A leukemia patient was mistakenly given a bone marrow transplant from the wrong donor, after which the incorrect stem cells ravaged her body from within, causing her to die an “unimaginably horrific death.”
The tragic circumstance was caused by a simple—and totally avoidable—“labeling error,” according to a gut-wrenching lawsuit filed Tuesday in New York State Supreme Court.
Elizabeth Aloisio “received the full treatment without anyone cross-checking or testing the products to ensure she received the correct batch,” states the complaint, which names the German stem cell donor network AKB Stiftung Sktion Knochenmarkspende Bayern as the defendant.
It says the mixup caused severe Graft Versus Host Disease (GVHD), resulting in a year’s worth of agonizing pain and suffering for Aloisio as she waited to die.
“You can imagine her reaction when she was told, ‘We gave you the wrong stem cells and there’s nothing we can do about it,’” attorney Joseph Ciaccio told The Daily Beast. “We hope this case serves as a wake-up call to the process, and to make some change.”
AKB’s attorney, Oliver Beiersdorf, did not immediately respond to a request for comment late Tuesday afternoon.
When Aloisio, a Queens, New York resident, was diagnosed with leukemia in October 2018, her doctor recommended a stem cell donation as her best hope for recovery, according to the complaint, which was filed by Aloisio’s brother John. The National Marrow Donor Program, also known as Be The Match, worked with AKB to find an appropriate donor, the complaint explains. Once a “near-perfect match” was found in Italy, the marrow was sent to Germany, and on to New York, it continues.
“The donor ID assigned was ‘DE-AKB 78459,’ identifying AKB as the collection center performing the collection for the donor,” the complaint says. “It was decided by Ms. Aloisio’s physicians that she would undergo a stem cell transplant, scheduled for January 16, 2019. There was significant hope on the part of Ms. Aloisio and her family that this transplant would help lead to her recovery. Surprisingly, following the transplant Ms. Aloisio did not show the expected signs of improvement.”
Ciaccio told The Daily Beast that stem cell recipients are routinely tested a month or two after the procedure, to see if the body is accepting the infusion. When Aloisio’s results came back, her doctors realized “something’s not right here, these are not the stem cells she was supposed to get,” Ciaccio said.
An investigation was launched, and Aloisio’s worst fears were confirmed—she had been “implanted with stem cells from the wrong donor,” the complaint goes on.
A researcher observes the confocal image on a screen showing the nucleus of human stem cells.
On March 14th, 2019, the head of quality control at the AKB subsidiary that collected and shipped the marrow emailed Aloisio’s doctors, saying, “[T]o our great dismay, we have to tell you, that it is very likely, that the wrong… product has been delivered on January 15th, 2019, for your patient. Most likely is mixing up of final products labels. This probably resulted in the wrong labeling of another product with labels dedicated for your patient.”
A member of the AKB board of directors then contacted Aloisio directly, apologizing to her that ‘a small mistake of one of our experienced coworkers was enough to cause a problem—and make you suffer.’” He also also stated that ‘[w]e have, of course, taken all activities to prevent such a mistake from happening ever again.’”
But, the complaint contends, the apology letter “failed to address the glaring issue in this matter: this mistake was completely preventable.” There were “multiple opportunities” to check and double-check the marrow samples, it says.
“On the incident report produced by AKB, it was discovered that the responsible employee added the wrong final label to the collection samples,” it states. “As a result, the wrong collection samples were added to both bags. At the time of this error, AKB’s standard… procedure did not include a double-check at this step, but they have since implemented a new step including such a check. Unfortunately, in Ms. Aloisio’s case, the cells were not tested until after they were transfused into her body.”
The unnamed employee responsible for the “labeling error” was removed from his position at AKB, according to the complaint.
From there, Aloisio “went on to suffer an unimaginably horrific death,” the complaint states. “This suffering was not quick, as she fought on and suffered through deterioration for one year from the time she was given the wrong transplant.”
The GVHD set in almost immediately, and steadily worsened, the complaint says. Aloisio was also too sick by now to receive a second transplant from a suitable donor, according to the complaint, which says that as her GVHD intensified, her leukemia also got more advanced.
“From the date of transplant until her death, Ms. Aloisio suffered from worsening fevers, vomiting, dizziness, pain, diarrhea, infections, pneumonia, and a long list of other symptoms,” the complaint states. “This, of course, was in addition to her severe GVHD, which took over her body and destroyed her skin and internal organs. After a year of suffering due to this tragic mistake, Ms. Aloisio died on January 7, 2020.”
She was 63.
Ciaccio told The Daily Beast that mistakes happen in every area of life, and that human error is inevitable. However, he said, something “as sensitive and important as stem cells” should require a higher standard of diligence.
John Aloisio, who lives in Toronto, said his sister’s dying wish was that her unnecessary death serve as a cautionary tale for others in the same position, according to Ciaccio. He said he hopes this case “is a wake-up call” for everyone involved at every step of the stem cell transplant process.
“That person is counting on [those stem cells] to save their life,” Ciaccio said, “and if you put the wrong stem cells in there, you’re basically killing that person.”
Aloisio’s family is asking for as-yet to be determined damages and a jury trial. AKB has not yet filed a formal response to the charges.
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