Articles Posted in Transplants

tbbacteria-300x200A rare outbreak of tuberculosis among dozens of surgical patients — some of them at hospitals in northern Virginia — is under investigation by federal health authorities, including the Centers for Disease Control and Prevention.  The CDC  suspects the infections may be tied to a malleable bone putty used in spinal and other orthopedic procedures.

The substance includes human cells harvested from cadavers, according to Aziyo Biologics Inc., a regenerative medicine company that has voluntarily recalled 154 containers of its FiberCel product.

Patrick Malone & Associates represents patients infected with tuberculosis apparently from this FiberCel bone putty product. Our firm is actively investigating what happened to determine the legal liability of everyone involved and to see where the  breakdowns occurred in the checks and balances intended to keep medical products safe.

UMMC-Gudelsky-300x168A Maryland attorney has been indicted by the U.S. Department of Justice for an alleged scheme seeking a multi-million dollar payoff by the University of Maryland Medical System. Attorney Stephen Snyder is alleged by the government to have proposed a sham “consulting agreement” with the hospital, which would pay him $25 million, in order to keep secret some alleged facts about the hospital that he had learned in the course of representing a patient’s family.

Readers might wonder why our blog that focuses on patient safety and medical malpractice would write about this. Here’s why. We believe that attorneys who represent patients in medical malpractice lawsuits have an ethical duty to look out for the public’s interest, not just the narrow interests of themselves or even of their clients. That means that when a lawyer finds out in the course of representing someone that a hospital has a big patient safety problem, the lawyer should not try to personally profit from that knowledge by keeping quiet.

The Snyder indictment involves allegations about the organ transplant program at UMMS. (The building for the program is shown in the photo on the right.)

kidneylabels-300x200For tens of thousands of patients anxiously awaiting lifesaving transplants, a new media investigation has provided what must be heart-breaking news on the laxity with which dozens of donated organs get transported, causing them to be lost or delayed “cargo” and rendered unusable.

The nonprofit, independent Kaiser Health News Service and the Center for Investigative Reporting deserve kudos for following up on the jaw-dropping story of how a human heart got left behind in 2018 on a Southwest Airlines flight. Medical specialists involved at the time downplayed the incident, noting that surgeons had not planned a direct transplantation of that heart in a patient in dire shape, taking various of its valves and tissues, instead.

Still, when reporter JoNel Allecia dug into the ghastly gaffe, she found an organ transplant nightmare. As Allecia described it:

catheterablation-300x193It’s one thing when modern medicine becomes so hidebound that it struggles over shedding a bit of traditional doctors’ garb. But new information emerging about cardiology’s entrenched reliance on maverick surgeons and evidence-light therapies in treating heart problems raises real questions: Exactly what’s going on in this costly area of care?

Haider Warraich ── a cardiology fellow at Duke and author of “Modern Death,” a book exploring how technology and modern mores are changing patients’ end-of-life experiences ── deserves praise for raising major concerns about the too easy acceptance by doctors and surgeons of existing, device-based treatments for heart conditions. The headline on his Op-Ed in the New York Times summarizes well his tough point: Don’t Put That in My Heart Until You’re Sure It Really Works.

He, of course, points to recent challenges about the effectiveness of cardiac stents. They have been commonly used for years now ── in hundreds of thousands of surgeries ── supposedly to relieve blockages in patients with stable chest pain. But recent research has started to show they provide no benefit over drugs, and it was only after further study showed that a new kind of dissolving stent contributed to increased heart attack risks that the device maker pulled the already in-use product, Warrich notes.

Let’s give credit where it’s due: Transplant surgery, in popular lore, has become one of modern medicine’s most miraculous practices, not only saving individual lives but also blazing new frontiers about the functions of organs in the body and providing insights of large significance into the workings of the human immune system. This progress hasn’t come without considerable cost to health care as a whole — and recent developments should prompt some deep thinking on how transplants work now.

