There have been two recent developments regarding the spread of CRE Superbugs via duodenoscopes used in ERCP procedures that the FDA warned about in February 2016.
The Senate investigation released today (Jan 13, 2016) indicates at least 141 patients were infected during a three year delay in reporting of the dangers of duodenoscopes, a medical scope used in ERCP procedures. The investigation identified 25 outbreaks across the country, which was “far more” than previously reported according to the Los Angeles Times coverage. Across the world, at least 250 people were infected with life-threatening illnesses, including the CRE superbug, after medical procedures with duodenoscopes. The CRE superbug is resistant to most antibiotics and has a high mortality rate (approximately half die from it).
Over the past few years, our personal injury lawyers have been representing more clients in cases of defective or improperly used medical devices. Although part of this may be due to an expansion of our interests in this area, health technology is a growing part of the practice of medicine and this no doubt has something to do with the fact that we are seeing more defective products in potential medical malpractice cases.
Last month, we reported that the DOJ had opened up an investigation into the development of the duodenoscope at Olympus in connection with the superbug outbreak that has been experienced at hospitals around the country following ERCP procedures. The Justice Department has now now expanded its investigation with subpoenas to the two other major medical scope manufacturers, Fujifilm Holdings and Pentax Medical.
In other superbug news, the White House opened its first summit to fight antibiotic resistance on Tuesday. The gathering included representatives from food companies, pharmaceutical and agricultural companies, hospitals, retailers and other groups.
There are also potential implications under the False Claims for the changes happening at the Government. The White House has ordered the development of a preference for the purchase of antibiotic-free meat and poultry at government cafeterias through General Services Administration (GSA) contracts. If food suppliers falsely claim that they are entitled to this preference, while providing food that does not qualify, they may be subject to liability under the False Claims Act and a whistleblower could get a share of the recovery as a relator. This is some time away – the administration set a 2020 deadline for the creation of this preference, but some agencies may do so quicker than required.
It turns out the superbug lawsuits aren’t the only legal problems for the manufacturer of duodenoscopes. Olympus has now reserved almost $450 million to settle claims of illegal marketing of its products from 2006 to 2011. These allegations involve the payment of kickback to doctors in violation of the False Claims Act, which is among the type of cases that our whistleblower attorneys handle.
The investigation may not be confined to the US. It looks like Olympus has also reported problems to the DOJ with payments to doctors in Brazil for travel, meals and entertainment. I haven’t done any research into the Brazil health care system, but if these doctors work for state-owned enterprises, I suspect the investigation is into potential FCPA violations.
Olympus has also been sued in Pennsylvania state court by two women accusing the company of spreading cancer with their device for laparoscopic power morcellation. The lawsuits accuse the company of failing to design the PKS PlasmaSORD Bipolar Morcellator to reduce the risk and argues that the company should have known about the problem.
Also in the news from Olympus, but related to its scopes and superbug contamination:
A two day advisory committee meeting declared duodenoscopes unsafe but did not instruct the FDA to stop their use by doctors. Instead, the 16 member panel of doctors, health experts and consumer representatives recommended that the FDA require the devices be redesigned.
Olympus and the two other scope manufacturers declined to participate in the two-day FDA panel. They haven’t released safety data about the effectiveness of their new, revised cleaning instructions, either.
Yet, Olympus is now claiming that human errors in the reprocessing of duodenoscopes may be at least partially to blame for the superbug infections. Physicians have contended that a design flaw in the devices makes them difficult to clean.
In early May, the FDA disclosed that it has received 142 reports of contaminated devices and possible patient infections since 2010. Approximately 50% of those came in 2013 and 2014.
Photo Credit: Kitmondo LAB.
A World Health Organization report found few nations are prepared to handle superbug infections. The report released today reviewed government plans to fight antibiotic resistance and found that only 34 out of 133 countries even had them.
Did Olympus Instruct Europe to Clean Duodenscopes with the MAJ-1888 Brush Two Years Before the United States?
We recently acquired a document that makes us believe that Olympus told Europe to clean contaminated duodenoscopes with the smaller MAJ-1888 brush two years before it told U.S. healthcare professionals. If it did so, it put millions of individuals undergoing ERCP procedures in the United States at risk of CRE superbug infections.
The document, which is in the form of a Dear Customer letter and appears to have been created and distributed by Olympus Europe located in Hamburg, Germany, is dated January 2013. It recognizes that there has been a reported case of contamination and advises Olympus’ customers to use the MAJ-1888 brush in cases of heavy soiling or delayed reprocessing. The brush “enables deeper access to the forceps elevator.” This is one of the areas that requires particular attention while reprocessing, according to the bullet points in the first paragraph of the document.
In the United States, Olympus issued new reprocessing instructions for the TJF-Q180V model on March 26, 2015. The instructions call for additional brushing of the forceps elevator recess area with the MAJ-1888 brush. It said “Olympus anticipates shipping the MAJ-1888 brushes to facilities no later than May 8, 2015.” It makes no mention of the fact that it told European customers to use the brush over two years.
