Medical Malpractice & Nursing Homes

FDA reveals duodenoscope procedures likely infected far more than initially reported

Why didn't FDA and hospitals come out earlier and more forcefully about the risks of scope procedure?

Why didn’t FDA and hospitals come out earlier and more forcefully about the risks of scope procedure?

Ahead of next week’s advisory panel convening, the FDA released some eye opening details related to the superbug outbreaks linked to dirty duodenoscopes. Reports of these outbreaks occurred at hospitals across the country, including Virginia Mason Medical Center in Seattle, WA

Federal regulators disclosed additional clues about the potential harm to patients from a controversial medical scope, providing 142 reports of contaminated devices and possible patient infections since 2010. This came out via a May 7, 2015  LA Times article.

The Food and Drug Administration (FDA) had previously said it received about half that many reports, 75, on duodenoscopes that caused patient infections in 2013 and 2014.

The number of patients involved could be far higher than 142 given that one adverse event report may include many individual procedures/people.

The FDA panel of medical experts is expected to recommend additional steps to regulators, device manufacturers and hospitals. These are steps needed to protect patients undergoing a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP.

Officials report that 669,000 ERCP procedures were performed last year on patients battling cancer, gallstones and other digestive issues.

As we have seen in the news, advocates and lawmakers are directing harsh criticism at the FDA and Olympus Corp., maker of duodenoscopes. Why did they not sooner and more emphatically to report these hospital outbreaks? This would have alerted the broader medical community about the risks of the scope procedure.

Investigations have revealed that patients were infected even when medical centers followed the manufacturers’ (Olympus, Pentax Medical, and Fujifilm) cleaning instructions. Health officials learned that deadly bacteria are easily trapped at the tip of these duodenoscopes.

“The transmission of infectious material from patient to patient during ERCP, although uncommon, represents a serious public health concern,” the FDA states in its latest report.

Federal officials acknowledged that their surveillance system for medical devices has limitations and that incidents can be underreported by manufacturers.

Wrongful Death lawsuit against Scope-maker Olympus & Virginia Mason Medical Center

Lisa Miller, 53 year old mother of two, died weeks after her second "routine" ERCP procedure at Virginia Mason. Her husband and family are suing both scope maker Olympus & VMMC.

Lisa Miller, 53 year old mother of two, died weeks after her second “routine” ERCP procedure at Virginia Mason. Her husband and family are suing both scope maker Olympus & VMMC.

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.

SKW’s Karen Koehler along with our top notch wrongful death/medical malpractice legal team is representing the Miller estate. For updates, visit this blog often.

*See previous blog post to learn about the other Seattle Times article that appeared on today’s front page.

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: 

Virginia Mason patients didn’t know that they had the superbug

Via a duodenescope at Virginia Mason, at least 25 patients contracted the superbug, Eleven patients died. Photo: KIROTv

Via a duodenescope at Virginia Mason, at least 25 patients contracted the superbug, Eleven patients died.
Photo: KIROTv

On my way to work a few days ago, I heard an astonishing news story on NPR about how at least 35 patients at Virginia Mason grew ill and 11 of whom died after contracting a superbug infection. The part that stunned me the most was that Virginia Mason did not disclose to the patients or patients’ family any details that would have clued them in on the fact that they had contracted this superbug. The rationale was that there was nothing that the patients could do to reverse the damage already done. Wow. There are no known medical malpractice/negligence lawsuits against Virginia Mason–not yet.  As the NPR interview of JoNel Aleccia, Seattle Times Health reporter, emphasized, this information has just surfaced from publicly disclosed reports.

According to a recent Seattle Times article, dozens of patients at Virginia Mason Medical Center were infected with a drug-resistant bacteria known as carbapenem-resistant Enterobacteriaceae (CRE) between 2012 and 2014. This was as a result of contact with contaminated endoscopes.

