In February 2015, the FDA issued a Safety Communication to warn that ERCP endoscopes or duodenoscopes have a “complex design” that may be “extremely difficult” to sterilize effectively – allowing the transmission of dangerous, and often deadly, “superbug” infections. The FDA alert followed reports that associate multidrug-resistant bacterial infections in patients who have undergone ERCP with inadequately cleaned duodenoscopes, even when manufacturer cleaning (reprocessing) instructions had been followed.
A number of lawsuits have recently been filed on behalf of patients who were exposed to the deadly CRE bacteria (carbapenem-resistant Enterobacteriaceae) due to the use of a contaminated duodenoscope. An increasing number of cases are being reported, with UCLA medical center stating that 7 patients had been infected with the CRE superbug from scopes made by Olympus. Through the end of last year, the FDA registered 135 reports of patients who had microbial transmission from duodenoscopes, but it is likely that many cases were never reported.
If you or someone you care about has been diagnosed with a CRE “superbug” infection, please contact our firm for more information regarding your rights and a free and confidential review of your situation.