Duodenoscope Manufacturer Knew It Could Kill and Did Nothing
This is Michael Brady Lynch, lead trial attorney for the Michael Brady Lynch Firm.
Patients try to do their homework and make the best decisions when concerning their health; however, for many simple, routine medical procedures often skate by us without a second thought. How many times have you been warned of the risks associated with seemingly routine medical procedures?
This lack of disclosure meant death in 2014 when 179 patients at a UCLA hospital were severely infected following a common medical procedure. The outbreak of the deadly antibiotic-resistant CRE infection was traced back to a duodenoscope made by Olympus.
Duodenoscopes are used in over 500,000 procedures annually in the U.S. The most common being endoscopic retrograde cholangiopancreatography (ERCP) procedures. The scope is a flexible tube that is inserted down a patient’s throat to access the upper part of the intestine. The issue is the moving parts on the tip of the scope makes it extremely difficult to sterilize properly.
The Senate Health Committee uncovered that Olympus, who manufacturers 85% of all duodenoscopes, knew in 2012 that their scopes were not sterilizing properly and could transmit infections back but did nothing. Meanwhile, at least 250 people were infected in 25 different outbreaks. It took the FDA 4 years to even consider recalling the scopes since they said the risk was too minimal when compared to the life-saving procedures being performed. People died from these outbreaks and experience long-term effects from contracting CRE, the “super bug”.
CRE (carbapenem-resistant enterobacteriaceae) is a dangerous bacterium that leaves the intestine and begins to infect other areas of the body such as the lungs or skin. It is extremely difficult to treat since it is antibiotic resistant. Half of the people that contract CRE die.
It wasn’t until last month that Olympus finally issued a recall to make design changes to their scopes to help reduce the spread of CRE. However, data from independent studies suggest that 3% of scopes in circulation still remain contaminated. This means that an estimated 15,000 patients are exposed to infected scopes every single year.
If you or a loved one were infected with CRE from a dirty duodenoscope following a ERCP procedure, please call us at 877-513-9517.