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As superbug spreads, device manufacturer sued for negligence, fraud

Hospitals link superbug outbreaks to endoscopes; now two patients are suing the company that makes them

SEATTLE –  Walking along train tracks in June 2011 on his way to his volunteer job at an orphanage, David Ricci says the noise of the train coming from behind him didn't register over the sounds of traffic and morning crowds in Kolkata, India. It caught his clothing and pulled his leg between two wheels, crushing his knee.

Ricci was rushed to a grimy clinic where medical students held him down on a table. When he awoke, much of his leg was gone. But a month later, when he was back in Seattle, Ricci got more bad news.

“[Doctors] said, ‘Hey, we need to isolate you and put you in a room by yourself because you have an infection that we’ve never seen here before,’” Ricci remembered.

Ricci had contracted multiple superbugs known as carbapenem-resistant enterobacteriaceae, or CRE. The bacteria are extremely difficult to treat, and they were spreading through his body. His doctor put a call-out on a listserv for infectious disease doctors and ultimately came up with a complex and toxic cocktail of antibiotics, giving Ricci the biggest dose he could take. Surgeons also carved off more of Ricci's leg. In the end, Ricci was saved. 

A three-dimensional computer-generated image of a group of carbapenem-resistant Enterobacteriaceae bacteri, released by the Centers for Disease Control and Prevention.
AP/Centers for Disease Control

“It’s like we’ve been under the safety of these magic bullets, these antibiotics for 80 years,” he said. "We don’t have to worry about anything. We’ve been invincible."

You don’t have to go to India to get a superbug. In Los Angeles, two people are dead and five patients are infected after being exposed to CRE during endoscopic procedures at Ronald Reagan UCLA Medical Center Hospital. Last week, UCLA notified another 179 patients that may have been exposed to the superbug while also undergoing the procedure.

The federal Centers for Disease Control and Prevention says the "nightmare bacteria" infects more than 9,000 people a year at health care facilities. Multiple American hospitals have seen superbug outbreaks in the last few years, and they believe the culprit may be duodenoscopes, a device with a camera on the end that's placed down the throat of a patient to investigate gastrointestinal complaints. 

Now, two lawsuits obtained by America Tonight accuse Olympus Medical Systems, the maker of the scopes, of negligence, fraud and misrepresentation. The plaintiffs, 18-year-old Aaron Young and the family of a deceased 48-year-old California woman, say Olympus didn't provide effective cleaning protocols when it rolled out its latest version of the device.

According to the complaint, Young was exposed to a contaminated duodenoscope. Young was treated for the infection in 2014, but was then re-infected and is still at UCLA receiving treatment, according to Pete Kaufman, who’s representing Young and the family of the deceased UCLA patient.

In October 2014, the 48-year-old California woman, who underwent multiple medical procedures at UCLA, was also exposed to a dirty scope, according to the lawsuit. The lawsuit claims that the woman died because of that exposure.

The lawsuit claims that the makers failed to reevaluate the cleaning protocols when it introduced a redesigned model last year. Failing to update the cleaning protocols rendered the device defective, according to the filing.

"It appears what happened, the tweak was made to the device – something Olympus itself has described as a complete redesign – without adjusting the cleaning protocol," Kaufman said. "If that happened, Olympus was asleep at the wheel."

More outbreaks to come?

On Monday, news broke that two patients had died in recent months in North Carolina after coming contact into contact with a superbug. In Seattle, 11 people died and another 32 were sickened after being exposed to a superbug at Virginia Mason Hospital between 2012 and 2013, although it's unclear if that bug caused the deaths because the patients had other health problems.

Since 2013, there have been outbreaks at hospitals in three more cities: Philadelphia, Pittsburgh and Chicago.

“Unfortunately, I was not surprised," said Dr. Lawrence Muscarella, president of LFM Healthcare Solutions, who's been tracking these outbreaks for years. "I believe there are several more of these outbreaks occurring around the country, but they have not yet been disclosed."

Dr. Muscarella says he first learned of the link between CRE and scopes in early 2013, when Advocate Lutheran General Hospital, near Chicago, notified a couple hundred patients of possible superbug exposure due to contaminated endoscopes.

Since then, Washington state public health officials and the CDC have investigated scopes and found problems keeping them clean. But according to Dr. Muscarella, the hospitals where the outbreaks have occurred were cleaning and disinfecting the scope according to the manufacturer's instructions.

"I am speechless when it comes to this," said Dr. Muscarella. "When a medical device or drug is being used is harming people and it's risen to the level that it has today, action needs to be done. Ideally, action should have been done yesterday. It should have been done two years ago. I can't explain to you why it hasn't been done." 

The tip of an endoscopic retrograde cholangiopancreatography (ERCP), attached to a long tube, not shown. The superbug outbreak is raising disturbing questions about ERCP's design.
AP/U.S. Food and Drug Administration

The FDA has known about problems with the dirty scopes for years. A 2009 FDA safety communication letter [PDF] cautioned hospitals and medical facilities to reduce the risk of cleaning scopes and listed suggestions on how to minimize that risk. Over the next few years, the FDA was aware of superbug outbreaks from coast to coast and their links to the scopes, but was virtually silent until just last week. Two days after the UCLA outbreak made the front page of the Los Angeles Times, it issued a safety alert about the scopes, warning that "effective cleaning of all areas of the duodenoscope may not be possible."

The FDA did not respond to our questions as to whether it had approved the new model and whether it came with updated cleaning instructions. Kaufman suspects the FDA fast-tracked its approval, known as a 510(K), which it grants devices that are "substantially equivalent" to something already legally on the market.

"Tweaking the device gives your sales rep something to talk about," said Kaufman. "You're in a hotly-contested and highly competitive market. When you change the device… you can go to a hospital and say, 'Doc, you need to buy two of these, or four of these, or six of these devices, because we've made this excellent change."

Kaufman names three Olympus sales representatives in his lawsuits. The representatives met with UCLA staff and doctors between July 2014 and January 2015, and made “false representations in an effort to mislead” UCLA into purchasing the scopes, according to the lawsuit.

Olympus would not provide any comment on the suits, but the company did give America Tonight this statement: “While all endoscopes, including duodenoscopes, require thorough reprocessing after patient use in order to be safe, the Olympus TJF-Q180V requires careful attention to cleaning and reprocessing steps, including meticulous manual cleaning, to ensure effective reprocessing.”

The company added that it’s monitoring the situation and is offering video demonstrations on how to clean the devices.

The call for protocol

Since its outbreak, the UCLA hospital has begun using a toxic gas to sterilize the scopes and some other hospitals are following suit. But Dr. William Maisel, deputy director and chief scientist at the FDA's center for regulating medical devices, told the Los Angeles Times this week that the practice is "not something that we routinely recommend." 

Washington Sen. Patty Murray has asked the FDA to step up its regulation of the devices. In a Feb. 3 letter [PDF], she asked the agency to finalize guidance on how to clean the devices – guidance it drafted four years ago. She also suggested it should consider doing “more robust post-market surveillance” of the devices.

The senator’s office told America Tonight, to date, the FDA has not responded to the letter.

"Medical device manufacturers are the customers of the FDA," said Kaufman. "And all to often, that's how they're treated by the FDA – with far too much deference." 

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