Duodenoscope Lawsuit Lawyers Look At New FDA Warning On Risk Of Medical Scope Infections

   

Duodenoscope Lawsuits Complaints Allege Patients Potentially Develop Deadly Superbug Infections From Bacteria Transmitted From Tainted Medical Scopes.

duodenoscope-infection-lawsuit-southern-med-lawWhile Duodenoscope lawsuit complaints have been filed nationwide after people have developed the superbug infections after a procedure using the medical scope, the U.S. Food and Drug Administration (FDA) recently issued an updated medical scope safety warning about a design issue with the Pentax ED-3490TK duodenoscope that could increase the risk of patient infection. Medical scope manufacturers have been under scrutiny because their devices, when not properly disinfected, have the potential to transmit bacteria to patients during procedures. As a result, patients and their survivors are filing Duodenoscope lawsuits alleging they have been seriously or fatally injured by the Carbapenem-resistant enterobacteriaceae (CRE) superbug infection transmitted by the medical scopes.

In its January 17 safety communication, the FDA warned that cracks and gaps can occur in the adhesive that seals the Pentax duodenoscope’s distal cap to its distal tip, “which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.” The FDA recommended medical facilities and staff follow updated and validated instructions for manual reprocessing, or cleaning, which Pentax issued in February 2016. As an alternative, the FDA advised facilities and staff to use the ED-3490TK with an Automated Endoscope Reprocessor that data and tests provided to the FDA showed “acceptable high-level disinfection or liquid chemical sterilization of duodenoscopes.”
[fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm537146.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery]

“Although the FDA has been working with manufacturers on this issue, patients are seeking legal recourse because they still remain the victims of contaminated duodenoscopes,” says Dr. François Blaudeau, founder of Southern Med Law.

Southern Med Law is investigating potential duodenoscope infection lawsuit claims on behalf of individuals who were diagnosed with a superbug infection following an ECRP procedure, or their surviving loved ones. 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.

Duodenoscopes are flexible lighted tubes used in procedures to diagnose and treat problems in the pancreas and bile ducts. Since February 2015, the FDA has issued two safety alerts over the potential for duodenoscopes to become contaminated and spread dangerous bacteria even when users properly follow the manufacturers’ instructions on cleaning, disinfecting, and sterilizing the devices. The FDA also sent warning letters to Pentax, Olympus, and Fujifilm for inadequately reporting problems with their duodenoscopes and for failing to make sure that their scopes could be cleaned properly between uses.
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm]

Over the past two years, CRE infection outbreaks stemming from tainted duodenoscopes have occurred at hospitals nationwide. For instance, a CRE superbug infection at UCLA’s Ronald Reagan Medical Center from October 2014 to January 2015 was allegedly traced back to Olympus Corp.’s TJF-Q180V duodenoscope. According to Kaiser Health News, at least 35 patients in hospitals have died since 2013 after developing infections stemming from tainted Olympus duodenoscopes.
[khn.org/news/grilled-about-deadly-superbug-outbreaks-execs-at-scope-maker-olympus-take-fifth/]

Duodenoscope infection lawsuits have been filed on behalf of patients or their survivors who contracted the superbug infection after undergoing procedures in which tainted scopes were used. For instance, what is believed to be the first duodenoscope lawsuit stemming from the UCLA superbug outbreak was filed against Olympus Corp. on behalf of an 18-year-old high school student who allegedly developed a CRE infection after his exposure to an Olympus Q180V duodenoscope in October 2014 and again in January 2015. (Case No. 15-02302, Superior Court of California, County of Los Angeles)

Southern Med Law And How To File A Duodenoscope Lawsuit

Southern Med Law is an experienced law firm that provides personable legal representation to men and women across the country who have been victims of medical device injuries and infections such as the duodenoscope superbug infections. The firm possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success. If you or a loved one have been injured or suffered side-effects from medical devices contact the firm by calling 1-205-547-5525 or by visiting www.southernmedlaw.com for additional news and contact information.

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

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