In 2014, duodenoscope maker Olympus redesigned its gastrointestinal scope used in approximately 80 to 85 percent of the half million endoscopic retrograde cholangiopancreatography (ERCP) procedures performed across the U.S. each year. This redesign incorporated an “elevator” mechanism with a hinge created to provide greater maneuverability.
But the risk for organic debris such as tissue and fluids to remain within small parts of the device was high, even when following the manufacturer’s instructions for proper cleaning and sterilization. In some cases, this led to the transfer of dangerous bacteria known as carbapenem-resistant Enterobacteriaceae (or CRE) between patients.
This bacterial transfer resulted in serious, sometimes deadly, infections in patients. CRE (or “superbug”) outbreaks occurred in hospitals across the nation, such Cedars-Sinai and UCLA. As a superbug, CRE is difficult to treat due to its resistance to most antibiotics including carbapenem, which is usually an antibiotic of “last resort,” meaning it’s typically reserved for more serious infections. The CDC estimated that nearly half of all cases of individuals infected by CRE bacteria result in death.
Furthermore, the company and the U.S. Food and Drug Administration (FDA) were aware of the difficulty in cleaning the particular scope prior to Olympus’ redesign. Despite that knowledge, patients (now plaintiffs) suing the medical-technology company asserted that the redesign did not take into account ways in which to ensure proper cleaning and disinfection of the device, nor did it come with updated reuse protocols.
Additionally, it was found that the manufacturer did not seek FDA clearance prior to the marketing and sale of the modified device, stating that it was not aware such clearance was needed.
The manufacturer did not seek FDA clearance prior to the marketing and sale of the modified device.
However, Olympus was not the only company responsible for marketing and selling a non-FDA-approved device. Fujifilm and Pentax were also called out for not submitting 510(k) applications for FDA clearance of the marketing and sale of their duodenoscopes. These applications are also known as premarket notifications that alert the FDA of a manufacturer’s intent to market a medical device at least 90 days in advance.
All of the discrepancies ultimately led to the U.S. Department of Justice issuing subpoenas, first to Olympus in May 2015 and immediately after to Fujifilm and Pentax as well, seeking information relating to duodenoscopes manufactured and sold by the three companies. One of the hospitals, Virginia Mason Medical Center in Seattle, which experienced one of the largest superbug outbreaks associated with the contaminated scopes used in ERCP procedures, also received a subpoena.
In June 2015, six individual lawsuits filed against Olympus in the U.S. District Court Central District of California were transferred to the Superior Court of California, County of Los Angeles. All of the lawsuits resulted from patient injuries and/or deaths related to the use of allegedly contaminated duodenoscopes at the University of California Los Angeles (UCLA) Ronald Reagan Medical Center between October 2014 and December 2014.
Defective Design and Ineffective Cleaning Protocol
The FDA has repeatedly pointed out that the complex design of duodenoscopes, intended to make the device easier to use for its purpose, also makes the scope extremely difficult to clean. The elevator mechanism, which contains many small moving parts, according to the FDA, can harbor hard-to-reach organic debris and bacteria that can be passed along to subsequent patients.
Following its own investigation, the FDA also determined that this patient-to-patient contamination can occur even if the manufacturer’s cleaning and reprocessing instructions are properly followed.
In 2015, the Los Angeles Times reported that the FDA was giving duodenoscope manufacturers a third attempt to validate their cleaning protocols despite patients continuing to fall ill with potentially life-threatening superbug infections. The FDA said it received reports of 135 possible patient infections from January 2013 to December 2014 linked to duodenoscopes used in ERCP procedures.
U.S. Rep. Ted Lieu, D-California, called for a congressional investigation of the FDA and the three main duodenoscope manufacturers in the U.S., including Olympus, following a superbug outbreak at UCLA Ronald Reagan Medical Center. Lieu asserted that “if the FDA had acted earlier there would be fewer unnecessary deaths.”
