A Seattle hospital has joined a widow's lawsuit against Olympus Corp., claiming that the company allegedly sold defective duodenoscopes that led to a "superbug" infection.
The Virginia Mason Medical Center in Seattle was hit by a superbug outbreak that affected 39 patients from 2012 to 2014.
The hospital has joined a suit filed by Theresa Bigler that is seeking damages from both the hospital and Olympus, according to a report in the Seattle Times. Bigler claims that her husband, Richard Bigler, 57, died in August 2013 after contracting a superbug infection at the hospital, the newspaper said.
Interestingly, the hospital will remain a defendant in the case.
Even after hospital staff cleaned the scopes according to the manufacturer's directions, at least 39 people developed multidrug-resistant infections following endoscopic retrograde cholangiopancreatography procedures (ERCP) between 2012 and early 2014, the Seattle Times and Los Angeles Times reported. A duodenoscope is a type of endoscope threaded down through the digestive tract and into the small intestine.
At least 18 affected patients at Virginia Mason have died, although the Seattle Times reported that it is not clear whether the infections from the scopes played any role in their deaths.
FDA issued a new guidance document in March for reprocessing reusable medical devices.
"Despite the recent concerns about multidrug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low," William Maisel, MD, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in the an earlier FDA news release.
Mike Drues, PhD, president of Vascular Sciences (Boston), says that this case is not unique nor is it limited to products like duodenoscopes. "Any medical device--even a scalpel that is reused has the potential of cross contamination," he says. "To hold Olympus out as a special villain seems unfair to me. It also seems unfair to assume that the duodenoscope was defective. When you go to a restaurant, do you wonder how many mouths a spoon has been in at a restaurant? And if you get sick because it wasn't cleaned properly, would you say the spoon is defective?"
Olympus expressed sympathy to the patients who experienced infections and to their families, according to company spokesman Mark Miller.
"We are taking this matter extremely seriously," Miller wrote in an email to Qmed. "We do not normally comment on active legal matters, however, we are continuing our investigation into the reports at Virginia Mason to be able to provide a more thorough and balanced perspective on the issues including potential causes of the infections."
Seattle attorney John Gagliardi accused Olympus of misleading the hospital and its patients about the duodenoscopes' safety. Gagliardi told reporters that Olympus likely knew for years that the devices could spread bacteria, but that the company did not inform hospitals, the Seattle newspaper's story said.
Previous reports have suggested that Olympus skirted proper regulatory channels by amending their duodenoscope but neglecting to file a new 510(k) for it.
"I strongly defend Olympus in this case," Drues says. "What Olympus has done, in my understanding, is something that virtually every single medical device company has done and continues to do: making what it believes to be insignificant changes to a device and using a letter to file rather than notifying FDA via a 510(k) or PMA supplement. This is a practice that is widespread and, when it is done properly, there is no problem."
The hospital, which remains a defendant in Bigler's lawsuit, joined the plaintiff by filing a cross-claim against Olympus.
Olympus Corp. appears to be facing a growing number of lawsuits related to its TJF-Q180V duodenoscope, which health authorities have implicated in the spread of the drug-resistant bacterial strain carbapenem-resistant Enterobacteriaceae (CRE).
At least seven patients were infected and two died from CRE at UCLA's Ronald Reagan Medical Center from October to January 2014. The hospital believes that 179 patients may have been exposed to CRE from a contaminated, reprocessed Olympus duodenoscope.
Duodenoscopes are also sold in the United States by manufacturers including Fujifilm and Pentax, and are used in half a million U.S. procedures a year.
|Hear Mills' talk at MD&M East in New York City, June 9-11, 2015.|
Like what you're reading? Subscribe to our daily e-newsletter.