CONTACTS
SUBJECTS
Default Null Subject Account for Blank Record
0403 -
0403 - ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 32 0000. ref SDS 31 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040508 - ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - National reporting by CNBC today says...
040902 -
040903 - 35 deaths linked to scope infections after Olympus told execs
040904 - not to warn hospitals
040905 -
040906 - http://www.cnbc.com/2016/07/25/35-deaths-linked-to-scope-infections-after-olympus-told-execs-not-to-warn-hospitals.html
040907 -
040908 - Dan Mangan @_DanMangan
040909 - Monday, 25 Jul 2016 | 12:04 PM ET
040911 - ..
040912 - Don't tell ? unless they ask.
040914 - ..
040915 - Thirty-five people died in the United States after contracting
040916 - infections from contaminated medical scopes made by Olympus
040917 - Corp. in the years after a company official told American
040918 - executives not to issue widespread warnings to U.S. hospitals
040919 - "about potentially deadly infections from tainted medical
040920 - scopes," a new report says.
040922 - ..
040923 - That decision not to proactively issue warnings to US hospitals
040924 - was made despite the fact that Tokyo-based Olympus ? which
040925 - controls 85 percent of the American gastrointestinal scope
040926 - market ? was already warning European customers that a scope
040927 - made by the company had a risk of contamination after two dozen
040928 - infections were reported in hospitals in France and Holland,
040929 - according to the joint Los Angeles Times and Kaiser Health News
040930 - story that cited internal company emails.
040931 -
040933 - ..
040934 - An Olympus vice president in Pennsylvania in January 2013,
040935 - knowing about the cases in Europe, and also knowing that
040936 - Olympus was investigating a similar case in a Pittsburgh
040937 - hospital, asked in an email, "Should [we] also be
040938 - communicating to our users the information that [Olympus
040939 - Europe] is communicating to their European users?"
040941 - ..
040942 - Olympus's chief manager for market quality administration in
040943 - Tokyo in a Feb. 6, 2013, email, replied to that query.
040945 - ..
040946 - "Although it is not need[ed] to communicate to all the users
040947 - actively, you should communicate with the user who has asked a
040948 - question" wrote the manager, Susumu Nishina, according to the
040949 - email linked in the L.A. Times/Kaiser story.
040951 - ..
040952 - Nishina's email continued, telling the American vice president
040953 - that Olympus' "risk assessment" had indicated that that risk
040954 - was "acceptable."
040956 - ..
040957 - The story noted that in the three years after that email, at
040958 - least 35 people have died in American hospitals after
040959 - contracting infections from contaminated Olympus scopes.
040961 - ..
040962 - And the article said, "At the time of the safety alert in
040963 - Europe, Olympus was already aware that design flaws could make
040964 - it difficult to clean its duodenoscope for the next patient.
040965 - Used in about 700,000 procedures annually in the U.S., the
040966 - snake-like device is put down a patient's throat to diagnose
040967 - and treat problems in the digestive tract such as cancers and
040968 - blockages in the bile duct."
040970 - ..
040971 - Olympus only announced a U.S. recall of its duodenoscopes,
040972 - which is expected to be completed by next month, this past
040973 - January.
040975 - ..
040976 - The emails, and others cited in the article, are contained in
040977 - a court case file in Pennsylvania, where a patient is suing
040978 - Olympus, which also is under investigation by federal
040979 - prosecutors in New Jersey.
040981 - ..
040982 - Olympus declined to comment on the emails for the story,
040983 - citing pending litigation.
040985 - ..
040986 - The article said that Olympus, in a statement said, "patient
040987 - safety is our top priority. The duodenoscope issue continues
040988 - to receive the highest level of attention at Olympus, and we
040989 - remain committed to working with the proper authorities and
040990 - our stakeholders to understand and address the potential root
040991 - causes."
040993 - ..
040994 - The company has not yet responded to CNBC's request for
040995 - comment.
040996 -
040998 - ..
040999 - Another version of this article is....
