Personal Injury

CRE, Superbugs & Other Deadly Bacteria from Contaminated Medical Scopes

Issue: Patients develop antibiotic-resistant bacterial infections

Lieff Cabraser has successfully represented thousands of patients across America injured by defective and dangerous medical devices. We currently represent patients who developed “Superbug” CRE infections after undergoing Endoscopic retrograde cholangiopancreatography (ERCP), as well as the families of patients who died as a result of post-ERCP CRE infection.

OCTOBER 2016: REUTERS, LA TIMES ON “SUPERBUG SCOURGE SPREAD”

As reports from news sources like the Los Angeles Times and Reuters proliferate, the full extent of America’s superbug scourge is beginning to surface, and the truth isn’t just distubring — it’s terrifying. Though health authorities have been warning about deadly drug-resistant infections for over 15 years, a widespread practice among doctors and hospitals that can only be seen as active concealment has hidden the breadth of the crisis, while at the same time hindering efforts to make a dent in the situation. Learn more.


AUGUST 2016 FDA DUODENOSCOPE SAFETY ALERT

AUGUST 2016: FDA SAFETY ALERT ON DUODENOSCOPE CLEANING DEVICES

On August 17, 2016, the FDA issued a Safety Alert directing all U.S. health care facilities to immediately stop using Custom Ultrasonics’ “System 83 Plus AERs” for the cleaning of duodenoscopes. The Alert references a May 6, 2016 Urgent Medical Device Recall and earlier FDA safety warnings relating to an unacceptible risk of bacterial infection from inadequate reprocessing (cleaning).

“Because inadequately reprocessed duodenoscopes have been associated with patient infections and death, health care facilities should not use Custom Ultrasonics’ System 83 Plus AERs for reprocessing duodenoscopes, and should have transitioned to alternative methods of reprocessing these particular endoscopes.”




JULY 2016 OLYMPUS EMPLOYEES TOLD NOT TO WARN U.S. HOSPITALS

July 2016: Olympus Corp. Told Employees Not to Warn U.S. Hospitals About Contaminated Scopes

On July 25, 2016, Medtech Pulse reported that despite potential risks to patients, Olympus Corp. executives based in Japan told U.S. employees “not to warn hospitals in the United States about contaminated scopes that led to superbug outbreaks in Europe.” Referencing investigations by U.S. media and documents unearthed in endoscope superbug infection death lawsuits, the journal noted that “internal conflicts” within Olympus led company superiors to direct against communication of device risks.



Read Answers to Common Questions on the National Superbug Outbreak

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If you or a family member developed CRE following an endoscopic procedure, please use the form below to contact an experienced injury lawyer at Lieff Cabraser to discuss your case. There is no charge or obligation for our review, and all your information will be held in the strictest confidence.

You are also welcome to call us toll-free at 1 800 541-7358 and ask to speak to personal injury attorney Fabrice Vincent.

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We are also investigating injuries relating to medical device-borne Pseudomonas bacterial infections, Klebsiella bacterial infections, Escherichia coli (more commonly known as “E. coli”) bacterial infections, and injuries relating to other multi-drug resistant organisms (“MRDO”).

If you or a loved one have developed a drug-resistant bacterial infection after an ERCP procedure, please contact us by completing the contact form below or call us toll-free at 1-800-541-7358 and ask to speak to attorney Fabrice Vincent for a free, prompt, thorough, and no-obligation review of your case.

Attorney Lexi Hazam Discusses Superbug Infections from Contaminated Medical Scopes

Our law firm has been recognized by U.S. News, Best Lawyers, and the National Law Journal as one of the top plaintiffs’ law firms in the nation.

Medical Scope Infection Injuries Continue Despite FDA Efforts

June 2016: California Hospital Broke State Law By Not Quickly Reporting Superbug Outbreak

The LA Times reported that Huntington Hospital in Pasadena broke California law by not quickly reporting a suspected deadly superbug infection outbreak in 2015. Sixteen patients developed “superbug” bacterial infections, and 11 of those patients died. Only one patient’s death certificate, however, listed the superbug infection under the cause of death.

Earlier, in May 2016, the Los Angeles Times reported that two of Los Angeles’ largest hospitals had new scope safety violations appearing to put “far more patients at risk.”

Though both hospitals were able to get the infectious contaminations under control within a day, patient advocates have highlighted the incidents to illustrate “how infection control practices can lag even at top hospitals that had recently responded to bacteria outbreaks.”

December 2015: Fujifilm Issues New Warning & Corrective Notice

On December 23, 2015, Fujifilm issued an “Urgent Field Correction” for its duodenoscopes providing comprehensive revisions to scope operation manuals for “Preparation and Operation” and “Cleaning, Disinfection and Storage.” These urgent updates are an attempt to try to stop the spread of deadly CRE “superbug” bacteria infections plaguing duodenoscopes and similar medical exam devices. You can click here to read a copy of the full notice.

