The U.S. Department of Justice announced on December 10, 2018 that Olympus Medical Systems Corporation (“Olympus”), and a former senior executive in Japan, have pled guilty to failing to file required adverse event reports involving infections connected to its duodenoscopes, and to continuing to sell the duodenoscopes in the United States despite those failures. Olympus pleaded guilty to three counts and the former senior executive pleaded guilty to one count of distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
The FDCA requires manufacturers to file initial adverse event reports known as Medical Device Reports (MDRs) when a manufacturer becomes aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury. The FDCA also requires manufacturers to file supplemental MDRs if they subsequently obtain information about the event that was not known or available when the initial MDR was filed.
Olympus had received a report in the summer of 2012 that was prepared by an independent expert of Delft University of Technology in the Netherlands that noted numerous problems with Olympus’s TJF-Q180V duodenoscope (Q180V), including that the Q180V’s tip had various cracks, corners, and crevices that could harbor bacteria and could be cleaned only with great difficulty. The report recommended immediate further investigation of all such scopes, updating the cleaning instructions, and improving the quality of the seals.
Olympus admitted that it failed to file with the Food and Drug Administration (FDA) required adverse event reports in 2012 and 2013 relating to three separate events involving infections in Europe connected to the Q180V: the infection of approximately 22 patients with Pseudomonas aeruginosa at the Erasmus Medical Center in the Netherlands in early 2012; the infection of three patients with Escherichia coli at Clinique de Bercy in France in November 2012; and, the infection of five patients with Pseudomonas aeruginosa at Kremlin Bicetre in France in July 2012.
Olympus admitted that it failed to file MDRs regarding the Kremlin Bicetre infections, and failed to file required supplemental MDRs relating to the Erasmus Medical Center and Clinique de Bercy infections, for which Olympus had filed initial MDRs.
At the time the guilty pleas were entered, the federal judge fined Olympus $80 million and ordered $5 million in criminal forfeiture. Olympus further agreed to enact extensive compliance reforms.
Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce. Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit. Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes.
If you or a family member suffered a serious infection following a procedure using a duodenoscope, you should promptly consult with a local medical malpractice lawyer in your U.S. state who may investigate your possible duodenoscope claim for you and represent you or your family member in a claim for compensation due to the injuries suffered following the endoscopic procedure.
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