Lieu also pointed out that Olympus clearly had knowledge of the “cleaning problems” with its scope because the company previously changed the device’s cleaning protocol in Europe. Several lawsuits asserted similar allegations that Olympus committed negligence and fraud by selling a scope it knew could not be cleaned effectively and therefore was prone to harboring and transferring bacteria.
“My view is that we sent human beings to the moon 45 years ago. We can certainly invent a device that can be cleaned properly.”
- U.S. Rep. Ted Lieu stated in a media interview
In January 2016, the FDA issued a news release stating that Olympus modified its design of the elevator channel sealing mechanism “to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.” But Deputy Director of Strategy for the FDA’s Office of External Affairs Karen Riley said it seems that the modifications did not result in a safer device.
FDA Takes No Action Against Olympus
Despite modifications to its duodenoscope device in what the company stated is an ongoing effort to improve the safety and efficacy of its products, Olympus never sought FDA clearance, per federal regulations, prior to marketing and selling its redesigned model TJF-Q180V duodenoscope. But even once the FDA became aware of Olympus’ non-compliance, the agency did not issue a recall on the supposedly defectively designed duodenoscopes, but it did require Olympus to submit the required 510(k) application for approval of its “new” device.
Once the FDA became aware of Olympus’ non-compliance, the agency did not issue a recall on the defective duodenoscopes.
On March 4, 2015, the FDA issued a statement saying, “[The] FDA is not recommending that health care providers cancel ERCP procedures for their patients who need them… [The FDA is not taking action against Olympus regarding its device during our review of the application, because, based on the information currently available to the agency, we believe that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.”
The FDA concluded in its statement that “at this time, [the] FDA has no evidence that the lack of a 510(k) clearance was associated with the infections.” However, the FDA did note that “reported duodenoscope infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers.”
The director of Consumers Union’s Safe Patient Project, Lisa McGiffert, told the Los Angeles Times “the agency’s handling of this crisis reflects an agency culture that’s too secretive and too protective of the industry.”
Some of the Plaintiffs Suing Olympus
Plaintiffs are suing duodenoscope-maker Olympus over superbug outbreaks occurring across the nation that have resulted in serious illness, and in some patients, death. Lawsuits filed by patients and their family members have alleged fraud and negligence against the company in the manufacture and marketing of what was determined to be a flawed, difficult-to-clean device.
Plaintiffs alleged in their lawsuits that Olympus knew its design was difficult to clean and that it would therefore “pose health risks to patients exposed to the devices.” The lawsuits also claimed that despite knowing this, Olympus failed to issue updated reprocessing protocols in connection with the redesign of its scope at its market release thereby placing patients “at a high risk of developing debilitating and potentially lethal infections.”
Jeffery John and Annie Ruth Hughes
These parents are suing on behalf of their son who died after contracting a superbug infection allegedly from a contaminated duodenoscope. The couple’s minor son had cancer requiring him to undergo multiple procedures with the Olympus scope at UCLA’s Ronald Regan Medical Center between September 2014 and December 2014.
The parents claimed in their lawsuit that even before the redesign and marketing of its device in 2014 Olympus was “on notice” that its devices were difficult to clean and that such difficulty “posed health risks to patients exposed to the devices.” The lawsuit further stated that in 2013, “Olympus was informed of infections to patients in the State of Washington… [and] at least four patients who were infected as a result of exposure to contaminated duodenoscopes died.”
The plaintiffs said that despite this information regarding the potential for harm to patients, Olympus “negligently, recklessly and with conscious disregard of the extreme risks to the public of serious infection, pain and death, aggressively marketed and sold” its allegedly defective device claiming it was safe and effective for repeated use in ERCP procedures.
Their complaint concluded that due to Olympus’ negligent and fraudulent actions, the parents “have been, and will be, deprived of the love, care, society, affection, comfort, moral support, protection, companionship, guidance, solace, services and support of their son.”
