June 27, 2016 — San Diego, CA. Patients who underwent surgery with a device called a duodenoscope and were infected by a drug-resistant form of bacteria are filing lawsuits against the makers of the device. Olympus Inc., which holds 85 percent of the duodenoscope market in the US, manufactured the TJF-Q180V scope but never received FDA approval for it. If you or a loved one were harmed by Olympus’ device, you may be entitled to compensation.
Hundreds infected by ‘superbug’ outbreak
After eight people were infected and two people died from a superbug outbreak at the University of California Los Angeles Ronald Regan Medical Center in late 2015, a manhunt to track down the source of the deadly infection began.
Medical experts at UCLA’s hospital, along with members of the Food and Drug Administration and the Centers for Disease Control, launched an investigation that eventually led them to a reusable medical device called a duodenoscope.
The duodenoscope is a special type of endoscope used in a procedure called endoscopic retrograde cholangiopancreatography, or ERCP. During the procedure, the scope is threaded through a patient’s mouth and throat into the top of the small intestine where it is used to drain fluids from the pancreas and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. About 500,000 ERCP procedures are performed every year throughout the country using these scopes.
The outbreak at UCLA’s hospital prompted significant media coverage and helped medical experts and officials connect the dots between other outbreaks from across the country — the Los Angeles infections were just one of many, experts realized.
Roughly 200 people were infected in hospitals nationwide by duodenoscopes harboring drug-resistant superbugs between 2012 and 2015. The infections killed at least 21 people. A superbug is a bacterium that is highly resistant to antibiotics. An especially virulent superbug, called carbapenem-resistant Enterobacteriaceae, or CRE, was identified in many of these outbreaks. The bacteria, which health officials call “nightmare bacteria,” kill as many as 40 to 50 percent of infected patients.
Scopes never approved by FDA
The duodenoscopes responsible for many of the tragic outbreaks were never actually approved by the FDA.
Olympus Inc., which holds about 85 percent of the duodenoscope market in the US, redesigned a 2008 version of its scope, sealing a portion of the device that was previously accessible and could be cleaned and sterilized. Olympus began selling the newly designed scope, marketed as TJF-Q180V, in 2010, but never received FDA approval to do so.
In a letter sent to Olympus in March 2014, the FDA said the changes made to the scope prevented sterilization and impacted the safe use of the device. For these reasons, the agency said the device should have been approved through its 510(k) program before the company began marketing it.
The FDA announced in January 2016 – six years after Olympus started selling the TJF-Q180V scope – it had approved the new design, along with labeling intended to help reduce the risk of bacterial infections. It also said Olympus would be recalling the original model linked to the outbreaks.
New design puts patients at risk
Duodenoscopes have been in use for nearly four decades. Olympus helped pioneer the first devices, but two other players eventually entered the game: Fujifilm and Pentax. Still, Olympus sells the vast majority of duodenoscopes in the US.
In 2010, Olympus’ competitors rolled out a newly redesigned duodenoscope they said was easier to clean because a portion of the device was sealed to keep out bacteria. Olympus soon put out its own revamped version of the device, also marketing the $40,000 scope as easy-to-clean.
What the makers would soon find out is the sealed portion of the devices could actually trap bacteria and make them nearly impossible to clean.
Shortly after the UCLA superbug outbreak was confirmed, the FDA issued a safety communication regarding the scopes and their “complex design.” Even after the device was cleaned following the manufacturer’s instructions, they could still harbor potentially deadly bacteria that could be passed from patient to patient, the communication warned.
Several months after the agency’s initial safety communication, it released a detailed list of supplemental measures to clean the scopes on top of the manufacturer’s instructions. The measures, the FDA conceded, required specific resources, training and expertise that not all medical facilities could implement. Those facilities that could often purchased even more duodenoscopes because the time-consuming measures could take the devices out of service for 48 hours.
It appears previous scope designs did not present as many contamination problems. After UCLA’s outbreak, Olympus disclosed it was aware of 95 complaints tying its scope to patient infections, an LA Times report indicated.
A top Olympus executive reportedly told the Times the company received far fewer complaints for previous scope models.
“This rash of incidents couldn’t be explained away,” the former official told the Times. “They should have pulled the scope.”
Scope maker withholds information
Lawsuits filed against Olympus allege the company knew of its scopes’ design defects but sold the defective products anyway.
The newly redesigned scopes hit the market in 2010. By 2012, superbug outbreaks had infected more than 80 patients at hospitals in Europe and the United States.
The first infections were reported at a Dutch hospital where 30 patients were sickened by the superbugs. The outbreak was eventually linked back to Olympus’ duodenoscopes and the company issued an alert in Europe in 2013 and again in 2014, but failed to warn its partners in the United States.
The company would not issue an alert in the US until 2015. Between 2012 and 2015, nearly 200 patients were infected with superbugs at 19 hospitals across the US – 13 of those outbreaks involved Olympus scopes, the other six involved either Pentax or Fujifilm scopes.
An investigation into the outbreaks led by the US Senate found Olympus knew of its device’s potential to retain bacteria back in April 2012. The report also found Olympus did not have data to show that its scopes could be cleaned properly between uses, nor did it consistently report the information it had regarding infections linked to the device to the FDA.
But the Senate report did not stop at the device’s manufacturer. The report also called out the FDA and its “outmoded” system for tracking and monitoring the safety of medical devices in the US.
“FDA’s first safety communication regarding duodenoscope cleaning did not occur for almost 17 months after the agency first became aware of the spread of infections. In the interim, at least 68 patients were affected in seven different hospitals in the United States,” the report stated.
Patients file lawsuits against Olympus
Patients sickened by drug-resistant bacteria after undergoing surgery with Olympus’ TJF-Q180V duodenoscope are filing lawsuits against the company. In some cases, family members are filing wrongful death lawsuits against Olympus on behalf of their loved ones who died from the infections.
The lawsuits against Olympus allege the company sold a product without FDA approval, knowingly sold a faulty product, and manufactured and marketed a defective product.
If you or someone you love was infected by an Olympus TJF-Q180V duodenoscope, you may be entitled to compensation. The lawyers and attorneys at Hood National Law Group are currently accepting cases involving the Olympus TJF-Q180V model and its potential to cause drug-resistant bacterial infections.
Not sure if your case qualifies? Call us today at 1-800-214-1010 for a free case evaluation, or use the form on the right-hand side of your screen.