Tagged Patient Safety

Scope Maker Olympus Hit With $6.6 Million Verdict In Superbug Outbreak Case

A jury ordered the giant medical scope maker Olympus Corp. to pay a Seattle hospital $6.6 million in damages tied to a deadly superbug outbreak — and told the hospital to pay $1 million to a deceased patient’s family.

But jurors on Monday also handed the Tokyo-based manufacturer a key win, rejecting claims that its flagship duodenoscope was unsafe as designed.

The decision follows an eight-week trial, the first in the U.S. related to gastrointestinal scopes causing outbreaks of drug-resistant infections.

The case was filed by Theresa Bigler, 61, and her four children in connection with the August 2013 death of Richard Bigler, a pancreatic cancer patient who contracted an infection linked to a contaminated Olympus scope. The hospital, Virginia Mason Medical Center, later joined in the suit against Olympus, but the jury found it shared some blame in the case.

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An Olympus official offered condolences to the Bigler family in a statement and praised the jury’s decision.

“We are appreciative that the jury recognized that Olympus’ duodenoscope design was not unsafe and did not contribute to Mr. Bigler’s unfortunate passing in 2013,” said Sam Tarry, an attorney for the company.

But the jury also said Olympus failed to provide adequate warnings about the scope or instructions for its use after it was manufactured. The jury said that failure harmed Virginia Mason Medical Center.

Theresa Bigler’s attorneys cast the decision as a win for patient safety.

Theresa Bigler sued Olympus for the death of her 57-year-old husband, Richard, a pancreatic cancer patient who contracted an infection linked to a contaminated Olympus scope. (Courtesy of the Bigler family)

“Olympus hasn’t been playing by the rules for some time and this verdict holds them accountable,” lawyer David Beninger said in a statement.

He said the case should send a broad signal to Olympus and other device manufacturers.

They “must make patient safety a priority and not just a sales pitch,” Beninger’s statement said. “As Olympus’ own expert admitted at trial, lawsuits can change behavior and big lawsuits can make big changes. Hopefully this verdict will convince Olympus and others to listen.”

Medical and legal experts said they were surprised at how well Olympus fared in this case, which was closely watched by other plaintiffs’ lawyers who are waging similar suits against the company.

“In the jury’s opinion, the hospital shared some of the blame,” said Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa.

Muscarella said each case is different and plaintiffs’ attorneys can learn from the evidence presented at this trial. “It remains to be seen what this portends for other cases on the docket,” he said.

More than 25 patients and families, from Pennsylvania to California, have sued Olympus alleging wrongful death, negligence or fraud. Federal prosecutors also are investigating Olympus and two smaller manufacturers over their potential roles in patient infections.

Richard Bigler was one of at least 35 patients in American hospitals to have died since 2013 after developing infections tied to Olympus duodenoscopes — snake-like tubes threaded down a patient’s throat. Doctors use the scope to diagnose and treat problems in the digestive tract, such as gallstones, cancers and blockages in the bile duct. About 700,000 such ERCP procedures are performed annually in the U.S.

Last year, Olympus recalled all 4,400 of its TJF-Q180V duodenoscopes — the model used in Bigler’s case — and made repairs to reduce the risk of bacteria becoming trapped inside after cleaning.

Bigler’s attorneys said Olympus had acted recklessly by not warning U.S. hospitals about previous outbreaks and failing to fix a design flaw that hindered cleaning and allowed dangerous bacteria to become trapped inside these reusable scopes.

Olympus had said its gastrointestinal scopes were safe and effective with proper cleaning and disinfection. At trial, the company said Virginia Mason was to blame for Bigler’s infection because the hospital didn’t follow the company’s cleaning instructions.

Olympus criticized Virginia Mason for not telling Bigler and other families about the scope-related infections, forcing them to find out from a newspaper account about the outbreak.

In his closing argument, Olympus attorney Mark Anderson told the jury that the Seattle outbreak would have occurred regardless of whether Olympus’ or another company’s scopes had been used.

“The proof in this case, from their witnesses, is there is no increased risk with the [Olympus scope],” Anderson told the jury.

