Duodenoscope Infection Lawsuit Claims Investigated By Southern Med Law After Patients Allegedly Suffered Superbug Infections Due to Contaminated Medical Scopes Manufactured by Olympus, Pentax and Fujifilm.
Southern Med Law announces the launch of a new duodenoscope infection lawsuit page in response to growing concerns about the potential for contaminated medical scopes to cause dangerous superbug outbreaks. As both a practicing gynecologist and attorney, Dr. François Blaudeau, the founder of Southern Med Law, possesses a unique understanding of the medical and legal questions relating to duodenoscope lawsuits filed on behalf of patients who may have been harmed by a contaminated scope.
Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) to diagnose and treat problems in the pancreas and bile ducts. During these procedures, the small flexible, lighted scopes are threaded through the mouth, throat, and stomach into the top of the small intestine. While ERCP is a potentially life-saving procedure, duodenoscopes contain many small working parts that if not thoroughly cleaned and disinfected may lead to patient-to-patient infection.
In February, the U.S. Food & Drug Administration (FDA) warned that duodenoscopes manufactured by three companies – Olympus, Pentax and FujiFilm – could potentially trap bacteria in their “elevator” mechanism. In October, the agency issued a second duodenoscope infection alert, disclosing that such 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 recent months, a number of duodenoscope infection lawsuits have been filed in U.S. courts, all of which accuse device manufacturers of failing to notify regulators and the medical community about the infection risk associated with their scopes. Most recently, an Olympus duodenoscope lawsuit was filed in the U.S. District Court, Eastern District of Pennsylvania, on behalf of a North Carolina man who died after a long battle with an antibiotic-resistant bacterial infection he allegedly sustained during a routine ERCP procedure in 2013. Among other things, the complaint points out that a Custom Ultrasonics Automated Endoscope Reprocessor (AER) device was used to clean the Olympus duodenoscope involved in the decedent’s procedure, and alleges that it failed to disinfect or sterilize the scope.
[outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/widow-sues-olympus-and-custom-ultrasonics-over-husband-s-superbug-death–11-23-15, Outpatientsurgery.net, November 2015]
In August, the FDA cited Olympus for failing to notify it of serious injuries or deaths possibly caused by its duodenoscope, including 16 patients who contracted Pseudomonas aeruginosa infection after their endoscopy. And just last month, 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/ICECI/EnforcementActions/WarningLetters/2015/ucm458510.htm, FDA, August 2015]
[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. 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 Infection 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.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203