Here Come the Lawyers

Over the past month, 5 lawsuits have been filed in California Superior Court, Los Angeles County, over the deaths and debilitating infections caused by the superbug CRE (carbapenem-resistant Enterobacteria) to patients at the Ronald Reagan UCLA Medical Center. The harm resulted from the use of CRE-contaminated scopes that are threaded down the throat into the intestines of patients to diagnose and treat various GI tract illnesses.

The plaintiff’s argue – and virtually everybody agrees – that these scopes have a design flaw: they are such intricate devices that they can’t be properly cleaned between procedures, thus CRE bacteria are transferred from one patient to the next. Accordingly, the makers of this device have been sued on the grounds that they knew their scope had this problem yet they failed to correct it. These lawsuits are a big deal because the scopes are used in about 570,000 procedures each year across the country. And because once CRE enters your bloodstream there’s a 1 in 2 chance you will die.

As the escalating number of CRE infections become known to the general public, more lawsuits are likely to be filed nationwide. What’s more, we are learning that researchers have issued unheeded warnings to the medical community about these scopes since at least 1984. In other words, we’re entitled to ask how much of this pain and suffering could have been avoided. For instance, to 18-year-old high school student Aaron Young, 1 of our 5 plaintiffs.

Lori (a nurse), and Glenn Smith, are the adoptive parents of Aaron Young.

Lori Smith, who is a nurse, and husband Glenn, are the adoptive parents of Aaron Young.

Aaron is still in the hospital fighting his infection. Though he’s expected to eventually return home he will do so with this knowledge: the CRE bug will remain in his body for the rest of his life forever putting him at an elevated risk for infection. And just because he’s beat it so far is no guarantee he will again, especially if he becomes immunocompromised by age or disease.

Aaron is not alone. We’re learning of more cases like his in Seattle, Chicago, Pittsburg, Philadelphia, Tampa, and Charlotte. And there’ll be more to come: “Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that’s got to change,” says Jeffrey Duchin, an infectious disease expert in Seattle. Thus, these infections “may go unnoticed.”

The reported cases of CRE are “probably the tip of an iceberg,” says Marcia Patrick, of the Association for Professionals in Infection Control and Epidemiology. “But we don’t know how big that iceberg is.”

But we know when the iceberg began forming – some 30 years ago:

“We have known about this even as early as 1983 or 1984,” said John Allen, a professor at the Yale School of Medicine who is president of the American Gastroenterological Association. In 1987, Allen wrote in an academic journal about 10 of his patients in Minnesota mysteriously becoming infected with a bacteria known as Pseudomonas. He and his colleagues traced the infections to a single [scope], whose small crevices harbored bacteria despite repeated cleanings.

An investigation this month by the LA Times offers further evidence of years of red flags:

“Since 2007, ECRI Institute, a nonprofit group that evaluates medical devices for hospitals and other organizations, has listed the risk of contaminated endoscopes and other surgical instruments among its top 10 health hazards.

In 2008, the U.S. Centers for Disease Control and Prevention urged that endoscopes be redesigned so they don’t represent a ‘potential source of infectious agents.’

Last year, the Joint Commission, which accredits and inspects hospitals, raised alarms about tainted endoscopes and other equipment posing an immediate threat to patients’ lives.

The FDA said it has received 75 reports of contaminated scopes causing possible infections in 135 patients who underwent [the scope procedure], from January 2013 to December 2014.”

But there’s more. Where the LA Times really earns its stripes is in showing us that there are deep, often hidden institutional structures that drive disease – it’s not as simple as bug bites boy:

“Three years ago, [the maker of the scope] Japanese electronics giant Olympus Corp. was in crisis amid a massive accounting scandal and plunging sales of its signature cameras.

Executives vowed to save the 93-year-old firm by turning aggressively to healthcare and selling more medical scopes to doctors and hospitals in the U.S. and worldwide.

The bet paid off: Medical sales soared 25% last year, and Olympus boasts a commanding 70% share of the global market for gastrointestinal endoscopes … a record breaking performance.”

