Last April, it was revealed that between 2010 and 2015 more than 41 hospitals worldwide reported bacterial infections linked to duodenoscopes, likely affecting 300 to 350 patients.
The duodenoscope is a flexible long snake-like tube with a tiny camera on the tip that is inserted into a patient’s throat and upper gastrointestinal tract. The scope contains a hollow channel that allows for the injection of contrast dye, the insertion of other instruments to obtain tissue samples for biopsy, or the treatment of certain abnormalities. It is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other problems.
Now, a news report has confirmed that at least 35 people at U.S. hospitals have died since 2013 after being infected from contaminated gastrointestinal scopes manufactured by Olympus. If that wasn’t bad enough, internal company emails revealed that all the deaths came years after a company official told U.S. executives not to issue widespread warnings in the U.S. about the infected scopes. This decision was made despite the company previously warning its European customers, after two dozen infections were reported in hospitals in France and Holland.
Knowing about the European cases, as well as a similar case at a Pittsburgh hospital, Laura Storms, vice president of regulatory and clinical affairs in Center Valley, PA, sent an email to Olympus’s chief manager for market quality administration, Susumu Nishina. She said:
“Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?”
Nishina replied in an email on Feb. 6, 2013 saying:
“Although it is not need[ed] to communicate to all the users actively, you should communicate with the user who has asked a question.” His email also said that the risk was “acceptable.”
According to the report, these email exchanges continued for months, with U.S. officials becoming more and more concerned about the growing number of infections at U.S. hospitals. In other emails, Storms challenged Japan executives’ handling of the investigation into the University of Pittsburgh Medical Center cases. The hospital initially linked one contaminated scope to 18 sickened patients but later downgraded that total to one case. She even questioned the company’s insistence that the hospital was at fault for failing to clean the scopes properly. Yet, despite Olympus’ knowledge that there was clearly a design flaw that made it nearly impossible to clean its duodenoscope, the company continued blaming U.S. hospitals for the infections.
It wasn’t until January 2016 that Olympus issued a recall. The devices remain on the market and in use while the company recalls them for repairs. The recall is expected to be completed nationwide next month. Some doctors and researchers say the problems will persist unless Olympus completely redesigns the duodenoscope to keep bacteria from becoming trapped in tiny crevices at the tip.
No one should be ever be exposed to life-threatening infections due to a poor manufacturer design. These incidents are entirely preventable. With an estimate of more than 500,000 endoscopic procedures performed in the U.S. each year, the extent of those affected remains an open question. How many more patients will suffer, and at what cost?
Why would Olympus purposely withhold information about potential dangers from the U.S.? There is only one obvious reason – profits are more important than patient safety!
Since the U.S. outbreak, several patients and their families have filed lawsuits alleging negligence by Olympus. The e-mails were filed in a Pennsylvania court as part of one patient’s lawsuit. Despite the outcome of any lawsuits against Olympus, the sad fact is that the innocent victims will suffer again when their rights are restricted from fair compensation due to tort reform.
Instead of safety advances, we, the people, often times suffer serious injuries or disabilities; some will succumb to death because of lax safety standards and defective designs. Then, corporations like Olympus use tort reform to make taxpayers cover the costs of their negligence. When legislatures take away the juries rights, they are giving corporations a “free pass” to design medical equipment, manufacture cars, build roads, develop pharmaceuticals, and sell other products with less concern for the value and sanctity of human life than for their bottom lines.
Guilty corporations should be held accountable for negligent and/or deliberate corporate choices. When tort reform restricts the rights of innocent victims, it shifts responsibility to entitlement programs (taxpayers). The next time you hear about tort reform and think it is a good idea, consider the victims due to the actions of Olympus.
Mark Bello is the CEO and General Counsel of Lawsuit Financial Corporation, a pro-justice lawsuit funding company.
Experienced attorney, lawsuit funding expert, certified civil mediator, and award-winning author of the Zachary Blake Betrayal Series. The series consists of "Betrayal of Faith", "Betrayal of Justice", and "Betrayal in Blue", with a fourth book due out in 2019. You can learn more about these topical political, legal thrillers at markmbello.com. Mark Bello is also a member of the State Bar of Michigan, a sustaining member of the Michigan Association for Justice, and a member of the American Association for Justice.