Widow says Olym­pus hushed scope is­sues

A trial is un­der­way over Theresa Bigler’s law­suit, which al­leges one of the com­pany’s tainted med­i­cal de­vices led to her hus­band’s death

Los Angeles Times - - BUSINESS - By Chad Ter­hune and JoNel Alec­cia

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 in 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 that were 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.

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 5th Amend­ment right against self-in­crim­i­na­tion in de­po­si­tions late 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 this week, tear­fully re­call­ing how they thought the funny, af­fec­tion­ate hus­band, fa­ther and grand­fa­ther was beat­ing pan­cre­atic cancer di­ag­nosed in late 2012. Then he con­tracted the in­fec­tion. His wife told ju­rors Wed­nes­day 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, who lives in Wood­way out­side Seat­tle.

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 that fed­eral pros­e­cu­tors in New Jer­sey could use against Olym­pus in a pos­si­ble crim­i­nal case. Olym­pus said it’s co­op­er­at­ing with the pros­e­cu­tors, who have de­clined to com­ment on their investigation.

In his open­ing ar­gu­ment in the Seat­tle court­room, plain­tiff’s at­tor­ney David Beninger said the com­pany put sales ahead of safety to achieve mar­ket dom­i­nance. Olym­pus con­trols 85% 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. The Seat­tle hospi­tal said the pa­tients who died had other un­der­ly­ing ill­nesses. Bigler, a small­busi­ness owner who loved the out­doors, had been bat­tling pan­cre­atic cancer when he un­der­went a scope pro­ce­dure in 2013.

Olym­pus at­tor­ney Mark An­der­son de­fended the com­pany’s scope as a med­i­cal break­through and cast blame on the hospi­tal for fail­ing to fol­low the com­pany’s 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 pri­mar­ily on Susumu Nishina. He told the com­pany’s U.S. man­agers in Fe­bru­ary 2013 not to is­sue a broad warn­ing to Amer­i­can 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.

Nishina and the two other ex­ec­u­tives who de­clined to tes­tify, Hisao Yabe and Hiroki Moriyama, hold top roles in reg­u­la­tory af­fairs, qual­ity as­sur­ance or med­i­cal man­u­fac­tur­ing. All three have de­clined to com­ment.

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

“I found there was com­pletely in­ad­e­quate pre­mar­ket val­i­da­tion test­ing. It was essen­tially noth­ing, in my opin­ion,” Wil­liam Ru­tala, an in­fec­tion-con­trol ex­pert at the Univer­sity of North Carolina, told the jury.

Ru­tala has served as an ex­pert wit­ness for Olym­pus in the past dur­ing lit­i­ga­tion in­volv­ing other types of scopes. He said that the com­pany asked him twice to tes­tify on its be­half for this trial but that he re­fused be­cause of the com­pany’s fail­ure to en­sure pa­tient safety.

“I have been de­ceived. I thought there were mean­ing­ful data as­so­ci­ated with [re­pro­cess­ing] val­i­da­tion,” Ru­tala tes­ti­fied. “This de­vice was in­trin­si­cally de­fec­tive.”

Other doc­u­ments re­leased at the trial 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. Dur­ing the trial, a com­pany of­fi­cial said there was no ev­i­dence of in­fec­tion or other de­vices be­com­ing con­tam­i­nated so Olym­pus didn’t re­port the mat­ter to fed­eral reg­u­la­tors.

Out­breaks at Euro­pean and U.S. hospi­tals started to oc­cur soon af­ter.

In 2012, af­ter an out­break at a Dutch hospi­tal, an in­de­pen­dent ex­pert hired by Olym­pus and the hospi­tal con­cluded in a re­port 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 all of its scopes if sim­i­lar prob­lems turned up.

Nishina dis­puted many of the ex­pert’s find­ings in his own 2012 re­port, re­leased pub­licly for the first time as ev­i­dence in this case.

The Olym­pus ex­ec­u­tive said the en­gi­neer’s re­port in­cludes “many un­sci­en­tific views, and isn’t valu­able to be trusted.” Nishina said the ex­pert has a “prej­u­diced imag­i­na­tion” and “the en­do­scope has been con­firmed to be suf­fi­ciently re­pro­cess­able fol­low­ing the in­struc­tion man­ual,” ac­cord­ing to the re­port.

By 2013, Olym­pus ex­ec­u­tives in the U.S. were com­plain­ing in­ter­nally about Tokyo’s re­sponse to the in­fec­tions, ac­cord­ing to com­pany doc­u­ments filed in court. Some U.S. hospi­tals and clinics had asked about a safety alert the com­pany 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,” Laura Storms, vice pres­i­dent of reg­u­la­tory and clin­i­cal af­fairs in Cen­ter Val­ley, Pa., wrote in a Feb. 6, 2013, email to a U.S. col­league that was in­tro­duced as ev­i­dence.

“There­fore, it places us in an awk­ward po­si­tion,” she added. “How­ever, 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 Olym­pus’ chief de­fender dur­ing sev­eral days on the wit­ness stand.

She em­pha­sized that the com­pany thor­oughly in­ves­ti­gated each re­port of con­tam­i­na­tion or in­fec­tion and reg­u­larly sent com­pany em­ploy­ees to hospi­tals to pro­vide train­ing and tech­ni­cal as­sis­tance.

But Beninger, the plain­tiff’s at­tor­ney, pressed Storms as to why she didn’t tell doc­tors at Vir­ginia Ma­son about pre­vi­ous out­breaks in the Nether­lands, France, Ger­many, New York, Wis­con­sin, Mas­sachusetts and Penn­syl­va­nia that had al­ready been re­ported to Olym­pus.

“I told them we did have com­plaints,” Storms said.

The Bigler family

RICHARD BIGLER and his wife Theresa with their grand­chil­dren in June 2013. He was one of at least 35 pa­tients in U.S. hospi­tals to have died since 2013 af­ter de­vel­op­ing in­fec­tions tied to Olym­pus duo­deno­scopes.

Robert Gau­thier Los An­ge­les Times

AN OLYM­PUS duo­deno­scope is cleaned at Los An­ge­les County-USC Med­i­cal Cen­ter in 2015.

Chad Ter­hune Kaiser Health News

A POSTER BOARD shows the three Olym­pus ex­ec­u­tives who de­clined to ap­pear at the Seat­tle trial.

Robert Gau­thier Los An­ge­les Times

IN 2012, af­ter an out­break at a Dutch hospi­tal, an in­de­pen­dent ex­pert con­cluded that the Olym­pus scope’s de­sign could al­low blood and tis­sue to be­come trapped.

The Bigler family

THERESA BIGLER at Vir­ginia Ma­son Med­i­cal Cen­ter in Seat­tle in Au­gust 2013 with her hus­band.

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