The Times also questions doctors and their conflict of interest:

“One key part of that success has been the company’s close ties to doctors, industry analysts say.

Olympus is a major donor to the American Society for Gastrointestinal Endoscopy. The company also contributed more than $1 million to the society’s new Institute for Training and Technology.”

And now the feds are on the case:

“The company’s relationship with medical providers has already come under scrutiny. Last month, Olympus said federal investigators are looking into whether it violated laws that ban improper kickbacks to doctors and other customers.”

aaron 9The Times report ends with a cruel observation. As hospitals replace the contaminated scopes with new ones it’s generating more business for Olympus. In Seattle, Virginia Mason Medical Center bought 20 additional scopes, at a price close to $1 million. Dr. Andrew Ross, the hospital’s section chief of gastroenterology, said placing such a big order with Olympus “certainly seemed ironic from our perspective.”

None of this is pretty. But neither is this photo. It’s Aaron, hardly visible, in the bed where he lives these days.

 

 

 

 

 

 

The Personal Side of the Current CRE Outbreak

ricci“I just thought it’s just an infection, you know? I really didn’t realize what they meant by infection.” Those are the words of Cheryl Perron, mother of then 19 year old David Ricci (“reach-y”) who was struck down by the superbug CRE. (p.53)

David’s story began one morning on his way to work. Walking along side railway tracks he got sucked underneath a speeding train by its backdraft. His right leg crushed, he was rushed to hospital. Still conscious, he watched a doctor take out a machete-style knife and begin “hacking” his leg off. His friends, standing outside the room, could hear him screaming before he passed out. David never made it to the Mother Theresa Orphanage in Calcutta where he worked as an HIV/AIDS volunteer.

Then things got worse. Some of his amputated leg became infected with CRE. “They said I don’t have that much longer,” says a weakened David on what looks like a cell phone video taken by one of his friends. His family got him home to Seattle as soon as they could but the ordeal continued. David was placed under quarantine. His infection continued to spread. Multiple antibiotics were tried but failed. Then a doctor remembered one from the 1940s that was shelved because it was too poisonous. But it was the only one left so they tried it. As David put it, “It started to eat away at my organs on the inside, you know? I could just feel it, just— just this poison rushing through my blood.” One option remained – cut off the rest of his right leg to within 6 inches of his hip and maybe, just maybe, they’d get all the CRE. But they wouldn’t know for months, so in the meantime all they could do was wait …

That was 2011. David’s story was told 2 years later in the outstanding PBS Frontline episode “Hunting the Nightmare Bacteria.” We’re presenting it here because CRE is now on the move across the United States. As we reported 2 weeks ago, it was an outbreak at the University of California hospital system in Los Angeles this year that brought the problem to the public’s attention. But with a little digging we found out that CRE had also surfaced in Illinois, Pennsylvania, and Washington, dating back to 2012. And since our last report we’ve learned of more outbreaks occurring this year in North Carolina, Wisconsin, and a second hospital in California, Cedars-Sinai.

The unique feature of the US outbreak is they’re all caused by the same thing, a medical device called an endoscope. It’s threaded down the throat deep into the intestines to diagnose and treat people suffering serious illnesses of the GI tract. It’s the only tool we have to do the job and so it’s used all the time, in about 500,000 procedures every year across the country. The problem is, the endoscope has a design flaw. It’s such an intricate complex device that it can’t be properly cleaned between procedures and so the CRE from one patient will sometimes transfer to the next. Nevertheless, because it’s an indispensable tool in the treatment of life-threatening disease we continue to use it.

The total number of people affected so far is probably less than 1,000. But the story doesn’t lie in the numbers. It lies in the lives of the people afflicted and everyone close to them. And what it does to the ones that survive changes them forever.

David’s story begins at the 12 minute mark and resumes again at 46 minutes. Our hope, though, is that once you meet David you’ll want to see the episode in its entirety.

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