Feds widening probe of deadly bacteria outbreaks tied to medical scopes

WASHINGTON — The Justice Department is seeking thousands of page of documents in an investigation that has entangled all three manufacturers of a specialized medical scope tied to a deadly series of superbug outbreaks at hospitals across the country.

The three manufacturers of duodenoscopes — Olympus, Pentax and FujiFilm — all received subpoenas in recent weeks as part of the probe, according to two sources who are familiar with the investigation and spoke on condition of anonymity because they were not authorized to discuss it.

A subpoena also was delivered to Virginia Mason Hospital in Seattle, which suffered one of the largest and deadliest outbreaks of antibiotic-resistant bacterial infections linked to contamination in the scopes. Several other hospitals that have had similar scope-related infection problems told USA TODAY they have not been subpoenaed.

The subpoenas do not detail the precise nature of the investigation. According to the subpoena sent to Virginia Mason, it relates to health care offenses as defined in federal criminal statutes.

The supervising attorneys "certainly are casting their net widely in terms of what kind of documents they're seeking," said Rando Wick, a lawyer representing Virginia Mason in the matter. "We're talking about, literally, thousands of pages of material that they're asking for."

USA TODAY and other news outlets reported last week that Olympus had received a subpoena related to its manufacturing of duodenoscopes — a fact the company revealed in a financial disclosure. But the broader reach of the investigation, including the subpoenas to other duodenoscope manufacturers, has not been reported previously.

According to the Virginia Mason subpoena, the investigation is being run by the healthcare and government fraud unit at the U.S. attorney's office in Newark, N.J. The Justice Department would not comment or confirm the existence of the investigation.

Olympus declined to comment, as did Pentax. FujiFilm did not respond to inquiries on the matter.

The subpoenas come amid rising federal concern over the safety of duodenoscopes, which are guided down the throats of more than 650,000 U.S. patients a year, mainly to treat blockages in the bile and pancreatic ducts, such as tumors or gallstones. USA TODAY first reported in a January investigation that the scopes had been linked to superbug infections, and scores of cases have been reported at hospitals in Chicago, Los Angeles, Seattle, Pittsburgh, Hartford and other cities. Most involve CRE, an antibiotic-resistant bacteria with mortality rates of 40% or more.

Medical investigators have found that bacteria can lodge in a tiny mechanism at the tip of the duodenoscopes, even after cleaning, and pass infections from patient to patient. Last month, a Food and Drug Administration advisory panel found that the scopes cannot be cleaned effectively as currently designed, but the panel backed the FDA's decision to leave the devices in use while solutions are sought because infection risks are low and the scopes remain the safest option for critical procedures.

The contamination problems have raised questions among regulators and lawmakers about whether the scopes' manufacturers filed required reports to alert the FDA when they learned that their devices might have safety problems. USA TODAY reported in April that some of those reports weren't submitted until months after duodenoscopes were linked to superbug outbreaks — and in some cases the reports weren't filed at all.

According to Wick, the Virginia Mason subpoena seeks records related to when Olympus learned that its scopes were implicated in a 2013 outbreak of drug-resistant infections at the hospital and how the company responded to the incident.

As USA TODAY noted in April, Olympus didn't submit a medical device report to the FDA until nine months after company representatives visited the hospital in November 2013 and validated that the scopes implicated in the outbreak were being cleaned properly. In that report, Olympus said the company did not visit the hospital and had no chance to inspect the duodenoscopes that were linked to the infections — assertions that ran counter to official accounts.

The subpoena "asked for any and all communications we had with Olympus, any documents pertaining to Olympus' visit to Virginia Mason ... and any feedback we got from them," Wick said. "They want not only our communications with Olympus, but with the FDA, the Centers for Disease Control and Prevention, and state and local health authorities."

The FDA declined to comment on the investigation.

Virginia Mason is the only hospital so far to report getting a subpoena in the Justice Department's investigation. Other hospitals that have had outbreaks of duodenoscope-related infection say they have not been subpoenaed, including UCLA Medical Center in Los Angeles, Advocate Lutheran Hospital outside Chicago, and the University of Pittsburgh Medical Center.

According to FDA records released last month, the agency has received 142 reports since 2010 of infection problems with duodenoscopes, but each report can account for multiple cases in a single outbreak, so the true number of infected patients is unclear. At least 30 patients have died after contracting CRE or other antibiotic-resistant infections linked to duodenoscopes, including 11 in the Virginia Mason outbreak and another 15 in a 2008 outbreak at an unidentified hospital in Central Florida (some of those victims had other serious illnesses that also may have contributed to their deaths).

"I'm pleased that the Department of Justice is moving forward with an investigation," Sen. Patty Murray, D-Wash., said in a statement.

Murray noted that she is "deeply concerned" by news reports that Olympus may not have acted appropriately after learning that its scopes were tied to the outbreak at Virginia Mason. "Patients need to be able to trust that the devices used for their treatment are safe and effective."