Lawsuit Filed in Death from a “Superbug” Infection Linked to Medical Scope

A North Carolina woman has filed a wrongful death lawsuit against Olympus Corp. after her husband died from an antibiotic-resistant bacterial infection following a routine medical procedure. The lawsuit was filed on November 20, 2015, in United States District Court in the Eastern District of Pennsylvania.

The man had undergone endoscopic retrograde cholangiopancreatography (ERCP) at Carolinas Medical Center in Charlotte, North Carolina. During an ERCP, a medical device known as a duodenoscope is inserted into the patient’s digestive tract through the throat. A small camera allows the doctor to visualize certain problems of the biliary and pancreatic duct systems, take tissue samples for biopsy, and, in some cases, treat the problem. The duodenoscope used in the procedure was an Olympus TJF – Q180V manufactured by Olympus America, Inc. and Olympus Medical Systems Corp. The lawsuit also names Custom Ultrasonics, the company that made the duodenoscope cleaning device.

According to the complaint, the duodenoscope used in the procedure was contaminated with a “superbug” known as carbapenem-resistant Enterobacteriaceae (CRE) and the bacteria was transmitted to the patient, causing a virulent infection that eventually killed him. The suit further alleges that the device’s design was defective and his death could have not have been avoided if the device could have been adequately cleaned and disinfected. The medical center cleaned its duodenoscopes, including the one used in the man’s procedure, with an automated endoscope reprocessor (AER), a cleaning device manufactured by Custom Ultrasonics, Inc., but the device did not adequately disinfect or sterilize the unit.

The widow alleges that her husband, a cement-mixer driver, suffered from the CRE infection for more than eight months before he died. He was in excruciating pain and was repeatedly hospitalized. During the illness, he lost 60 pounds, required a feeding tube, required external wound drainage, and suffered delirium and oxygen deprivation. He became unable to perform any routine tasks for himself and needed constant care. Because CRE is highly infectious, the man was isolated from friends and family during his illness.

Since the man’s death, both the endoscope and the AER cleaning device have been the subjects of Food and Drug Administration (FDA) safety alerts. On February 19, 2015, the FDA issued a safety communication warning that, because of their design, ERCP endoscopes, including the Olympus 180, cannot be effectively cleaned, and they can transmit multi-drug-resistant bacteria even when the manufacturer’s cleaning instructions are correctly followed. On November 13, 2015, the FDA issued a safety communication warning that Custom Ultrasonics had “not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.” The FDA has directed Custom Ultrasonics to recall the AERs and the agency recommends that health care facilities find alternative cleaning methods.

A number of CRE outbreaks have been lined to contaminated endoscopes. Seven patients at Ronald Reagan UCLA Medical Center contracted CRE after undergoing endoscopic procedures with a device made by Olympus; two of them died from the infection. Earlier this year, Cedars-Sinai Medical Center in Los Angeles reported that four patients were infected with the same superbug strain after undergoing procedures with the same endoscope. Reuters has reported that infections from exposure during endoscopy have also occurred in Pittsburgh, Seattle, and Chicago.

 

from Parker Waichman http://www.yourlawyer.com/blog/lawsuit-filed-in-death-from-a-superbug-infection-linked-to-medical-scope/