041000 -
041001 - Los Angeles Times
041002 -
041003 - Olympus told its U.S. executives no warning about tainted
041004 - medical scopes was needed, despite superbug outbreaks
041005 -
041006 - http://www.latimes.com/business/la-fi-olympus-scopes-emails-20160721-snap-story.html
041007 -
041008 - By Chad Terhume
041009 - July 24, 2016 3:00 AM
041011 - ..
041012 - Faced with superbug outbreaks in three countries by early 2013,
041013 - Japanese device giant Olympus Corp. told U.S. executives not to
041014 - issue a broad warning to American hospitals about potentially
041015 - deadly infections from tainted medical scopes, internal emails
041016 - show.
041018 - ..
041019 - After two dozen infections were reported in French and Dutch
041020 - hospitals, the company alerted European customers in January
041021 - 2013 that a scope it manufactured could become contaminated.
041023 - ..
041024 - A top Olympus executive in the U.S. grew concerned because the
041025 - company was investigating a similar outbreak at a Pittsburgh
041026 - hospital.
041027 -
041028 - "Should [we] also be communicating to our users the
041029 - information that [Olympus Europe] is communicating to their
041030 - European users?" Laura Storms, vice president of regulatory and
041031 - clinical affairs in Center Valley, Pa., asked in an email to
041032 - Tokyo headquarters on Jan. 31, 2013.
041034 - ..
041035 - No, that?s not necessary, said Susumu Nishina, the company?s
041036 - chief manager for market quality administration in Tokyo in a
041037 - Feb. 6, 2013, reply.
041039 - ..
041040 - It is ?not need[ed] to communicate to all the users actively,?
041041 - Nishina wrote, because a company assessment of the risk to
041042 - patients found it to be ?acceptable.? However, he added that
041043 - Storms should respond to questions from a customer.
041045 - ..
041046 - Outbreaks of infection at hospitals in Los Angeles, Milwaukee,
041047 - Denver and other cities followed over the next three years.
041048 - All told, at least 35 people at U.S. hospitals have died since
041049 - 2013 - three of them at UCLA's Ronald Reagan Medical Center -
041050 - after suffering infections from contaminated gastrointestinal
041051 - scopes manufactured by Olympus, according to hospitals and
041052 - public health officials.
041054 - ..
041055 - Olympus' actions - and inaction - are being closely examined in
041056 - lawsuits by American patients and their families who contend
041057 - that the manufacturer was negligent and might have prevented
041058 - the outbreaks and deaths had it been more forthcoming. In
041059 - addition, federal prosecutors are investigating Olympus?
041060 - handling of the infections ? and the emails could become
041061 - crucial evidence in any future case.
041063 - ..
041064 - The company's internal emails reveal conflicts inside Olympus
041065 - over how to respond to a growing threat to patient safety,
041066 - pitting U.S. executives against their superiors in Japan who
041067 - had the final say. The emails were filed in a Pennsylvania
041068 - court this month as part of a patient lawsuit and obtained by
041069 - Kaiser Health News working in collaboration with the Los
041070 - Angeles Times.
041072 - ..
041073 - Olympus, which controls 85% of the U.S. market for
041074 - gastrointestinal scopes, declined to comment on the emails,
041075 - citing the pending litigation. It also declined to discuss the
041076 - ongoing investigation by the US attorney's office in New
041077 - Jersey.
041079 - ..
041080 - Storms, Nishina and other company officials named in the emails
041081 - didn't respond to requests for comment.
041083 - ..
041084 - Read the Olympus internal emails
041086 - ..
041087 - In a statement, the company said "patient safety is our top
041088 - priority. The duodenoscope issue continues to receive the
041089 - highest level of attention at Olympus, and we remain committed
041090 - to working with the proper authorities and our stakeholders to
041091 - understand and address the potential root causes." The company
041092 - declined to address why it didn't feel it was necessary to
041093 - inform U.S. hospitals when it was alerting those in Europe.
041095 - ..
