An influx of cases against manufacturers of duodenoscopes have entered the District Court of Central California after a number of patients at the UCLA Ronald Reagan Medical Center contracted serious, and often deadly infections from the use of duodenoscopes. Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat, and stomach into the top of the small intestine. They are used during endoscopic retrograde cholangiopancreatography (or ERCP) procedures. This is a process where doctors see inside the stomach and intestines and inject radiographic contrast in order to treat conditions of the bile duct and pancreatic duct. Consequently, the main manufacturers of these duodenoscopes implicated in the lawsuits are Olympus Corp., Pentax, and FujiFilm.
Nearly 500,000 ERCP procedures are performed in the United States each year. Because of the difficulty in cleaning all of the small and complex parts of the duodenoscope tube, patient-to-patient infection has spread even in cases where sterilization instructions provided by the manufacturers were strictly followed. Following the outbreak at UCLA, the FDA issued an emergency warning to healthcare providers emphasizing the importance of sterilization procedures. As well as the possibility that the manufacturer’s instructions may not be sufficient to avoid infections. In May 2015, the FDA organized an advisory panel. They also added precautions such as regular bacteria cultures of certain parts of duodenoscopes as part of the sterilization process.
Many of the patients that contracted the infections that led to the FDA’s re-evaluation of the duodenoscope sterilization procedures have turned to the courtroom in an effort to be compensated for the harm done to them. The first case that was filed in the Central District of California was filed by a father on behalf of his deceased son. (Jeffrey John Hughes et al. v. Olympus America, Inc. et al., CV No. 15-02103 BRO (JCx).). The complaint in Hughes listed causes of action for products liability, negligence, fraud – intentional misrepresentation, fraud – negligent misrepresentation, survival action, and also wrongful death. The defendants are Olympus America, the manufacturer of the TJF-Q180V Duodenoscope that was used by doctors at UCLA hospital. Furthermore, the complaint stated that Olympus failed to provide an effective and validated reprocessing protocol for this scope. Instead providing the cleaning protocol for an older endoscope design it once manufactured.
After the Hughes case was filed, seven other similar cases were filed in the Superior Court of California, County of Los Angeles. The plaintiffs in these cases each brought state law tort claims for products liability, negligence, intentional and negligent misrepresentation, and in some cases, survival actions and wrongful death claims. After originally being removed to the Central District Court to join the Hughes case, six of the plaintiffs filed motions to remand their cases back to the Superioir Court. (Young v. Olympus America; Leo Palomino v. Olympus America; Estate of Silvia Patricia Aroche et al v. Olympus America; Estate of Antonia Cerda et al v. Olympus America; Estate of Mehrangiz Bohaderi et al v. Olympus America; Domingo Gomez v. Olympus America).
In June, 2015, the Central District of California granted these plaintiffs’ motions to remand. Then they also removed these six cases back to the Superior Court of LA County. However, as the FDA continues to study the effectiveness of different sterilization methods, more lawsuits from many different states continue to arise against Olympus, Pentax, and FujiFilm.