Software mistake leads to $15M settlement
A $15 million settlement has been reached in a products liability and medical malpractice lawsuit brought by the family of a Kahului man who died after he received about two and a half times the appropriate dose of radiation to treat his cancer.
The overradiation of Zacarias Chichioco Jr. occurred as a result of a programming error in software developed by Varian Medical Systems Inc. and used by the Pacific Cancer Institute in Wailuku, where he received the radiation treatments, according to the plaintiffs’ pretrial statement filed in 2nd Circuit Court.
In the three years that followed, Chichioco suffered significant problems and side effects, including difficulty and pain in swallowing, hallucinations, hearing loss and paralysis on the left side of his face. He underwent multiple operations for skin grafts and had part of his brain removed before he died May 19, 2011, at home while under hospice care.
He was 45 years old.
“A lot of people think radiation treatment is more benign when compared to chemotherapy,” said Wailuku attorney Michael Tateishi, who represented the Chichioco family in the lawsuit. “But it’s not, and this is proof of it.”
By speaking about what happened, Tateishi and Chichioco’s wife, Marites “Tess” Chichioco, said they hoped to increase awareness to help others who might find themselves in similar situations.
“Zach was showing signs of being burned,” Tateishi said. “He had pain in his mouth. His skin was reddening, and he had open sores. You have to be vigilant if you have these signs, talk to your doctors, make sure that they provide you with the proper care. If it doesn’t happen, look what can occur.”
In addition to working full time, Marites Chichioco provided much of the 24-hour care her husband needed.
The couple’s son, Zacarias III, now 16, and daughter, Zo’e Marie, now 9, “saw how hard it is for me to take care of their dad every day,” Marites Chichioco said. “They saw him suffer every day.”
Family members had to wear masks and gloves to be in the same room and get close to him. “That was what really made him so sad,” she said. “We’re all so close.”
Chichioco’s case led to a worldwide recall of the Eclipse software that was designed, manufactured and sold by Varian.
A September trial date had been set before the case was resolved. Dr. Bobby Baker, founder and president of the Pacific Cancer Institute, and Dr. Daryl Makishi, a physician there, settled the case for $1 million each, the limit of their insurance policies, Tateishi said. The remaining $13.25 million was paid by Varian, he said.
Referring to the settlement, Tateishi said: “They saw a seriously hurt man. I think they recognized there was a mistake made. I think they did the right thing.”
Honolulu attorney Corlis Chang, representing Varian, declined comment on the settlement.
In its pretrial statement, Varian said evidence would show “a series of egregious errors during the treatment planning process that resulted in the delivery of more than twice the intended dose of radiation.”
“Cases get settled when the parties feel that’s in their best interest and wish to end the litigation, and that’s what happened here,” said Honolulu attorney Thomas Cook, who represented Pacific Cancer Institute and Baker in the lawsuit. “The Pacific Cancer Institute and Dr. Baker wish the Chichioco family all the best.”
Honolulu attorneys John Nishimoto, representing Makishi, and Kelvin Kaneshiro, representing medical physicist Joe McMahon, who was working for Pacific Cancer Institute at the time, didn’t return calls seeking comment.
Baker said what happened in Chichioco’s case “was a single incident.”
“As soon as I learned about this, I immediately instigated a thorough review of every case that had been treated here,” Baker said. “We found that in every other case, the prescription was absolutely correct.”
Since it opened in 1993, the center has treated almost 6,000 patients, Baker said.
“It provides a critical service for Maui people,” he said. “I want people to be able to know when they go to sleep at night, that they can rest assured that their treatment – whether it’s in the past or present or in the future – that the calculation and the dose is exactly as we prescribed.”
Baker said most patients are at the center daily for six to seven weeks.
“We build a relationship with our patients. We become almost like a second family to them,” he said. “This incident, when it occurred, everyone here was just devastated really. But we have certainly learned a lot. In medicine, when you do have a situation that didn’t go exactly the way you planned, it’s time to step back and really analyze that situation and learn as much from it as you can.”
Along with Tateishi, the Chichioco family was represented by the Seattle law firm of Luvera, Barnett, Brindley, Beninger & Cunningham, which has extensive experience in medical device litigation and established the case against Varian.
“The doctors made mistakes, but it started with the software,” Tateishi said.
He said Varian knew about the problem with its software, “and they didn’t inform the doctors.”
Zacarias Chichioco was referred for a radiation consultation after he was diagnosed with Stage 4 undifferentiated nasopharyngeal carcinoma on Feb. 19, 2008.
When he was diagnosed, his wife said doctors told the couple that they couldn’t do surgery because the cancer was behind his eyes, but his prognosis was good because he was a strong and healthy young man.
