Tokyo-based Olympus, a producer of 85 percent of the American gastrointestinal scope market, intentionally failed to warn hospitals in the United States of deadly infections that had been transmitted to patients after surgeries using the Duodenoscope in Europe and Japan. The Duodenoscope is a medical device that is used to scope a patient’s gastrointestinal tract to visualize problems in the biliary and pancreatic duct systems. These devices have been blamed for transmitting “superbugs” that can not be treated with antibiotics and are most often a death sentence for patients. Not only are the infections painful and deadly, they are so easily transmitted that many patients unfortunate enough to contract a “superbug” end up suffering and dying a horrible death alone, without support or comfort of having their loved ones near in order to prevent transmission of the infection.
In January of 2013, Olympus officials told European hospitals of possible dangers of using the Duodenoscope. At that time, French and Dutch hospitals had reported over 24 cases of the deadly infections that had been diagnosed after procedures were done with the device. Becoming concerned about patients in the U.S. market, VP Laura Storms at Olympus America, asked Tokyo officials if she should be communicating the same information to U.S. hospitals that was being shared with the European market. The answer was no.
Tokyo officials simply directed Olympus America to answer questions about the device, but not to communicate [the warning] to all active users. The company stated that they believed the level of risk to be “acceptable.”
Since then, 35 patients have DIED from painful, deadly superbug infections. They have suffered from dehydration, excessive vomiting, breathing difficulties, exhaustion, delirium and finally wrongful death when their bodies could not longer fight back against the tiny organisms that were destroying them from the inside out. These microscopic deadly organisms were placed inside these patients’ bodies by a medical professional using a medical device that simply could not be cleaned effectively.
Olympus deemed this suffering of U.S. patients “acceptable”. I wonder if it had been their own family members if they’d have felt the same way.
Recognizing the company’s failure to do so, the FDA issued a warning to all users of the Duodenoscope, stating that the complex design of the device may make cleaning difficult or impossible. They also warned that infections were being transmitted even in cases where hospitals had documented cleaning the devices exactly as Olympus had instructed them to do. Olympus had previously blamed hospitals for the transmission of infection because they said that hospitals were not cleaning the device according to the manufacturer’s specifications.
If you or a loved one has injured or killed by a dangerous medical device, call Paul Thomson of The Thomson Law Firm today. The Thomson Law Firm offers free consultations to potential clients with a personal injury.