Hospital officials said the faulty Olympus scopes were the cause of Bigler’s infection and others, and they implemented an expensive test-and-hold protocol for cleaning the devices that halted the spread.

“We’re sorry for the grief and anguish experienced by the Bigler family,” the hospital said in a brief statement. “This was a complicated trial that lasted more than eight weeks. The verdict includes multiple decisions and we will continue reviewing them over the next few days.”

Theresa Bigler was not available for comment, lawyers said.

Olympus is the industry leader for these devices and other specialty endoscopes, with an 85 percent share of the U.S. market.

One of the largest superbug outbreaks in the nation occurred at Virginia Mason, where 39 people’s infections were linked to Olympus scopes. Eighteen patients died. The Seattle hospital said the patients who died, including Richard Bigler, had other underlying illnesses.

The 12-member jury, which had begun deliberating July 18, said the damages to Virginia Mason amounted to $25.4 million. But jurors agreed the hospital had been negligent, so they sharply reduced the damages owed to Virginia Mason.

The plaintiffs’ attorneys repeatedly reminded jurors that three key Olympus executives declined to testify at trial and instead invoked their Fifth Amendment right against self-incrimination.

The three executives who declined to testify were Susumu Nishina, Hisao Yabe and Hiroki Moriyama. They hold top roles in regulatory affairs, quality assurance or medical manufacturing. All three have declined to comment, citing the pending litigation.

Several of Nishina’s internal company emails were introduced as evidence. In one email exchange in February 2013, Nishina told the company’s U.S. managers not to issue a broad warning to American hospitals despite reports of scope-related infections in Dutch, French and U.S. hospitals, court records show.

In addition to Olympus, device makers Pentax and Fujifilm sell these sorts of duodenoscopes, which can cost up to $40,000 apiece. Overall, as many as 350 patients at 41 medical centers worldwide were infected or exposed to contaminated scopes made by those three manufacturers from 2010 to 2015, according to the U.S. Food and Drug Administration.

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Calif. Hits Nerve By Singling Out Cardiac Surgeons With Higher Patient Death Rates

Michael Koumjian, a heart surgeon for nearly three decades, said he considered treating the sickest patients a badge of honor. The San Diego doctor was frequently called upon to operate on those who had multiple illnesses or who’d undergone CPR before arriving at the hospital.

Recently, however, Koumjian received some unwelcome recognition: He was identified in a public database of California heart surgeons as one of seven with a higher-than-average death rate for patients who underwent a common bypass procedure.

“If you are willing to give people a shot and their only chance is surgery, then you are going to have more deaths and be criticized,” said Koumjian, whose risk-adjusted death rate was 7.5 per 100 surgeries in 2014-15. “The surgeons that worry about their stats just don’t take those cases.”

Now, Koumjian said he is reconsidering taking such complicated cases because he can’t afford to continue being labeled a “bad surgeon.”

California is one of a handful of states — including New York, Pennsylvania and New Jersey — that publicly reports surgeons’ names and risk-adjusted death rates on a procedure known as the “isolated coronary artery bypass graft.” The practice is controversial: Proponents argue transparency improves quality and informs consumers. Critics say it deters surgeons from accepting complex cases and can unfairly tarnish doctors’ records.

“This is a hotly debated issue,” said Ralph Brindis, a cardiologist and professor at UC-San Francisco who chairs the advisory panel for the state report. “But to me, the pros of public reporting outweigh the negatives. I think consumers deserve to have a right to that information.”

Prompted by a state law, the Office of Statewide Health Planning and Development began issuing the reports in 2003 and produces them every two years. Outcomes from the bypass procedure had long been used as one of several measures of hospital quality. But that marked the first time physician names were attached — and the bypass is still the only procedure for which such physician-specific reports are released publicly in California.

California’s law was sponsored by consumer advocates, who argued that publicly listing the names of outlier surgeons in New York had appeared to bring about a significant drop in death rates from the bypass procedure. State officials say it has worked here as well: The rate declined from 2.91 to 1.97 deaths per 100 surgeries from 2003 to 2014.

“Providing the results back to the surgeons, facilities and the public overall results in higher quality performance for everybody,” said Holly Hoegh, manager of the clinical data unit at the state’s health planning and development office.

