Olympus Duodenoscope Infection Lawsuit
In 2012, the University of Pittsburgh Medical Center reported an outbreak of serious antibiotic-resistant infections related to duodenoscopes—a small, tube-like medical device used in diagnostic procedures. The bacteria that was reported in patients was the dreaded CRE (carbapenem-resistant Enterobacteriaceae), a superbug known to be resistant to most antibiotics. As a result, superbug infections are notoriously difficult to treat and reportedly kill up to 40-50% of the people infected.
The staff at Pittsburgh determined that the normal process for disinfecting the duodenoscopes that had been recommended by the manufacturer, Olympus Medical Systems Corporation, failed to eliminate all the bacteria present. Some remained in the device where it could spread to other patients when the device was reused.
The hospital contacted Olympus, and shared the concerning findings that its staff had learned. They took cultures from one of the devices and found bacteria remained even after it had been cleaned three times. It wasn’t until January 2016, however, that the company finally recalled the defective devices. Meanwhile, duodenoscope-related infections sickened at least 250 patients worldwide, according to a 2016 Congressional report.
Pittsburgh residents who had a medical procedure with a duodenosope and then suffered from a serious, antibiotic-resistant infection may be eligible to file a personal injury lawsuit. Evidence shows that manufacturers of these devices were aware of certain risks associated with the design, yet failed to adequately communicate those risks to doctors or patients.
What is an Olympus Duodenoscope?
Patients who are undergoing tests to check for health problems in the liver, bile ducts, and pancreas, often undergo a procedure called an “endoscopic retrograde cholangiopancreatography (ERCP).” During this procedure, the doctor inserts a small, tube-like device through the mouth and down into the small intestine just past the stomach.
Attached to the tube is a chip that transmits images, as well as a light, which allows the doctor to see any problems that may exist. Doctors can also insert dyes for X-rays, stents to relieve obstructions, or tools used to biopsy potentially diseased tissue, through the duodenoscope tube.
More than 500,000 ERCP procedures are performed each year. Olympus had been manufacturing duodenoscopes for years, but then in 2010, it changed the device design in an attempt to reduce the risk of infections. It called the redesigned device a “closed channel” duodenoscope—the Olympus TJF-Q180V—because it had an advanced seal meant to better keep out potentially infectious material like blood and tissue. It was also supposed to be easier to clean.
Only two years later, however, it was discovered that the new design was flawed.
Dutch Doctors Raise the Alarm about Olympus Duodenoscopes in 2012
Pittsburgh wasn’t the only hospital to raise the alarm about duodenoscope-related superbug infections. In January 2012, there was a superbug outbreak at the Erasmus Medical Center in Rotterdam, the Netherlands affecting 30 patients. Hospital staff traced the infection to patients who had gone through ERCP with an Olympus TJF-Q180V closed-channel scope.
Erasmus medical center contacted Olympus, after which an independent investigation of the device was conducted. The study, which was completed in April 2012, reported two design flaws in the device that made it difficult to effectively clean it. There were tiny crevices too small to clean with a brush (but large enough to trap bacteria), and poor-quality sealing at the end of the scope that could transmit bacteria between patients. Additionally, the investigators found that the O-ring that sealed off the elevator channel, was worn, torn, and contained a “brownish scale” indicating it had not created a proper seal.
Dr. Arjo Loeve of the Delft University of Technology, who conducted the study, recommended design changes to correct these flaws. Olympus filed a report with the FDA, but failed to discuss the findings of Loeve’s report, and allegedly misstated the number of patients that had been infected and suggested that it could not conclusively determine the cause of the infections.
A follow-up report by the Dutch National Institute for Public Health and the Environment confirmed many of Dr. Loeve’s findings. Yet, the FDA remained in the dark about these findings until March 2015.
Olympus Sits on Test Findings While More Patients Infected
A few months later, the University of Pittsburgh Medical Center reported their superbug outbreak to Olympus, which had infected 13 patients. Olympus asked an outside consulting group to evaluate the medical center’s cleaning processes. The investigators concluded that, though the center had complied with the manufacturer’s cleaning instructions, the infections had still occurred.
According to a January 2016 Minority Staff Senate Report, between December 2012 and 2014, Olympus conducted additional independent lab tests on its closed-channel duodenoscope. The outcomes of these tests showed similar defects to those being reported to the manufacturer, specifically, that the device design made it difficult to eliminate all contamination. Olympus sent a letter to some European hospitals, informing them to pay particular attention to cleaning instructions, but sent no such letter to American doctors or medical centers at the time.
