The Olympus Colonoscope lawsuit claims the device is defective in that it’s difficult to properly clean after each use, which results in the device spreading a bacterial infection from one patient to another.
What We Know About the Olympus Colonoscope Lawsuits
In June 2012, Olympus Corporation received reports that the design of its colonoscope product contained a flaw, allowing blood and tissue from a patient to become trapped, and then spreading a bacterial infection to others patients.
A company technician discovered that a rubber seal designed to prevent bacteria from entering the instrument was cracked and worn. An independent investigator hired by Olympus, and a hospital in the Netherlands, recommended that further investigations be carried out – and that all defective units be recalled if the problems were apparent elsewhere.
Despite this information, Olympus continued to sell its products in the U.S. without any warnings, even as patients died from resultant infections. In January 2013, Olympus issued “important safety advice” in Europe for one of its products, the TJF-Q180V duodenoscope. However, no such warnings were issued in the U.S.
With today's virulent strains of antibiotic-resistant bacteria posing serious threats in hospitals around the world, Olympus Corporation's willful negligence in this matter is patently clear. In the meantime, the FDA issued new guidelines in December 2016 on how to minimize the risk of cross-contamination and the spread of infections from endoscope systems.
In June 2017, a Superior Court judge in Massachusetts determined that a lawsuit filed by patients who sustained injuries due to the Olympus colonoscope could proceed. The complaint, filed by 25 plaintiffs who underwent colonoscopies between June 2012 and April 2013, names Olympus Corporation and Baystate Noble Hospital as defendants.
What is the Purpose of Endoscopic Devices
Endoscopy is the procedure by which physicians examine the inside of a patient's body without having to resort to invasive surgical procedures. While the procedure itself dates back to 1806, the first self-illuminated endoscope was invented in 1894 by Dr. John MacIntyre of Scotland's Royal Infirmary, one of the first medical facilities in the world to be wired for electricity.
A trained electrician, MacIntyre was also a pioneer in the field of radiology. His invention was first used to examine a patient's larynx. In the decades that followed, the field of endoscopy evolved and expanded and can be used today to examine virtually any part of a patient's body. Endoscopy is also used in conjunction with cutting tools in order to perform delicate, otherwise difficult surgical procedures (known as “keyhole” surgery).
The modern endoscope typically consists of a flexible tube with some type of illumination system delivered by way of fiber optics, a lens, and a relay system that transmits the images to a viewer. Originally, endoscopes were designed with integrated eyepieces. However, modern computer imaging technology now allows images to be displayed on a video screen. This technology can also allow a surgeon to perform operations remotely, as was done in 2001 when a surgical team in New York City successfully removed a gallbladder from a patient in Strasbourg, France.
Today, there are many specialized types of endoscopes, the design of which varies depending upon what part of a patient's body is being examined. As its name suggests, the colonoscope is used for examination of the colon as well as the large intestine.
Risk Factors Involved in Endoscopy
While infection is always a risk for patients undergoing an endoscopic procedure, other risk factors include:
- organ perforation
- tear in the lining of the stomach or esophagus
- internal bleeding
- drug interactions
- inflammation at the sedative injection site
- complications due to patient co-morbidities
Most of these potential side effects are fairly uncommon, particularly bleeding and perforation. The majority of bleeds are minor and can be stopped with cauterization if they do not stop on their own. Patients are advised to inform their doctors of any medical conditions they have or any medications they may be taking, particularly if undergoing sedation.
After use, all endoscopes must be thoroughly disinfected. Unfortunately, while rigid endoscopes can be disinfected in an autoclave like surgical instruments and tools, special methods are required for the more common flexible type.
How Does the Olympus Video Colonoscope Work
The Olympus Evis Exera II Video Colonoscope is a medical device used by gastroenterologists to perform colorectal screenings. This is normally a routine procedure, particularly for patients over fifty.
The Tokyo-based Olympus Medical Systems Corporation is the largest manufacturer and distributor of colonoscopes in the U.S., commanding approximately 85% of the market. The first Exera II model received FDA approval in September, 2006. Since that time, subsequent models have been approved through the 510(k) Pre-Market Clearance process, which allows the manufacturer of a medical device to bypass normal safety testing procedures when it can be demonstrated that the new product is “substantially similar” to one currently approved for the market.
Over the past few years, the Olympus Exera II and similar devices have been implicated in hundreds of cases in which patients have contracted antibiotic-resistant infections, some of which have been fatal.
According to a report from the Food and Drug Administration, nearly 450 patients at 30 hospitals across the U.S. were exposed to bacteria-tainted endoscopes between January 2010 and October 2015 – over 400 of whom contracted serious infections.
In July 2016, the Los Angeles Times reported that the Olympus Corporation sent emails to its executives in the U.S., instructing them not to issue warnings to hospitals about these potentially fatal infections after two dozen cases were reported in Europe in 2013. As a result, outbreaks occurred at several hospitals in major U.S. cities, resulting in at least 35 patient deaths.
Olympus has a demonstrated record of acting in its own interests in order to maximize profits. Even while under investigation for its role in patient infection outbreaks, the company agreed to pay $646 million in 2016 to settle criminal and civil allegations of illegal kickbacks and bribes to physicians and health care institutions.
Recently, Olympus was ordered to pay $6.6 million to the Virginia Mason Medical Center in Seattle, Washington, and an additional $1 million to the widow of a patient who died in 2013, as the result of a procedure carried out with the company's TJF-Q180V duodenoscope, another product that was approved under 510(k) Pre-market Clearance.
Although the jury found the device itself was not the cause of the patient's death, it found that Olympus failed to provide adequate warnings about the device and did not issue proper instructions on cleaning and maintenance.