Each week gets busier at our offices at Stritmatter Kessler Whelan. In today’s Seattle Times, one of the two* articles about SKW’s cases focuses on a senseless tragedy arising out of a routine procedure that 53 year old Lisa Miller had at Virginia Mason Medical Center in June 2013. Ms. Miller was the mother of two children and wife to Allen Miller. A VMMC doctor recommended to Lisa that she have a routine procedure (endoscopic retrograde cholangiopancreatography or “ERCP”) to get to the bottom of her recurrent pancreatitis. But, a few weeks after her second “routine” procedure, she died of acute necrotizing pancreatitis. The autopsy report points to Virginia Mason contaminated duodenoscope made by medical device manufacturer Olympus.
For several years, Olympus America had known that its instructions for cleaning its duodenoscopes were ineffective and had resulted in severe infections and death. But it had not timely disclosed this critical, life-threatening detail to medical centers around the country, which used its scopes.
Then, once VMMC learned (the news came out earlier this year) that Olympus America scopes had caused illness and death to some of its patients, it chose to sit on this information. VMMC, contrary to its well-publicized policy of “transparency,” chose not to tell the family that Ms. Miller died due to an infection caused by a contaminated Olympus duodenoscope.
When Allen read the initial news story in the Seattle Times, he reached out to our firm to pursue justice against the scope-maker, Olympus and against Virginia Mason Medical Center (VMMC). VMMC had never informed Lisa or Allen about the superbug outbreak or concerns about the routine procedure that was tied to a superbug outbreak among at least 32 VMMC patients.
*See previous blog post to learn about the other Seattle Times article that appeared on today’s front page.
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.
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