Hospital and public health officials in Seattle did not disclose to patients and their families the cause of the infection at the time of illness, according to the Seattle Times. Nevertheless, public health officials point out that no one is yet certain what role the bacteria had> After all, these patients who underwent the procedure were already critically ill with colon or pancreatic cancer.

“We discovered a problem more than a year ago, we responded quickly to investigate potential causes, and we worked to fix the problem,” the hospital said in a statement to CBS News. “The few patients who were affected by this bacteria received appropriate and timely medical treatment.”

The specialized endoscopes — known as a duodenoscopes — are used to treat patients with pancreatic cancer and other gut illnesses. Hospital personnel say the devices were cleaned in compliance with the manufacturer’s instructions but they still carried traces of the bacteria. The bacteria found on the endoscopes matched cultures taken from ill patients, according to officials investigating the case.

According to a CBS website article, CRE is resistant to a majority of antibiotics and, on average, kills 50% of those infected. Similar cases of patients contracting superbugs in Pittsburgh and Chicago via contact with endoscopes have emerged recently.

“We determined that the endoscope manufacturer’s, as well as the federal government’s, recommended guidelines for processing the scopes are inadequate,” the hospital statement said. “This is a national problem. We’ve developed and implemented a better and more thorough process for preparing scopes that is the most rigorous in the nation. We believe our method for preparing endoscopes for medical procedures should now become the national standard.”

Some experts are blaming the device’s design for causing the infection. The end of scope contains “elevator wire channels,” which are essentially small flaps that hold stents and other components of the device. These channels may harbor hidden bacteria that’s difficult to thoroughly clean. Commenting on the case, the U.S. Centers for Disease Control and Prevention say the design “makes them difficult to clean with the potential for contamination persisting following reprocessing and subsequent transmission of pathogenic bacteria to patients.”

The CDC has contacted the U.S. Food and Drug Administration about the case. However the FDA, the agency tasked with reviewing and approving all medical devices used in the U.S., has not yet issued a warning or recall for this particular model of endoscope.

A spokesperson for the FDA told the Seattle Times that the agency believes the infection rate from the device is very low, and it is critical for performing a life-saving procedure on as many 500,000 patients in the U.S. each year.

Dr. Michael Gluck, Virginia Mason’s chief of medicine, said the hospital is joining forces with patient advocate groups to urge the FDA and manufacturers of duodenoscopes to change the design and make it easier to thoroughly clean. (UPDATE March 4, 2015 For more recent news about this issue, read “Could the FDA Have Done More?“)

Technology in Healthcare Can Result in Dangerous Errors

For decades, Paul Whelan (one of SKW’s partners) has represented plaintiffs in tragic cases resulting from the negligence of healthcare providers. Paul has written a number of articles and papers on some of his cases and what he has learned. One fact that he brought to my attention was that medical providers’ errors are a leading cause of death and serious injuries at hospitals. This was somewhat of a revelation to me, as I had always thought that hospital deaths were the inevitable outcome of profoundly injured or ill patients.

Now, with more healthcare facilities using technology to keep track of medical records, there is apparently another great source of errors. An article in Kaiser Health News details some of the growing problems with healthcare information technology. A leading critic, Dr. Scot Silverstein of Drexel University, points to poorly designed medical software–among other issues.

Dr. Silverstein told KHN: “We know it causes harm, and we don’t even know the level of magnitude. That statement alone should be the basis for the greatest of caution and slowing down.”

A rush to switch gears and use digital technology for medical records has supposedly led to incorrect prescriptions, treatment orders, etc., according to Dr. Silverstein. A data entry mistake led to the death of a baby in Illinois. In a major midwest health system, doctors’ orders were logged in the wrong patients’ charts.

Because the government doesn’t require healthcare facilities to report these types of problems, only a small percentage of all the errors stemming from digital medical records are likely reported.

