A jury handed down a $6.6 million verdict in the first lawsuit against duodenoscope makers. Hundreds more potential lawsuits may be filed over the devices after the scopes spread “superbug” infections that killed 35 people and sickened hundreds more at more than 40 different hospitals.
If you developed a bacterial infection or other side effects after an ERCP duodenoscope procedure, you may be eligible for compensation.
Duodenoscopes are used during a potentially life-saving procedure to diagnose and treat conditions of the pancreas and bile duct. The procedure is called ERCP, which stands for endoscopic retrograde cholangiopancreatography.
These long, flexible tubes are snaked down a patient’s throat, through the stomach and into the small intestine. Their tips contain cameras and can be fitted with different medical instruments to carry out different procedures.
The design of recent duodenoscope models left small nooks and crannies in the tip, creating hiding places for bacteria and making the devices difficult to sterilize between uses. The U.S. Food and Drug Administration determined that dangerous bacteria could survive in these crevices even if hospitals followed cleaning instructions from the devices’ makers.
The Centers for Disease Control and Prevention (CDC) associated this design flaw with several outbreaks of so-called “superbug” infections between 2010 and 2015.
People who were infected, or relatives of people who died from these infections have been filing lawsuits claiming duodenoscopes are responsible for their injuries.
There were at least nine lawsuits filed, underway or resolved by mid-2017.
Duodenoscope lawsuits remain in the early stages and attorneys are still weighing the potential for individual lawsuits. But they think hundreds of people could qualify to file lawsuits against duodenoscope manufacturers.
People who underwent an endoscopic procedure between 2010 and 2015 and later developed an infection requiring additional hospitalization have been filing lawsuits against duodenoscope makers.
People who have filed lawsuits against duodenoscope manufacturers claim that the companies made and marketed an unsafe product. They claim that the manufacturers knew or should have known that their devices were unsafe but failed to warn doctors and patients of the risks.
The Los Angeles Times reported on company emails between Olympus executives indicating they knew of problems disinfecting the devices in 2013. But the company told its U.S. executives that there was no need to warn hospitals or doctors of the risk even as the number of outbreaks was increasing.
At least three device manufacturers face potential lawsuits in the wake of the infection outbreaks.
Olympus produced more than 8 in 10 of the duodenoscopes in service across the U.S. when the outbreaks occurred, and has been the focus of most lawsuits and government scrutiny. But other manufacturers potentially face lawsuits over the outbreaks as well.
Duodenoscope lawsuits are in the very early stages, but there have already been jury verdicts and at least one settlement totaling close to $7 million.
In February 2016, Olympus also paid $612 million to settle claims it violated federal law to sell and market its duodenoscopes through an illegal kickback scheme
There are currently no class-action lawsuits against duodenoscope makers. As more individual lawsuits are filed, lawyers may seek another form of mass legal action such as a multidistrict litigation (MDL). MDLs allow the combination of multiple cases with similar injuries and facts to cut expenses and move lawsuits through the legal process more quickly.
The Centers for Disease Control and Prevention alerted the FDA to the connection between infection outbreaks and duodenoscopes in 2013. The FDA spent another two years collecting information and investigating the connection before any of the devices were recalled.
During this time, infections continued to spread, people continued to suffer infections, and some died.
“If [the] FDA had acted earlier, there would be fewer unnecessary deaths.”
The CDC, FDA, U.S. Department of Justice and the Congress all conducted separate investigations into how duodenoscopes spread superbug infections during ERCP procedures.
|Deaths||35 or more|
|Procedures Performed||500,000 per year|
The FDA came under criticism for not discovering the problem sooner. The agency turned over reports showing that as many as 448 people may have been infected or exposed to superbugs through duodenoscope procedures. But the agency said it may have received multiple reports of the same incident and could not determine exactly how many people had actually been affected.
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