Antonia Torres Cerda
Antonia Torres Cerda was a 48-year-old patient at UCLA’s (University of California, Los Angeles) Ronald Regan Medical Center in October 2014. Her family filed a wrongful death lawsuit against Olympus in February 2015, after Cerda underwent an ERCP procedure prior to a liver transplant that exposed her to an allegedly contaminated Olympus duodenoscope. The lawsuit claimed Cerda “suffered significant injury and died,” as a result. The family further accused Olympus of negligence and fraud in the manufacture and marketing of the allegedly defective duodenoscope.
Cerda’s death and subsequent lawsuit were resultant of a superbug outbreak at UCLA that left other patients injured as well, according to several news reports.
Eighteen-year-old high school student Aaron Young was hospitalized at UCLA due to a superbug infection following the use of an allegedly contaminated duodenoscope. Young was first admitted to the hospital with after experiencing stomach pain and vomiting for several months. He underwent an ERCP procedure after receiving a diagnosis of acute pancreatitis and developed a superbug infection that resulted in a persistent high fever and almost three months in the hospital.
Young had to undergo another procedure to have a stent removed from his bile duct that again left him hospitalized when the infection returned. The complaint claimed that Young was still in the hospital at the time his adoptive parents filed suit against the manufacturer of the allegedly defective scopes. The lawsuit alleged that Olympus committed fraud and negligence, and that updated cleaning instructions were not provided to hospitals following a redesign of the device in 2010.
The Washington Post reported that Young’s adoptive mother, Lori Smith, said, “The lawsuit is almost beside the point… Nobody said [Young] could get something from these scopes that could kill him… We just had no idea.” Smith said that she wanted something put in place that would keep patients and the public better informed about the risks involved.
Domingo Gomez was the third patient from UCLA Ronald Reagan Medical Center to sue Olympus on allegations of products liability, negligence and fraud. Gomez was just one of several patients at UCLA Medical Center affected by an antibiotic-resistant bacterial infection linked to a supposedly contaminated duodenoscope made by Olympus.
Gomez’s lawsuit does not blame UCLA for any injuries resulting from a superbug outbreak that occurred within its facility. CBS Los Angeles reported that hospital officials were able to trace the origin of the serious, sometimes life-threatening, CRE infections to a couple of Olympus duodenoscopes used recurrently in ERCP procedures.
Gomez alleged that he experienced “extraordinary pain and suffering” following his exposure to an allegedly contaminated Olympus duodenoscope. The lawsuit stated that Olympus acted negligently in failing to provide the hospital and doctors with validated reprocessing protocols following device modifications, and “as a result, end-users were not able to effectively sanitize and clean the new redesigned scope.”
Silvia Patricia Aroche
Paul Campbell sued Olympus on behalf of his deceased wife, Silvia Patricia Aroche, after she was exposed to CRE bacteria from an allegedly contaminated duodenoscope used in multiple procedures she underwent at UCLA’s Ronald Reagan Medical Center in December 2014. Campbell’s lawsuit stated that Aroche “suffered significant injury and died.”
The wrongful death suit also claimed that Olympus engaged in negligence and fraud in selling and promoting the allegedly defective device “so as to maximize sales and profits at the expense of the health and safety of the public.”
Leo Palomino, from Inglewood in southwestern Los Angeles County, was 72 when he filed his lawsuit against Olympus in 2015. He underwent multiple ERCP procedures at UCLA Medical Center from October 2014 to December 2014 and contracted a superbug infection. Palomino alleged that a contaminated Olympus scope caused his injuries.
Palomino’s attorney, Pete Kaufman, reported that he thinks the number of patients affected by the Olympus duodenoscope device at UCLA and other hospitals is likely than higher than initially thought. Kaufman said, “I think the numbers will go higher because hospitals have been very cautious in reporting cases.”
Theresa Bigler filed a wrongful death lawsuit on behalf of her husband, Richard Bigler, who died in 2013 after becoming infected with an antibiotic-resistant E. coli infection. Bigler alleged that the infection was the result of a contaminated duodenoscope used in the treatment of her husband’s pancreatic cancer.
