The Senate investigation released today (Jan 13, 2016) indicates at least 141 patents were infected during a three year delay in reporting of the dangers of duodenoscopes, a medical scope used in ERCP procedures. The investigation identified 25 outbreaks across the country, which was “far more” than previously reported according to the Los Angeles Times coverage. Across the world, at least 250 people were infected with life-threatening illnesses, including the CRE superbug, after medical procedures with duodenoscopes. The CRE superbug is resistant to most antibiotics and has a high mortality rate (approximately half die from it).
The Senate investigation report concludes that patients were needlessly infected with deadly bacteria because of failures by manufacturers, hospitals and regulators to report outbreak. The report details how the largest manufacturer of devices, Olympus, knew of potential flaws in the spring of 2012 because of an investigation into a Netherlands outbreak. But Olympus and the FDA did not warn hospitals about the problem until February 2015.
The report called on the FDA to consider a phased recall of the scopes for disinfection and repair or modification. The FDA previously decided that it would not recall the devices because of the importance of the ERCP procedure, which is performed hundreds of thousands of times a year.
Our firm filed the first lawsuit in Philadelphia alleging an infection from an Olympus duodenoscope. If you or a family member suffered a potentially deadly infection following a medical scope procedure, please call our office at (800) 590-4116 to speak to Jim McEldrew or one of our personal injury attorneys.