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Duodenoscope Manufacturer Chose Not to Warn of Risks




by:
Law Offices of Peter G. Angelos A Professional Corporation - Baltimore Office

 
March 17, 2017

Previously published on January 25, 2017

UPDATE: On January 17, 2017, the United States Food and Drug Administration updated safety information regarding the Pentax ED-3490TK video duodenoscope. Within this update, the FDA warned consumers that the device had the capacity to crack—making the transfer of fluids and bacteria to the device possible. Similar to other duodenoscope devices, the Pentax device can pose problems to medical professionals when attempting to clean and sanitize between procedures. Due to this fact, the FDA advised consumers that there is a higher risk of infection when undergoing a procedure using this device.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions within the bile duct and main pancreatic duct, such as gallstones and cancer. The duodenoscope can be used to drain fluid from bilary and pancreatic ducts that is blocked by tumors, gallstones, or other conditions affecting the gastrointestinal system. The device is used in more than 500,000 procedures each year in the United States.

In 2015, evidence surfaced connecting the devices to the transmission of Carbapenem-resistant enterobacteriaceae (CRE), a form of antibiotic resistant infection. These infections are exceedingly difficult to treat and are often fatal. The Ronald Regan UCLA Medical Center reported seven incidences of CRE infection in patients and three deaths related to the infection. The hospital found the source of the infection to be two duodenoscopes, both manufactured by the Olympus Corporation and used in routine endoscopic procedures in the five months leading up to the outbreak.

Since 2013, at least 35 people have died after suffering infections from contaminated scopes manufactured by Olympus. In July 2016, reports surfaced alleging that Olympus Corporation advised company executives in the United States not to issue a broad-scale warning to American hospitals about potentially deadly infections from contaminated duodenoscopes. Further, internal company emails suggest that the company was aware of the occurrences of CRE infection and the risks that contaminated devices posed to patients, yet failed to take action that could have prevented further outbreaks.

Lawsuits are now being filed by patients, and their families, who contracted CRE and other antibiotic resistant infections after undergoing routine endoscopic procedures using a duodenoscope. If you or a loved one suffered from severe abdominal pain, gallstones, pancreatic cancer, or bilary or pancreatic duct obstructions between 2012 and 2015, and underwent an ECRP procedure using a duodenoscope, you may be able to seek legal redress. 

 

The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.
 

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