Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks

Federal prosecutors investigate company’s inaction

Faced with superbug outbreaks in three countries by early 2013, Japanese device giant Olympus Corp. told its U.S. executives not to issue a broad warning to American hospitals about potentially deadly infections from tainted medical scopes, recently released internal emails show.

After two dozen infections were reported in French and Dutch hospitals, the company alerted European customers in January 2013 that a scope it manufactured could become contaminated.

A top Olympus executive in the U.S. grew concerned because the company was investigating a similar outbreak at a Pittsburgh hospital, according to an article posted on the Kaiser Health News website.

“Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?” Laura Storms, vice president of regulatory and clinical affairs in Center Valley, Pennsylvania, asked in an email to Tokyo headquarters on January 31, 2013.

“No, that’s not necessary,” said Susumu Nishina, the company’s chief manager for market quality administration in Tokyo in a February 6, 2013, reply. It is “not need[ed] to communicate to all the users actively,” Nishina wrote, because a company assessment of the risk to patients found it to be “acceptable.” However, he added that Storms should respond to questions from a customer.

Outbreaks of infection at hospitals in Los Angeles, Milwaukee, Denver, and other cities followed over the next three years. In total, at least 35 people at U.S. hospitals have died since 2013 after developing infections from contaminated gastrointestinal (GI) scopes manufactured by Olympus, according to hospitals and public health officials.

Olympus’ actions—and inaction—are being examined in lawsuits by American patients and their families who contend that the manufacturer was negligent and might have prevented the outbreaks and deaths had it been more forthcoming. In addition, federal prosecutors are investigating Olympus’ handling of the infections—and the emails could become crucial evidence in a future case.

The company’s internal emails, filed in a Pennsylvania court this month as part of a patient’s lawsuit, reveal conflicts inside Olympus over how to respond to a growing threat to patient safety, pitting U.S. executives against their superiors in Japan who had the final say.

Olympus, which controls 85% of the U.S. market for GI scopes, declined to comment on the emails, citing the pending litigation. It also declined to discuss the ongoing investigation by the U.S. attorney’s office in New Jersey.

In a statement, the company said “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.” The company declined to address why it didn’t feel it was necessary to inform U.S. hospitals when it was alerting those in Europe.

As reported by the Los Angeles Times in December 2015, an investigator hired by Olympus and a Netherlands hospital concluded in a June 2012 report that the scope’s design could allow blood and tissue to become trapped, spreading bacteria from one patient to another. The independent expert called on Olympus to conduct a worldwide investigation and to recall all of its scopes if similar problems turned up.

A Senate report released this year said Olympus knew about at least three outbreaks—at hospitals in the Netherlands, France, and Pittsburgh—affecting an estimated 46 patients when the European alert went out in early 2013.

Sources: Kaiser Health News; July 24, 2016; and Olympus Emails; September 2013.