- A jury ordered Tokyo-based Olympus Corp. to pay a Seattle hospital $6.6 million in damages related to a superbug outbreak involving its top-selling duodenoscope, citing the company’s failure to adequately warn about the risk of infection or instructions for use, Kaiser Health News reports.
- But in a partial win for the company, the jury shot down claims that the scope’s design was unsafe.
- The case, the first in the U.S. tied to antibiotic-resistant infections caused by medical scopes, stemmed from the death of a patient at Virgin Mason Medical Center. The hospital had joined the patient’s widow in the lawsuit, but jurors found it shared some of the blame and told it to pay the deceased patient’s family $1 million.
The Olympus scopes have been linked to at least 35 deaths in U.S. hospitals since 2013. In 2015, the Food and Drug Administration issued warning letters to Olympus, Pentax Medical and other duodenoscope makers for various manufacturing and reporting violations. The devices have been linked to drug-resistant outbreaks in at least 25 hospitals.
In an odd twist, Olympus warned European hospitals nearly two years before the U.S. outbreaks began about issues with disinfecting its duodenoscopes, but never alerted U.S. hospitals to the problem. When the FDA learned of the warnings, it held off notifying hospitals because it was working with scope manufacturers on finalizing cleaning guidelines.
The FDA issued a safety communication to healthcare providers in February 2015 warning that the design of endoscopic retrograde cholangiopancreatography duodenoscopes could hamper effective cleaning.
In fact, a recent study in the American Journal of Infection Control found scopes often continue to harbor infectious bacteria after standard cleaning methods. Of 20 gastroscopes and colonoscopies analyzed, 12 tested positive for bacterial growth after one cleaning and 11% were not bacteria-free after two manual cleanings, two rounds of automated cleaning and high-level disinfection.
Last year, it was learned that Olympus officials in Japan sent internal emails to company executives in the U.S. asking them not to issue a warning to hospitals that the scopes were tied to deadly infections. During the Seattle trial, three senior executives of the company invoked the Fifth Amendment when asked to testify about the safety concerns.
Device safety has been on the public health radar in recent year with reports of superbug outbreaks tied to gastrointestinal scopes and morcellators spreading uterine cancer. Inspections at 17 hospitals found widespread underreporting of device-related adverse event, according to an FDA blog post from last year.
In December, the FDA held a public workshop on ways to enhance hospital-based surveillance and increase reporting of medical device-related adverse events. The agency also wanted to discuss hospitals’ role in assessing how well devices perform in clinical settings.