Duodenoscope Superbug Lawsuits

Duodenoscope Superbug Lawsuits 2017-06-01T15:37:58+00:00

FDA experts say a string of deadly bacterial outbreaks were caused by a widely-used medical device:

  • Duodenoscopes
  • Olympus Manufacturing

Nearly impossible to clean thoroughly, duodenoscopes have been linked to hundreds of severe infections, many of which cannot be cured by traditional antibiotics. In the wake of these outbreaks, patients are fighting back, taking Olympus to court.

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Hospitals across the country have struggled to contain a rash of deadly outbreaks caused by antibiotic-resistant bacteria known as “superbugs.” The infections are nearly untreatable; in an estimated 50% of cases, the bacteria prove fatal. As the medical community searches for a cause, one medical device has been implicated in the majority of superbug outbreaks: the duodenoscope.

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Meanwhile, survivors are faced by mounting medical expenses, to say nothing of the psychological trauma inflicted by a terrifying diagnosis and lengthy battle against virulent disease. Banville Law, lead sponsor of TheProductLawyers.com, has joined forces with an alliance of experienced trial attorneys to protect the rights of patients harmed by superbugs.

Victims File Duodenoscope Superbug Lawsuits

Manufactured primarily by Japan’s Olympus Corporation, duodenoscopes are thin tubes that can be inserted down a patient’s throat. They transmit color video of internal organs and can remove obstructions blocking glands and vessels.

But duodenoscopes are also virtually impossible to clean, and numerous medical experts, including the US Food & Drug Administration, believe duodenoscopes are behind the spread of aggressive, antibiotic-resistant bacteria known as “superbugs.”

Patients have begun to file lawsuits, claiming Olympus failed to provide hospitals with adequate cleaning guidelines and placed a device that was defective by design into the hands of unsuspecting gastroenterologists nationwide.

Is Olympus Marketing “Breeding Ground For Superbugs”?

In at least five legal claims, patients and survivors say Olympus failed to notify physicians of the significant risks presented by duodenoscopes.

Many have claimed the company designed and marketed an inherently flawed device, a “breeding ground for virulent bacteria.” All have said that duodenoscopes remain a serious threat, even when cleaned according to the manufacturer’s specifications.

One hospital has gone so far as to join a widow in levelling these damning allegations.

Widow & Hospital Team Up Against Manufacturer

In March of 2015, widow Theresa Bigler filed a wrongful death suit against Olympus over the death of her husband Richard Bigler. The late Bigler, 57, was one of 11 patients who died after an antibiotic-resistant strain of E. coli swept through Seattle’s Virginia Mason Medical Center. Bigler’s widow also named the hospital as a defendant in her claim.

But in a virtually unprecedented move, Virginia Mason Medical Center switched sides, agreeing to join with Theresa Bigler in suing Olympus. Speaking with the Seattle Times, a hospital spokesperson said:

“it’s likely Olympus had known for years that the devices could spread bacteria, but that the firm never informed Virginia Mason or other hospitals.”

Of Virginia Mason’s decision to side with patient rights over corporate interests, Bigler told reporters: “I hope by joining with us, we’ll strengthen our fight so other families don’t have to go through what we’ve had to go through.”

A Second Washington Patient Files Suit Against Olympus

The same month, a second patient from Washington State filed suit against Olympus, claiming an infection contracted at Seattle’s Harborview Medical Center left her struggling to stay alive.

In court documents obtained by Banville Law, Plaintiff Debbie Newton tells the horrific story of her battle against a superbug. In early 2013, Newton was diagnosed with gallstones by physicians at Harborview, a hospital affiliated with the University of Washington. One month later, she was admitted for a “routine – same day – procedure” to address her gallstones, a procedure in which Olympus’ Q180V duodenoscope was used. But after the procedure, doctors informed Newton that she would be kept overnight for observation.

At midnight, Newton’s mother received a phone call: her daughter was being placed on life support. Newton had suffered “heart failure, respiratory failure, renal failure, pancreatitis, septic shock and bacteremia,” according to the complaint. After a culture turned up positive for three forms of bacterial infection, she was administered a carbapenem-based antibiotic through a catheter inserted in her heart. But the bacteria, it would seem, were antibiotic resistant. Only 12 days after being discharged, Newton was readmitted with a pancreatic infection.

