Olympus Corporation of the Americas is a company perhaps most known for cameras, but which also makes medical devices and has faced a number of lawsuits over the complications arising from one of those products. The main issue is the redesign of an endoscope that has led to a number of serious infections in patients. These infections were caused by what are referred to as superbugs, bacteria that are particularly difficult to kill.
Infections caused by Carbapenem-resistant Enterobacteriaceae (CRE) can easily be deadly because these superbugs resist many antibiotics. Superbug endoscope lawsuits have been piling up, filed against Olympus by those derailed by the infections and by those loved ones who lost someone to a CRE infection. Olympus has paid out many settlements and will likely continue to do so as lawsuits against the company mount.
CRE Infections Can Be Deadly
The type of infection in question is so serious because it can be fatal. CRE is a family of bacteria, all of which cause infections that are very difficult to treat or cure. These superbugs have developed a resistance to a number of modern antibiotics and to treat them requires last-resort medications. One type of CRE that most people have heard of is E. Coli, normally found in the intestines, but deadly when it spreads to other parts of the body.
CRE bacteria are named this because they resist even one of the most important antibiotics used as a last defense against resistant bacteria: carbapenem. The bacteria in this family can produce an enzyme that breaks down the antibiotic. As a result, nearly half of the CRE infection cases end in fatalities.
Infections from CRE are most common in people who are ill or have compromised immune systems. Healthy people are usually able to resist an infection, which is why outbreaks of CRE infections are most often seen in hospitals, where there are more vulnerable people. Despite efforts to keep clean, contamination in a hospital setting is the number one cause of a CRE infection.
The Olympus Endoscope and Superbug Infections
Olympus Corp. makes endoscopes, medical devices that can be inserted through small openings to image the inside of the body. A duodenoscope made by Olympus called the TJF-Q180V has been the source of the lawsuits filed against the company because of CRE infections. The scope is used to image the duodenum, the upper portion of the small intestine, and to remove tissue, a foreign object, or to take a biopsy. The scope is inserted through the patient’s mouth and threaded down to the intestines.
Because of the way in which this scope is used, it is crucial that it be disinfected between uses. Any bacteria on the scope could infect a patient, and for those vulnerable patients who are sick or have weakened immune systems, the risk is especially great. Olympus has gotten into trouble over its so-called superbug scope because a part of its design made it impossible to fully sterilize.
Even when hospital and other medical workers followed the manufacturer instructions for cleaning the scope, not all bacteria could be eliminated from it. This particular scope is used around the country in the majority of procedures that use a duodenoscope, which means that Olympus put thousands of patients at risk. The scope is believed to have contributed to 25 outbreaks of CRE infections and to have caused hundreds of infections and a handful of deaths.
Problems with Approval and Design
After the outbreaks, several investigations looked into the Olympus scope and found that its design was flawed. An interior elevator channel in the scope caused fluids to seep into it that could not then be flushed out or sterilized between patients. This faulty design made it impossible to fully clean the scope.
Another issue is that the company failed to get full approval from the U.S. Food and Drug Administration (FDA). It only had to clear the relaxed 510(k) process, which approves medical devices with minimal testing because other similar devices already exist. Olympus had changed the design of the scope and was required to resubmit it for 510(k) approval, but failed to do so. By 2016 Olympus had recalled the faulty scopes and redesigned the product to correct the flaw. Unfortunately this came too late for many people and for the company to protect itself from lawsuits.
Reasons for Superbug Scope Lawsuits
Patients who suffered from infections or the loved ones of patients who died from CRE infections caused by the Olympus scopes have filed lawsuits against the companies, as have state governments. The reasons for the suits include allegations that Olympus sold a medical device that was not approved by the FDA, that the company was negligent and guilty of wrongful death, that the company sold a product known to be faulty, and that it manufactured and then marketed a defective product.
Many individuals or their families have stepped forward to sue Olympus over the CRE infections. The first one came in 2015 when a teenager came down with a serious infection at UCLA’s hospital. As the family started this first lawsuit, the young man was still in the hospital fighting for his life. In another individual case the family of a 48 year old woman who died from a CRE infection sued Olympus for wrongful death. She too contracted the infection at the UCLA hospital.
Another outbreak occurred at Virginia Mason Medical Center in Washington. One woman who lost her husband to the CRE infection sued both Olympus for wrongful death, and the medical center for failing to warn patients about the risk of infection and that the scope was the likely cause.
In addition to these individual cases, there was also a whistleblower lawsuit in New Jersey. The case alleged that Olympus had paid kickbacks to doctors to buy scopes and was brought by an Olympus compliance officer who knew what was going on. The case was settled for $306 million to be split between several states. The company also had to pay several hundred million dollars in criminal penalties because it violated anti-kickback laws.
If you have suffered a CRE infection and you believe that an Olympus scope was to blame, you may be able to file your own superbug scope lawsuit. You will need to talk to a lawyer about your options and to find out if you have a case to make that could result in a settlement. Olympus is being forced in case after case to pay up for the negligence, kickbacks, wrongdoing, and making of a flawed device that caused so much damage and even death. You too may be able to be a part of this.