Defective Drug and Medical Devices Attorneys
Duodenoscope Superbug Infection Lawsuit | Duodenoscope Infection Lawsuit | Duodenoscope Superbug Lawsuit Lawyer
Duodenoscopes have been connected with outbreaks of superbug infections that have caused serious injuries and death to patients who underwent a procedure in which the surgical tool was used. Infections are more likely to occur when duodenoscopes are used between patients but are not properly cleaned and disinfected, even though medical personnel are following the manufacturer’s cleaning instructions. The spread of infections prompted the U.S. Food and Drug Administration (FDA) to order manufacturers of the endoscopic device to conduct new clinical studies to evaluate how the products are cleaned in the “real-world.”
Duodenoscope CDC Information “superbug” bacteria Carbapenem-Resistant enterobacteriaceae (CRE)
Duodenoscopes are used in patients undergoing a routine endoscopic retrograde cholangiopancreatography procedure (ERCP). Contaminated duodenoscopes expose patients to Carbapenem-resistant enterobacteriaceae (CRE), a “superbug” bacteria that is nearly resistant to antibiotics. The U.S. Centers for Disease Control (CDC) describes CRE as an important emerging threat to public health.
The defective drug and medical devices attorneys at Alonso Kragle LLP are investigating duodenoscope infection lawsuit legal claims of those who have experienced complications from the CRE “superbug” or whose loved ones have died after undergoing an ERCP in which duodenoscopes were used. For a free, no obligation duodenoscope infection lawsuit review of your claim, contact Alonso Krangle LLP today or visit our website, http://www.FightForVictims.com.
Duodenoscopes and ERCP a routine endoscopic retrograde cholangiopancreatography procedure
A duodenoscope is a flexible lighted tube with a tiny camera attached to the tip. The tube is inserted through a patient’s mouth, throat, stomach, and into the top of the small intestine (the duodenum). It is often used when patients are treated for gallstones or pancreatic cancer.
The FDA estimates that more than 500,000 ERCP procedures using duodenoscopes are performed every year in the United States. ERCP procedures are the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. Duodenoscopes are manufactured by Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division).
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm, March 4, 2015]
The FDA and Superbug Outbreaks
Earlier this year, an FDA advisory committee revealed that the CDC alerted the FDA in Fall 2013 about the potential link between the CRE superbug bacteria that is resistant to multiple drugs. The FDA, however, did not issue a warning about duodenoscopes until the UCLA Ronald Reagan Medical Center announced in February that a CRE outbreak occurred between October 2014 and January 2015. UCLA Medical Center officials said two patients died and a number fell ill due to the infections. They also sent warning letters to at least 179 patients about their possible exposure to CRE. The outbreak was linked to the Olympus TJF-Q180V duodenoscope.
Olympus endoscopic device was also connected in a superbug infection outbreak at Cedars-Sinai Medical Center in Los Angeles in March where four people were infected and one died. Officials at Virginia Mason Medical Center in Seattle said 39 patients fell ill due to drug-resistant strains of E.coli bacteria from 2012 to 2014. Of that total, 11 patients died, according to the Advisory Board report. Medical center officials traced the contamination back to Olympus’ duodenoscopes.
[advisory.com/daily-briefing/2015/05/14/hospital-joins-patients-lawsuit-against-maker-of-duodenoscopes, The Advisory Board Company, May 14, 2015]
After the outbreak, Olympus revised its instructions on how to clean its duodenoscopes. In August, the FDA issued additional steps for health care providers to take to clean and disinfect the devices besides following the manufacturers instructions. However, the FDA noted that the additional cleaning measures will not guarantee a bacteria-free medical device because the complex design of duodenoscopes may make it difficult to effectively clean.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm, August 4, 2015]
Duodenoscope “Superbug” infection Lawsuit Filings
Duodenoscope Infection Lawsuits have been filed against Olympus Corp. over the infections outbreak connected to its Olympus TJF-Q180V duodenoscope. The so-called duodenoscope “superbug” lawsuit claims purport that Olympus sold its product without first receiving clearance from the FDA. The duodenoscope infection lawsuit complaints also contend that the company manufactured and marketed a defective product that places patients in jeopardy of developing a CRE infection.
About Alonso Krangle LLP And Filing A Duodenoscope Infection Lawsuit
Andres Alonso and David Krangle, attorneys with 40 years of collective legal experience, have focused their law practice on the handling of significant personal injury cases, defective drug and medical device, construction site accidents, nursing home abuse, medical negligence, qui tam/whistleblower actions and consumer fraud cases. A nationwide law firm representing injured victims throughout the U.S., Alonso Krangle LLP is headquartered in Long Island, New York, with offices in New York City, and New Jersey.
For more information about Alonso Krangle or duodenoscope infections or the duodenoscope superbug infection, or for filing a FREE duodenoscope infection lawsuit, please contact us or visit our website, https://www.FightForVictims.com.
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