Meanwhile, a number of other hospitals began to report outbreaks of CRE and other superbug infections related to the use of duodenoscopes. In December 2012, the prominent New York-Presbyterian/Weill Cornell Medical Center in New York City reported 15 infected patients, and the University of Massachusetts Medical Center reported another 20 cases. In January 2013, the Thomas Jefferson University Hospital in Philadelphia reported 8 additional patients infected by the dangerous superbug.
In September 2013, after another outbreak at the Advocate Lutheran General Hospital in Illinois, the FDA opened an investigation into closed-channel duodenoscopes.
Olympus Marketed Device without FDA Clearance
On March 18, 2014, the FDA sent a letter to Olympus stating that the company was marketing the TJF-Q180V duodenoscope without proper FDA clearance. Indeed, the XTJF-Q160 had received FDA clearance in 2008. However, the manufacturer then redesigned the device and released the new TJF-Q180V (with the “sealed elevator wire channel”) on the market without obtaining proper FDA clearance prior to selling the device.
Olympus had not applied for clearance, believing its new design was similar enough to the old one that FDA clearance was not needed. The FDA stated, however, that the new design prevented “sterilization and high level disinfection of the elevator channel,” impacting “safe use of the device.” Thus, the manufacturer had to apply for a new 510(k) clearance before marketing the device, which it had not done.
Though Olympus isn’t the only manufacturer of these devices (Pentax and Fujifilm also make them), it has around 85% of the market share. Because of that, the FDA decided not to pull the product from the market as it was investigating the issues surrounding these devices.
Later, it was discovered that Olympus had not only failed to get clearance, but had also failed to adequately test or “validate” the cleaning instructions to ensure that they worked in real-world settings. Indeed, several laboratory tests later found that the cleaning instructions were not adequate and yet Olympus failed to take any meaningful action to protect patients.
In April 2014, the FDA concluded that Olympus did not have sufficient data to show that their devices could be reliably cleaned. The FDA also found that the company failed to provide appropriate reporting of the infectious events that had occurred.
Olympus Duodenoscope Lawsuits
On January 15, 2016, the FDA announced that Olympus was recalling theTJF-Q180V and that it had cleared an updated design of the device intended to reduce risk of infections.
For many patients, however, the recall and repairs come much too late. At least 16 major U.S. hospitals have reported antibiotic-resistant infections directly linked to duodenoscopes (some made by Pentax and Fujifilm as well as Olympus). The true numbers may be even higher, as the initial reports came from large research hospitals and medical centers that are experienced at detecting these types of infections. Other, smaller hospitals may have unreported superbug cases because they are only now learning of the link between duodenoscopes and superbug infections.
“Most hospitals that do these procedures are not even looking for this problem,” Jeffrey Duchin, a physician who heads up communicable disease control at the Seattle and King County (Washington) Public Health Department, told USA Today, “or they may not be aware, and that’s got to change.”
Officials at the University of Pittsburgh Medical Center upgraded their own cleaning processes after experiencing the outbreak, using a process called EtO gas sterilization to destroy remaining bacteria. Still, hundreds of reported patients in the United States have been affected, and some have already died as a result of a superbug infection.
For example, Jeffrey Hughes, a sixth-grader from Santa Monica, California, had been fighting cancer and was treated with an Olympus scope at UCLA Medical Center during their outbreak in 2014. He developed an infection afterwards and died a month later. His parents have filed a wrongful death lawsuit against Olympus in Los Angeles.
Antonia Cerda, a 48-year-old mother, also died in the UCLA Medical Center outbreak, and her family filed a lawsuit against Olympus. Bill Warner, a 55-year-old man who was treated with an Olympus scope at Carolinas Medical Center in Charlotte, also died of an infection. His family has filed suit against Olympus in Philadelphia.
As awareness increases of the defective scopes and their potentially deadly effects, more patients are coming forward seeking redress for their injuries.
The Pittsburgh Olympus Duodenoscope Lawyers Can Help
If you or a loved one suffered from a serious, antibiotic-resistant infection after undergoing a procedure with a duodenoscope, the Pittsburgh attorneys at Chaffin Luhana LLP can help. We understand that manufacturers like Olympus, Pentax, and Fujifilm are responsible for adequately testing and designing their products and for ensuring that they can be safely used in patients. At the very least, they are responsible for promptly warning doctors and patients of safety risks associated with the use of their devices. This is particularly so where, as here, the risks at issue are potentially life-threatening.
Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Pennsylvania, Ohio and throughout the country, and will give you an initial consultation for free. Contact us today.