Olympus Scopes and Superbug Infections
Olympus Medical manufactures a medical device called a duodenoscope which is being linked to recent "superbug" infection outbreaks affecting hospital patients worldwide.
As the leading duodenoscope manufacturer, Olympus's scopes were identified in a series of deadly superbug outbreaks in U.S. hospitals between 2010 and 2015. Olympus's scopes directly infected patients with superbugs as a result of internal contamination. As a result, Olympus faces mounting personal injury and wrongful death lawsuits.
Duodenoscopes are specialized medical scopes used to diagnose and treat upper gastrointestinal tract problems, including gallstones, pancreatic tumors, and more. The devices have a camera, light, and surgical apparatus used in endoscopic retrograde cholangiopancreatography (ERCP) procedures.
Duodenoscope Superbug Bacteria Infections
A "superbug" is a potentially deadly bacteria infection that is highly resistant to antibiotic treatment. Several of the recent hospital outbreaks included the superbugs E. coli and carbapenem-resistant enterobacteriaceae (CRE).
The superbugs that caused the outbreaks in U.S. hospitals were transmitted from patient to patient via Olympus scopes which carried the infecting bacteria. In the case of "dirty scope" use, one patient's bacteria became trapped in the device and infected the following patients each time the scope was reused.
After a scope is used, it is cleaned and sanitized for reuse through a process called "reprocessing." However for a number of reasons, Olympus's devices have proven difficult to thoroughly sanitize.
Outbreak Hospitals and Infection Rates
To date, Olympus scope superbug bacteria outbreaks have affected as many as 30 medical facilities and up to 350 patients nationwide though the extent of the infections hasn't yet been fully accounted for. Hospitals that have publicly disclosed their reports include:
- University of California, Los Angeles's Ronald Reagan Medical Center. Up to 180 patients were infected, including two deaths.
- Virginia Mason Medical Center in Seattle, WA. Up to 40 patients were infected, including 18 deaths.
- University of Colorado Hospital . Nine patients were infected, including three deaths.
- Huntington Hospital in Pasadena, CA. The number of infected patients is currently unknown, but three deaths were reported.
Many plaintiffs allege Olympus's FDA-approved reprocessing protocols are responsible for patient injuries. The prevailing view is that hospital staff had been following flawed reprocessing guidelines as opposed to negligently spreading disease and recklessly endangering patients. This may change as health regulators continue to investigate all potential contributing factors to the outbreaks, including hospitals and staff.
Manufacturer and FDA Response
While the root of the crisis is complicated, the superbug outbreaks seem to have been facilitated by a) the scopes' design, b) Olympus's alleged negligence, and c) insufficient FDA regulatory policies. Patients and their families, the affected hospitals, and lawmakers are claiming:
- Olympus marketed its scope with an unapproved modification that allowed for bacteria to become trapped despite sterilization attempts following Olympus's reprocessing guidelines.
- Olympus failed to notify the FDA of the device modification. (Note that the FDA's medical device regulatory policies do not require manufacturers to verify post-market modifications for safety with the FDA.)
- Olympus had prior knowledge of the infection risk the modified device posed, but failed to act. Europe experienced a similar superbug outbreak resulting from Olympus's scopes in 2012. Olympus responded with the same updates to its reprocessing guidelines it had eventually given the U.S. in 2015, but did not alert U.S. authorities at the time of the European outbreak.
- The FDA had prior knowledge of the infection risk as early as 2009 and also failed to act until 2015. Despite private alerts from U.S. medical experts about the scope's design flaws, the FDA refused to issue a formal public alert due to its uncertainty about the causal link between the scopes and the outbreaks.
The FDA released its first safety communication about the infection risk in February 2015 after the link between the scopes and the outbreaks was publicly announced by a UCLA doctor. The communication instructed medical staff to strictly adhere to the device's reprocessing guidelines but when that proved inadequate, the FDA released another communication in March 2015 with Olympus's updated guidelines.
While Olympus had initiated a recall for the scopes beginning in January 2016, the FDA has yet to demand a full recall. Both the FDA and U.S. medical experts recognize its immense value to medical health. Despite Olympus's recall, hospitals continue to purchase new scopes to offset the extensive reprocessing procedure under the new guidelines despite the still-present infection risk.
Litigation against superbug-spreading Olympus scopes is still in its infancy. New Olympus scope lawsuits are being filed every month but none have yet to be settled or decided. Government and medical officials continue to investigate and collect information.
The lawsuits involve hospital patients who sustained serious and permanent injuries and who died from superbug infections. All of the lawsuits share a similar set of allegations, including:
- Olympus failed to address the infection risk their scope posed despite having prior knowledge of the risk.
- Olympus didn't seek or receive FDA approval for the life-threatening modification to its scope's design.
- Olympus provided misinformation concerning the safety and effectiveness of its scope and its cleaning protocols.
- Olympus wrongfully paid kickbacks to doctors and hospitals to sell devices. (The company settled civil and criminal allegations based on this claim in March 2016 for $623.2 million.)
Get Legal Help
Survivors of superbug infections can face ongoing health issues, resulting in recurring medical costs and loss of work. The families of patients who died from these duodenoscope infections also endure intense financial and emotional hardship from their loss.
If you were affected by the superbug outbreaks, contact an attorney experienced in medical malpractice and product liability. Having a qualified attorney on your side can open opportunities for financial compensation and peace of mind.
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