Dr. Jeffrey Shuren, J.D., also has voiced such concerns:

From January 2008 to December 2010, the FDA received approximately 370 reports of adverse events or near misses purportedly associated with different types of HIT, including electronic health records (EHRs). They likely reflect a small percentage of the actual events that do occur.Most of the causes involve the failure to adequately address interoperability with other technologies, user error, inadequate workplace practices, design flaws, failure to properly test the technology prior to distribution, upon installation or during maintenance (such as validation testing), or failure to adequately address human factors, which is the design of a technology to address problems that can arise when people interface with machines.

Check out Dr. Silverstein’s blog, Health Care Renewal, for more details and words of caution against healthcare technology.

 

U.S. Chamber’s Hypocrisy Exposed: Do As I Say, Not As I Sue

New report shows hypocrisy of Institute for Legal Reform’s corporate board members that aggressively litigate while blocking justice for everyday Americans

Washington, D.C. –As the U.S. Chamber’s Institute for Legal Reform (ILR) holds its annual summit – a strategy session on eliminating Americans’ access to the civil justice system – a new report exposes ILR’s corporate board members that hypocritically use the courts for their own gain against competitors, customers and even each othersay_sue_coverFIN.jpg_sized.jpg.

In its newest report, Do As I Say, Not As I Sue, the American Association for Justice (AAJ) exposes the hypocrisy of 10 ILR board members that regularly use the legal system to advance their own agendas, while at the same time advocating legislation that would close the courthouse doors to anyone who would hold them accountable for their own wrongdoing.

“These corporations, like all Americans, have a right to seek justice through the legal system,” said AAJ President Gary M. Paul. “What makes their actions shameful and hypocritical is that these companies are members of ILR’s board for the sole purpose of denying American workers and consumers this same right.”

One ILR board member highlighted in the report is Honeywell International, which has regularly taken competitors to court, but would prefer not to be held accountable for distributing defective body armor to law enforcement personnel across the country, or downplaying the dangers of asbestos exposure.

In return for its financial contributions to ILR, Honeywell has received policy and public relations help when its negligence has been uncovered. Four days after an Illinois jury delivered a multi-million dollar verdict against Honeywell for conspiring to hide the dangers of asbestos, ILR issued a press release stating that the decision “confirms a troubling trend in the State of Illinois where there is a hostile ligation environment.” Additionally, the Madison County Record, an Illinois-based propaganda-as-news outlet fully owned by ILR, featured an article headlined, “McLean County Continues Inching Closer to Becoming a ‘Judicial Hellhole.'”

The irony does not stop with Honeywell – AAJ’s report also highlights the litigation hypocrisy of ILR board members FedEx, Dow Chemical Company, General Motors Corporation, Caterpillar, State Farm, Koch Industries, Abbott Laboratories, Prudential and Johnson & Johnson.

Online ads will run this week on major news sites and blogs to promote the report, Do As I Say, Not As I Sue: Exposing the Lawsuit-Happy Hypocrites of U.S. Chamber’s Institute for Legal Reform, which can be found at www.justice.org/USChamber.

WA Supreme Court Rules in Favor of SKW Medical Malpractice Client, Lisa Unruh

The Washington State Supreme Court today filed its opinion in favor of SKW medical malpractice client, Ms. Lisa Unruh.Temple of Justice.jpg

At nine years old, Lisa Unruh began seeing Dr. Cacchiotti. Because of a severe underbite, her lower jaw was growing faster than her upper jaw. Cacchiotti put Lisa on a treatment plan with braces from 1995 – 1999 with her final visit with him in November 2000. Because of her braces, the roots of her teeth were essentially destroyed. Lisa and her stepmother believed the problems were due to Lisa’s hereditary predisposition to these problems.  

In the years that followed, various doctors informed Lisa that her prior orthodontic care had caused her root resorption. However, not until an orthodontist in 2006 took the time to explain the etiology of Lisa’s problem did she realize that Cacchiotti’s negligence was the reason for her root resorption. The bottom line was that her braces were in place for too long.

Ms. Unruh filed a lawsuit soon after realizing the actual cause of her ongoing orthodontic issues. When moving for summary judgement under the statute of limitations, Cacchiotti prevailed.

