During an endoscopy, medical scopes are inserted into a patient’s body. Whenever a foreign instrument is placed inside the body, additional risks are introduced. Here, the danger is that the medical scope can cause the patient to develop an infection. The harm caused by the medical instrument goes beyond the standard infection and is a superbug that can be resistant to treatment with antibiotics. This has caused some significant injuries and fatalities.
This issue affects a specific type of endoscope called a side-viewing duodenoscopy. These devices are used in a procedure called endoscopic retrograde cholangiopancreatography. This procedure can treat the following affected areas:
- Bile ducts
The duodenoscope is a flexible and thin instrument that is intended to reach far into the body. The endoscope has lights and a camera attached allowing the doctor to view the affected areas. When used properly, the endoscope allows the surgeon to assess the area and remove tissue if necessary. An endoscopy can be used to treat anything from gallstones to pancreatic cancer.
An endoscope is reused for different procedures so it’s critical that this instrument is thoroughly cleaned and sanitized between uses in order to kill the harmful bacteria. As described below, this process can be difficult.
The specific risk is that Carbapenem-resistant Enterobacteriaceae (CRE) will infect the patient. Otherwise known as a superbug, this bacteria is generally resistant to antibiotics. While these types of infections are not necessarily common, affecting less than one in 200 patients, they are certainly deadly. Up to half of the patients who contract this type of infection can die. Those who survive can suffer serious long-term consequences.
One of the problems that cause the superbug can result from the design of the endoscope. The instrument is designed to be flexible and has many different parts. However, the intricacy and flexibility can also make the endoscope difficult to thoroughly clean. It is hard to reach all of the areas on the endoscope that can accumulate bacteria. As a result, the bacteria can build up and place the patient at risk of infection. Compounding the effects of the infection is the fact that those who undergo the procedure are already likely to have compromised their immune systems.
The design of the endoscope may make it more likely to transmit bacteria which could be considered a defect that could make the manufacturer liable to those who contract the superbug after an endoscopy. An FDA alert specifically addressed the challenges of properly cleaning the endoscope given its complex design. The FDA ordered the manufacturers of these devices to take further samples and study the issue.
One of the lawsuits that has been filed has also alleged a design defect insofar as the manufacturer allegedly made the product without including and factoring in updated sterilization protocols. When a product is this complex, the manufacturer should have been aware of this issue. One of the lawsuits argues that a manufacturer was informed in 2013 of the matter when there was an infection outbreak that affected dozens of patients. In addition to having knowledge at a certain point in time, this is something that the manufacturer should have learned through proper product testing. Attorneys are currently in the process of filing suits against all three manufacturers of these products or are investigating the possibility of further lawsuits.
Medical device lawsuits are complicated pieces of litigation that require a well-versed and experienced attorney. The lawyers at KBA Attorneys have a wealth of experience that comes from their years of experience in filing and litigation product liability cases. They have litigated cases involving defective medical devices and can use this experience to help those who have been affected by the superbug or have had a loved one who has suffered. Call KBA Attorneys today for a free consultation about a possible claim against the maker of the medical device that caused injury.