Continued Fallout from Three-Year Delay to Recall Problematic Endoscopes

Washington, DCOne distinct ‘added value’ of any lawsuit, regardless of genre or subject matter, is the unearthing of useful documentation during the discovery process. Such has been the case with an Endoscope lawsuit filed earlier this year in a Pennsylvania court against Olympus Corp. (Olympus), the manufacturer of an allegedly problematic duodenoscope thought to be at the center of serious infections.

A collection of previously confidential emails released in association with an endoscopic infection lawsuit has revealed Olympus, a juggernaut in the endoscope industry, knew about problems with its newly-designed duodenoscope in early 2013, but is alleged to have decided in February of that year that it would not warn hospitals in the US about the potential for the spread of bacteria associated with so-called ‘superbugs.’

It was further revealed, according to a report in the Pittsburgh Tribune Review (8/9/16), that Olympus had introduced the new device into the marketplace three years before actively securing a clearance from the US Food and Drug Administration (FDA).

The duodenoscope in question was thought to be an improvement over a previous design, but was soon found to be infection-prone based on the difficulty of hospital staff to adequately clean and disinfect the reusable devices, in spite of claims that the manufacturer’s detailed cleaning protocols were followed to the letter.

Plaintiffs embroiled in an endoscope negligence lawsuit hold that Olympus should have divulged the problems with its new duodenoscope in a timelier manner, and in fact should have recalled the device.

That recall eventually happened, in January of this year - but not before 11 months had gone by since the manufacturer, in concert with the FDA, notified hospitals in the US about the potential for serious, antibiotic-resistant infections.

Plaintiffs are not impressed with the fact Olympus duly notified, or so it is alleged, hospitals and the health care industry affiliated with the European Medicines Agency, as to the infection risk associated with the duodenoscopes. That took place, according to confidential emails released as part of a medical malpractice lawsuit, in January 2013 - a full three years before Olympus triggered a recall in the US.

Duodenoscopes - like other devices in the endoscopic industry - have helped to revolutionize internal medicine by allowing access within the inner sanctums of the human body for diagnostic purposes, in real time. The equipment, however, is prohibitively expensive and therefore inappropriate as a disposable device.

Instead, they were designed to be re-used pending proper cleaning, disinfection and sterilization. Plaintiffs assert that a defective design made this kind of thorough cleaning next to impossible, creating a situation where a duodenoscope carrying infection can be used on another patient, unaware of the potential stormy seas ahead.