Since the state began issuing the reports, the number of surgeons with significantly higher death rates than the state average has ranged from six to 12, and none has made the list twice. The most recent report, released in May, is based on surgeries performed in 2013 and 2014.

In this year’s report, the seven surgeons with above-average death rates — out of 271 surgeons listed — include several veterans in the field. Among them were Daniel Pellegrini, chief of inpatient quality at Kaiser Permanente San Francisco and John M. Robertson, director of thoracic and cardiovascular surgery at Providence Saint John’s Health Center in Santa Monica. Most defended their records, arguing that some of the deaths shouldn’t have been counted or that the death rates didn’t represent the totality of their careers. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

“For the lion’s share of my career, my numbers were good and I’m very proud of them,” said Pellegrini. “I don’t think this is reflective of my work overall. I do think that’s reflective that I was willing to take on tough cases.”

During the two years covered in the report, Pellegrini performed 69 surgeries and four patients died. That brought his risk-adjusted rate to 11.48 deaths per 100, above the state average of 2.13 per 100 in that period.

Pellegrini said he supports public reporting, but he argues the calculations don’t fully take the varying complexity of the cases into account and that a couple of bad outcomes can skew the rates.

Robertson said in a written statement that he had three very “complex and challenging” cases involving patients who came to the hospital with “extraordinary complications and additional unrelated conditions.” They were among five deaths out of 71 patients during the reporting period, giving him an adjusted rate of 9.75 per 100 surgeries.

“While I appreciate independent oversight, it’s important for consumers to realize that two years of data do not illustrate overall results,” Robertson said. “Every single patient is different.”

The rates are calculated based on a nationally recognized method that includes deaths occurring during hospitalization, regardless of how long the stay, or anytime within 30 days after the surgery, regardless of the venue. All licensed hospitals must report the data to the state.

State officials said that providing surgeons’ names can help consumers make choices about who they want to operate on them, assuming it’s not an emergency.

“It is important for patients to be involved in their own health care, and we are trying to work more and more on getting this information in an easy-to-use format for the man on the street,” said Hoegh, of the state’s health planning and development office.

No minimum number of surgeries is needed to calculate a rate, but the results must be statistically significant and are risk-adjusted to account for varying levels of illness or frailty among patients, Hoegh said.

She acknowledged that “a risk model can never capture all the risk” and said her office is always trying to improve its approach.

Surgeons sometimes file appeals — arguing, for example, that the risk was improperly calculated or that the death was unrelated to the surgery. The appeals can result in adjustments to a rate, Hoegh said.

Despite the controversy it generates, the public reporting is supported by the California Society of Thoracic Surgeons, the professional association representing the surgeons. No one wants to be on the list, but “transparency is always a good thing,” said Junaid Khan, president of the society and director of cardiovascular surgery at Alta Bates Summit Medical Center in the Bay Area.

“The purpose of the list is not to be punitive,” said Khan. “It’s not to embarrass anybody. It is to help improve quality.”

Khan added that he believes outcomes of other heart procedures, such as angioplasty, should also be publicly reported.

Consumers Union, which sponsored the bill that led to the cardiac surgeon reports, supports expanding doctor-specific reporting to include a variety of other procedures — for example, birth outcomes, which could be valuable for expectant parents as they look for a doctor.

“Consumers are really hungry for physician-specific information,” said Betsy Imholz, the advocacy group’s special projects director. And, she added, “care that people receive actually improves once the data is made public.”

But efforts to expand reporting by name are likely to hit opposition. Officials in Massachusetts, who had been reporting bypass outcomes for individual doctors, stopped doing it in 2013. Surgeons supported reporting to improve outcomes, but they were concerned that they were being identified publicly as outliers when they really were just taking on difficult cases, said Daniel Engelman, president of the Massachusetts Society of Thoracic Surgeons.

“Cardiac surgeons said, ‘Enough is enough. We can’t risk being in the papers as outliers,’” Engelman said.

Engelman said the surgeons cited research from New York showing that public reporting may have led surgeons to turn away high-risk patients. Hoegh said research has not uncovered any such evidence in California.

