Duodenoscope Lawsuits Are Being Investigated By Southern Med Law That Allege Olympus’ Tainted Medical Device Transmits Deadly Infections To Patients.
>Olympus Corp. is recalling 4,400 duodenoscopes nationwide to repair and redesign the products that allegedly have caused deadly “superbug” infection outbreaks in hospitals across the country. Olympus Corp. is currently facing duodenoscope lawsuits filed by patients or their survivors who allege the contaminated duodenoscopes transmit a bacteria that is nearly resistant to antibiotics and sickens or kills patients.
According to a January 15 news release issued by the U.S. Food and Drug Administration (FDA), Olympus will replace the elevator channel sealing mechanism on the TJF-Q180V duodenoscope to create a tighter seal and reduce the potential for patient fluids and tissue to leak into the closed elevator channel. Leakage into this channel could pose an infection risk to patients because the sealed areas cannot be cleaned and disinfected between uses. Olympus also plans to conduct annual inspections of each scope in use by facilities to identify any wear and tear on the elevator channel sealing mechanism or the presence of attached debris at the scope’s tip, which would require replacement of the potentially contaminated parts. Olympus estimates that the problems can be corrected by August.
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htm, FDA, January 15, 2015]
“Although changes will be made to reduce the risk of bacterial infections, many patients are already suffering–or have died–because of Olympus Corp.’s contaminated medical scope,” says Dr. François Blaudeau, founder of Southern Med Law.
The Firm is investigating potential duodenoscope infection lawsuits on behalf of individuals or their surviving loved ones, who were diagnosed with a superbug infection following a medical procedure. 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 used in more than 500,000 procedures annually as a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions, according to the FDA. The medical scopes are flexible enough to be inserted through a patient’s mouth, throat, stomach and into the top of the small intestine (the duodenum). The design of duodenoscopes, like the one recalled by Olympus, makes them difficult to properly clean and renders them contaminated. Tainted scopes have transmitted Carbapenem-resistant enterobacteriaceae (CRE), a bacteria that has a nickname of “superbug” because it is nearly resistant to antibiotics.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm, FDA, March 4, 2015]
Olympus’ recall came two days after the U.S. Senate released a report criticizing the oversight of medical scopes by manufacturers, the FDA and hospitals. Superbug infection outbreaks due to tainted medical scopes have sickened and killed patients over the past several years in hospitals in California, Florida, New York, Washington and other locations. Since February 2015, the FDA has issued two warnings concerning contaminated duodenoscopes. The regulatory agency said in February that it had received 75 medical device reports involving possible bacteria transmission from duodenoscopes to 135 patients.
[chicagotribune.com/news/ct-tainted-duodenocopes-cre-bacteria-20160114-story.html, Chicago Tribune, January 14, 2016]
As Olympus Corp. begins to modify the design and labeling of its product, patients or their survivors are filing duodenoscope infection lawsuits nationwide. The complaints allege that Olympus manufactured, marketed and sold a defective product that transmits bacteria even when users properly follow the manufacturer’s cleaning instructions.
About Southern Med Law and Filing A Duodenoscope Lawsuit: Southern Med Law is an experienced law firm providing legal representation to the men and women across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at 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
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