In addition to filing suit against Olympus, Bigler also sued the hospital, Virginia Mason Medical Center (VMMC), where her husband was treated. Richard Bigler allegedly acquired a superbug at VMMC between November 2012 and January 2014. He was among the 39 patients infected at that hospital. Of those, 18 died, including Bigler.
His wife claimed Olympus knew for years that its duodenoscope cleaning instructions were ineffective and that use of the scopes could thereby result in serious infections and/or death. Bigler further alleged that despite this knowledge, the company failed to adequately warn hospitals, doctors and patients.
The hospital said that it took actions to stop the superbug outbreak including spending more than $1 million to put a “culture-and-quarantine” protocol into place that holds contaminated duodenoscopes until they test free of bacteria.
Hospital Joins Lawsuit Against Olympus
Virginia Mason Medical Center (VMMC) answered Theresa Bigler’s wrongful death lawsuit by filing a cross-claim against Olympus, essentially teaming up with the plaintiff. VMMC denied that it had any fault in Bigler’s husband’s death, and instead, pointed to Olympus, accusing the company of fraud and alleging that it hid information regarding the device’s design flaws and ineffective cleaning instructions.
The medical center’s lawsuit claimed the company’s actions and “resulted in significant harm to VMMC, including, but not limited to, harm to VMMC’s business reputation, loss of goodwill and economic damages.”
While legal experts said VMMC’s decision to come alongside a patient in suing a device manufacturer is not common, one attorney said this case “may be fairly unique in that it has both adverse-reputation and reimbursement implications for the hospital.” The attorney, Lynn Gordon, who is a partner with Nixon Peabody in Chicago, said that given the extent and severity of the cases, damages may be worth pursuing for VMMC.
But this also means the hospital will be on both the offense and the defense heading into the courtroom. Counsel for Bigler, John Gagliardi, said while VMMC remains a defendant in his client’s lawsuit, he doesn’t intend to pursue those claims. Gagliardi said, “Based on what we learned… it doesn’t appear they did anything wrong.”
Olympus filed its own cross-claim against Virginia Mason Medical Center (VMMC), stating that its duodenoscope devices are not responsible for the death of Theresa Bigler’s husband. Olympus alleged that rather it was the hospital that was “entirely at fault.”
In its countersuit, Olympus said VMMC failed to properly use and clean the device used in ERCP procedures and thereby the medical center damaged the manufacturer’s reputation when it alleged that Olympus duodenoscopes could not be effectively cleaned.
Department of Justice Investigates Olympus
In May 2015, the U.S. Department of Justice issued a subpoena to Olympus related to its marketing and sale of duodenoscopes. The federal department’s investigation into Olympus was followed by two subpoenas being issued to two other companies manufacturing and distributing duodenoscopes in the United States, Fujifilm and Pentax.
Rando Wick, an attorney for Virginia Mason Medical Center in Seattle, which was also issued a subpoena, said the federal officials “certainly are casting their net widely in terms of what kind of documents they’re seeking.” Wick gave some examples of requested documents including the hospital’s communications with Olympus, the FDA, the Centers for Disease Control and Prevention (CDC), and state and local health authorities, related to Olympus’ knowledge of when its duodenoscopes first became linked to a 2013 outbreak of superbug infections and how the company responded.
Other hospitals experiencing superbug outbreaks associated with duodenoscopes, including UCLA Ronald Reagan Medical Center in Los Angeles and Advocate Lutheran Hospital in Chicago, reported they had not received subpoenas.
In February 2016, Olympus entered into a deferred-prosecution agreement with the Justice Department on criminal charges of violations of the Anti-Kickback Statute (AKS). This statute is designed to prevent undue influence by medical device and drug manufacturers aiming to entice doctors to use their products over others that may be more suitable for their patients.
As a part of the pact, Olympus agreed to pay $612 million plus interest in two payments to the Department of Justice to resolve the charges. Furthermore, the company was required to accept the department’s publicized statements of fact regarding its “criminal conduct,” as well as take several corrective steps to prevent future wrongdoing.
Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.