury, resulting in between 22% to 50% proceeding to kidney failure by early adulthood.
Dane and Jenn Donaldson have been preparing for the possibility of a kidney transplant for their youngest son Tanner since their pregnancy. It was difficult enough for the Donaldsons to get the news that their unborn child had a major, life-threatening complication, (Posterior Urethral Valve Syndrome) but it was another level of devastation for the expecting couple to discover “there was no medical fix,” said Dane.
Meet the Donaldsons
The parents spoke to TrialSite News to explain the circumstances surrounding their legal battle with Tanner’s hospital, the Cleveland Clinic, (one of the top hospitals in the country). The hospital is no longer accepting Dane as a kidney donor for his son because Dane has not been vaccinated. According to their recent COVID-19 vaccination policy, all patients of elective surgeries must be vaccinated, and Dane falls under that technicality.
Despite the Donaldsons’ attempts to reason with the hospital: utilizing their religious exemption, proving Dane already acquired natural immunity, and releasing the hospital of any liability, the Cleveland Clinic will not budge. Here are the details of their case.
Tanner’s Story
For the past nine years, the Donaldsons have dedicated their lives to creating the best possible outcome for Tanner’s health. Jenn Donaldson quit her job to care for Tanner so she can meet the frequency of his medical needs.
“I make my day around what I need to take care of him.” Thankfully, she has been able to work a bit as a CrossFit coach which is ideal for a caretaking parent who’s short on time, dedicated to her health, and in need of a mental respite.
Jenn must make daily trips to his school because Tanner needs a catheter to help manually drain his urine every three hours without exception–even during the night. This tedious-yet-important process reduces the chance of his urine flowing back into his body and damaging his organs and must be conducted in a regimented and sterile fashion by his parents. If not, they run the risk of causing Tanner a kidney infection, (which is common for kids with PUV to contract more than a few times a year).
Due to their dedication, the Donaldsons have only had one incidence of kidney infection in Tanner’s lifetime. Dane said that up until the change in policy at Cleveland Clinic, the Donaldsons were praised for their successful efforts in meeting Tanner’s needs: the doctor visits, donor screening steps, medications, proper hygiene, and of course, nutrition.
Like any child his age, Tanner is a fan of treats and snacks that aren’t optimal for his health. The Donaldsons help guides their sons to make wise choices about their nutrition which Jenn Donaldson says, “can influence (kidney) function big time.”
Talking to Tanner about the severity of his health “is getting tougher and tougher each day,” said Jenn Donaldson. Thankfully, since his birth, Tanner has done much better than his doctors had expected. Furthermore, Tanner has no other comorbidities. This makes Tanner a prime candidate on the donor list.
Tanner’s Kidney Options
Tanner does not have many options on the table. His body is currently surviving on one kidney, with between 18% – 22% functionality. It is medically optimal for Tanner to live on his native kidney as long as possible. While the threat of needing a transplant loom, at the moment, it is best for them to buy time with Tanner’s own kidney through their meticulous efforts at preserving Tanner’s most optimal health.
However, if Tanner’s kidney were to drop below 15% function, then a kidney donation transplant surgery would need to be immediate. The Donaldsons have turned down some opportunities (before COVID-19) to utilize a deceased donor’s kidney because a living donor’s kidney will provide 18-20 years of functionality. In contrast, a deceased person’s kidney will fail Tanner after only a decade.
When Tanner was about 5 years old, the Donaldsons got the news that both parents had 4 out of 5 markers as quality candidates. There were many factors that drove their decision to use Dane as the donor.
Gravely, if the children lost a parent due to surgical complications, the Donaldsons agreed that the children needed their mom most to survive. The Donaldsons also must consider their teenaged son, Ryder, who is high-functioning autistic.
Dane immediately took responsibility to improve the surgical outcomes for his family by drastically improving his eating and exercise habits, ultimately losing 60-70 lbs.
The Cleveland Clinic’s Contradictory Mandates
The Donaldsons were astonished to learn that there would not be any patient-specific consideration regarding the mandate put in place by the Cleveland Clinic in the last quarter of 2021. The Donaldsons requested a meeting with the decision-makers, but instead got the team of doctors who were involved: the nephrologist, the urologist, the infectious disease doctor, and the surgeon who would operate on Dane. “That’s who we got, we got the doctors that make no decisions,” said Jenn.
What was the Cleveland Clinic’s main objection to Dane not being vaccinated? Simply that he would run the risk of contracting COVID-19. They dismissed Dane’s willingness to absolve the hospital of liability. Dane also brought up the Cleveland Clinic’s own pre-print study that concluded:
“Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.”
TrialSite covered one of the first studies in America, led by Cleveland Clinic, that showcased the robust protection of pre-existing SARS-CoV-2 infection.
Jenn Donaldson questioned the doctors about the risks of adverse reactions. Their answer was that if Dane were to develop any adverse reactions because of COVID-19 vaccines, such as myocarditis or Guillain-Barré syndrome (GBS), that Dane would no longer be eligible.
Beyond the ways in which an adverse reaction could eliminate him as a donor for Tanner, he’s also the sole breadwinner of the family. If he were to become disabled because of vaccination, would the Cleveland Clinic compensate the Donaldsons? After all, the Donaldsons would run the risk of financial ruin and a lifetime of medical care for yet another member of their family. The answer is no. TrialSite reminds there is powerful liability shield in place protecting the vaccine makers, hospitals, and others from COVID-19 liability thanks to the PREP Act.
But even if he could count on financial compensation, Dane said “I’m not going to take $5 million for my family, but not be able to function anymore. What good is that for everybody?’
When Dane repeatedly asked what the medical benefit would be for him to be vaccinated, the Cleveland Clinic doctors could only say it could shorten his time-fighting COVID-19 for a day or so, said the Donaldsons.
The Donaldsons also point out that the Cleveland Clinic fired unvaccinated nurses from their staff, but then had to rehire them as contract workers. This is a medically and epidemiologically illogical loophole that many health care facilities around the nation have used when staff shortages became desperate.
Furthermore, the Donaldsons asked whether a dead donor is required to be vaccinated to give a kidney to Tanner. No, the Cleveland Clinic would still do the transplant.
“This is where the story comes full circle, said Dane. “What’s better? A living donor or deceased donor? Now they’re taking a deceased donor unvaccinated, right? So, they’re willing to do it, only if I’m dead.”
The Donaldsons brought up the fact that there are no long-term studies that would confirm the spike proteins in the vaccine are safe for Tanner or Dane, or any transplant recipient in the long term. Their exemptions based on their religious beliefs are also being ignored.
“They did not have that meeting with us to have dialogue. They had that meeting with us to tell us the benefits of the three shots that they had available. That was it. At least from my opinion,” said Dane.
Now the Donaldsons have filed an official lawsuit against the hospital. Elizabeth A. Brehm Esq, with the Law Firm of Aaron Siri Esq., reiterated Donaldson’s points in a letter to their Bioethics Director, and included a follow-up, but the Cleveland Clinic has neither responded to or even acknowledged the receipt of the letters. Hard copies were also delivered to the medical doctors on the case.
“I’m still blown away. Regardless of the lawsuit, they have not even acknowledged us from that time,” said Dane Donaldson.
What is Plan B?
The Donaldsons are hoping for a legal overturn utilizing Ohio legislature that aims to end vaccine discrimination. The Donaldsons live in Ohio, where Jennifer Gross, district 52, is a primary sponsor (along with 15 other representatives,) of House Bill 248, “Enact Vaccine Choice”.