Keller Rohrback Investigates CRE “Superbug” Infections Caused by Duodenoscope Manufacturers’ Negligence

Keller Rohrback L.L.P. is investigating legal claims for those patients, and their families, who developed CRE “Superbug" infections after undergoing ERCP procedures between 2012 and 2014.  CRE stands for carbapenem-resistant Enterobacteriaceae, a group of different species of bacteria that inhabit the human gut.  ECRP procedures are commonly performed to diagnose and treat certain diseases of the liver, bile ducts, and pancreas, such as stones, narrowing, tumors, and blockages.

These infections are directly associated with drug-resistant “Superbugs” that have been found to have been spread through contaminated duodenoscopes because the manufacturers’ recommended cleaning instructions were inadequate.  Even if the recommended steps were followed to clean the ERCP medical scopes, flaws in the manufacturers’ design may allow them to become easily contaminated.

CONGRESSIONAL INVESTIGATION

Senator Patty Murray launched a yearlong investigation into the cause and response to these outbreaks, and in January 2016 the U.S. Senate’s Health, Education, Labor and Pensions Committee, released its report.  The report confirmed that the duodenoscopes spread life-threatening, antibiotic-resistant infections, including Superbug infections between 2013 – 2014.  The report also recommends a series of legislative and regulatory changes to ensure the FDA is able to effectively monitor and evaluate the post-marketing safety of medical devices and calls on the FDA to evaluate whether repairs to closed-channel duodenoscopes are necessary to prevent the spread of infections, and if so, requiring manufacturers to implement those repairs through a phased recall.

According to reports, Superbug outbreaks following ERCP procedures have occurred in several hospitals throughout the nation, including:

• Advocate Lutheran Hospital, Chicago, Illinois
• Allegheny General Hospital, Pittsburgh, Pennsylvania
• Carolinas HealthCare System, Lincoln County, North Carolina
• Cedars-Sinai Medical Center, Los Angeles, California
• Hartford Hospital, Hartford, Connecticut
• Huntington Memorial Hospital, Pasadena, California
• Medical College of Wisconsin, Milwaukee, Wisconsin
• Ronald Reagan UCLA Medical Center, Los Angeles, California
• Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
• Unidentified hospitals in Charlotte and Highland Counties, Florida
• University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
• Virginia Mason Medical Center, Seattle, Washington

For more information about this investigation please visit our CRE "Superbug" case page.