Product Liability

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.

Manufacturer of dangerous Trinity ET Plus guardrails ordered to unseal entire court files

An image from the Harman v. Trinity complaint. (Courtesy credit: PublicJustice.net)

An image from the Harman v. Trinity complaint. (Courtesy credit: PublicJustice.net)

Yesterday, a court order to unseal the entire court file in the massive whistleblower case against Trinity Guardrails (maker of now infamous ET Plus guardrails) will likely save many lives. This file contains literally hundreds of sealed pleadings and exhibits relating to a dangerous highway guardrail that’s been linked to dozens of deaths and injuries.  The court also held that all of the testimony and exhibits from a recent trial of the case must also remain open to the public, effective immediately.

Below is an excerpt from the Public Justice website*:

The [court order to unseal all of the files for public access] is so important in this case. A major highway guardrail manufacturer, Trinity, will not be able to hide the fact that it kept its changed guardrail design from the federal government and that that guardrail design is unsafe. The victory also means that the public has access to facts that will be critical for making the case that the federal government should withdraw its approval of these guardrails. And it’s ammunition for states seeking to phase out and remove these lethal guardrails from our highways.

Trinity was sued for defrauding the federal government by changing the design of its guardrail end terminals, not conducting appropriate crash tests on the new design, and not telling the federal government about the changes—meaning that the guardrails remained on the Federal Highway Administration’s list of approved guardrails. A jury found that Trinity defrauded the government to the tune of $175 million.

Because of the design change, when the terminal is hit by a car, instead of absorbing the energy of the crash and slowing the vehicle, the guardrail jams and turns into a potentially lethal spear. Drivers and their passengers have been decapitated, their limbs have been severed, and they have been stabbed by these guardrails. A study by Public Justice client, The Safety Institute found that the redesigned Trinity guardrail was 2.86 to 3.95 times more likely to be involved in a lethal accident and 1.36 to 1.95 times more likely to be involved in an accident with serious injury than Trinity’s older design.

In the case against Trinity, huge swaths of court records—including crash test documents—were filed under seal. On behalf of The Safety Institute and the Center for Auto Safety, consumer protection attorneys sought to intervene to unseal the records. Although our motion to intervene was denied, our efforts to unseal the records helped to convince the court to do the right thing.

*NOTE: Stritmatter Kessler Whelan partner Brad J. Moore currently serves as President Elect of Public Justice, the country’s largest public interest law firm.

 

 

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: 

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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Honda breaks history…hit with $70 million fine

Yesterday, Obama administration fined Honda $70 million for failure to report complaints re injuries/deaths & warranty issues.

Yesterday, Obama administration fined Honda $70 million for failure to report complaints re injuries/deaths & warranty issues.

“Holey moley!” That’s what I thought when I read that Honda got hit with a $70 million fine. The Obama administration imposed this history-making fine because the Japanese automaker failed to report to regulators roughly 1,700 complaints about its vehicles, claiming serious injuries and deaths. Moreover, the automaker apparently failed to report warranty claims. The complaints spanned an 11 year period, beginning in 2003.

This past November, Honda admitted that it didn’t report the aforementioned complaints to the National Highway Traffic Safety Administration (NHTSA). When did its executives learn of these omissions? It was in 2011 — three years ago.

Because the company also failed to report customer satisfaction/warranty claims (same 11 year period), NHTSA doubled the $35 million fine. One was for the failure to report the death/injury complaints; the other $35 mil for its failure to report the warranty/customer satisfaction claims. Ouch.

In case you’re wondering, yes – some of the complaints related to the Takata air bags along with other defective parts.

News about Takata Airbags–Not Just a Lot of Hot Air

Takata's Dangerous Air Bags - Recalls are in the Millions

Takata’s Dangerous Air Bags – 11 million recalled at last count. (Credit: Bloomberg, Center for Automotive Safety)

Airbag manufacturer Takata has been in the news a lot lately. But the saying “no news is bad news” doesn’t apply for Takata these days. Their dangerous airbags are a big problem for them as it is for Honda and Toyota. Moreover, there are plenty of auto manufacturers that Takata has supplied, which are nervous.  On the heels of some enormous settlements/fines with GM and Toyota, automakers including BMW, Chrysler, Ford, Mazda, Subaru and Nissan are facing the potential of auto products liability lawsuits.

