Consumer Advocate Blames both Manufacturer and FDA for Dragging their Heels

Washington, DCPublic Citizen is an internationally-recognized consumer advocacy group founded by perhaps the original consumer advocate, Ralph Nader. He’s the guy who railed over the safety of cars, and advocated for seat belts. And today, the organization he founded holds, amongst other things, the feet of the pharmaceutical and medical device industries to the fire over safety and efficacy. Whenever an endoscope lawsuit, for example, appears on a court docket you have to know that Public Citizen is watching in the wings. They have even launched lawsuits themselves, taking both manufacturers and the federal regulator to task.

Last February, Public Citizen was carefully watching the situation with regard to endoscope and duodenoscope infections. But true to its nature, Public Citizen chooses not to observe quietly. This is an organization that makes noise, when it sees a slight.

In February of last year, the headline from Public Citizen was ‘Outrage of the Month: Failures by Device Manufacturer, FDA Exposed Patients to Life-Threatening Infections.’

In his health letter a year ago February, Michael Carome MD referenced the release, the month prior, of a detailed and damning report stemming from a year-long investigation by the federal Senate Health, Education, Labor, and Pensions Committee (HELP) with regard to recent outbreaks of serious infections linked to medical procedures utilizing contaminated duodenoscopes.

The latter, which are a part of the endoscope family, are complex medical instruments used for internal medical diagnostic procedures. While the medical community agrees that such instruments have succeeded in revolutionizing the diagnostics industry, the fact the complex instruments are not disposable and designed to be re-used begets an even more complex problem…

When the instruments are not cleaned and decontaminated properly, they risk passing on contamination from one patient, to another.

That was the focus of the HELP Committee report, and Carome pulled no punches: “The damning report reveals critical failures by both the leading manufacturer of these devices and the [US] Food and Drug Administration (FDA) that likely contributed to avoidable patient illnesses and deaths,” he wrote.

Carome referenced the infection outbreak at the Virginia Mason Medical Center in Seattle, about which The Seattle Times reported on January 21, 2015. No fewer than 32 patients had developed serious bacterial infections that were resistant to antibiotics, between 2012 and 2014. Eleven patients died.

The reusable duodenoscopes had been reportedly cleaned, and disinfected according to the manufacturer’s instructions.

In the time since that outbreak, it has been revealed that even following those instructions may not be sufficient to safely eliminate contamination. More needs to be done, and various hospitals and nursing associations have been advocating for more detailed protocols in an effort to increase margins of safety.

“In the several weeks following the Seattle Times story,” Carome wrote in February, 2016, “a flurry of news reports documented similar outbreaks that had occurred at other medical facilities across the country, including at hospitals in Los Angeles, North Carolina and Wisconsin. Most of these reported outbreaks were linked to duodenoscopes sold by medical device manufacturer Olympus, which makes 85 percent of such scopes used in the US. News about the outbreaks grew even more troubling in March 2015 when the media reported that Olympus had not obtained the required clearance from the FDA before it began selling the scope model linked to the infections in 2010.

“Soon after the Seattle Times exposé, Senator Patty Murray, the leading Democrat on the HELP Committee, launched an investigation. Committee investigators discovered that infections linked to use of the duodenoscopes were more widespread than was reported by the media. From 2012 to 2015, these devices had been linked to at least 25 different outbreaks of antibiotic-resistant infections in 10 states and three other countries, sickening approximately 250 patients.”

Carome went on to opine that the investigation found two issues that were, in Carome’s view “particularly troubling.” Olympus was identified as being aware, by early 2013 that its troubled duodenoscope possessed the potential for harboring, and spreading bacteria even after the device was cleaned and decontaminated according to the manufacturers’ instructions. However, it would be two years before Olympus would share this revelation with the FDA and its client hospitals. The delay, according to the Senate report, likely contributed to a further 141 infections in the US during that time frame.

The FDA doesn’t come out of this unscathed either. It was also revealed that the FDA itself was aware of serious infections linked to duodenoscopes under the Olympus brand and at least one other manufacturer, thanks to an alert the agency received from the Centers for Disease Control and Prevention (CDC) in Atlanta. This was late in 2013, Carome notes, and the FDA duly began looking into the situation – only to keep silent for some 17 months during which time investigators said 68 patients in seven US hospitals were hit with antibiotic-resistant infections linked to the duodenoscopes.

“Senior leaders at both Olympus and the FDA almost certainly knew of the dangers posed by the duodenoscopes many months before the media alerted the public,” Carome writes.

Little wonder that endoscope infection lawsuits have grown from such revelations.