Over the past two years, there have been a significant number of incidents at hospitals involving contaminated duodenoscopes spreading CRE superbug infections including Ronald Reagan UCLA Medical Center, Virginia Mason Medical Center in Seattle and UPMC Presbyterian in Pittsburgh. We have already filed one lawsuit here in Philadelphia against Olympus on behalf of a patient that was diagnosed with a severe infection following a duodenoscope procedure.
The document from Olympus Europe is below:
Following meticulous manual cleaning done by a Seattle Hospital over the past year, three percent of duodenoscopes are still contaminated. Virginia Mason Medical Center started the “costly and extraordinary measures” of manual cleaning and testing of each ERCP endoscope after a CRE superbug outbreak at its hospital. Researchers published their findings in a journal article online Monday in Infection Control and Hospital Epidemiology.
Bloomberg estimated that about 15,000 operations in the country would be performed with a contaminated scope if other hospitals experienced a similar rate of dirty endoscopes following cleaning. In February, the FDA issued an alert that it may not be possible to clean the medical scopes.
Olympus, the largest manufacturer of duodenoscopes, subsequently issued updated instructions for decontamination of its devices. It is unclear whether the procedures followed by Virginia Mason exceeded the standards set by Olympus for cleaning. Since the updated instructions were only sent to medical facilities at the end of March, and a device needed to perform the full procedure was not immediately available, it is unlikely that any of the device decontaminations used the new guidelines.
UPMC in Pittsburgh, following its own outbreak, purchased additional duodenoscopes and put contaminated scopes into quarantine until they could be assured that they were not infected with bacteria.
Last week, stories ran in both the Seattle Times and the News & Observer that mentioned our law firm. For additional information about this area of our practice, please visit the section of our website dedicated to superbug infections.
A Pittsburgh resident has reportedly contracted a superbug at Allegheny General Hospital following exposure to a contaminated Olympus duodenoscope, according to her lawsuit filed in Allegheny County Court of Common Pleas yesterday.
It is the third hospital to have a potential CRE infection outbreak caused by contaminated endoscopes. University of Pittsburgh Medical Center’s Presbyterian Hospital previously announced an infection outbreak linked to its use of scope in ERCP procedures. Jefferson Hospital here in Philadelphia has announced an outbreak but denied that testing warranted a conclusion that their use of duodenoscopes were linked to the spread of hospital acquired infections.
The article in the Pittsburgh Tribune-Review that I saw did not have a comment from the North Side hospital. That means that we have no idea yet if this is an isolated incident or if there are additional infections. We also don’t know how many procedures it performs a year.
This lawsuit in and of itself will be interesting in part because it will be a unique case. The procedure took place after the FDA warned about the dangers of the medical device but before the manufacturer issued updated instructions for cleaning the scopes.
If you are interested in additional information, please visit our page dedicated to the CRE superbug infections. We offer a free 20+ page ebook written by one our personal injury attorney for download.
Spurred by the CRE superbug infections linked to contaminated duodenoscopes, the White House announced a five year plan to fight antibiotic resistance in a 60-page report released today on the White House blog.
The Obama plan calls for an increase in the government’s budget in this area to $1.2 billion to be used on investments in antibiotics, new diagnostic tools and better use of antibiotic drugs. The plan will also involve greater surveillance of prescribing practices and collaboration internationally with organizations such as the World Health Organization and foreign countries.
The report hopes the plan will lead to two antibiotic drugs that can be used on difficult to treat bacteria. Because of the rise of antibiotic resistance, the current pharmaceutical of last resort has been moving back to a toxic drug developed in the 1950s and prescribers stopped using in the 1970s.
The plan also reportedly calls for infection control programs related to the cleaning of hospital equipment and hand washing. Medicare and Medicaid doctors will be required to report antibiotic prescriptions to the federal government.
The goal is to reduce carbapenam-resistant Enterobacteriaceae (CRE) infections by 60 percent. The CRE infections were central. The plan also seeks to cut C. difficile and MRSA infections by at least 50 percent.
According to the U.S. Centers for Disease Control and Prevention, 2 million people are infected each year with antibiotic resistant bacteria.
The increased scrutiny of infection control procedures and antibiotic drugs can be linked to the recent outbreak of superbug infections reportedly from contaminated duodenoscopes. Over the past few years, hospitals in Philadelphia, Pittsburgh, Seattle and Los Angeles, to name a few, have had outbreaks. UPMC Presbyterian in Pittsburgh, Virginia Mason in Seattle and Ronald Reagan UCLA Medical Center in Los Angeles have linked the spread of the deadly infections to duodenoscopes.
Olympus is the largest manufacturer of duodenoscopes in the US. It made a change to its device in 2010 without seeking the FDA’s 510(K) clearance that has still not been granted clearance by the FDA. The company advised doctors and other medical professionals in a letter yesterday that they should immediately begin new cleaning procedures for the device.
For our free ebook covering the spread of CRE infections by contaminated duodenoscopes and other related information, visit https://www.mceldrewyoung.com/superbug-infections/