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Sunday, 02/22/2015 10:20:26 AM

Sunday, February 22, 2015 10:20:26 AM

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‘Superbug’ infected spouse at Virginia Mason, widow told over a year later
Originally published February 21, 2015 at 6:46 pm Updated February 21, 2015 at 8:35 pm
By JoNel Aleccia
Seattle Times health reporter



Losing her husband to pancreatic cancer in August 2013 — six days shy of their 35th wedding anniversary — was wrenching enough, said Theresa Bigler.

But learning now, more than a year later, that Rick Bigler, 57, was also part of a “superbug” outbreak at Virginia Mason Medical Center, the Seattle hospital that treated him, is beyond heartbreaking.

Officials there say contaminated medical scopes spread drug-resistant bacterial infections to 32 people, including 11 who died.

“Initially, I kind of felt like I was kicked in the gut,” said Bigler, 59, of Woodway, south of Edmonds. “It was quite shocking and surprising.”

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Worse, she found out about the outbreak by reading a Seattle Times story last month about the problem. Only when she requested her husband’s medical records and then demanded direct answers from Virginia Mason did the hospital’s chief of medicine, Dr. Michael Gluck, confirm her fears, she said. None of the deaths has been linked directly to the infection, but questions remain.

“He was very kind and sympathetic,” said Bigler. “But I wish I didn’t have to be the one to call them.”

For Bigler and her large family — three daughters, a son, six grandchildren — the loss has been compounded by growing concerns about a widely used endoscopy tool now linked to similar outbreaks nationwide.

“It’s tough to think we could have had more time with him if this didn’t happen,” she said.

Rick Bigler, an insurance executive from Woodway, was diagnosed with pancreatic cancer in November 2012. He was doing fine — working part time, visiting grandchildren, sitting in the sun in his lush backyard — when he developed a blocked bile duct in the summer of 2013.

Like some 500,000 patients each year in the U.S., he was advised to undergo endoscopic retrograde cholangiopancreatography, or ERCP, a procedure that snakes a scope down the throat and into the gut to view and treat problems with the pancreatic and bile ducts.

Within a week of undergoing the treatment, Bigler developed complications, including what the family said doctors described as an E. coli infection. Within two weeks he died. “It just seemed like it went way too fast,” said Bigler’s eldest daughter, Stephanie Burrell, 34.

ERCP procedures increasingly have been associated with such infections. Last week, officials at UCLA Ronald Reagan Medical Center in Los Angeles reported that seven ERCP patients were infected, two died and scores more may have been exposed to drug-resistant germs known as carpabenem-resistant Enterobacteriaceae, or CRE, transmitted by the specialized scopes.

That follows the Seattle outbreak, apparently the largest so far in the nation, which occurred between November 2012 and March 2014, but was first announced at an infectious-disease conference in October. Investigators detected some strains of carbapenem-resistant bacteria but also multidrug-resistant E. coli bacteria known as hyper-AmpC producers, or HACs. Additional CRE outbreaks, marked by more virulent bacteria, have been detected in Chicago, Pittsburgh and Philadelphia in the past few years.

In all cases, the bacteria have been traced to the devices known as duodenoscopes, which have hard-to-clean components on the distal, or far end. Virginia Mason doctors found that even after the devices were cleaned according to manufacturers’ directions, they remained contaminated with the potentially deadly bacteria.

It was only after hospital officials said they implemented a special protocol in which duodenoscopes are cleaned, cultured for bacteria and then held for 48 hours to ensure that they’re clean that the rising numbers of superbug infections stopped.

“There have been no known new cases of bacterial infections associated with the ERCP procedure,” said Gale Robinette, a Virginia Mason spokesman.

After the Virginia Mason outbreak was disclosed, Sen. Patty Murray, D-Wash., sent a letter to Food and Drug Administration Commissioner Dr. Margaret Hamburg, urging the agency to finalize cleaning guidelines and step up tracking of infections tied to the devices. Murray is the senior Democrat on the Senate health committee.

FDA officials last week issued a warning about the ERCP scopes, telling health professionals and patients that the complex design of the devices may make them difficult to clean thoroughly, even when manufacturers’ instructions are followed correctly.

But the FDA stopped short of recalling the devices or advising any new procedures to ensure sterilization, noted Lawrence Muscarella, a Philadelphia infection-control expert who has been monitoring the agency for the ERCP problem for years.

“It clearly looks the like FDA panicked and released it because it looked like a tipping point had been reached,” Muscarella said. “It makes no sense. It’s a useless warning.”

Another problem has been the reluctance of many hospitals to tell patients when they may have been harmed by the devices, Muscarella said.

In Seattle, Virginia Mason leaders and officials with Public Health — Seattle & King County said they declined to inform patients or the public, in part because there wasn’t a wider health risk.

“Appropriate corrective actions had already been put in place,” said Dr. Jeffrey Duchin, interim local health officer for King County.

In contrast, UCLA officials reached out to 180 people who may have been exposed to two contaminated endoscopes between Oct. 3, 2014, and Jan. 28, 2015, according to a hospital statement.

Virginia Mason officials said the situations were different because the Seattle outbreak evolved over time and wasn’t clearly linked to specific devices early on. All patients who developed bacterial infections after ERCP procedures were informed they had infections and received “appropriate and timely” medical treatment, the hospital spokesman said.

That response wasn’t enough for Theresa Bigler, who said she spoke to Gluck earlier this month. Virginia Mason officials wouldn’t confirm that Gluck told Bigler about her husband’s condition, citing federal privacy laws.

Bigler and her children have met with a lawyer, but haven’t decided whether to pursue legal action against Virginia Mason. Most of all, she said, she wishes she’d known the truth from the start.

“We should have been told,” she said. “We would have tried to go somewhere else if we knew this was a problem.”

Growing awareness that contaminated ERCP devices can spread deadly infections is good, experts said. Duchin said he applauds the FDA’s safety warning as a first step toward more detailed guidance.

Muscarella said he hopes the attention pushes manufacturers and the agency closer to the goal of redesigning the tools entirely.

But for the family of Rick Bigler, whose kids recalled him as “a jokester,” an outdoorsman and a die-hard Seattle Seahawks fan, the attention has come too late. Bigler’s brother had been diagnosed with pancreatic cancer two years earlier — and he has survived, Theresa Bigler said.

Who knows how long her husband may have lived, she wonders, if he hadn’t developed the superbug infection?

“He is missed each and every day,” she said. “There was so much we wanted to do and to say to each other.”

JoNel Aleccia at 206-464-2906 or jaleccia@seattletimes.com Twitter @JoNel_Aleccia

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