Medical-scope maker Olympus hit with $6.6M verdict in superbug case

[TexasTowelie]

A Washington state jury has ordered medical-scope maker Olympus Corp. to pay a Seattle hospital $6.6 million in damages tied to a deadly superbug outbreak, and told the hospital to pay $1 million to a deceased patient’s family.

But jurors on Monday also handed the Tokyo-based manufacturing giant a key win, rejecting claims that its flagship duodenoscope was unsafe as designed.

The decision follows an eight-week trial, the first in the United States related to contaminated gastrointestinal scopes’ causing outbreaks of drug-resistant infections.

The case was filed by Theresa Bigler, 61, and her four children in connection with the August 2013 death of Richard Bigler, a pancreatic cancer patient who contracted an infection linked to a contaminated Olympus scope. The hospital, Virginia Mason Medical Center, later joined in the suit against Olympus, but the jury found that it shared some blame in the case.

Read more: http://www.philly.com/philly/business/medical-scope-maker-olympus-hit-with-6-6m-damages-verdict-in-superbug-case-20170725.html

[Docreed2003]

1. Since the article provides little in the way of medical detail...but several nuances

I'll say this:

Olympus is the largest manufacturer of endoscopic equipment in this country. I would wager that the majority of folks on this board who have had an upper or lower endoscopy had their procedures performed using an Olympus scope. As such, that company has a huge target on their head.

To the content of the story, as it is, it suggests an "outbreak of superbugs" at this Virginia hospital. The story wants you to believe that it is the fault of the manufacturer of the scope but, again I'm shootings from the hip here, since this outbreak is localized to this hospital...I'd be willing to bet that proper steps in sterilizing scopes weren't adhered to between cases, likely because they had such volume that they needed quick turnover on the scopes, which isn't an excuse. Then an outbreak of "Superbugs" takes place, a man dies as a result and everyone is looking to point blame. The lawyers, naturally, go after the big bucks and focus on the company rather than the institution that is likely at fault.

Now, that's me reading between the lines, but I think most of us could see that as well. I'll be interested to see the actual story behind this, and it will come out..it always does, and when it does I'll be happy to provide a more nuanced, medical opinion!

[TexasTowelie]

2. I think that your suspicions are certainly possible

and undoubtedly the verdict will be appealed. As an observer that has family members who are clinicians (RN and CRT) and as a stat analyst that used to process tort claim reports for the state insurance agency, I'm often surprised by the unprofessional conduct by those in the medical community. So would it be a shock that someone took shortcuts such as not properly sterilizing equpment--sadly, the answer is no.

[Docreed2003]

3. Exactly TT,

But you and I both know, in cases like this, the money is with the big corporations, not the hospitals!

I don't even know if it's unprofessionalism as much as it is: "we have x amount of scopes for today's proceduress and Dr Reed has Y amount of cases....well we better do the fastest turnaround possible to keep Dr Reed happy". I've seen this mentality in multiple centers and I bet that's what happened here! The staff cut corners to provide quick turnaround and the patients suffered as a result. When time came to point blame in the lawsuit, the lawyers do what they do, and I can't blame them because they want the biggest compensation for their patients and so they pull the manufacturer into a big lawsuit, when the real problem is the hospital catering to specialists and cutting corners on the part of staff.

[countryjake]

4. But 18 patients died at Virginia Mason Medical Ctr in Seattle

of the 39 infections at the hospital that were traced back directly to those Olympus scopes. It was not just one man nor one simple case of neglectful sterilization. It was only after the hospital put a 48 hr hold on each scope in order to culture and quarantine them that they were able to contain that infectious bacteria outbreak. And even tho the FDA never did, the Olympus manufacturer did eventually put out a recall on that particular model of scope involved in previous infections to improve design in order to make more efficient disinfection possible.

It was Virginia Mason's failure to notify those patients who were affected by the "Superbug" outbreak where this particular jury found them to be at fault.


Undisclosed Superbug Sickened Dozens at Virginia Mason ~ January 21, 2015
http://o.seattletimes.nwsource.com/html/localnews/2025515506_endoscopeoutbreakxml.html#_ga=2.65263022.1253836812.1501093952-1488297724.1501093952

Originally published February 21, 2015:
http://www.seattletimes.com/seattle-news/health/superbug-infected-spouse-at-virginia-mason-widow-told-over-a-year-later/

This week's Seattle article on the King County jury's decision:
http://www.seattletimes.com/seattle-news/health/virginia-mason-awarded-66m-in-contaminated-scope-lawsuit/

[Docreed2003]

5. Again...

I don't doubt that the infections were traced back to the scopes, in fact, I think that's exactly what happened. My point was that, while the scopes are the cause, it's not an issue with the manufacturer, rather it's an issue with the hospital and how they processed the scopes between cases. If it were truly an issue of the scopes themselves there would be widespread, across the nation infections, that's how many Olympus scopes are used, and, despite the limited recall, we haven't seen any huge recalls or issues nationwide from the scopes. For a single institution to have this big of a problem, it strongly suggests inappropriate processing of the scopes.

[countryjake]

6. Senate Investigation of Olympus begun by Sen Patty Murray ...

found that the infections linked to that specific scope were much more widespread (worldwide) than the company had reported.

Medical Device Maker Failed to Report Infections, Senate Report Says ~ by Catherine Saint Louis ~ Jan. 13, 2016

https://www.nytimes.com/2016/01/14/science/medical-device-maker-failed-to-report-infections-senate-report-says.html

Serious infections linked to poorly cleaned medical devices called duodenoscopes, used to examine the small intestine, have been more widespread than previously known, according to a Senate report released Wednesday.

The yearlong investigation was begun by Senator Patty Murray, Democrat of Washington, after a cluster of cases in Seattle. The report found that so-called closed-channel duodenoscopes, which can be difficult to clean and sterilize, were linked to at least 250 cases of antibiotic-resistant infections worldwide from 2012 to early 2015.

From January 2013 through December 2014, however, the Food and Drug Administration received just 75 reports relating to possible infection from duodenoscopes, involving roughly 135 American patients.

Manufacturers are supposed to report to the F.D.A. within 30 days of learning information that reasonably suggests a device might have contributed to a death or serious injury — including any outside the United States.

The Senate report says that by early 2013, Olympus, the Japanese maker of 85 percent of duodenoscopes used in the United States, already knew of two independent investigations in the Netherlands that found their scopes could transmit bacteria even after thorough cleaning. The company did not inform American hospitals or the F.D.A. until February 2015, the report said.

[Docreed2003]

7. "Difficult to clean and sterilize"

That's the key point. I'm not an apologist for Olympus, I'm just pointing out that a). In this case, the likelihood is that this institution cut corners in the processing of scopes because such a rate of infection would be unheard of otherwise and b). These scopes are the most used in the US. Despite the study you quoted, there has been no major recall effort or notification to providers.