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Early Olympus Duodenoscope Lawsuits Started in 2015

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In March 2015, a woman filed an Olympus duodenoscope lawsuit in King County Superior Court, in Seattle, Washington, on behalf of her husband who suffered a life-threatening bacterial infection after going through a procedure in which doctors used the medical device.

A few months later, the hospital where the man was treated—the Virginia Mason Medical Center (VMMC) in Seattle—joined that lawsuit, claiming the manufacturer failed to reveal design flaws in their device that put patients at risk. In fact, 39 patients were sickened at VMMC after being exposed to the duodenoscopes between 2012 and 2014, even though the hospital had followed the directions for cleaning and disinfecting.

The Seattle hospital wasn’t the only one. According to a 2016 report by the U.S. Health, Education, Labor, and Pensions Committee, at least 16 hospitals in the U.S. reported antibiotic-resistant infections directly related to duodenoscopes. Experts in the healthcare industry believe the number was probably even higher, but that many cases went unreported.

New Olympus Duodenoscope Design Increased Risk of Bacterial Transference

The patient who was sickened was 57-year-old Richard Bigler, who went through a routine diagnostic procedure at VMMC in which an Olympus duodenoscope was used.

A duodenoscope is a small, tube-like medical device used mainly in a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is meant to diagnose and treat health problems in the liver, bile ducts and pancreas. More than 500,000 ERCPs are performed each year.

The medical device is meant to be cleaned and disinfected and then reused. The cleaning procedures are supposed to eliminate all bacteria so that the device is safe to use in multiple patients. In 2010, however, Olympus modified their design to close off a narrow internal channel, calling it the “closed-channel” duodenoscope.

The idea was to keep blood and other potentially infectious material out of the scope, reducing risk of infections. Subsequent investigations, however, discovered that the design was flawed, and could allow dangerous bacteria to remain inside the device even after cleaning.

Olympus Delayed Important Duodenoscope Recall

Bigler was one of 11 patients that died at VMMC because of superbug infections, apparently contracted after being exposed to an Olympus duodenoscope device. Similar outbreaks occurred at hospitals in Los Angeles, Pennsylvania, Illinois, Connecticut, and Florida. The 2016 government report stated that “closed channel” duodenoscope-related infections were linked with antibiotic-resistance infections that sickened at least 250 patients worldwide.

Olympus initially claimed that the hospitals had not cleaned their devices correctly. Later investigations revealed that the company was aware that their new design made thorough cleaning difficult. It wasn’t until January 2016, however, that they implemented a recall of the devices to update them with new design and labeling modifications. The changes are meant to reduce the risk of superbug infections.

Andrew Ross, head of gastroenterology at VMMC, told the Advisory Company that the hospital was misled about the risks to patients. “Olympus failed to inform our organization about this safety risk associated with its product,” he stated.