FDA

Could the FDA have done more?

 

Ms. Bigler lost her husband and only learned about the superbug outbreak at Virginia Mason from the news. (Photo:  Steve Ringman/Seattle Times)

Ms. Bigler lost her husband and only learned about the superbug outbreak at Virginia Mason from the news. (Photo: Steve Ringman/Seattle Times)

 

As potential clients continue to call our firm, more details about what the FDA knew and didn’t do with its knowledge continue to surface. When I first learned about the “dirty duodenescope” problem at Seattle’s Virginia Mason, I wondered how much information that the FDA had regarding these duodenescopes used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. Then, when the latest news broke about the UCLA Medical Facility’s similar issues with improperly cleaned duodenescopes, I realized that this issue extends well beyond just a couple of medical facilities. The problem relates to the fact that these thin, flexible scopes are extraordinarily difficult to clean. Even UCLA’s latest announcement of using a toxic gas to clean these duodenescopes are doubtful per the FDA. This begs the question, then, why hasn’t the FDA done more to ensure that devices are not used until a more practicable ways to clean the device are identified?

Now, remember when Obama signed an Executive Order last fall to combat antibiotic resistant bacteria? I do. So do some federal lawmakers, who are now asking Congress to investigate what the U.S. Food and Drug Administration and device makers are doing to prevent further patient deaths and infections. Earlier this week, Rep. Ted Lieu (D-Torrance) sent a letter to the House Committee on Oversight and Government Reform, pointing out that outbreaks related to contaminated medical scopes “have national security ramifications.”

In an LA Times interview, Rep. Lieu reminded us of Obama’ executive order, issued this past September that made it a national security priority to combat antibiotic-resistant bacteria such as CRE (which stands for Carbapenem-resistant Enterobacteriaceae). The California congressman pointed out that an FDA safety alert issued last week post the UCLA incident does not give the public assurance that further outbreaks can be prevented, “While federal agencies such as the Centers for Disease Control and Prevention are combating superbugs, the current recommended sterilization procedures would continue to result in superbug outbreaks and deaths.”

The FDA acknowledged that cleaning the ERCP duodenoscopes to the manufacturers’ specifications may not remove all of the deadly bacteria that can be passed from patient to patient.

In the meantime, family members of Virginia Mason patients who now know about the link between these ERCP procedures and the recent superbug outbreak are asking important questions. For example, the Biglers’ heartbreaking story came out last week in the Seattle Times. Mr. Rick Bigler, a 57 years old insurance exec, was suffering from pancreatic cancer. Only after his wife, Theresa, requested his medical records, did she find out that he had suffered from an E.coli infection. As the Seattle Times article points out, ERCP procedures are linked to these types of infections. What is alarming is that the Seattle outbreak is the largest of its kind in the U.S.  But, unlike the UCLA Medical Facility, which was also recently reported to have similar issues with the superbug-dirty-duodenescope issue, Virginia Mason did not reach out to its patients. While UCLA had informed 180 individuals about the possible contamination, the Seattle medical facility insisted that its situation was somehow different because the outbreak apparently spanned over a larger period of time.

Understandably, family members of Virginia Mason patients who likely contracted the superbug, have many questions that they want answers to: Some of them have contacted our law firm, given SKW’s track record as renowned attorneys in the areas of products liability and medical negligence. If you have questions, we are interested in comparing your stories with the ones that we’ve already learned about. Email us at Counsel@Stritmatter.com or call us at 206.448.1777.

If it is easier, simply complete the following form:  [contact-form to=’Counsel@stritmatter.com’ subject=’Possible Case RE: Superbug Infection’][contact-field label=’Name’ type=’name’ required=’1’/][contact-field label=’Email’ type=’email’ required=’1’/][contact-field label=’Best Phone # To Reach You’ type=’text’ required=’1’/][contact-field label=’Comment’ type=’textarea’ required=’1’/][/contact-form]

Some patients suffered or died from “dirty” duodenescopes

FDA warns of duodenescopes housing deadly superbug

FDA warns of duodenescopes housing deadly superbug

Recently, I wrote about a jaw-dropping story about the carbapenem-resistant Enterobacteriaceae (CRE) “superbug” related deaths stemming from duodedenscope procedures done at Seattle’s Virginia Mason. The news was just surfacing as I wrote about it, as the public started to learn about the details. Shortly after the news hit the airwaves, victims and their family members contacted our law firm, Stritmatter Kessler Whelan, to hear their tragic stories. As we delve into their stories, it is unfortunately not a surprise to see that the FDA just issued a warning addressing those including gastroenterologists, gastrointestinal surgeon, endoscopy nurses, as well as patients considering endoscopic retrograde cholangiopancreatography (ERCP) procedures.

The FDA’s purpose in issuing this February 19, 2015 warning:

The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it. [emphasis added]

The ERCP endoscopes or duodenescopes are apparently quite difficult to clean, despite the detailed reprocessing instructions. This detail, however, is little comfort to those who have lost a family member or who themselves have had to battle the CRE. At the UCLA Health System at least two deaths related to the “superbug” endoscopic procedure occurred at its facility.  Additionally, over 100 patients are thought to have likely been exposed to the “superbug” at the UCLA facility during endoscopic procedures between October 2014 and January 2015.

According to the AP,  an 18-year-old student now hangs on by a thread after he was infected by a “superbug” outbreak tied to contaminated medical instruments at the Ronald Reagan UCLA Medical Center.

Between the beginning of 2013 to the end of 2014, the FDA received 75 device-related reports relating to 135 patients linked to possible microbial transmission from reprocessed duodenoscopes. More troubling news is that the agency states that it’s possible more cases went unreported. The FDA it’s working with the Centers for Disease Control and Prevention and the manufacturers of the devices in order to find solutions to the problem.

Sadly, as certain as we will see more tragedies linked to this procedure, we will see more potential lawsuits against the manufacturer and lawsuits against various medical providers. Stay tuned…

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