Duodenoscope Infection Lawsuits Claim Contaminated Medical Scope, Faulty Cleaning Device, Caused Superbug Infection That Led to North Carolina Man’s Death
Duodenoscope infection lawsuits are mounting in U.S. courts, following multiple warnings from U.S. health regulators regarding the potential for medical scopes to harbor and spread dangerous bacteria. According to court records, one of the most recent claims was filed in the U.S. District Court, Eastern District of Pennsylvania, on behalf of a North Carolina man who died as a result of a scope contaminated with Carbapenem-resistant Enterobacteriaceae (CRE).
(charlotteobserver.com/news/local/crime/article45671688.html, Charlotte Observer, November 20, 2015)
According to the November 20th filing, the Decedent underwent a diagnostic procedure in January 2013 that involved the use of a duodenoscope manufactured by Olympus America and Olympus Medical Systems Corp. The complaint alleges that the scope suffered from a design flaw that allowed it to harbor biological debris in its chamber, including the CRE infection that was the cause of the Decedent’s death. Following the procedure, the 55-year-old Statesville, North Carolina man endured 8 months of suffering due to the CRE infection, during which time he lost 60 pounds, was hospitalized on numerous occasions, required a feeding tube and external wound drainage, and suffered delirium and oxygen deprivation. Because the CRE infection was considered to be contagious, he was deprived the comfort of friends and family during his illness.
In addition to Olympus American and Olympus System, the complaint also names Custom Ultrasonics Inc. as a Defendant. Per the complaint, Custom Ultrasonics designed and built the automated endoscope reprocessor (AER) that was supposed to decontaminate the duodenoscope used in the Decedent’s procedure.
Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) to diagnose and treat problems in the pancreas and bile ducts. Since February, the U.S. Food & Drug Administration (FDA) has issued two alerts regarding the potential for these instruments to become contaminated and spread dangerous pathogens. The most recent alert issued in October disclosed that dangerous duodenoscope infections were occurring even when users were properly following manufacturer cleaning, disinfection or sterilization instructions.
(fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm. FDA, February 2015)
(fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454630.htm, FDA, October 2015)
In November, the FDA ordered Custom Ultrasonics to recall its AERs for, among other things, failing to validate that the devices can sufficiently wash and disinfect medical scopes to mitigate patient infection risk. The FDA disclosed that it had received 21 complaints regarding the Custom Ultrasonics AERS, and recommended that hospitals and clinics currently using the devices switch to alternative cleaning procedures.
(fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472605.htm, FDA, November 2015)
Southern Med Law is investigating potential duodenoscope infection lawsuits on behalf of individuals who were diagnosed with a superbug infection following an ECRP procedure, or their surviving loved ones. To arrange for a free, no obligation legal consultation, please call Southern Med Law today, at (205) 547-5525. More information about this issue can be obtained by visiting www.southernmedlaw.com.
About Southern Med Law and Filing A Duodenoscope Lawsuit: Southern Med Law is an experienced law firm providing legal representation to the men and women across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
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