November 2015: FDA Recommends Enhanced Alternate Cleaning (Reprocessing) for Some Endoscopes

On November 13, 2015, the U.S. FDA issued a Safety Communication to all Health Care Facilities in the U.S. recommending immediate transition to increased, alternate reprocessing (cleaning) methods for “all Custom Ultrasonics Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs).” As the Agency went on to note,

As part of the FDA’s ongoing investigation into infections associated with reprocessed medical devices and AER devices used for cleaning and disinfection, the FDA has been reviewing the validation test methods and performance data for all AER manufacturers. To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.

FDA Orders Surveillance of Health Care Facilities’ Cleaning of Endoscopes

On October 5, 2015, the U.S. Food and Drug Administration ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

August 17, 2015 Superbug Outbreak Update

As reported by Bloomberg, the LA Times, and numerous other media outlets, the U.S. Food and Drug Administration sent warning letters out the week of August 10, 2015 to three medical device manufacturers whose endoscopes have been blamed for spreading lethal bacteria among patients. This is the agency’s strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere made headlines earlier this year.

The FDA superbug outbreak warning letters were sent to Fujifilm, Hoya/Pentax, and Olympus (copies of the FDA warnings can be read via the links on each company name).

Earlier Superbug Outbreak News Updates

As reported earlier this summer by the LA Times, disturbing numbers of medical professionals continue to report the spread of dangerous, even deadly infections by a variety of medical scopes.

These horrific outbreaks are continuing despite growing public awareness of the problems with medical scopes, problems that have been revealed to be far broader than previous information in the federal database relating to device risks had indicated. Over the last three years, patients have been exposed to bacteria and human tissue left inside a variety of scopes commonly used to examine the lungs, the colon, the bladder and the stomach. Tragically, the growing warnings from the FDA are often ignored by the doctors performing the procedures.

One study found that 9% of gastroscopes, 7% of colonoscopes and 4% of bronchoscopes had traces of potentially infectious material even after cleaning. Federal regulators say they don’t know how many patients have been sickened by the scopes, which as a group are used tens of millions of times each year. Time after time, the same story emerges: a scope transferred bacteria among patients even though medical staff believed it had been disinfected.

Though the FDA recently approved new rules for some scopes, these new rules don’t apply to devices already on the market. That means hospitals will continue to use current scopes for years. The rules also do not cover cystoscopes, used to examine the bladder, and gastroscopes, used to look inside the stomach. According to the FDA’s injury database, those devices have also been found to be dirty after cleaning.

Answers to Common Questions on the National Superbug Outbreak

What is the CRE Superbug?

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CRE is an abbreviation for carbapenem-resistant Enterobacteriaceae, which are germs that have high levels of resistance to antibiotics.

The Centers for Disease Control and Prevention (CDC) states that CRE infections usually occur in hospitals, nursing homes, and other healthcare settings, and notes that CRE infections can be deadly. One study found one out of every two patients who became infected died.

What is ERCP?

As noted above, ERCP is an abbreviation for endoscopic retrograde cholangiopancreatography. It is a medical procedure used to diagnose and treat certain diseases of the liver, bile ducts, and pancreas, such as stones, narrowing, tumors, and blockages. Often patients with pancreatic cancer and colon cancer receive ERCP. More than 500,000 ERCP procedures occur each year in the U.S.

What is a duodenoscope?

endoscope

The tip of an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope. Photo from the FDA.

Duodenoscopes consist of flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) and used in ERCP procedures. Duodenoscopes are complex instruments with many small working parts, channels, and side ports.

How are patients becoming infected by medical scopes?

Each duodenoscope is designed and intended for repeated use on different patients. After every procedure, the duodenoscope must be “reprocessed” before the scope can be used on a new patient. Reprocessing is a detailed, multistep, manual process to scrub and clean the medical scopes, followed by a soaking in disinfecting fluid.

As explained by the U.S. Food and Drug Administration (“FDA”), if “not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.” This can lead to patient-to-patient CRE infections.

In the Fall of 2013, the CDC alerted the FDA to a potential association of multi-drug resistant bacteria and duodenoscopes. The FDA states, “it became clear that these cases of infection were occurring despite confirmation that the users were following manufacturer cleaning and disinfection or sterilization instructions.”

Is this the first time contaminated medical scopes have been linked to deadly infections?

No. Problems in cleaning and disinfecting the devices have been known for years. In November 2009, the FDA warned hospitals and physicians about the risks to patients if flexible endoscopes and their accessories were not cleaned properly and recommended steps to reduce these risks.