041096 - At the time of the safety alert in Europe, Olympus was already
041097 - aware that design flaws could make it difficult to clean its
041098 - duodenoscope for the next patient. Used in about 700,000
041099 - procedures annually in the U.S., the snake-like device is put
041100 - down a patient's throat to diagnose and treat problems in the
041101 - digestive tract such as cancers and blockages in the bile
041102 - duct.
041104 - ..
041105 - Progress Notes for EDG Dilation Procedure on 151204 says in part...
041106 -
041107 - After a bite block was placed in the patient's mouth, an
041108 - Olympus GIF-H180J video gastroscope was advanced under
041109 - direct vision into the esophagus. ref SDS 18 P66H
041111 - ..
041112 - Patient had another EGD dilation with conscious sedation on 160617,
041113 - and afterwards experienced stroke symptoms. ref SDS 19 5F6F
041115 - ..
041116 - The next day, Doctor Yoo reported MRA found large area of inflammation
041117 - covering the brain, reported on 160618 0800, ref SDS 20 MX8L At that
041118 - time the doctor said this condition could be caused by...
041119 -
041120 - 1. Bacteria
041121 - 2. Virus infection
041122 - 3. Tumor/cancer growth
041124 - ..
041125 - Research a few days later on 160621 found...
041126 -
041127 - Infectious complications related to diagnostic endoscopy
041128 - result either from the procedure itself or from the use of
041129 - contaminated equipment. Transient bacteremia may occur
041130 - during a diagnostic endoscopic procedure and is found more
041131 - often for therapeutic procedures. The incidence is
041132 - relatively low and the rate of bacterial endocarditis or
041133 - other complications in patients not at risk for
041134 - endocarditis (e.g. normal cardiac valves) is extremely low
041135 - and estimated to be 1 in 5 to 10 million. ref SDS 24 UQ8O
041137 - ..
041138 - Seems like a matter that should be considered for upgrading
041139 - performance at VA GI Clinics. This should be cleared before Neurology
041140 - clears patient for another EGD dilation scheduled on 160909,
041141 - previously submitted to Doctor Lee in a letter from Doctor Yoo on
041142 - 160715 1630. ref SDS 27 MO6F
041144 - ..
041145 - Article continues...
041146 -
041147 - As The Times reported in December, an investigator hired by
041148 - Olympus and a Netherlands hospital concluded in a June 2012
041149 - report that the scope's design could allow blood and tissue to
041150 - become trapped, spreading bacteria from one patient to another.
041151 - The independent expert called on Olympus to conduct a worldwide
041152 - investigation and recall all its scopes if similar problems
041153 - turned up.
041155 - ..
041156 - A Senate report released this year said Olympus knew about at
041157 - least three outbreaks - at hospitals in the Netherlands,
041158 - France and Pittsburgh - affecting an estimated 46 patients
041159 - when the European alert went out in early 2013.
041161 - ..
041162 - Inside Olympus, the debate about how to respond to the emerging
041163 - outbreaks in the U.S. came to a head on Feb. 6, 2013, the
041164 - emails show.
041166 - ..
041167 - Just a few hours after her exchange with the Tokyo official,
041168 - Storms was confronted by her own U.S staff.
041170 - ..
041171 - Read Olympus' legal response
041172 -
041173 - http://documents.latimes.com/olympus-legal-response-patient-lawsuit/
041175 - ..
041176 - Donny Shapiro, a director of regulatory affairs for Olympus in
041177 - San Jose, Calif., sent an email to Storms and seven other
041178 - employees with "Duodenoscope safety recall??" in the subject
041179 - line. He cited the problems in Europe and results from the
041180 - company's microbiology lab showing Olympus scopes had tested
041181 - positive for bacteria at the University of Pittsburgh Medical
041182 - Center.
041183 -
041184 - "Why was the alert only issued in Europe?" Shapiro asked his
041185 - colleagues.
041187 - ..
041188 - Six minutes later, Storms wrote back: "Donny, [Olympus Japan]
041189 - has determined that a global communication is not required."
041191 - ..