First, let’s look at the disturbing study that suggests that wealth gives patients needing a transplant an edge when it comes to getting an organ. As the Associated Press notes in describing the research just presented to the American Heart Association, “You can’t buy hearts, kidneys or other organs but money can still help you get one. Wealthy people are more likely to get on multiple waiting lists and score a transplant, and less likely to die while waiting for one …[This work] confirms what many have long suspected — the rich have advantages even in a system designed to steer organs to the sickest patients and those who have waited longest. Wealthier people can better afford the tests and travel to get on more than one transplant center’s waiting list, and the new study shows how much this pays off.”

Who is to blame for this seeming inequity or gaming of the system? The United Network for Organ Sharing, or UNOS, has a government contract to run the system that decides who among 100,000 Americans waiting for various organs will get one suitable for transplant. The independent body “considers medical urgency, tissue type, distance from the donor, time spent on the waiting list and other factors.” Despite criticism of its practices, such as occurred when Apple tycoon and California resident Steve Jobs got on the liver transplant list in Tennessee, UNOS allows patients to traverse the country seeking the optimal situation for themselves and possible procedures. To even get on the lists, however, the patients–each time–must fork over, depending on the organ the need, anywhere from $23,000 to $51,000 for various suitability tests. Ouch.

Despite programs to encourage people to donate their organs for transplant, most state initiatives aren’t working to enlarge the pool of potential donors.

Researchers writing in JAMA Internal Medicine earlier this month said the only thing that seems to work is when states create a fund to promote organ donations.

According to the Organ Procurement and Transplantation Network (OPTN), more than 123,000 patients are on organ transplant waiting lists in the U.S. About 21 people die every day in the U.S. die waiting for a transplant.

In addition to their willingness to undergo a potentially risky invasive procedure for the benefit of someone else, living organ donors also are financially generous. Their out-of-pocket expenses average $5,000 because, although a recipient’s insurance covers the donor’s medical expenses, it doesn’t cover transportation, lodging, child care and lost wages.

So there’s a movement to relieve this enormous burden that could spur an increase in organ donations. Given this country’s extreme shortage of donor organs, that would be w welcome development.

According to Reuters, experts suggest that removing the financial barriers to organ donation might include “careful consideration and testing of potential financial incentives for organ donation.” That is, an ethical way to “get rid of financial ‘disincentives'” to donating one’s organs.

Rarely does the law of supply and demand have a sadder application than in the world of organ donations, and the latest case of too much need and too few resources has states doing battle with each other.

According to a story on TheHill.com, “A heated redistricting battle has gripped the nation’s heartland this fall, but instead of votes, the debate has centered on livers.” Many congressional representatives from Midwestern and Southern states are disputing how the United Network for Organ Sharing (UNOS) wants to allocate livers.

UNOS is a private nonprofit outfit that manages the nation’s organ transplant system under contract with the federal government.

The story begins in 2011, when a young Florida man died of brain inflammation from an unknown cause, and organs from his body were transplanted into four recipients. Fifteen months later, a Maryland man died of rabies, and now it turns out to have come from the transplanted kidney he got from the Florida donor. The question now is, could anything have been done to prevent this tragic outcome?

The Centers for Disease Control and Prevention just confirmed the link after DNA testing matched the disease in the two victims. The recipient received his transplant at Walter Reed National Medical Center in Bethesda, Maryland and just died at the Veterans Hospital in Washington, DC.

Organ donation officials stress that rabies is extremely rare — you can count the number of human deaths in the United States each year on one hand. The other problem is that there is no simple test that can be done quickly enough to get an answer while the organ being transplanted is still viable.

Why were more than 2,600 kidneys recovered from deceased donors and discarded last year while 4,720 people in the U.S. died awaiting kidney transplants?

According to a story last month in the New York Times, a significant number of discarded kidneys-maybe as many as half-could be transplanted if the system for allocating them was more efficient at matching the right organ to the right recipient.

Many industry observers say that outdated computer technology, over-regulation, over-reliance by doctors on inconclusive tests and laws against age discrimination all contribute to a system of organ rationing that puts fairness above saving lives.

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