A Washington state jury has ordered Olympus to pay $6.6 million to Virginia Mason Medical Center in connection with a deadly superbug infection outbreak linked to duodenoscopes manufactured by the company; which will include $1 million to be paid to the family of one of the victims.
The verdict was handed down on Monday, in King County Superior Court, according to a report in the Seattle Times.
The lawsuit was filed by the family of Richard Bigler, who died in August 2013, after contracting a carbapenem-resistant enterobacteriaceae (CRE) infection traced back to an Olympus duodenoscope. Virginia Mason joined the lawsuit later, as a result of damages caused an outbreak of similar infections at the hospital among at least 39 patients exposed to the medical device, including at least 18 deaths.
Over the past two years, serious concerns have emerged about the risk of duodenoscope infections, following a number of “super bug” outbreaks at different hospitals nationwide. Investigations by health officials have identified problems with the cleaning procedures provided by Olympus and other manufacturers, which may allow the devices to transfer tissue or bacteria between patients.
The verdict came following an eight week trial, with the jury rejecting claims that the Olympus TJF-Q180V duodenoscope were defective, but finding that Olympus failed to warn and adequately instruct Virginia Mason on the risks of infections and how to properly clean the devices. However, the jury placed some of the blame for Bigler’s death on Virginia Mason, who will have to give the family $1 million of that $6.6 million it will receive from Olympus.
Duodenoscope ERCP Outbreaks
Duodenoscopes are medical devices used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, which involves use of the scope to examine the bile ducts, pancreatic duct or gallbladder. However, problems with cleaning the endoscopes have emerged in recent years, with several high-profile “superbug” infection outbreaks linked to the devices, even when facilities following the recommendations provided by Olympus and other manufacturers.
According to a report released in January 2016, by the minority staff of the U.S. Senate Health, Education, Labor and Pensions Committee, duodenoscopes may have been linked to more than two dozen outbreaks of antibiotic resistant infections worldwide.
Concerns about the risk of ERCP duodenoscope infections began to gain widespread media attention in early 2015, after nearly 200 patients treated at California’s UCLA Medical Center were told that they may have been exposed to a deadline bacteria known as carbapenem-resistant enterobacteriaceae (CRE).
After at least seven confirmed infections were identified among individuals who underwent an ERCP involving use of duodenoscopes at UCLA, problems were identified with the cleaning instructions provided by Olympus.
Similar outbreaks at other hospitals, such as Virginia Mason, have been linked to devices made by Olympus and other manufacturers, with reports suggesting that a movable “elevator” at the tip of the device may trap pathogens and blood from prior patients, even when recommended reprocessing steps are followed to clean the device between techniques.
In addition to the UCLA outbreak, the Senate report found at least two dozen other incidents of antibiotic-resistant infections linked to duodenoscopes worldwide between 2012 and the Spring of 2015. Of the 25 incidents, at least 19 involved a device manufactured by Olympus, which apparently knew for years that their endoscopes were likely a vector for the transmission of infections, some of which resist standard antibiotic drugs.
The ongoing litigation involves internal communications dating back to at least January 2013, well before a number of the outbreaks occurred. The concerns were raised by U.S. Olympus officials following reports of two dozen infections in French and Dutch hospitals. Since then, an estimated 35 people have died in U.S. hospitals due to infections they are believed to have contracted from Olympus duodenoscopes.
In May 2015, an FDA advisory committee determined that the devices “do not provide a reasonable assurance of safety and effectiveness” due to the difficulty cleaning them. The panel said that manual cleaning is still important and needs to continue, but also recommended that the FDA reclassify duodenoscopes from semi-critical medical devices to critical medical devices and said reprocessing needs to be taken from “high level disinfection” processes to full sterilization.
The FDA issued a safety communication expanding cleaning instructions for duodenoscopes used in ERCP procedures in August 2015. In addition, manufacturers have issued new cleaning instructions, and some have redesigned the elevator tips believed to be the area where blood and tissue get trapped to make them easier to clean.