Duodenoscope Infection Lawsuit News: U.S. Senate Investigation Finds Contaminated Duodenoscopes Sickened More Than 250 Patients During a Three Year Period
As duodenoscope infection lawsuit claims continue to mount in courts throughout the country, a new U.S. Senate report has revealed that tainted medical scopes manufactured by Olympus, Pentax and Fujifilm sickened far more patients than previously thought. The report, which was released on January 13th, also faulted manufacturers for failing to notify the U.S. Food & Drug Administration (FDA) about problems with their duodenoscopes in a timely manner.
Duodenoscopes are used during a procedure called endoscopic retrograde cholangiopancreatography (ERCP) to diagnose and treat problems in the pancreas and bile ducts. The instruments include an elevator mechanism at one end, which makes the devices difficult to sterilize. Since February 2015, the FDA has issued two alerts regarding the potential for duodenoscopes to become contaminated and spread dangerous pathogens. The most recent alert issued in October 2015 disclosed that dangerous duodenoscope infections were occurring even when users were properly following manufacturer cleaning, disinfection or sterilization instructions. Olympus, Pentax and Fujifilm were also cited via FDA warning letters for inadequate reporting of duodenoscope problems and for failing to ensure that the instruments could be cleaned properly between uses.
(fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm. FDA, February 2015)
The U.S. Senate report, “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients”, was the result of year-long investigation initiated by Sen. Patty Murray (D-WA) in January 2015. Among other things, the probe linked tainted duodenoscopes to more than two dozen outbreaks of antibiotic-resistant infections that sickened at least 250 patients in the U.S. and Europe from 2012 to 2015. Many victims were infected with carbapenem-resistant Enterobacteriaceae (CRE), an antibiotic resistant superbug that kills about half of those it infects.
(help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf, U.S. Senate, January 13, 2016)
The report also faults manufacturers, hospitals and the FDA, finding that:
- Duodenoscope manufacturers failed to adequately test whether their scopes could be properly cleaned in a real-world setting
- Manufacturers didn’t meet requirements to self-report problems quickly to regulators
- Many hospitals were slow to report infections to manufacturers and federal agencies
- As a result of an ineffective surveillance system, the FDA failed to spot the deadly duodenoscope infections or alert the public
The report also recommends a series of legislative and regulatory changes to ensure the FDA is able to effectively monitor and evaluate the postmarketing safety of medical devices, including:
- An FDA assessment of whether repairs to closed-channel duodenoscopes are necessary, and issuance of a duodensocope recall if such repairs are needed
- Requiring that unique device identifiers (UDI) be included in medical data to allow the FDA to more quickly identify risks associated with a given device
- Strengthening FDA guidance regarding clearance of modified medical devices by manufacturers
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.
About Southern Med Law and Filing A Duodenoscope Infection Lawsuit: Southern Med Law is an experienced law firm providing legal representation individuals 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.
Contact:
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@sml-legal.i-mlaw.com
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