The New York Times recently reported that 179 patients at the UCLA Ronald Reagan Medical Center were exposed to a potentially deadly “superbug” between October of 2014 and January of 2015. As of February 18, the infection of seven patients was confirmed. UCLA issued a press release in which it stated that the infection was a “contributing factor” in the death of two of those patients.
National news, including the NYT, Washington Post, and Chicago Tribune, rapidly mobilized to report on the deadly “superbug” — “Carbapenem-Resistant Enterobacteriaceae” (CRE). The CDC states that “some CRE bacteria have become resistant to most available antibiotics. Infections with these germs are very difficult to treat, and can be deadly—one report cites they can contribute to death in up to 50% of patients who become infected.”
It quickly became apparent that the infections were due to the use of infected (reusable) duodenoscopes manufactured by Olympus for use in endoscopic retrograde cholangiopancreatography. According to the the LA Times and Chicago Tribune, while such scopes are used in about 500,000 patients annually, they are increasingly being linked to an ever-rising death-count (including, for example, an outbreak 6 years ago in Florida that killed 15).
The LA Times reports that the FDA has been aware for more than two years that the design of Olympus’ scope may be so flawed that “it cannot be properly cleaned.” CNN reports, however, that the problem may have been known for much longer. CNN quoted the president of the American Gastroenterological Association, Dr. John Allen, as claiming that “[t]his problem has been known since at least 1987.” In response, the FDA has stated that, for most patients, the benefits of the procedure using the duodenoscope “far outweigh the risks of possible infection.”
The recent CRE outbreak has sparked a lively debate over the liability of the device manufacturers for such allegedly flawed designs. That debate has recently found a new forum as two suits have been filed against Olympus in California State Court.
The first suit, the LA Times reports, was filed by 18-year-old Aaron Young who was exposed to infected scopes in October and January. Reuters reports that Mr. Young alleges negligence and fraud because the cleaning protocols for the complex device were not updated following a recent redesign. Bloomberg reports that the complaint names Olympus and three members of its endoscopy team as defendants.
The LA Times reports that the second suit was filed by the family of now-deceased 48-year-old Antonia Torres Cerda and alleges wrongful death as well as products liability, negligence, and fraud in selling and promoting a “defective scope.” The complaint names Olympus and several members of its Endoscopy sales group as defendants.
Peter Kaufman, of Panish Shea & Boyle, the attorney representing both Young and Cerda’s family, has been quoted as saying that he expects to file four to six more cases in the next week, three of which will be wrongful death suits.
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