Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that uses a flexible tube known as a duodenoscope to examine the pancreas and bile ducts. Duodenoscopes used in ERCP have been linked to infections that are resistant to many common antibiotics. These dangerous infections are called superbugs.
If you developed a bacterial infection or other side effects after an ERCP duodenoscope procedure, you may be eligible for compensation.
In 1928, Sir Alexander Fleming made an accidental discovery when a petri dish of staphylococci (bacteria responsible for sore throats and abscesses) was contaminated by a mold from the plant genus Penicillium. That led to the invention of our modern-day antibiotic penicillin. His discovery of this “miracle drug” would usher the world into the “era of antibiotics.” The American Chemical Society called the introduction of penicillin “one of the greatest advances in therapeutic medicine.”
But Fleming also recognized the dangers of penicillin and antibiotics in general. Fleming was awarded the Nobel Prize in 1945 following his unintended finding, and in his Nobel Lecture of December 11 the same year, he said, “I would like to sound one note of warning.”
Fleming pointed out that under-dosing (not finishing medications) and other misuses of antibiotics, such as prescribing them when they are not needed, could very well lead to bacteria developing resistance to penicillin and other antimicrobial drugs and therefore making them ineffective for curing illness.
Now, more than 70 years later, Fleming’s prediction has come true.
Certain bacteria, often termed “superbugs,” have become resistant to several antibiotics, including a strain of E. coli discovered in a woman in the U.S. in 2016, according to the Washington Post.
That particular superbug was determined to be resistant to a drug called colistin, also known as an “antibiotic of last resort.”
Colistin is also used to treat bacteria known as carbapenem-resistant Enterobacteriaceae (CRE). CRE are most commonly found in hospitals and other health care facilities. This superbug family includes strains of Klebsiella and E. coli, which are naturally occurring in a person’s intestines and usually cause no problems there. But when spread to other parts of the body, they can cause infections so severe that they can kill up to half of infected patients, the CDC said.
The Washington Post reported CRE has been dubbed “nightmare bacteria.”
The bacteria are not spread by normal contact. Instead, a non-infected person has to touch an infected person’s stool or an open wound and then somehow transfer that bacteria to an open wound on their own body.
Contaminated devices that are used and then reused in certain medical procedures can also put a patient at risk. Duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) have caused a rise in exposure to these deadly bacteria due to their alleged defective design, which makes proper cleaning difficult.
The U.S. Food and Drug Administration (FDA) said that thorough and effective cleaning of all areas of the duodenoscope “may not be possible.”
When bacteria change and become able to resist the effects of an antibiotic, the bacteria are known as “superbugs.” Bacterial strains can also pass this trait along to other bacteria, causing those strains to become resistant as well.
Bacteria are found inside and outside of people’s bodies. It’s reported that about one-third of people are “colonized” with the Staphylococcus aureus bacteria. That means bacteria live on people’s skin and other areas without causing problems.
It is thought that about 1 percent of people are colonized with an antibiotic-resistant strain of the bacteria staph aureus known as MRSA, or methicillin-resistant Staphylococcus aureus. The risk for acquiring this version of bacteria is higher for those who are hospitalized.
A scratch or open wound can lead to an infection with the infiltration of the bacteria. Sometimes these infections are minor, such as a pimple or boil. Having a weakened immune system can cause these infections to become more severe. In 2014, the National Institutes of Health, citing Centers for Disease Control and Prevention (CDC) information, estimated more than 80,000 MRSA infections occur, resulting in 11,000 related deaths, annually in the U.S.
A balance of good bacteria and bad bacteria are also present inside everyone’s body, such as those present in digestive systems known as Clostridium difficile, or C. diff. The bacteria typically do not cause any problems unless the balance is disturbed, causing bacteria such as C. diff to colonize out of control.
In 2015, Consumer Reports told the story of a 56-year-old kindergarten teacher from Brooklyn, N.Y., Peggy Lillis, who was prescribed the antibiotic clindamycin to prevent a dental infection.
Clindamycin may cause an overgrowth of dangerous (bad) bacteria in the large intestine by eliminating much of the “good” gut bacteria. For this reason, it is usually used to treat only serious infections that cannot be treated by other antibiotics, such as penicillin.
In Lillis’ case, the bad bacteria became so extensive that she developed a severe intestinal infection due to the bacteria C. diff and required emergency surgery to remove her colon. Despite these emergency measures, Lillis died within 10 days of taking the antibiotic.
Consumer Reports stated that at least 250,000 individuals each year develop C. diff infections linked to antibiotic use and about 14,000 die from the superbug invasion.
Antibiotic resistance can sometimes occur due to the overuse of antibiotics. Each time antibiotics are taken, bacteria sensitive to the drug are wiped out. But bacteria that are resistant to antibiotics are left behind to grow and multiply. These bacteria can also spread to other people and cause infections that cannot be cured by common antibiotic treatments.
According to the CDC, repeated use of antibiotics can thereby increase the number of drug-resistant bacteria. Since antibiotics are not effective against viral infections, the use of such drugs for illnesses such as the common cold, flu, most sore throats, bronchitis, and many sinus and ear infections can result in the overuse (and misuse) of antibiotics, which promotes the spread of antibiotic resistance.
The NIH reported that “antibiotics are among the most commonly prescribed drugs for people.” It was also noted that these drugs are given to livestock, which we later eat, to prevent disease and promote growth.
The CDC said bacteria can become antibiotic-resistant in several different ways. It can “neutralize” the antibiotic by changing it to become harmless. Other bacteria can expel the antibiotic before it can do any damage. Some bacteria can even change its outer structure, leaving the antibiotic no way to attach, ultimately killing it.
If just one bacterium can find a way to survive exposure to antibiotics, it can then multiply and replace other bacteria that were killed off. This means that the surviving bacteria are more likely to be resistant. Likewise, bacteria can also sometimes mutate its genetic material causing it to become resistant.
In an interview following his winning of the Nobel Prize, Sir Alexander Fleming (the one who inadvertently stumbled upon penicillin) stated, “The thoughtless person playing with penicillin treatment is morally responsible for the death of the man who succumbs to infection with the penicillin-resistant organism.”
“The thoughtless person playing with penicillin treatment is morally responsible for the death of the man who succumbs to infection with the penicillin-resistant organism.”
Fleming pointed out that while penicillin is not poisonous and cannot result in an overdose, there is a particular danger in underdosage. He explained that laboratory testing showed it was not difficult to make bacteria resistant to penicillin by exposing them to concentrations of the drug that were not sufficient to kill them. He said that the same outcome was possible of happening in people’s bodies.
Fleming used a hypothetical scenario involving Mr. and Mrs. X. He said that Mr. X has a sore throat and is given penicillin, but he does not take enough to kill the bacteria but rather just enough to teach the bacteria how to resist penicillin. This bacteria in Mr. X now infects Mrs. X, who acquires pneumonia. Mrs. X is treated with penicillin but the treatment fails, and Mrs. X dies from the same illness Mr. X had that was previously treatable.
The CDC estimated that approximately 2 million adults become infected with antibiotic-resistant bacteria each year and that about 23,000 die from them. An article published by the National Institutes of Health (NIH) stated that while antibiotics have “transformed the medical response to bacterial illness” providing effortless treatment to formerly deadly infections, their mishandling is now transforming the bacterial population “such that many antibiotics have partially or entirely lost their efficacy.”
The author pointed out that the problem is so severe that many experts are now uncertain about the value and future of antibiotics over the next 100 years. Director of the Antibiotic Resistance Action Center and George Washington University professor Lance Price stated, “We may soon be facing a world where CRE infections are untreatable.”
And that’s not all. NIH News in Health reported that among the dangers the United States is now facing are drug-resistant forms of tuberculosis, gonorrhea and staph infections. The Washington Post stated that “if the resistant bacteria continue to spread, treatment options could be seriously limited.” This means that even minor infections and routine operations could become life-threatening ordeals.
Business Insider said, “The world is facing a potentially disastrous future… If this post-antibiotic era comes to pass, by 2050 it could kill more people every year than cancer.”
In 2013, CNN Health reported that the CDC developed a new ranking system to warn the public about health threats due to antibiotic-resistant bacteria, or superbugs. The levels were categorized as urgent, serious and concerning. To rank each superbug, the CDC considered how many people were getting sick, the number of hospitalizations that resulted and the number of deaths that occurred. The CDC also determined how many antibiotics could still defend against the bacteria, if any at all.
The drug-resistant form of this bacteria causes gonorrhea. Gonorrhea is spread through sexual contact. It is the second most commonly reported communicable (able to be passed to others) disease. In 2013, the CDC estimated that approximately 820,000 infections occur each year, and in about one-third of those cases treatment is difficult due to the bacteria’s growing ability to resist antibiotics.
Complications arising from the inability to adequately treat the bacteria or prevent the spread of the bacteria throughout the body can include scarring, chronic pain and infertility (inability to become pregnant), as well as serious infections to the heart and brain. The bacteria can also grow in the eyes.
The FDA issued an announcement linking CRE superbug infections to cleaned duodenoscopes used in ERCP (endoscopic retrograde cholangiopancreatography) procedures. Duodenoscopes are flexible, lighted tubes inserted into the body through the mouth and threaded through the throat and stomach into the top of the small intestine, or duodenum. They are used in more than 500,000 ERCP procedures in the United States each year to diagnose and treat problems in the pancreas and bile ducts.
In 2013, the CDC informed the FDA of a potential link between multi-drug resistant bacteria and duodenoscopes. Later, investigators learned that CRE infections were occurring despite confirmation that users were following appropriate manufacturer instructions for cleaning, disinfecting and/or sterilization.
The organic residue (tissue and/or fluids) left behind on the scopes even after proper cleaning can potentially be shared to other patients through the subsequent use of the device. This sharing of debris can result in potentially life-threatening CRE infections in patients.
In early 2017, CNN reported that a study published in the Proceedings of National Academy of Sciences showed that superbugs from the CRE group “may be spreading more widely than previously thought.” And researchers said it may even be spreading from person to person without any apparent symptoms.
Outbreaks of the bacteria have been found in cities across the United States, including Los Angeles, Boston, Pittsburgh, Reno and Chicago. An abstract published by the National Institutes of Health (NIH) in 2014 stated that the 2013 outbreaks of CRE following ERCP procedures account for the largest overall outbreak of CRE in the United States.
In 2015, CNN reported that two out of seven patients at Ronald Reagan UCLA Medical Center in Los Angeles who had contracted CRE infections following ERCP procedures died from the superbug. Another 179 patients who underwent the same procedure within three months before the deaths were contacted to take screening tests for the bacteria.
The Seattle Times reported that between 2012 and 2014, 32 patients at Virginia Mason Medical Center in Seattle fell ill with the superbug after being exposed to presumably contaminated duodenoscopes during ERCP procedures. Of those 32 individuals, 11 died.
In 2015, Congress stepped in, providing hundreds of millions of dollars to federal agencies, such as the CDC and NIH, who are already involved in efforts to fight antibiotic-resistant bacteria. The funds were administered to aid in research and to prevent and monitor superbug outbreaks.
When CRE bacteria spread outside of the gut, they can cause serious infections.
The symptoms associated with a CRE infection vary depending on the type and location of the infection. For example, if the bacteria cause pneumonia, then the patient experiences symptoms associated with pneumonia. A laboratory test can confirm the presence of a CRE infection in a person’s body.
Healthy people typically do not acquire CRE infections. CRE is more likely to affect individuals with weakened immune systems and/or those on ventilators (breathing machines) or having invasive devices such as intravenous (IV) catheters and scopes going into their bodies.
CRE is treated with antibiotics. But since the bacteria is classified as a superbug, that means very few, if any, antibiotics are available to combat it. Commonly prescribed antibiotics, such as penicillin, do not work to treat CRE. The CDC advises that treatment of CRE infections be determined on a case-by-case basis.
The CDC has also noted that some people might be colonized with the bacteria rather than infected, requiring no treatment. It is unknown how long colonization with CRE may last, but it is likely that it may be long-term. Officials recommend hand washing and good environmental cleaning as being paramount.
However, CRE infections can be difficult to treat, and the CDC has reported that they kill approximately 50 percent of infected patients. Therefore, the best line of defense is to take precautions to avoid acquiring an infection altogether.
Please seek the advice of a medical professional before making health care decisions.
Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.
Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.(855) 993-6647