Senate Report Implicates Olympus and FDA in Deadly Bacterial Infection
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
A Senate report released earlier this week found the superbug infection linked improperly-cleaned duodenoscopes to be more widespread than previously thought.
The bacteria, known as the antibiotic resistant superbug carbapenem-resistant Enterobacteriaceae (CRE), has been affecting numerous sickly patients being treated in hospitals. CRE is labelled a "superbug" because it is notoriously difficult to treat: nearly 50 percent of those infected do not survive.
The duodenoscope was developed for use in endoscopic retrograde cholangiopancreatography (ERCP). It is a long, flexible tube with a camera at the tip. The scope is inserted into the digestive track, down the patient's throat, in order to diagnose and treat cancers, gallstones, and similar conditions without invasive surgery. In the U.S. alone, roughly 700,000 of these procedures are performed each year.
Olympus quickly took over the market for scopes, making 85 percent of duodenoscopes used in the United States.
Federal regulations require a manufacturer report any information that a device may have contributed to a death or serious injury within 30 days of receiving notice of such complications. Because patients undergoing ERCPs are often more ill than the general population, and more prone to infection, it is extremely important that these scopes are sterilized well between uses, and that regulations are adhered to.
However, according to the Senate report, Olympus knew by early 2013 that its duodenoscopes could transmit bacteria even after proper cleaning and sterilization, after a Dutch hospital outbreak of the deadly bacterial infection.
The Senate's probe showed that Olympus' scope's design actually allowed for blood and tissue to become trapped inside the device, thereby spreading bacteria from patient to patient when used in successive procedures.
Over the past three years, in Pittsburgh, Seattle, and Los Angeles, 21 people died from these bacterial infections, and at least two dozen more became ill. Of the 10 infection outbreaks identified by the U.S. Food and Drug Administration, 7 involved Olympus scopes.
However, the Senate report found that the FDA, rather than warn the public of the antibiotic resistant superbug, "wasted valuable time" by asking Olympus and two other manufacturers to prove that the devices could be properly cleaned. The senators also wrote that the findings "point to flaws in the federal government's oversight of medical devices, as lax regulation leads to life-threatening consequences."
Despite patient deaths and illnesses, Olympus continued to sell its duodenoscopes without warning U.S. hospitals that the device had been linked to serious infections. Instead of reporting the pattern of infection that had emerged, Olympus treated each instance as an isolated instance-blaming the hospitals for failing to clean the scopes properly.
In early 2015, UCLA found its infections to be connected with Olympus duodenoscopes and in February, the FDA finally issued a warning about the danger of the scopes spreading deadly bacteria. Later in September the FDA updated its warnings about medical scopes, expanding the warning to include bronchoscopes-scopes used to examine the throat, larynx, trachea, and lungs.
A number of lawsuits have been filed against Olympus, including one by the parents of an 11-year-old California boy who was treated with an Olympus scope at UCLA during the outbreak and developed an infection.
If you or someone close to you have suffered on account of a duodenoscope, please contact us today online or by telephone at (888) 260-0473. Our experienced attorneys are here to listen to you, and fight for your compensation. At Rheingold, Giuffra, Ruffo & Plotkin LLP, you get the experience of a big firm with the personal attention of a small firm.