“They said, ‘We’re going to do radiation and chemotherapy at the same time ’cause he’s a strong guy, he can handle,’ ” Marites Chichioco recalled. “Trusting them, we said, ‘OK, let’s do it.’ “
Chichioco was athletic, active in tennis leagues and ran his own “Zach of All Trades” fix-it business. He had been maintenance department supervisor at Aston Mahana in Kaanapali, where he worked for more than 20 years.
After Chichioco was seen by Makishi for an initial radiation oncology consultation at Pacific Cancer Institute on March 3, 2008, McMahon formulated a treatment plan created using Varian’s Eclipse system, according to the lawsuit. The radiation treatment was delivered by a linear accelerator also designed by Varian.
The plan called for Chichioco to undergo five intensity modulated radiation treatments a week for a total of 35 treatments from March 17 to May 7, 2008.
During the course of the treatment, Chichioco “experienced significant problems and side effects from the treatment,” according to the plaintiffs.
“He was having progressively worsening pain, primarily in his mouth, difficulty swallowing, painful swallowing, fevers and mucositis,” the plaintiffs’ statement said. “Significantly, he was experiencing reddening of the skin and skin ulcerations/breakdown in his neck area, as well as lip lesions, weight loss, fatigue and ringing in his ears.”
On April 15, 2008, Makishi requested an evaluation to verify the radiation dose and the plan was modified and a smaller dose was implemented for the rest of Chichioco’s treatment, according to the lawsuit.
When Makishi told the Chichiocos that there might have been some overradiation, “we told him don’t worry about it,” Marites Chichioco said. “We’re thinking maybe it’s better ’cause then it killed the cancer,” she said.
After his CAT scan came back clean, “we’re happy, thought maybe it did help,” she said. “But after that it’s not healing.”
Tateishi said Baker and Makishi suggested that the family consult with a lawyer.
“I wanted to make sure that they were treated properly and fairly,” Baker said. “This case had been weighing heavily on Dr. Makishi. He had been trying to see if we could find out anything. We kept digging and digging.
“Once this came to our attention and I was able to analyze it and talk to our staff, it was clear what had occurred. I wanted to be forthright with the patient and his wife and let them know what we had discovered. We genuinely care about every patient that comes in here for treatment.”
According to the lawsuit, Varian had discovered the programming error, or “bug,” in its Eclipse treatment planning software in about May 2007. “In or around June or July 2007, a Varian committee met and concluded in part that, while unlikely, a patient could suffer catastrophic injuries or death should the bug manifest itself and a physician complete a course of radiation treatment,” the statement said.
In January 2008, Varian sent out notes about the bug in a version of its Eclipse software and how to avoid its consequences. The following month, Varian updated the Eclipse software used by Pacific Cancer Institute to the version containing the bug but didn’t provide the center with the notes about the bug and how to avoid it.
Baker said Varian had done the software upgrade the night before Chichioco’s treatment plan was formulated. While Makishi’s prescription was correct, “it just happened that this particular method of the way it was delivered resulted in that miscalculation,” Baker said.
“It was kind of a perfect storm,” he said.
In July 2008, Varian sent a bulletin to its customers “explicitly describing the bug and how to avoid it from corrupting data,” according to the lawsuit.
In January 2009, after Chichioco’s radiation treatments had ended, Pacific Cancer Institute reviewed its records and discovered the actual dose of radiation Chichioco had received was two and a half times the appropriate dose during the first 21 of his 35 radiation treatments, according to the lawsuit. Pacific Cancer Institute notified Varian about the case and in September 2009, Pacific Cancer Institute’s software was updated to fix the bug.
On Dec. 9, 2009, based on Chichioco’s case, a worldwide recall of Eclipse software was sent out and the software was fixed with an updated version over the following months. The recall notice wasn’t sent to Pacific Cancer Institute.
Chichioco died of lung cancer, Tateishi said. “Our position was that it may have been related because his system was so weakened by the overradiation,” Tateishi said. “He didn’t want to see the doctors. He didn’t want any treatment. He didn’t want to get treatment for it because he lost trust for the medical system.”
Before he died, Chichioco was unable to work, go to church or do other activities with his family, his wife said. While he had skilled nursing help six days a week, Marites Chichioco would care for him after work and sometimes go home on her lunch and other breaks when he would insist that his wife be the one to do something for him. “He lost the trust from the doctors because of what happened,” she said. “I would have to be the one.”
On Sundays, she would be the one who prepared his medication, changed his bandages and provided other care.
Unable to speak, he used a notepad to write and communicate with his family and others.
“Before Zach passed, he asked me to make sure I took care of his family,” said Tateishi, who had been the family’s lawyer even before representing them in the lawsuit. “I’m really happy we were able to do that. Tess and the kids, they don’t have to worry financially. And that’s what Zach wanted. I feel like I fulfilled a promise I made to them. Tess doesn’t have to work.”
She retired July 31 so she can be a “full-time mom.”
“It’s still so hard,” she said. “The settlement is big, but you can’t bring his life back.”
* Lila Fujimoto can be reached at email@example.com.