Olympus under fire: Internal emails reveal US execs told not to issue warning about possible fatal scope infection — 10 takeaways
Olympus' internal emails reveal the company told U.S. executives not to issue a broad warning to hospitals regarding a deadly infection from tainted scopes that was later linked to numerous deaths at major hospitals, according to Kaiser Health News.
Here are 10 takeaways:
1. Olympus officials allegedly told European customers in January 2013 about a contaminated scope after French and Dutch hospitals reported two dozen infections. Laura Storms, vice president of regulatory and clinical affairs at Olympus America in Center Valley, Pa., became concerned about a similar outbreak in Pittsburgh, and asked Tokyo officials if they would be communicating the same information to U.S. customers regarding the outbreak.
2. Susumu Nishina, the company's chief manager for market quality administration, replied via email that it was not necessary "to communicate to all the users actively" because a company assessment of the infection outbreak in Europe found the risk to be acceptable.
3. Following Ms. Storm's email exchange with Mr. Nishina, Donny Shapiro, a director of regulatory affairs for Olympus in San Jose, Calif., drafted an email to Ms. Storm and seven fellow staff members with a subject titled "Duodenoscope safety recall??" In the email, Mr. Shapiro detailed issues in Europe and lab results which showed the scopes tested positive for bacteria at the University of Pittsburgh Medical Center. When asked why the alert was only issued in Europe, Ms. Storms wrote, "Donny, [Olympus Japan] has determined that a global communication is not required."
4. Ms. Storm continued to question Tokyo officials, according to KHN, asking how Olympus reached the conclusion UPMC conducted inadequate reprocessing. A Tokoyo official said UPMC did not follow Olympus' cleaning instructions and discounted the lab results. The company reportedly mirrored this type of response in other federal injury reports, claiming the medical centers did not follow instructions properly.
5. In March, emails surfaced showing Olympus increased the price of its duodenoscopes following a fatal Carbapenem-resistant Enterobacteria outbreak at UCLA's Ronald Reagan Medical Center. Three people died from the infection.
6. The company continued to sell its duodenoscopes despite discovering the outbreak in January 2015, and linking the outbreak to improperly cleaned duodenoscopes. Olympus implored the medical center to purchase more scopes at a discount and reportedly rebuked two physicians who did not buy the amount of equipment they were obligated to buy based on their contract with Olympus.
7. Since 2013, almost 35 U.S. patients have died from infections due to contaminated gastrointestinal scopes Olympus manufactured. Severe outbreaks occurred at hospitals in Milwaukee and Denver. Los Angeles-based Cedars-Sinai Medical Center reported four patients contracted CRE from contaminated duodenoscopes.
8. In 2015, the Senate released a report which found the company was aware of at least three outbreaks at hospitals in the Netherlands, France and Pittsburgh. The outbreaks impacted an estimated 46 patients, according to KHN.
9. Various patients and their families have filed lawsuits against the company, claiming Olympus' negligence led to the outbreaks and deaths. Federal prosecutors are investigating the company's actions. Investigators may use the emails in future cases against the company.
10. Olympus did not comment to KHN regarding the emails or the ongoing investigation by U.S. attorney's office in New Jersey. However, the company said in a statement, "patient safety is our top priority. The duodenoscope issue continues to receive the highest level of attention at Olympus, and we remain committed to working with the proper authorities and our stakeholders to understand and address the potential root causes."
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