Justice Department Investigates Scope Maker Olympus Over Superbug Outbreaks

LOS ANGELES (Los Angeles Times/TNS) -

The Justice Department is investigating embattled scope maker Olympus Corp. in connection with recent superbug outbreaks at U.S. hospitals.

The Japanese company said it received a subpoena in March from federal investigators that “seeks information relating to duodenoscopes that Olympus manufactures and sells.”

The company disclosed the inquiry in a financial filing last month.

Officials at Olympus and the Justice Department couldn’t immediately be reached for further comment.

The Justice Department investigation into Olympus adds to other inquiries from federal lawmakers and a growing number of lawsuits filed by infected patients and their families accusing the company of negligence and fraud.

Critics say Olympus was aware of design flaws in its duodenoscope that allow deadly bacteria to become trapped at the tip of the device. Those germs are difficult to remove even when following the manufacturer’s cleaning instructions and can be spread to new patients.

Olympus learned of this problem in Europe and issued a safety alert to customers there in January 2013.

But the company didn’t issue a similar warning in the U.S. until Feb. 19 — the day after the Los Angeles Times reported that 179 patients at Ronald Reagan UCLA Medical Center may have been exposed to the deadly CRE bacteria from Olympus scopes.

The company’s response to these problems and what steps it took to address them are expected to draw heavy scrutiny, experts say.

“Who knew what and when did they know it about these risks?” said Lawrence Muscarella, a hospital safety consultant in Montgomeryville, Pa. “We don’t know how wide the Justice Department is casting its net.”

Federal health officials have said Olympus scopes were used in six of nine reported outbreaks at U.S. hospitals. Two other firms, Pentax Medical and Fujifilm, also make duodenoscopes.

A spokesman for Pentax said it wouldn’t confirm or deny “the existence of governmental inquiries.”

Olympus is the dominant maker of specialty endoscopes in the U.S., controlling an estimated 85 percent of the market.

In the UCLA outbreak, eight patients were infected, including three who died. In March, Cedars-Sinai in Los Angeles reported that four patients were sickened and 67 others may have been exposed from tainted Olympus scopes.

The Food and Drug Administration held a two-day hearing last month on these infection risks and all three scope manufacturers declined to participate.

The duodenoscopes are used to perform a procedure called endoscopic retrograde cholangiopancreatography, or ERCP, in which doctors thread the thin device down the patient’s throat to examine and treat conditions including cancer, gallstones and other issues in the digestive system.

FDA officials have said patients should continue to have access to these scopes because they are used in a potentially life-saving procedure with no better alternative. Nearly 700,000 ERCP procedures are done annually.

Before this latest subpoena, Olympus was already facing a separate Justice Department investigation into allegations of improper marketing to doctors and other customers.

The company has said previously that investigators were looking at its U.S. sales activities from 2006 to 2011. It is not clear what products may be involved.

Olympus announced last month that it has set aside about $450 million for an expected settlement of that investigation.