Duodenoscope Infection Lawsuit | Duodenoscope Lawsuit

Duodenoscope Infection Lawsuit | Duodenoscope Lawsuit

Duodenoscope Infection Lawsuit | Duodenoscope Lawsuit Lawyer | Duodenoscope Superbug Lawsuit

duodenoscope-infection-lawsuit-southern-med-lawDuodenoscope Infection Lawsuit: The spread of infections from duodenoscopes has prompted the U.S. Food and Drug Administration (FDA) to order manufacturers of endoscopic devices to conduct new clinical studies that will evaluate the way duodenoscopes are cleaned. The news studies were ordered after duodenoscopes were linked to outbreaks of a ‘superbug’ infection in patient who underwent endoscopic procedures and experienced serious illness and even death. The infections associated with the duodenoscope are more likely to occur when the surgical tool is not cleaned and disinfected properly and used between patients. The FDA’s concern comes after multiple outbreaks of infections occurred even after medical personnel followed the manufacturer’s cleaning instructions.

Southern Med Law is investigating complaints from patients who have been affected by the duodenoscope “superbug’ or experienced duodenscope infections that have caused serious illness or even the death of a loved one. The medical device attorneys lead by Dr. Francois Blaudeau offer free duodenoscope lawsuit evaluations and information on how to receive the legal representation you and your loved ones deserve. Contact one of the firms attorneys by calling 205-547-5525 or you can visit www.southernmedlaw.com and fill out a contact form.

The duodenoscope can become contaminated and expose patients to a “superbug” bacteria that is resistant to antibiotics, known as Carbapenem-resistant enterobacteriaceae (CRE). The U.S. Centers for Disease Control (CDC) alerted the FDA in Fall 2013 about the potential link between the duodenoscopes and the CRE superbug bacteria and its resistant to antibiotic drugs. However the FDA did not issue a duodenoscope warning until after the UCLA Medical Center reported a CRE outbreak had occurred between October 2014 and January of 2015. The FDA warning also came after two patients had died and others became ill after developing an infection after a procedure using the duodenoscope.

Twelve patients have reportedly died in other reported duodenoscope infection outbreaks. Cedars-Sinai Medical Center in Los Angeles had four patients become infected from the endoscopic device and one death. Virginia Mason Medical Center in Seattle reported 11 deaths after 39 patients fell ill to the drug-resistant bacteria over the course of 2012 to 2014. Officials from the medical center reported that the infections and contamination were traced 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]

Olympus has since revised the cleaning instructions for its duodenoscopes. And the FDA supplied healthcare providers with steps for cleaning and disinfect the devices besides in addition to Olympus’s instructions. The FDA further advised that due to the duodenoscopes design the added cleaning measures may not guarantee a bacteria-free endoscopic device.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm, August

Duodenoscopes is a medical device manufactured by Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division). The duodenoscope is used in routine endoscopic retrograde cholangiopancreatography procedures (ERCP). Which is a technique used to diagnose and treat patients with issues of the biliary or pancreatic ductal systems, and is often used when patients are treated for gallstones or pancreatic cancer. It is a flexible lighted tube with a tiny camera attached to the tip. The tube is inserted through the patient’s throat, mouth, or stomach, and then into the top of the small intestine, or the duodenum.

The FDA has estimated that more than 500,000 ERCP procedures using the duodenoscope are performed each 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]

Olympus is facing multiple Duodenoscope infection lawsuits alleging the medical device manufacturer did not FDA clearance and marketed a defective medical device that caused patients to develop serious infections and even died from the ‘superbug’ that is resilient to antibiotics.

About Southern Med Law and Filing A Duodenoscope Infection Lawsuit Claim: Southern Med Law is an experienced law firm who provides personable legal representation to the men and women across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, defective medical devices and defective products. 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
Phone: 205-547-5525

Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam