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With bacteria becoming more virulent by the day, FDA researchers have warned the public that duodenoscopes can spread deadly antibiotic-resistant superbugs. Outbreks have been caused by Duodenoscopes and Olympus Manufacturing.
Did you or a loved one contract an antibiotic-resistant infection? Our experienced medical device lawyers want to help.
Deadly outbreaks of virulent new bacteria have shocked and terrified the nation. Hospitals in Seattle, North Carolina, Philadelphia, Chicago, Florida and Los Angeles have seen nearly-untreatable “superbugs” jump from patient to patient at alarming rates. But these infections, which prove fatal in an estimated 50% of cases, aren’t spread by a cough or sneeze.
The medical community has struggled to tackle this problem, but their efforts are being hampered by a medical device that can spread invisible pathogens between hospital patients.
Researchers at the Food & Drug Administration have conclusively linked a series of virulent outbreaks to the duodenoscope, a device often used in minimally-invasive procedures in more than 500,000 people per year.
Most duodenoscopes are made by Olympus, a company that stands accused of falsifying test data and committing outright fraud. Injured patients and their families may be entitled to compensation.
For some, the idea of an invincible form of infectious bacteria may still sound like science fiction. It’s not. Public health officials have been worried about so-called “superbugs” for decades.
Many experts have even called these bacteria, strengthened by genes that neutralize the effects of multiple antibiotics, a threat to the existence of human life itself.
Humanity has come a long way in the fight against germs and other infectious agents. Before 1675, the very existence of microorganisms was completely unknown, and it would take another two centuries for anyone to make the link between invisible microbes and disease.
Thanks to astounding advances in pharmaceutical science and the design of medical devices, we don’t just know that tiny bacteria and viruses can harm us, we can effectively prevent or treat the illnesses they cause.
But like the course of medicine, bacteria are constantly changing. They grow stronger, build defenses and eventually can’t be combated at all. When microbes become invincible to drug treatments, we have few options other than to stop them from spreading in the first place.
The first antibiotic agent was identified in 1907, and quickly heralded as a “miracle.” Twenty years later, Penicillin was discovered and would start fighting infections in hospitals by 1942.
With antibiotics now available worldwide, no one thinks much of a bacterial infection anymore. Throughout most of human history, though, infections were deathly serious.
But our ability to neutralize microscopic invaders, best represented by the power of antibiotics+, is a double-edged sword. Bacteria learn, evolving to develop a resistance to our antibiotics.
Once a specific “strain” of bacteria becomes resistant to multiple antibiotics, we call it a “superbug.”
The creation of superbugs is like a vicious circle: the more antibiotics we prescribe, the more opportunities we give bacteria to build up their defenses. As a result, we need more antibiotics to combat the infections, and bacteria become even more advanced.
In early 2013, the World Economic Forum called antibiotic-resistant bacteria “arguably the greatest risk […] to human health.” More recently, with the world’s eyes turned to West Africa’s Ebola outbreak, the Swiss-based non-profit upgraded superbugs to the next global pandemic threat.
Since all bacteria evolve, any type can become a superbug. But the FDA has warned patients and surgeons using duodenoscopes about a specific family of germs: Carbapenem-Resistant Enterobacteriaceae (CRE).
Carbapenem-resistant Enterobacteriaceae are a set of related germs that have become immune to the effects of carbapenem, an antibiotic used as a last line of defense against several infectious agents.
Carbapenem was designed to destroy particularly dangerous bacteria, ones that are already resistant to more commonly-prescribed antibiotics. This makes the birth of microbes resistant to carbapenem an unprecedented “threat to public health,” according to the Centers for Disease Control & Prevention.
Salmonella and Escherichia coli (E. coli) are both examples of Enterobacteriaceae, but the family of microbes is extremely large.
Two specific germs were highlighted in the FDA’s duodenoscope warnings, E. coli and Klebsiella, but any Enterobacteriaceae can evolve into a superbug. In fact, superbugs can pass the genes that make them resistant to other bacteria.
Even following rigorous cleaning procedures, duodenoscopes can continue to harbor microscopic organisms, passing deadly, antibiotic-resistant bacteria from one patient to another.
A number of former patients have now filed superbug lawsuits against Olympus Corporation, the main manufacturer of duodenoscopes. In at least five legal claims, individuals who suffered the severe effects of superbug infection say Olympus failed to warn medical professionals and patients of the device’s risks. Some have gone so far as to claim that the dangerous devices should never have been brought to market.
One woman, Staci Simos, filed her lawsuit after contracting a superbug at a UCLA medical center. The outbreak killed three other people at the hospital. Prominent public safety advocates believe many other patients will turn to legal action in the coming months.
Duodenoscopes are long, flexible tubes used to provide a color view of the “duodenum,” the first portion of the small intestine.
But they don’t just give us a picture of your insides. The device’s complex design allows surgeons to dislodge obstructions that are blocking tiny ducts to the pancreas and gallbladder. According to the US Food & Drug Administration, this unique design has “improved the efficiency and effectiveness” of endoscopic procedures.
But it’s also had an unintended, and often tragic, effect.
Made for use in multiple procedures, duodenoscopes are virtually impossible to clean completely. With tiny nooks and crannies, the instruments can become a breeding ground for dangerous microbes. Cleaning procedures exist, but Olympus has failed to demonstrate that its suggested process can kill enough bacteria to meet the FDA’s standards.
A growing number of critics are now calling the device’s intricate design an inherent flaw, one that allows tiny microorganisms with deadly potential to travel from one patient’s intestines to the next.
It’s very likely.
In a recent public warning, the US Food & Drug Administration noted an “association between […] duodenoscopes and the transmission of infection agents.” After outbreaks in their own facilities, many hospitals have cautioned other medical establishments about the duodenoscope’s potential risks.
But the instruments’ risks came to light long before the recent superbug crisis.
After a pathogen spread by endoscopic instruments led to 8 French citizens contracting blood infections, the FDA released its first Safety Communication on duodenoscope risks.
That was almost 6 years ago, and the danger has only grown, with new antibiotic-resistant bacteria evolving at a frantic pace. But duodenoscopes remain in common use.
Spurred by a recent outbreak at UCLA, the US Department of Justice launched a formal investigation into Olympus’ duodenoscope business. In the company’s shareholder report for the first quarter of 2015, Olympus listed “Duodenoscopes” under its survey of potential “Business Risks,” noting that a subpoena had been issued by the federal government. In light of the recent superbug lawsuits, Olympus told its shareholders that the company’s “financial condition may be affected.”
On October 5, 2015, the FDA ordered the world’s three largest duodenoscope manufacturers to conduct “real-world” studies on how well, or poorly, their products are being cleaned after use.
A recent investigation led by CNN revealed that the Olympus endoscopes linked to UCLA’s superbug outbreak had never been approved by the FDA. Rather than seek clearance, the company simply started marketing and selling a potentially deadly product.
For more than two decades, physicians have reassured their patients that the risk of infection related to endoscopy is as low as 1 in 1.8 million procedures. This statistic, first reached in 1993, has never been correct. According to researchers at the American Journal of Infection Control, the “1 out of 1.8 million” risk estimate was “inaccurate, outdated [and] based on flawed methodology” from the start.
So how high is the risk of contracting a superbug infection from an inadequately cleaned duodenoscope? No one knows. Even with public scrutiny pointed squarely at duodenoscope procedures, many infections that may be linked to the device go unreported.
Despite the dangers, Olympus Corp. reported a 14% jump in duodenoscope sales so far this year, according to the Los Angeles Times.
CRE superbugs can cause any number of infections, depending on which organs they’re able to reach.
Once harmful bacteria get inside the body, they begin to multiply, producing toxins and ultimately invading body tissues. The immune system kicks into gear, sending antibodies and white blood cells toward the bacteria, and initiating a host of other mechanisms designed to stop microbes from growing or kill them.
Most symptoms of infection are actually the result of your immune system’s response to the invasion, not a direct effect of bacteria. Fever, for example, occurs because many bacteria can be killed by high heats. So the body turns up its internal temperature, fighting infection but resulting in considerable discomfort.
According to MedicineNet, several types of infection are considered signs that antibiotic-resistant CRE may be present in a patient:
Septic shock, more common in the elderly and other people with weakened immune systems, happens when the immune system’s response causes inflammation throughout the body. A drastic drop in blood pressure can result in death.
Untreated, all of these infections can be fatal. As we’ve seen, antibiotic-resistant bacteria are extremely difficult to treat, even with the latest in medical technology at our disposal.
The extreme danger of superbugs is universally acknowledged. With the risks of infection well-known, many industry critics have questioned how the duodenoscope, a medical device that spreads deadly bacteria, could remain in use.
As members of Congress demand answers, a series of revelations have called Olympus’ business practices into question:
Legal experts believe these recent developments will remain at the forefront of the growing superbug litigation for months to come.
Yes.
Antibiotic-resistant bacteria have been called the next “global pandemic” waiting to happen. But these microscopic organisms won’t have to travel across an ocean to reach our shores; they’re already here and being spread.
Duodenoscopes aren’t just a threat to individual patients; slowing the transmission of superbugs is critical to the safety of thousands.
For patients who have already been harmed, legal action may be possible. If you contracted a serious infection after undergoing an endoscopic procedure, contact the personal injury attorneys at Banville Law today.
Our lawyers can help you understand your rights and legal options. You may be entitled to significant financial compensation.
Your initial consultation is free and comes at no obligation.
In March of 2015, widow Theresa Bigler filed a wrongful death suit against Olympus over the death of her husband Richard Bigler. The late Bigler, 57, was one of 11 patients who died after an antibiotic-resistant strain of E. coli swept through Seattle’s Virginia Mason Medical Center. Bigler’s widow also named the hospital as a defendant in her claim.
But in a virtually unprecedented move, Virginia Mason Medical Center switched sides, agreeing to join with Theresa Bigler in suing Olympus. Speaking with the Seattle Times, a hospital spokesperson said:
“it’s likely Olympus had known for years that the devices could spread bacteria, but that the firm never informed Virginia Mason or other hospitals.”
Of Virginia Mason’s decision to side with patient rights over corporate interests, Bigler told reporters: “I hope by joining with us, we’ll strengthen our fight so other families don’t have to go through what we’ve had to go through.”
The same month, a second patient from Washington State filed suit against Olympus, claiming an infection contracted at Seattle’s Harborview Medical Center left her struggling to stay alive.
In court documents obtained by Banville Law, Plaintiff Debbie Newton tells the horrific story of her battle against a superbug. In early 2013, Newton was diagnosed with gallstones by physicians at Harborview, a hospital affiliated with the University of Washington. One month later, she was admitted for a “routine – same day – procedure” to address her gallstones, a procedure in which Olympus’ Q180V duodenoscope was used. But after the procedure, doctors informed Newton that she would be kept overnight for observation.
At midnight, Newton’s mother received a phone call: her daughter was being placed on life support. Newton had suffered “heart failure, respiratory failure, renal failure, pancreatitis, septic shock and bacteremia,” according to the complaint. After a culture turned up positive for three forms of bacterial infection, she was administered a carbapenem-based antibiotic through a catheter inserted in her heart. But the bacteria, it would seem, were antibiotic resistant. Only 12 days after being discharged, Newton was readmitted with a pancreatic infection.
She would be readmitted twice over the next two years, for kidney and colon infections.
After an outbreak at a University of California, Los Angeles hospital claimed two lives, three affected parties filed superbug lawsuits against Olympus. The outbreak, which occurred between October 2014 and January 2015, left upwards of 179 patients exposed to CRE bacteria.
According to the Orange County Register, UCLA officials traced the rash of infections back to two duodenoscopes manufactured by Olympus.
First to bring a claim was Aaron Young, an 18-year-old high school student who remained hospitalized for months after contracting a superbug he says was transferred by one of Olympus’ scopes.
The next, filed by the family of Antonia Torres Cerda, claims Cerda died at UCLA after being infected with a carbapenem-resistant Enterobacteriaceae, or CRE. CRE is used to describe a “family” of germs that have all become immune to the last defense antibiotic carbapenem. Cerda’s four surviving children are named as Plaintiffs, along with her widowed husband. In their lawsuit, the Cerda family claim that Olympus provided UCLA with an outdated cleaning manual, one ill-equipped to deal with a newer duodenoscope model’s intricacies.
Four months later, another UCLA victim filed suit. Staci Simos says she was one of those infected with CRE after undergoing an endoscopic procedure in October of 2014. In her complaint, Stimos writes:
“after each use [Olympus’ duodenoscope] necessarily requires cleaning and disinfecting before it can be used on a new patient. A manufacturer of a medical device like an endoscope […] has an obligation to develop and validate a [cleaning] protocol and to incorporate this protocol in the product’s labeling. [Olympus] failed to take these critical steps with [its] redesigned […] scope.”
By stepping forward, plaintiffs seek to hold duodenoscope manufacturers accountable for marketing a product they call “dangerous by design.” Our experienced trial lawyers are available 24 / 7. Call us now for a free legal consultation.
Olympus Duodenoscope manufacturers' website: TJF-Q190V Duodenoscope
Journal of Clinical Microbiology: Superbugs on Duodenoscopes: The Challenge of Cleaning
