Law360, Los Angeles (May 8, 2019, 10:08 PM EDT) -- A California judge denied Olympus America Inc.’s bid Wednesday to escape claims that a defective medical scope caused a patient to contract an antibiotic-resistant “superbug," rejecting its argument that the patient must show the device was properly cleaned yet still carried the bug.
At a short hearing in downtown Los Angeles, Superior Court Judge Daniel J. Buckley wasn’t convinced by Olympus’ counsel, Samuel L. Tarry Jr. of
McGuireWoods LLP, who argued plaintiff Aaron Young hasn’t provided evidence that the scope — a flexible, lighted tube — wasn’t properly cleaned according to the device's instructions before his procedure.
The judge told Tarry the burden is on Olympus to prove it’s not liable for the allegedly defective scope, rejecting his motion for summary judgment.
In Young's suit filed in February 2015, he claimed the endoscope Olympus designed and sold to UCLA has crevices and moving parts that are difficult or impossible to reach with a brush, making effective cleaning of the devices difficult. He said Olympus knew it was possible that fluids from one patient could get stuck in the scope and that another patient could be exposed to those fluids.
Olympus “completely redesigned” the TJF-Q180V duodenoscope in 2014, expanding the range of positions in which the device’s guide wire can be locked, according to Young’s suit, but didn’t reevaluate the cleaning and safety processes for the scope after the redesign.
Tarry said Wednesday that the real issue is whether the scope remained dirty after an improper cleaning when it was used in Young’s procedure, allowing it to then possibly pass on the superbug. He said Young has not provided any evidence this was the case.
But the judge again said that is not the point and that it's Olympus’ burden to show they are not liable for a defect in the scope that may have contributed to the superbug being passed to Young.
“We’re like two ships passing in the night,” Judge Buckley said.
With that, the judge denied Olympus’ motion.
Young’s lawsuit was consolidated in August 2016 with several other suits making the same allegations.
Last month, the U.S. Food and Drug Administration said three patient deaths in 2018 were related to contaminated medical scopes and that the contamination rate in duodenoscopes for serious infections like E. coli is nearly twice as high as previously thought.
Last March, the FDA accused Olympus, Fujifilm Medical Systems USA Inc. and Pentax of America Inc., all manufacturers of duodenoscopes implicated in a major outbreak of “superbug” infections, of flouting commitments to study the safety of their scopes.
The duodenoscopes were linked in 2015 to serious bacterial infections because they are reused and difficult to sterilize. The FDA ordered the companies to carry out studies to assess how they are used in the real world to learn about issues that lead to contamination and whether medical staff are following decontamination instructions.
In December, the FDA said preliminary findings from those studies indicated a 3% contamination for “high-concern” organisms. But on April 12, the FDA said in an update that interim results showed up to 5.4% of collected samples tested positive for bacteria associated with serious infections.
At the end of last year, Olympus and one of its former executives pled guilty in New Jersey federal court to distributing medical scopes in the U.S. without disclosing known risks of infection, which will cost the company $85 million in fines and forfeitures.
Olympus admitted that it knew about the existence of a report concluding there were various cracks and crevices in the device that could harbor bacteria and were difficult to clean, and that these design flaws were connected to infections in hospitals in the Netherlands and France in 2012 and 2013, but that it failed to make the U.S. Food and Drug Administration aware of this report.
Young's attorney, Peter L. Kaufman of Panish Shea & Boyle LLP, told Law360 over the phone Wednesday that he and his client are excited to get the case in front of a jury next year.
"Aaron Young and his lawyers are pleased that the judge saw through what was a pretty ill-considered swipe at this case," Kaufman said.
A representative for Olympus did not immediately respond to a request for comment.