Theresa Bigler, of Woodway, is suing Virginia Mason Medical Center and a medical-device manufacturer after the death of her husband following a “superbug” infection. Hospital officials have reversed course to reach out to affected patients and families.
The widow of a Seattle-area man who contracted a drug-resistant “superbug” infection at Virginia Mason Medical Center is suing the hospital — and the maker of the medical scope blamed for spreading the potentially deadly bacteria.
At the same time, Virginia Mason officials have reversed course and begun notifying patients and family members who were part of an outbreak that infected 32 people between 2012 and 2014.
“In retrospect, we should have circled back to these patients about the likely source of the infection,” Dr. Gary Kaplan, the hospital’s chairman and chief executive, said Wednesday in a meeting with The Seattle Times editorial board.
In the lawsuit filed in King County Superior Court, Theresa Bigler, 59, of Woodway, seeks damages for what she says is the wrongful death of her husband, Richard Bigler, 57.
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He was one of 11 patients who died after a scope made by Olympus America was used during diagnostic and treatment procedures at Virginia Mason.
“This is just about how and why did this happen,” Theresa Bigler said. “I just want to make sure this doesn’t happen again.”
The complaint also seeks an injunction to force Virginia Mason officials to inform the other 31 patients and their families that they were involved in the outbreak.
“VMMC, contrary to its well-publicized policy of ‘transparency,’ chose not to tell the family that Mr. Bigler died due to an infection caused by a contaminated Olympus duodenoscope,” states the complaint, filed by the Luvera Law Firm of Seattle.
Health officials have said it’s not clear what role, if any, the infections played in the patients’ deaths.
The injunction would also force the hospital to report the illnesses and deaths to the Washington state Department of Health as required by law. So-called adverse events include infections transmitted by contaminated medical devices. Virginia Mason has reported no adverse events related to the superbug infections, a health-department spokesman said Wednesday.
Virginia Mason and Olympus officials declined to comment on the lawsuit.
The lawsuit is the latest move in a growing scandal over hard-to-clean medical scopes spreading dangerous bacteria among patients at hospitals nationwide. Between 2013 and 2014, the U.S. Food and Drug Administration (FDA) received reports of possible transmission of bacteria from reprocessed, or cleaned, scopes to at least 135 patients who underwent so-called ERCP procedures, or endoscopic retrograde cholangiopancreatography.
The Seattle outbreak, one of the nation’s largest, involved strains of multidrug-resistant E. coli bacteria.
It was followed by reports of seven infections, two deaths and scores of patients being notified that they’d been potentially exposed to dangerous carbapenem-resistant Enterobacteriacea, or CRE, at a Los Angeles hospital between October and January.
On Wednesday, Cedars-Sinai Medical Center in Los Angeles said four patients had been infected by a “superbug” linked to contaminated scopes between August and January. One patient died, but hospital officials said the cause was not related to the infection.
Other outbreaks have been reported in recent years in Pennsylvania, Illinois and Florida.
Virginia Mason officials initially chose not to inform patients or family members that they were involved in an outbreak linked to the tainted scopes. Patients were told they had drug-resistant infections and were treated appropriately, said hospital officials, who consulted with federal and county health experts. The source of the infection was not identified until months later, they noted, and there was no clinical benefit to contacting patients or families about a condition that had no further action or treatment.
Patients and their families learned of the outbreak through a Seattle Times story in January.
Now, however, Virginia Mason officials have begun contacting patients involved in the outbreak.
Judy Kalpakoff, 71, of Anchorage, Alaska, said she was surprised to receive a call Tuesday from Dr. Michael Gluck, Virginia Mason’s chief of medicine, about the care of her late husband, Dennis Kalpakoff. He died in October 2013 at age 70.
“He just informed me that he thought my husband had been exposed to that superbug,” Judy Kalpakoff said. “My reaction was shock. I didn’t even believe it was them at first. I’m thinking ‘Who’s playing this game with me?’ ”
Kaplan, the hospital’s chairman, said Virginia Mason’s views about reaching out to patients have evolved, but offered no further explanation. A spokesman referred reporters to the hospital’s statement: “We understand our patients and their families would prefer to get information about this from Virginia Mason. We are in the process of reaching out to ERCP patients who were treated for this multi-drug resistant bacteria, or their families, to answer any questions that they have.”
Theresa Bigler’s lawsuit seeks damages for herself and her four adult children.
FDA officials warned health providers last month that the scopes may transmit bacteria, even after meticulous cleaning and high-level disinfection. That includes the Olympus TJF-Q180V scope, which is used at Virginia Mason and across the country. More than 500,000 people receive ERCP procedures in the U.S. each year.
The device is a duodenoscope, a specialized endoscope that snakes down the throat and into the gut to diagnose and treat problems with the pancreas and bile ducts. It is not like the types of scopes used to perform colonoscopies, hospital officials emphasize.
Once Virginia Mason became aware of the problem, the hospital implemented a culture-and-quarantine process that has become a model elsewhere. Officials at the Centers for Disease Control and Prevention (CDC) said they are finalizing a new protocol that includes Virginia Mason’s system, and the ECRI Institute, a respected patient-safety group, on Tuesday recommended that all hospitals culture duodenoscopes to reduce the infections.
Hospital officials are calling for the FDA and the CDC to force manufacturers to make the devices easier to clean.
“At its core, we see this issue as related to a defective endoscope design,” Kaplan said.