Tangle of Claims From Hospital Deaths

SEATTLE (CN) - The maker of a medical scope accused of transmitting "superbug" infections due to a design defect countersued a Seattle hospital, claiming its employees failed to properly clean the device.

Olympus America is facing numerous lawsuits and a Justice Department investigation over its duodenoscopes, used for pancreatic and bile duct treatments. The Food and Drug Administration believes the scopes are linked to drug-resistant bacterial infections.

Washington resident Theresa Bigler sued Olympus and Virginia Mason Medical Center in March after her husband died from an infection.

The hospital filed a cross claim against Olympus in May, but the hospital is still named as a defendant in Bigler's lawsuit.

Virginia Mason Medical Center claims Olympus gave inadequate instructions for cleaning the scopes and did not tell the hospital about previous infections associated with the device.

"Deceptively, Olympus America did not disclose to VMMC that its instructions for cleaning its duodenoscopes were inadequate, ineffective, and had resulted in severe infections," the hospital says in its May 15 answer and cross claim in King County Court.

"Without knowledge that the T JF-Q180 duodenoscopes were not reasonably safe as designed, and without knowledge that the instructions for cleaning the scopes were inadequate, ineffective, and had resulted in severe infections, VMMC allowed the Olympus duodenoscopes to be used in procedures on its patients and to be cleaned according to Olympus America's instructions," the claim states.

Olympus said in a statement: "The Olympus TJF-Q180V requires careful attention to cleaning and reprocessing steps, including meticulous manual cleaning."

Olympus filed its own cross claim against Virginia Mason on Monday, accusing the hospital of libel and slander, contributory fault and negligence, for failing to properly clean the scopes.

"VMMC negligently failed to follow the instructions, training, and warnings for the use and reprocessing of the TJF-Q180V duodenoscope," the countersuit states.

Olympus also claims Virginia Mason's "malicious publications" damaged its business reputation.

Virginia Mason said in a statement that it has implemented a new process for cleaning the scopes, "after determining that adhering to the device manufacturer's guidelines did not ensure a reliable cleaning process in every case."

"In addition to following the manufacturer's guidelines for manual cleaning, Virginia Mason also tests each scope for harmful bacteria and places every scope in quarantine for 48 hours. The scopes are used in medical procedures only after culturing indicates there is no harmful bacteria on the instruments," the hospital said in the statement.

Lawsuits have been filed in California, Washington and Connecticut alleging infections caused by the scopes.

An FDA advisory panel concluded in May that such scopes "do not provide a reasonable assurance of safety and effectiveness ," but unanimously agreed that use of the scopes should continue because the benefits outweigh the risks.

The panel did not specifically name Olympus or two other manufacturers of the scopes.

In 2013, Olympus warned hospitals in Europe about the infection risks associated with scopes, but failed to pass on the warning to U.S. hospitals until February of this year, according to the Los Angeles Times.

The Justice Department is investigating Olympus for possible violations of anti-kickback and false claims laws in connection with the scopes, according to The Wall Street Journal.

In her March 2 complaint in King County Court, Theresa Bigler says her 57-year-old husband died of a bacterial infection 2 weeks after undergoing endoscopic retrograde cholangiopancreatography with the Olympus scope at VMMC.

"For several years, Olympus America had known that its instructions for cleaning its duedenoscopes were ineffective and had resulted in severe infections and death," she says in the complaint. "On information and belief, this instruction was not disclosed to VMMC and other medical centers."

Bigler says she called VMMC after reading a January 2015 article in the Seattle Times that said 11 people had died from such infections at VMMC, and 32 people had been infected.

She says she called the hospital, "which confirmed that Mr. Bigler likely died due to an infection from a contaminated duodenoscope. She was told he was one of the 11 deaths mentioned in the Seattle Times article."

She adds: "Upon information and belief, VMMC still has not notified the approximately 31 other patients exposed to and infected by contaminated Olympus duodenoscopes." Nor had the hospital reported the "adverse health events" to the state by Dec. 31, 2014, as required, Bigler says in the complaint.

She seeks punitive damages for wrongful death and loss of consortium. She is represented by Joel Cunningham with the Luvera Law Firm.

Olympus's lead counsel in its counterclaim is Katherine Heaton, with DLA Piper's Seattle office.

VMMC's lead counsel in its counterclaim is Rando Berry Wick, with Johnson, Graffe, Keay, Moniz & Wick, also of Seattle.

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