041192 - In these emails, Storms seemed to accept the decision by the
041193 - corporate office. But in other messages to headquarters that
041194 - same day, she challenged Japan executives' handling of the
041195 - investigation into the University of Pittsburgh Medical
041196 - Center, or UPMC, outbreak. The hospital initially linked one
041197 - contaminated scope to 18 sickened patients but later
041198 - downgraded that total to one case.
041200 - ..
041201 - In a follow-up email to Nishina, Storms questioned the
041202 - company's determination that the hospital was at fault by
041203 - failing to clean the scopes properly - known as "insufficient
041204 - reprocessing."
041206 - ..
041207 - "Can you please explain how OMSC [Olympus Japan] reached the
041208 - conclusion that insufficient reprocessing was the cause for
041209 - this MDR [medical device injury report]? Since OMSC was not
041210 - on-site at UPMC and did not investigate this facility, how is
041211 - OMSC reaching this conclusion?" she asked.
041212 -
041213 - "Specifically what evidence does OMSC have that supports
041214 - inadequate reprocessing by UPMC? You do not cite any objective
041215 - findings, testing, etc. for this endoscope model," Storms
041216 - wrote.
041218 - ..
041219 - Nishina replied that the company?s cleaning instructions work
041220 - when followed and "no major observations were noted during the
041221 - inspection" of the scope in question. In the emails, he
041222 - discounted lab results showing bacterial growth on Olympus
041223 - scopes, suggesting that contaminants could have been
041224 - introduced during testing.
041226 - ..
041227 - This became the company's standard response in the US after
041228 - each outbreak over the next two years, according to federal
041229 - injury reports, company documents and interviews with
041230 - hospitals. Olympus contended that its scopes did not cause the
041231 - infections and blamed the hospitals for not cleaning the
041232 - reusable instruments properly. The company treated each case
041233 - as an isolated incident, not telling hospitals about outbreaks
041234 - elsewhere in the US.
041236 - ..
041237 - Pressure on the company increased in January 2014 when
041238 - physicians representing the American Society for
041239 - Gastrointestinal Endoscopy asked Olympus to fund testing at
041240 - hospitals on the effectiveness of scope cleaning against
041241 - antibiotic-resistant bacteria. Though Olympus months later
041242 - contributed to the research, the initial response was cautious.
041244 - ..
041245 - In Tokyo, Shigeki Okuno, who worked in regulatory affairs and
041246 - quality assurance, expressed concern about getting a "negative
041247 - result" because of improper testing procedures. Okuno
041248 - suggested that the company have a hand in the testing by
041249 - providing the data itself or working closely with the medical
041250 - society.
041252 - ..
041253 - In March 2014, an infection-control expert at the University of
041254 - North Carolina raised more red flags in an email to Olympus,
041255 - according to the correspondence filed in court.
041257 - ..
041258 - William Rutala, a UNC professor of infectious diseases,
041259 - notified the company that 40% of scopes tested at his academic
041260 - medical center were contaminated, even after following the
041261 - company's cleaning protocol.
041263 - ..
041264 - "This is a critical issue for US hospitals to
041265 - resolve/understand to ensure patient safety and I need your
041266 - input," Rutala wrote to Mary Ann Drosnock, head of infection
041267 - control at Olympus in the US at the time. "Despite substantial
041268 - time and effort we have been unable to discover the exact cause
041269 - of these positive cultures and implement a strategy to prevent
041270 - contamination."
041272 - ..
041273 - Drosnock shared the information with officials at Olympus under
041274 - the subject line "Urgent: Confidential."
041276 - ..
041277 - Rutala declined to comment for this story on the test results
041278 - at North Carolina or the company's response.
041280 - ..
041281 - The US Food and Drug Administration began looking into reports
041282 - of scope-related infections in September 2013. By May 2014,
041283 - the government investigation was intensifying and the agency
041284 - requested information from Olympus on a "potential safety
041285 - concern involving infections," according to FDA records and the
041286 - company emails.
041288 - ..
041289 - Storms forwarded the notice to the Tokyo headquarters and
041290 - labeled it "urgent."
