New York, New York

HomeNew YorkNew York

Email Kendra Goldhirsch
Kendra Goldhirsch
Kendra Goldhirsch
Attorney • (888) 480-1123

New Report Indicates Olympus Withheld Important Scope Safety Information

Comments Off

The FDA announced a recall of the Olympus TJF-Q180V duodenoscope on January 15, 2016. The medical and surgical products company stated that it was recalling the product to update it with a new design and labeling modifications meant to reduce the risk of superbug infections in patients.

For many, the recall was too little too late. Critics stated that Olympus was aware of issues related to their duodenoscope that increased risk of infection as early as 2012. In 2016, the U.S. Health, Education, Labor and Pensions Committee released a report on duodenoscope-related superbug infections, finding that these medical devices were linked to at least 250 case of antibiotic-resistant infections worldwide.

Now, The Los Angeles Times, in conjunction with Kaiser Health News, has released a new report revealing that executives at Olympus America expressed concern over these types of infections in 2013, but were told by Japanese headquarters not to warn American hospitals about the potential for tainted medical scopes to spread potentially deadly infections.

Olympus Advises U.S. Executives Not to Warn Users of Infection Risk

As a number of plaintiffs seek compensation from Olympus in court cases across the country, Olympus was required to disclose internal company emails as evidence in the litigation. These emails were disclosed in a Pennsylvania court in July 2016.

The LA Times reveals the content of some of these emails, which show internal conflicts within the company over how to respond to the growing threat to patient safety. In January 2013, about 24 superbug infections were reported in French and Dutch hospitals. In Europe, Olympus sent out alerts informing healthcare professionals that contaminated scopes could spread dangerous bacteria from patient to patient. These scopes are usually thoroughly cleaned between uses, but because of design flaws, some of the bacteria can remain in the scope, where it can then infect the next patient.

After the safety warning was issued in Europe, executives at Olympus here in the U.S. asked if they should be warning their users of the risk of contamination and infection. In a February 2013 reply, Olympus headquarters in Tokyo responded that it was not necessary.

Why Safety Alerts in Europe Only?

Over the next three years, several U.S. hospitals and medical centers reported outbreaks of serious antibiotic-resistant infections. These included hospitals in Los Angeles, Milwaukee, Denver, and other cities. Three people died at UCLA’s Ronald Reagan Medical Center of infections related to contaminated Olympus scopes.

Employees at Olympus in the U.S. were concerned. Before the exchange with Tokyo headquarters, a director of regulatory affairs for Olympus in California sent an email to top executives with the subject line reading, “Duodenoscope safety recall?” He mentioned the problems going on in Europe, as well as lab results showing Olympus scopes tested positive for bacteria at the University of Pittsburgh Medical Center, and asked why a safety alert was issued only in Europe and not the U.S.

Later, that director was informed that Olympus Japan had determined that a global warning wasn’t necessary. Executives continued to question what was going on and according to internal emails, asked not only why headquarters were handling things as they were, but why they had determined that the staff at the University of Pittsburgh Medical Center—who had also linked contaminated scopes to patient illnesses—had failed to properly clean the scopes. What evidence supported this conclusion?

Headquarters responded that the cleaning instructions, when followed, worked, and “no major observations were noted during the inspection” of the scope believed to have transferred the infection. Olympus continued to blame hospitals and medical centers for improper cleaning in many subsequent cases of infection outbreaks.

The FDA started looking into the issue in 2013, and requested additional information in May 2014. It wasn’t until 2015, however, that the FDA issued a safety alert noting that patients had become infected with Olympus scopes even when they were cleaned properly.

Olympus didn’t announce a recall of the suspected scope until January 2016.