In addition to Koumjian, Robertson and Pellegrini, the physicians in California with higher-than-average rates were Philip Faraci, Eli R. Capouya, Alexander R. Marmureanu, Yousef M. Odeh. Capouya declined to comment.

Faraci, 75, said his rate (8.34 per 100) was based on four deaths out of 33 surgeries, not enough to calculate death rates, he said. Faraci, who is semi-retired, said he wasn’t too worried about the rating, though. “I have been in practice for over 30 years and I have never been published as a below-average surgeon before,” he said.

Odeh, 45, performed 10 surgeries and had two deaths while at Presbyterian Intercommunity Hospital in Whittier, resulting in a mortality rate of 26.17 per 100. “It was my first job out of residency, and I didn’t have much guidance,” Odeh said. “That’s a recipe for disaster.”

Odeh said those two years don’t reflect his skills as a surgeon, adding that he has done hundreds of surgeries since then without incident.

Marmureanu, who operates at several Los Angeles-area hospitals, had a mortality rate of 18.04 based on three deaths among 22 cases. “I do the most complicated cases in town,” he said, adding that one of the patients died later after being hit by a car.

“Hospital patients don’t care” about the report. he said. “Nobody pays attention to this data other than journalists.”

KHN’s coverage in California is funded in part by Blue Shield of California Foundation.

Categories: Cost and Quality, Health Industry

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Medical Transportation Provider Accused Of Disserving L.A.’s Frail Patients

Some days, the drivers showed up late to take Julian Myers to and from dialysis. Other days, they didn’t come at all. When that happened, Myers, who has end-stage kidney disease, scrambled to find a ride.

“My blood pressure was rising and I’d get anxious,” he recalled. “I was frustrated. It’s a regular appointment. They should be here on time.”

Myers complained regularly to LogistiCare, the company contracted to provide his medical transportation, but said the situation didn’t improve.

Medicaid beneficiaries like Myers are entitled to non-emergency, free transportation for medical appointments if they physically can’t get there on their own. But patient advocates and social workers say low-income and vulnerable patients in Los Angeles County have frequently been unable to get to their appointments on time — or at all.

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“The uncertainty of when or if LogistiCare is going to come … takes a tremendous toll on people who have no resources,” said Toni Vargas, an attorney at Neighborhood Legal Services of Los Angeles County, a public interest law firm. “They don’t have the resources to say, ‘Enough is enough. I am going to go with another company.’”

Neighborhood Legal Services recently sued LogistiCare in Los Angeles County Superior Court, alleging that the company harmed the county’s Medicaid patients by failing to provide “safe, reliable, and timely transportation.” Among the patients ill-served by the company were a double amputee, a woman partially paralyzed from a stroke and a man with a brain injury, the suit said.

Patients who needed help were left on the curb or waiting for hours for rides, and others were harassed or driven in unsafe vehicles, according to the suit. Two patients allegedly were injured when their wheelchairs weren’t secured in a van.

Similar issues with LogistiCare, a Georgia-based private company that works in the majority of states around the nation, also have been reported in New Jersey, Connecticut, Wisconsin and elsewhere.

“This is a problem around the country,” said Sheldon V. Toubman, a staff attorney at New Haven Legal Assistance Association. “It directly impacts access to care, with people literally not going to medical appointments they had because they could not get there.”

They don’t have the resources to say, ‘Enough is enough. I am going to go with another company.’

Toni Vargas, Neighborhood Legal Services of Los Angeles County

LogistiCare officials declined to be interviewed but the general manager for California, Jody Gonzalez, said in an e-mail that the company takes the lawsuit very seriously, plans to mount a “vigorous defense” and believes the allegations will be disproven.

“We emphatically believe that the claims by [Neighborhood Legal Services of Los Angeles County] are completely inaccurate, and do not reflect the reality of how our system operates in LA or any of our operation centers,” Gonzalez wrote.

Gonzalez said the company serves 5.6 million people in California, including those on Medicaid (called Medi-Cal in the state), Medicare or with private insurance. The rides — done by a network of local drivers — help patients avoid unnecessary emergency room visits and hospitalizations.