On appeal, Cacchiotti raised another basis for dismissing Unruh’s claim based on the eight-year statute of repose (enacted in June 2006). RCW 4.16.350, which contained the statute of limitations for medical malpractice claims was amended to include this statute of repose.

Among a number of arguments, Cacchiotti claimed that the 2006 nontolling amendment of RCW 4.16.190 did away with the effect of Unruh’s minority on the tolling of the statute of limitations because the amendment applied retroactively to eliminate tolling during Lisa’s minority. The state Supreme Court disagreed, citing Hanford v. King County, 112 Wash. 659, 662 (1920): “[T]he limitation of the new statute, as applied to pre-existing causes of action, commences when the cause of action is first subjected to the operation of the statute…”

Although her statute of limitations was tolled due to Lisa’s minority and her 90-day notice of intent to sue, she needed the tolling proved by her request for mediation, for her action to be timely. The Supreme Court concluded that she timely filed her claim within the statute of limitations. The 2006 nontolling amendment to RCW 4.16.190 did not eliminate tolling during Lisa’s minorioty. Her notice of intent to sue and request for mediation effectively tolled the statute of limitations until she filed her lawsuit in September 2007. 

SKW personal injury lawyers, Paul Whelan, Ray Kahler, and Garth Jones obtained an important victory for Ms. Unruh. This successful result will also help many medical malpractice clients navigating similar facts with regard to RCW 4.16.190. Kudos to Paul, Ray, and Garth!

Don’t miss “Hot Coffee!”

This weekend I got to see my last movie at the Seattle International Film Festival. It was “Hot Coffee,” a documentary by Susan Saladoff. It made me incredibly proud to be in this profession and to work with some of the best trial lawyers in the country.cropped-hotcoffee.jpg

The movie is an absolute must-see. Period. Full stop. When the DVD comes out (later this summer), run, don’t walk to buy it. Better yet, you can see it if you have HBO later this month. It is not a dry, boring documentary: Al Franken and Paul Grisham keep things lively.

Although I work for a plaintiffs law firm, even I had misconceptions about the infamous “hot coffee” lawsuit against McDonalds. This documentary, however, is not just about opening everyone’s eyes to the jaw dropping injuries that Stella Liebeck, the then 79-year old woman sustained from spilling some scalding hot coffee on herself. It reveals how McDonalds had previously received 700 complaints about the ridiculously hot coffee.

Moreover, the film shows how some  corporations have spent many hundreds of million dollars on distorting the truth about tort claims — from “tort reform” to caps on damages. Trial lawyers are conveniently pegged as the villains, while insurance companies are portrayed as the victims: a comedy and utter tragedy at the same time.

A doctor specializing in burn injuries explains in “Hot Coffee,” that the holding temperature for coffee was so hot that at best, if the coffee touched one’s skin for a few seconds, one would suffer 3rd degree burns. Regardless, McDonalds chose to ignore the obvious threat to its customers’ safety until brave Ms. Liebeck attempted to hold them accountable.

The film also features a couple of other poignant stories: One, about an ex-Halliburton worker who was brutally raped by her coworkers in Iraq; but denied the ability to sue her employer/employees thanks to a mandatory arbitration clause. The other story is a needlessly tragic situation, where one twin boy was brain damaged in utero, because of a negligent doctor. That family was essentially robbed of the jury verdict due to the state’s cap on damages.

Buy this DVD for all of your friends, family, neighbors, etc., so that they learn how many corporations are attempting to dismantle the civil justice system.

Visit New KeepWASafe.com Website & Blog

As we head into this year’s first legislative session, the law firm of Stritmatter Kessler Whelan (SKW) wants to provide an informational resources via a new website, KeepWASafe.com. As the days and weeks progress, please visit it frequently for more information, which will help you understand why the agenda to bar lawsuits against the state for tort cases will make Washington less safer for all of us.  

KeepWASafe WEBSITE screenshot.jpg

We welcome your comments and questions.  

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