Lawsuit blames contaminated medical scope for superbug death at Charlotte hospital

The widow of a Statesville man who contracted a fatal infection during a routine medical procedure at Carolinas Medical Center has sued the makers of the diagnostic instrument used and the machine designed to clean it.

Olympus America Inc. and Custom Ultrasonics Inc. already are at the center of a nationwide scare over the safety and reliability of so-called medical scopes.

Now, a federal lawsuit by Carla Warner of Statesville holds the companies liable for the death of her husband, Willie.

The complaint, which was filed Friday in Pennsylvania where the companies are headquartered, accuses the pair of fraud, negligence and breach of warranty. The suit also names Olympus Medical Systems Corp. of Tokyo as a defendant. CMC is not being sued. The complaint calls for compensatory and punitive damages.

Warner died two years ago next week. The suit alleges he was struck down by a virulent “superbug” infection after undergoing a diagnostic procedure at a CMC facility in Charlotte. The checkup involved an instrument known as a duodenoscope that was inserted in Warner’s throat. The instrument is used to check the stomach and other organs, and it can drain internal fluids when needed. Olympus made the device used on Warner, the suit says. Custom Ultrasonics designed and built the machine that was supposed to decontaminate the duodenoscope and keep it safe for patients.

Olympus’ duodenoscope, however, had a design flaw that allowed biological debris to stow away in its chambers, the suit says.

Earlier this month, the Federal Drug Administration criticized Custom’s cleaning device, saying it “had not demonstrated that (it) can adequately wash and disinfect ... to mitigate the risk of patient infections.” The agency ordered a nationwide recall of almost 3,000 of the devices used at more than 1,000 hospitals nationwide.

Last February, the FDA put out a similar warning about the Olympus scope after 179 patients who were treated with it at the UCLA medical center were exposed to potentially lethal drug-resistant bacteria. The lawsuit claims that the company’s medical devices have been linked to health problems and medical warnings in this country and abroad going back as far as three decades.

A bacteria similar to the one that killed Warren claimed the lives of 10 patients in Minnesota in 1987, the suit claims.

The lawsuit alleges that a design change made cleaning the scopes more difficult and increased the likelihood of contamination, and that Olympus put the change in place without getting FDA approval.

Outbreaks of superbug infections linked to contaminated scopes have been reported recently in hospitals across the country, including some in Los Angeles, Seattle, Pittsburgh and near Chicago.

According to Warner’s lawsuit, her husband’s death is tied to a Jan. 11, 2013 CMC procedure using an Olympus scope. Warner, a 55-year-old truck driver, “suffered horribly” from the resulting infection for more than eight months, the lawsuit says. “He endured excruciating pain, lost 60 pounds, was repeatedly hospitalized ... and suffered delirium and oxygen deprivation.”

Because the infection was contagious, Warner also was cut off from his family and friends, the suit says.

Olympus, the industry leader in the production of medical scopes, could not be reached for comment. According to an earlier story in the Los Angeles Times, a company spokesman said Olympus was cooperating with at least one of the hospitals where infections had occurred. The company denied an FDA allegation that it withheld information from the government about 16 patient infections that occurred three years ago.

Company officials with Custom Ultrasonics were not immediately available for comment.

This story was originally published November 20, 2015 at 6:14 PM with the headline "Lawsuit blames contaminated medical scope for superbug death at Charlotte hospital."