“Given the scale of the trips that we manage, we have a very high level of satisfaction and a relatively low number of complaints,” Gonzalez wrote.

All complaints are investigated and addressed, though some are less serious than others, he said. Gonzalez added that the company regularly reaches out to families and facilities to address concerns and is already working to improve operations, by incorporating GPS technology for better oversight and adding more resources to serve the Medi-Cal population.

The California Department of Health Care Services, which oversees Medi-Cal in the state, declined to comment because of the pending litigation. Medi-Cal managed-care plans contract directly with LogistiCare.

In Connecticut, the state issued a bid for a new Medicaid contractor for non-emergency transportation because of the problems. The new company hasn’t yet taken over, and pediatric cancer patients and those with mental health issues, still frequently miss appointments because of delays and other problems, said Bonnie B. Roswig, a senior staff attorney at the Center for Children’s Advocacy in Connecticut. “Patients just aren’t getting the transportation they need,” Roswig said. “Medical providers are beside themselves.”

In New Jersey, a survey of more than 300 Medicaid recipients with mental health issues found that nearly a third had serious safety concerns and that almost one-quarter stopped using LogistiCare’s service because they were treated poorly or the services were not reliable. Proposed legislation in the state would require more accountability and training for Medicaid transportation services.

Vargas of Neighborhood Legal Services said she spent years trying to work with LogistiCare in California to improve the service. Though the company addressed some individual concerns, it failed to deal with broader underlying issues of untrained drivers, not enough drivers, poor management and a disorganized dispatch system.

“It was like putting Band-Aids on a leak in your swimming pool,” she said. “The exact same problems keep coming up again.”

The lawsuit also alleged that drivers often didn’t help certain patients to and from the door as required, and that some patients were transported without seat belts.

Myers gets into the ride-share van provided by Medicaid after his dialysis treatment at DaVita Dialysis Center in Hollywood. Myers, who has end-stage kidney disease, requires dialysis three times a week and relies on the medical transportation. (Heidi de Marco/KHN)

Shelly Frasier, a social worker at the DaVita Hollywood Dialysis Center in Los Angeles, where Myers receives treatment, said the unreliable transportation is both inconvenient and dangerous for patients.

“It’s really important to have the consistent filtration of the blood,” she said. “That is what is keeping them safe and alive. Missing just one treatment can put them in a perilous place.”

Frasier said she has often called LogistiCare, only to see the problems occur again. “There is no incentive to fix the problem,” she said. “It’s just a mess.”

Myers, an aspiring screenwriter, said he worried about his health each time a ride was late. If he was forced to have a shorter dialysis session, Myers said, he came home nauseated.

Another one of the plaintiffs, Hassan Allen, is diabetic and wears prostheses after having both legs amputated. He said he is weak and unsteady after dialysis and relies on the drivers to help him get home safely and quickly.

Several times, Allen said, drivers arrived long after his appointment ended. “When you finish dialysis and you have to sit around and wait an hour or two for transportation to pick you up, it’s a very tough situation,” said Allen, 44, who lives in Los Angeles. “You are agonizing and extremely frustrated.”

Allen is supposed to get help to and from the door, but he said LogistiCare regularly sent cabs with drivers who didn’t do that. “The taxicab situation was just untenable,” he said.

“It doesn’t matter what you tell them,” he said of LogistiCare. “Nothing changes. … Patients who are being poorly served by them deserve better.”

KHN’s coverage in California is funded in part by Blue Shield of California Foundation.

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DNA Links Deadly Germs, Tainted Heart Surgery Devices To German Factory

Contamination at a German factory that makes crucial machines used during open-heart surgery is the likely source of a global outbreak of deadly infections tied to the devices, the largest analysis to date shows.

Scientists using whole-genome sequencing matched the DNA fingerprints of samples taken from infected heart-surgery patients from several countries, including the U.S., to samples from the devices, called heater-cooler units, in multiple hospitals — and at the production site.

The study, published Wednesday in The Lancet Infectious Diseases journal, concludes that heater-cooler devices made at the LivaNova PLC plant in Munich, Germany, were contaminated during production.