What’s so bad about Takata airbags? Well, if you don’t mind getting shrapnel hurled at your face, neck or chest if your airbags deploy in a collision, then I suppose you’re fine. But a driver in a low speed collision had shrapnel fly into her eye socket in Florida. Also in Florida, another had her throat gashed with stab-like wounds that made the police think initially that the passenger was murdered. Turns out that it was the metal flying from a Takata airbag explosion.

Here’s what’s extra worrisome for those who have these cars in the more humid areas of the country–ahem, like the Pacific Northwest and like the Gulf Coast regions: The danger is heightened when there is more moisture in the air. When a Takata airbag, especially in an older model vehicle, inflates during a car accident, it can tear loose and blow out pieces of its housing that would fly into the car occupants’ face and/or upper bodies. As horrifying as this all sounds, car owners have been lackadaisical about responding to these recall notices. GM reported that only about 10% of its affected vehicles were brought in.

If there is a silver lining in any of this, it’s hopefully that car owners will take action and take their cars to address potentially faulty Takata airbags. If your car is on the recall list (or you’re just understandably concerned and cautious because you don’t want shrapnel to gash your face/neck/chest in a crash), call NHTSA’s safety hotline (1-888-327-4236) or use your car’s VIN to see if you’re affected by this or any other reported problem.

Below is a tally taken since October 22, 2014, but more will likely join the list:

BMW: 627,615 total number of potentially affected vehicles

2000 – 2005 3 Series Sedan
2000 – 2006 3 Series Coupe
2000 – 2005 3 Series Sports Wagon
2000 – 2006 3 Series Convertible
2001 – 2006 M3 Coupe
2001 – 2006 M3 Convertible

Chrysler: 371,309 total number of potentially affected vehicles

2003 – 2008 Dodge Ram 1500
2005 – 2008 Dodge Ram 2500
2006 – 2008 Dodge Ram 3500
2006 – 2008 Dodge Ram 4500
2008 – Dodge Ram 5500
2005 – 2008 Dodge Durango
2005 – 2008 Dodge Dakota
2005 – 2008 Chrysler 300
2007 – 2008 Chrysler Aspen

Ford: 58,669 total number of potentially affected vehicles

2004 – Ranger
2005 – 2006 GT
2005 – 2007 Mustang

General Motors: undetermined total number of potentially affected vehicles

2003 – 2005 Pontiac Vibe
2005 – Saab 9-2X

Honda: 5,051,364 total number of potentially affected vehicles

2001 – 2007 Honda Accord
2001 – 2005 Honda Civic
2002 – 2006 Honda CR-V
2003 – 2011 Honda Element
2002 – 2004 Honda Odyssey
2003 – 2007 Honda Pilot
2006 – Honda Ridgeline
2003 – 2006 Acura MDX
2002 – 2003 Acura TL/CL
2005 – Acura RL

Mazda: 64,872 total number of potentially affected vehicles

2003 – 2007 Mazda6
2006 – 2007 MazdaSpeed6
2004 – 2008 Mazda RX-8
2004 – 2005 MPV
2004 – B-Series Truck

Mitsubishi: 11,985 total number of potentially affected vehicles
2004 – 2005 Lancer
2006 – 2007 Raider

Nissan: 694,626 total number of potentially affected vehicles

2001 – 2003 Nissan Maxima
2001 – 2004 Nissan Pathfinder
2002 – 2004 Nissan Sentra
2001 – 2004 Infiniti I30/I35
2002 – 2003 Infiniti QX4
2003 – 2005 Infiniti FX35/FX45

Subaru: 17,516 total number of potentially affected vehicles
2003 – 2005 Baja
2003 – 2005 Legacy
2003 – 2005 Outback
2003 – 2005 Baja
2004 – 2005 Impreza

Toyota: 877,000 total number of potentially affected vehicles
2002 – 2005 Lexus SC
2002 – 2005 Toyota Corolla
2003 – 2005 Toyota Corolla Matrix
2002 – 2005 Toyota Sequoia
2003 – 2005 Toyota Tundra

(Source: NHTSA)

 

 

 

Crash course in surviving a plane accident

Despite the tragic Virgin Galactic space plane crash that claimed a test pilot’s life last week, Richard Branson, Elon Musk, Jeff Bezos among other high tech executives still believe in the future of commercial space tourism. In his first press conference after the crash of SpaceShipTwo in the Mojave Desert, Branson likened this new frontier (i.e., commercial space) to commercial flights, which experienced many fatal setbacks in its earliest days.