041291 -
041292 - "I am respectfully requesting that [Olympus Japan] assign
041293 - their best English writers to work on this letter draft," she
041294 - wrote in her email. "Please give this FDA letter urgent
041295 - priority. This letter is a clear indication of the FDA?s
041296 - concern."
041298 - ..
041299 - As Olympus carried out its decision not to warn American
041300 - hospitals, the number of patient infections linked to dirty
041301 - scopes continued to climb. Overall, as many as 350 patients at
041302 - 41 medical facilities worldwide were infected or exposed to
041303 - contaminated scopes made by Olympus or two other companies from
041304 - January 2010 to October 2015, according to the FDA.
041306 - ..
041307 - Eventually, in February 2015 - more than two years after
041308 - Olympus first warned European hospitals ? the FDA issued a
041309 - safety alert saying that patients had become infected even when
041310 - the manufacturer's cleaning instructions were followed
041311 - correctly.
041313 - ..
041314 - At the same time, Olympus notified customers that it was aware
041315 - of 95 infection complaints in the U.S. about its newest
041316 - duodenoscope model, and the scope required "careful attention
041317 - to cleaning."
041319 - ..
041320 - The FDA alert came one day after an outbreak was reported at
041321 - UCLA's Ronald Reagan Medical Center. Three patients died and
041322 - five more were sickened after being treated with Olympus
041323 - scopes there, according to UCLA. The university said one of
041324 - the patients who died also had cancer.
041326 - ..
041327 - Olympus didn't announce a US recall of its duodenoscopes until
041328 - January 2016 - two days after a congressional report
041329 - criticized the company for failing to notify patients, doctors
041330 - and hospitals sooner about a serious safety hazard.
041332 - ..
041333 - The Olympus devices remain on the market and in use while the
041334 - company recalls them for repairs. The recall is expected to be
041335 - completed nationwide next month.
041337 - ..
041338 - Some doctors and researchers say the problems will persist
041339 - unless Olympus completely redesigns the duodenoscope to keep
041340 - bacteria from becoming trapped in tiny crevices at the tip.
041342 - ..
041343 - In the meantime, US hospitals are trying a variety of new
041344 - cleaning and surveillance methods to prevent more infections.
041346 - ..
041347 - And patients are continuing to wage their legal fight against
041348 - Olympus. The internal emails were filed in the pending
041349 - Philadelphia County Court case of Daniel Nietzold, a patient in
041350 - Gastonia, N.C.
041352 - ..
041353 - Nietzold, who sued Olympus in February for negligence, said he
041354 - was exposed to a contaminated scope during multiple procedures
041355 - at Carolinas Medical Center in Charlotte between January 2013
041356 - and July 2015. The hospital declined to comment.
041358 - ..
041359 - The company is fighting Nietzold in court, saying Nietzold had
041360 - "failed to allege particular facts." This month, the
041361 - Philadelphia judge dismissed the Japanese headquarters as a
041362 - defendant on jurisdictional grounds but allowed the case to
041363 - proceed against the company?s US unit.
041365 - ..
041366 - Pete Kaufman, a Los Angeles attorney representing Nietzold and
041367 - nearly 20 other patients in scope-related lawsuits around the
041368 - country, said the internal documents show that Olympus knew
041369 - patients were in jeopardy but chose not to act.
041371 - ..
041372 - Charles McIntyre of Waxhaw, NC, another Kaufman client, said he
041373 - suffered a superbug infection after being treated with an
041374 - Olympus scope in February 2015 at the Charlotte hospital. The
041375 - 61-year-old auto mechanic, who sued the device maker earlier
041376 - this year in Philadelphia, said he's still struggling to regain
041377 - his strength after spending much of last year in the hospital
041378 - fighting the infection.
041380 - ..
041381 - "Olympus had plenty of time to tell everybody in the US that
041382 - they had an issue with the scope,? McIntyre said. "I feel
041383 - betrayed."
041385 - ..
041386 - Chad Terhune is a senior correspondent with California
041387 - Healthline, a service of the California Health Care
041388 - Foundation published by Kaiser Health News.
041389 -
041390 - eterhune@kff.org
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