She would be readmitted twice over the next two years, for kidney and colon infections.

After UCLA Outbreak, Olympus Hit By Three More Claims

After an outbreak at a University of California, Los Angeles hospital claimed two lives, three affected parties filed superbug lawsuits against Olympus. The outbreak, which occurred between October 2014 and January 2015, left upwards of 179 patients exposed to CRE bacteria.

According to the Orange County Register, UCLA officials traced the rash of infections back to two duodenoscopes manufactured by Olympus.

First to bring a claim was Aaron Young, an 18-year-old high school student who remained hospitalized for months after contracting a superbug he says was transferred by one of Olympus’ scopes.

Father’s Tragic Death Linked To Superbug Infection

The next, filed by the family of Antonia Torres Cerda, claims Cerda died at UCLA after being infected with a carbapenem-resistant Enterobacteriaceae, or CRE. CRE is used to describe a “family” of germs that have all become immune to the last defense antibiotic carbapenem. Cerda’s four surviving children are named as Plaintiffs, along with her widowed husband. In their lawsuit, the Cerda family claim that Olympus provided UCLA with an outdated cleaning manual, one ill-equipped to deal with a newer duodenoscope model’s intricacies.

Four months later, another UCLA victim filed suit. Staci Simos says she was one of those infected with CRE after undergoing an endoscopic procedure in October of 2014. In her complaint, Stimos writes:

“after each use [Olympus’ duodenoscope] necessarily requires cleaning and disinfecting before it can be used on a new patient. A manufacturer of a medical device like an endoscope […] has an obligation to develop and validate a [cleaning] protocol and to incorporate this protocol in the product’s labeling. [Olympus] failed to take these critical steps with [its] redesigned […] scope.”

Duodenoscopes “Expose All Patients To Serious Risks”

Elsie Florian, a 76-year-old from western Pennsylvania, says she was infected by an antibiotic-resistant superbug in late-February 2015. Used to examine her small intestine, an Olympus-made duodenoscope allegedly transferred the virulent bacteria from another patients’ body to her own.

In her complaint, Florian accuses Olympus of failing to update its cleaning protocols after redesigning the Q180V endoscope in 2014. She writes: “any patient who underwent a medical procedure with a contaminated scope was exposed to serious health risks, including severe infection and death.”

Olympus did not respond to a request for comment, according to TribLive, the Pittsburgh-based media company who broke Florian’s story.

Did Olympus Conceal Superbug Risks?

As members of Congress demand answers, a series of revelations have called Olympus’ business practices into question:

  • In collaboration with the FDA, Olympus has now released new guidelines on cleaning the devices, but a recent CNN investigation revealed the company’s duodenoscopes had been on the market without FDA approval for four years.
  • After being notified of a superbug outbreak in 2012, Olympus waited a full three years before reporting the infections to the FDA.
  • The US Justice Department has subpoenaed Olympus, along with two smaller duodenoscope manufacturers, asking for thousands of pages of documents in relation to what USA Today reports are “health care offenses as defined in federal criminal statutes.”

Legal experts believe these recent developments will remain at the forefront of the growing superbug litigation for months to come.

Can Other Patients File Lawsuits?

Yes.

Any patient who was diagnosed with an antibiotic-resistant infection after undergoing a duodenoscope procedure may be eligible to file a claim. The attorneys at Banville Law have been joined by a coalition of experienced lawyers devoted to providing legal counsel to injured patients. Together, our attorneys offer compassionate advocacy with an emphasis on individual attention.

Your case is our priority. That’s why we don’t intend on pursuing a superbug class action, only individual personal injury lawsuits. Every patient’s circumstances are unique. We believe every legal strategy should be, too. To learn more in a free consultation fill out our online contact form. Banville Law’s legal services are always offered on a contingency-fee basis: you pay nothing until we win a settlement or court award in your favor.

Additional Information On Duodenoscope Risks

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