The following year, in the medical journal Endoscopy, physicians in France reported that duodenoscopes “can act as a reservoir” for bacteria. They said 16 patients were identified between December 2008 and August 2009 as having developed serious infectious after such procedures.

While any hospital-acquired infection can be serious, the development of strains of bacteria like CRE that are resistant to antibiotics has increased the threat to patient safety and heightened concerns about these more recent cases of patient-to-patient infections linked to ERCP procedures.

Why has there been a recent focus on medical devices made and sold by Olympus?

Olympus boasts a 70% share of the global market for gastrointestinal endoscopes, and its duodenoscopes have been directly linked to the deadly “superbug” outbreak.

In 2010, Olympus redesigned and replaced its duodenoscope, the model Q160V, with the Q180V model. One significant design change from the earlier model was that the Q180V had a sealed part of the device, known as the “elevator channel,” intended to make it impervious to retaining microorganisms that could spread infections. The Q160V had an open elevator channel, which required time-consuming manual reprocessing after each exam. Olympus also sells hospitals a machine for the automated cleaning of its medical scopes.

How are Olympus duodenoscopes and Olympus bronchioscopes becoming contaminated with CRE?

In lawsuits filed against Olympus, the complaints charge that the Q180V duodenoscope is a defective medical device. The complaints specifically allege that despite the device’s seal, bacteria can become lodged in the elevator channel of the Q180V. Further, as alleged in the complaints, the Q180V’s sealed elevator channel is not accessible for cleaning and disinfection during reprocessing, thereby serving as a source for the spreading of deadly CRE infections.

Did the FDA review the safety of the Olympus Q180V duodenoscope?

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No. Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn’t notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market. In 2014, at the FDA’s request, Olympus applied for permission to sell the scope. That application is still pending.

In a safety alert in February 2015, the agency confirmed that duodenoscopes have caused infections in hospital patients “even when manufacturer reprocessing instructions are followed correctly” and that “effective cleaning of all areas of the duodenoscope may not be possible.”

In early June 2015, the Justice Department announced that it is seeking thousands of page of documents in an investigation that has entangled all three manufacturers of a specialized medical scope tied to the deadly series of superbug outbreaks at hospitals across the country.

Is Olympus the only manufacturer of duodenoscopes?

No. Pentax and Fujifilm sell duodenoscopes similar to the Olympus TJF-Q180V.

The FDA has asked all three companies to submit evidence that their scopes can be thoroughly cleaned. CNN reports that the companies have twice submitted data that failed to show that cleaning could get rid of 99.9999% of all microbes on the scope — the FDA’s standard for disinfection.

These companies must run validation tests on their devices to ensure they are free of bacteria when cleaned according to manufacturer guidelines. The FDA requested the test results last April, and all three companies’ data were found to be inadequate, FDA Chief Scientist Stephen Ostroff said in an interview. The companies were asked to try again, he said, but still have not provided acceptable results.

One of the most vexing problems is that there’s virtually no way for the FDA to know when manufacturers don’t file medical device reports. If a company fails to disclose problems with its device, they’re likely to remain hidden unless they happen to come to the FDA’s attention through agency inspections of the company’s operation or some other route, such as news stories, whistle-blower tips or reports from hospitals.

How many patients have developed CRE and other deadly forms of bacteria after an ERCP procedure?

Hospitals and medical device manufacturers are under no obligation to report to federal authorities infections associated with medical devices — even ones that caused the death of the patient. Consequently, it is unknown how many patients have been infected with CRE and other superbugs, or who developed Pseudomonas bacterial infections, Klebsiella bacterial infections, or Escherichia coli bacterial infections (more commonly known as “E. coli”) from a contaminated medical scope.

In February 2015, however, the FDA reported that it had received 75 reports involving duodenoscopes that transmitted bacterial infections to approximately 137 patients.

We believe this number of 137 CRE-infected patients substantially underestimates the extent of the national “Superbug” outbreak. In Los Angeles alone, between the Fall of 2014 and January 2015 duodenoscope-linked CRE infections contributed to the deaths of two patients and the possible infection of more than 200 others.

Hundreds of patients across America may have been infected by contaminated medical scopes. Kristen Wendorf, a doctor at King County’s public health department in Seattle, told the Los Angeles Times in April 2015, “We suspect endoscope-associated transmission of bacteria is more common than recognized and not adequately prevented by current reprocessing guidelines.”

Which hospitals have reported infections linked to contaminated endoscopes?

According to press reports, outbreaks of CRE infections and other antibiotic-resistant super germs including E. coli strains linked to medical scopes have occurred in numerous hospitals over the past several years. (Please note that this is not a comprehensive list of Superbug infections related to contaminated medical devices.)