The analysis provides a critical piece of the puzzle behind more than 100 severe — and sometimes fatal — infections in cardiac surgery patients worldwide since 2013, researchers said.

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“Our study closes the missing gap,” said Stefan Niemann, a professor with the German Center for Infection Research and one of the study’s co-authors.

However, officials with LivaNova said that the study was too limited to draw conclusions.

“LivaNova is concerned that the article expresses a level of certainty about a point source tie to the manufacturing process that is not warranted by the data,” spokeswoman Deanna Wilke wrote in an email.

Scientists from Germany, the Netherlands and Switzerland analyzed 250 DNA samples of Mycobacterium chimaera, an organism typically found in soil and tap water.

The review included samples from 21 infected patients in Switzerland, Germany, the Netherlands and the United Kingdom, and data from another 12 in the U.S. and Australia. The analysis included samples from heater-cooler devices by LivaNova and a second German brand, Maquet, plus hospital water sources and environmental sources.

Scientists found a high degree of similarity in samples from the patients and from the LivaNova heater-cooler units and the LivaNova factory.

The authors noted that they were not able to link individual patients to particular heater-cooler units because they lacked enough water and air samples to document transmission. Infections have been linked to contaminated water in the devices that is then misted into the air.

They also warned against ending investigations into the problem too soon. Researchers found that some hospital water systems and Maquet heater-coolers were contaminated, raising concerns about local contamination.

Vincent Karst, 55, of York, Pa., was among those infected with Mycobacterium chimaera. Known as Vinnie, the father of five and grandfather to 15 appeared to do well after open-heart surgery in March 2015. But, according to a lawsuit, he fell mysteriously ill and had to be re-hospitalized with what doctors later said was an infection tied to the heater-cooler unit used during his operation.

Karst died in May from complications of the infection, his lawyer said.

Patients in several other states have filed lawsuits claiming they were infected, too.

Karst’s surgery used a Sorin 3T heater-cooler, a device that circulates water to warm or cool patients’ blood during bypass operations. More than 250,000 operations using the devices are performed each year in the U.S., and about 60 percent are done with the Sorin 3T models approved for sale in 2006. After a 2015 merger, Sorin became LivaNova.

At least five other manufacturers also sell heater-coolers in the U.S. — and they all share a design that could pose a risk for infections, experts say.

The heater-cooler devices use fans to regulate airflow. If the water in the system is contaminated with bacteria, the machines can send the germs into the air, where they can settle in open surgical sites or on cardiac implants before insertion. One complicating factor is that it can take months or even years to detect the slow-growing infections.

Early reports of infections tied to heater-cooler units date to 2002, and Food and Drug Administration officials have said they were aware of the problem by 2014. At least 15 people in the U.S. have died, according to reports submitted to the agency.

But the FDA waited more than a year to warn the public about the risk — and even longer to provide recommendations for action to hospitals and patients. Critics contend that if the agency had intervened earlier, more patients would have avoided infections, even death.

The agency now warns that for 3T devices manufactured before September 2014, there is strong evidence of common contamination at the manufacturing site in Germany. But spokeswoman Stephanie Caccomo said local contamination can also occur and hospitals should “perform appropriate follow-up measures.”

Lawrence Muscarella, a Pennsylvania patient-safety consultant, said he’s concerned that a focus on contamination at the factory might lead hospitals to relax their vigilance about what are often called Nontuberculous mycobacteria, or NTM, infections.

“[They] might incorrectly conclude that what’s to blame for these infections is contamination at a company’s manufacturing plant, something the hospital can do nothing about, rather than understanding that hospitals can reduce the risk of NTM infections in open-chest patients,” he said.

At the University of Iowa Hospitals and Clinics, where six patients developed infections tied to heater-cooler units, experts solved the problem by putting the devices in a room connected to — but separate from — the operating room, said Dr. Michael Edmond.

“I don’t think we can safely say the machines can be decontaminated,” said Edmond, a clinical professor of infectious diseases. “The only safe mitigation strategy is you have to separate the air that comes out of that machine from the air in the operating room.”

Since the hospital took that action in January 2016, no new infections have been detected.

“It works beautifully,” Edmond said.

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