True, flying on commercial planes is one of the safest means of transportation. Over 8 million people fly each day. But in the past decade there has been no more than 138 crashes with fatalities. SKW has had the privilege of representing plaintiffs on some of those plane crashes.

!Plane Crash stats

In the last decade, there have been less than 140 plane crashes with fatalities.

Despite the statistics that should calm frequent fliers, I admit that I’ve wondered about my fate whenever my plane takes off or when we hit turbulence in the air. When I first started to fly with my husband, I used to secretly chuckle at him for his diligence in following along with the flight attendant’s review of the safety instructions. I hid my chuckling because another part of me knew that Eric was wiser for paying attention. He would know exactly what to do, if our plane was one of those several dozen flights that suddenly crashed into some body of water. At that point, his chances of surviving would greatly increase compared to the rest of the passengers, who had opted to ignore the instructions just to focus on their magazine or Kindle.

As the years go by, ever since I’ve started to fly with my little girl, I too will follow along with Eric and my daughter to review the flight safety instructions. In fact, I have more than once embarrassed my daughter by dancing (while buckled in my seat) and singing along to the new Virgin America flight safety video… hey, I’m not the only one (check out this entertaining video!).

Well, British Airways now offers airplane crash safety courses for the general public.  Those who take this course even get a chance to go down the inflatable slide and learn the proper brace position.

 

Class actions empower consumers

A widespread fallacy is that class action lawsuits only help to line lawyers’  pockets.  This is what corporations want everyone to believe. That way, consumers who are hurt–either physically or financially– as the result of a corporation’s wrongdoing are less apt to seek  a class action against a behemoth.  But the results that Stritmatter Kessler Whelan has consistently obtained on behalf of class action plaintiffs have empowered many consumers. They have truly found justice and appropriate compensations for their injuries.

Public Justice, the nation’s largest public interest law firm pursues actions on behalf of consumers to keep large corporations in check. PJ attorney, Paul Bland, explains in the video below why the U.S. Chamber of Commerce’s “analysis” of class actions is bunk.  We at SKW are proud of the many accomplishments of PJ. Our own Brad J. Moore is currently vice president (Public Justice’s president-elect by August 2014), involved in some PJ lawsuits that include the one against Yakima industrial dairies who are responsible for that region’s groundwater contamination.

Who wants to file a lawsuit against GM, Toyota or another auto manufacturer?

SKW attorneys have literally written the book when it comes to lawsuits against auto manufacturers. A few years ago, Paul Whelan published a booklet on Product Liability. Now, with the media tidal waves  regarding GM and its defective ignition switch, plaintiff’s lawyers are rising to the occasion. This is what makes the new two volume publication, WSAJ Products Liability Deskbook, so timely. The Deskbook is available for attorneys as a comprehensive reference for suing manufacturers. Paul and Garth Jones contributed with the chapter on Vehicle Crashworthiness. Here’s a snippet:

As explained in the landmark case of in Larsen v. General Motors Corp., 391 F.2d 495 (8th Cir. 1968), the concept of vehicle crashworthiness has its origins in the distinction between the liability of a manufacturer whose defective vehicle causes the initial collision and the liability of a manufacturer whose defective vehicle enhances a plaintiff’s injuries after the initial impact of the collision. In other words, a vehicle manufacturer may be held liable for any “enhanced” injuries suffered by the plaintiff that were proximately caused by the vehicle’s failure to be crash worthy.

The discussion outlines the historical development of the concept of crashworthiness and enhanced injury along with the status of relevant laws and the unique issue of accident causation versus injury causation (which remains unresolved in WA State’s enhanced injury canon.  Other chapters go in depth other issues and types of products liability, including the Consumer Expectations Test, defective medical devices, and a lot of other significant issues in this area of law. If you’re a practitioner, you may obtain your copy here.

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