Scoping Out Infections

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Richard and Theresa Bigler with grandchildren in June 2013. Her suit alleges his death was caused by an infection related to an Olympus Corp. duodenoscope during cancer treatment. The company, with a North American base north of Philadelphia, defends the scope and accuses the hospital of improper cleaning.

SEATTLE - Three executives from Japan loom large in a cramped courtroom here - at least their photos do, mounted on a white poster board propped in front of the jury.

"They were the key decision-makers," one attorney said during opening arguments to a lawsuit brought by a local widow against a giant Tokyo-based medical-device maker.

Theresa Bigler's case is the first to go to trial in the U.S. stemming from a series of deadly superbug outbreaks across the country linked to contaminated medical scopes. She is suing Olympus Corp., claiming that one of its tainted devices caused the infection that led to her husband's death in August 2013. Olympus' North American headquarters are in Center Valley, Pa., 50 miles north of Philadelphia.

The Olympus executives, her attorneys say, remained silent for too long about a design flaw that hindered cleaning of these reusable scopes.

The executives, however, will not be testifying. "Each is currently under criminal investigation and would potentially risk their freedom to attend," Olympus said in a May 22 court filing. Each executive invoked his Fifth Amendment right against self-incrimination in depositions last year in Tokyo.

Richard Bigler, 57, was one of at least 35 patients in U.S. hospitals to have died since 2013 after developing infections tied to Olympus duodenoscopes - flexible, lighted tubes used to peer deep inside the body. More than 25 patients and families, from California to Pennsylvania, have sued Olympus alleging wrongful death, negligence, or fraud.

Several members of Bigler's family testified last week, tearfully recalling how they thought the funny husband, father, and grandfather was beating pancreatic cancer diagnosed in late 2012 - then he contracted the infection. His wife told jurors last week that he declined so rapidly, neither she nor her four children had a chance to say goodbye.

Only months later, when she read a newspaper account of an outbreak of drug-resistant infections blamed on the scopes, did she realize what had happened and confirm it with the Seattle hospital, Virginia Mason Medical Center, said Bigler.

In California, Ronald Reagan UCLA Medical Center and Huntington Hospital in Pasadena have reported lethal infections linked to Olympus scopes.

The Seattle case may serve as a bellwether for future litigation. It also offers a preview of the evidence federal prosecutors in New Jersey could use against Olympus in a possible criminal case. Olympus said it's cooperating with prosecutors, who have declined comment.

In opening arguments in Seattle, plaintiff's attorney David Beninger said the company put sales ahead of safety to achieve market dominance. Olympus controls 85 percent of the U.S. market for gastrointestinal scopes.

It's a "don't ask, don't tell policy," Beninger said. "Keep selling, no telling."

At Virginia Mason Medical Center, 39 people were infected from contaminated Olympus scopes and 18 of them died.

Olympus attorney Mark Anderson defended the company's scope as a breakthrough and blamed the hospital for failing to follow cleaning instructions.

"Mr. Bigler missed out on life events as a result of the care he got at that hospital. . . . There is an issue about whether they were properly cleaning these scopes. But no, the data doesn't show that it is a product defect," Anderson told the jury.

An investigation by federal, state, and county officials concluded that Virginia Mason followed proper cleaning procedures. In an unusual strategy, the hospital and Bigler family have teamed up against Olympus at trial and both sides are seeking damages.

The hospital and the family have focused on the executive on the left of the plaintiffs' poster board, Susumu Nishina. He told the company's U.S. managers in February 2013 not to issue a broad warning to U.S. hospitals despite reports of scope-related infections in Dutch, French, and U.S. hospitals, internal emails show. Those emails, introduced as evidence in the trial, were first reported in July 2016 by Kaiser Health News and the Los Angeles Times.

An expert witness last week testified that Olympus would have realized its scopes were defective if it had sufficiently tested its cleaning and disinfection process before selling the devices in 2010.

"There was completely inadequate premarket validation testing. It was essentially nothing," William Rutala, an infection-control expert at the University of North Carolina, told the jury.

An expert witness for Olympus in other cases, Rutala said the company asked him twice to testify in this trial but he refused because of the company's failure to ensure patient safety.

"I have been deceived," Rutala testified. "This device was intrinsically defective."

Other documents show that Olympus received a complaint from Virginia Mason as early as January 2011 about "patient debris" trapped inside the tip of the scope that was "extremely difficult" to remove. Outbreaks at European and U.S. hospitals occurred soon after.

In 2012, after an outbreak at a Dutch hospital, an independent expert hired by Olympus and the hospital concluded that the scope's design could allow blood and tissue to become trapped, spreading bacteria from one patient to the next. The expert's report called on Olympus to conduct a worldwide investigation and recall its scopes if similar problems occurred.

Nishina disputed many of the expert's findings in his 2012 report, saying the expert had a "prejudiced imagination."

Olympus records at trial showed that Cooper University Hospital in Camden had three infections from 2010 to 2015. A spokesman said executives have no knowledge of the three infections cited by Olympus.

By 2013, Olympus' U.S. executives were complaining internally about Tokyo's response to the infections, documents showed. Some U.S. hospitals and clinics had asked about a safety alert Olympus issued to European customers that year.

"I was pushing [Olympus Japan] to take a position on this EU [European Union] action, but as you can see from my communications with [Japan], they feel that no universal communication is required," wrote Laura Storms, vice president of regulatory and clinical affairs in Center Valley, Pa., in 2013. "This is part of the bigger problem, in my viewpoint, of lack of leadership and direction from [Olympus Japan]."

With the Tokyo executives absent, however, Storms has been the company's chief defender during several days on the witness stand.

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.