Olympus Medical Systems Corporation Failed to Report Adverse Events Leading to Settlements
Olympus Medical Systems Corporations has entered a guilty plea after it was caught introducing devices into interstate commerce despite the fact that they were misbranded, and the company failed to file “Medical Device Reports” (MDR) after they were informed of the product causing severe infections in patients.
The device in question is the Q180V duodenoscope. Olympus entered a guilty plea in response to the charges and as part of the plea agreement, will be paying fines amounting to $80 million, and criminal forfeiture expenses of $5 million. The company must also enact a number of compliance reforms.
The company’s quality manager, Hisao Yabe, also pleaded guilty and is being fined $100,000 and could be sentenced to a maximum of one year in prison.
A duodenum is a part of the small intestine. This part of the body works to digest food by breaking it down through the use of enzymes. A duodenoscope is used to visually examine the duodenum by passing along and flexible endoscope through a patient’s mouth and down into the duodenum. The equipment uses a camera and a light and a forceps elevator. The device can be reused, but the cleaning of the device is critical. The product’s manufacturer provides cleaning guidelines that must be followed in order to remove anything infectious from the product prior to reusing it with another person.
The Centers for Disease Control and Prevention (CDC) warned the Food and Drug Administration of the possibility of these devices passing along drug-resistant bacteria. The alert was made in 2013. An FDA investigation indicated that the product was causing such infections even after the required sterilization procedures were met.
Olympus is a major manufacturer of these devices, and during the study period, the company manufactured 85 percent of the devices that were sold on the market.
According to the case against the company, Olympus failed to file supplemental MDRs when 22 patients developed infections in the Netherlands’ Erasmus Medical Center. An expert report indicated that the directions for cleaning the device and the processing instructions provided by Olympus were inadequate. Another 8 patients were infected in two clinics in France, and Olympus failed to file supplemental MDRs in those cases as well.
Olympus will not be subject to strict regulatory oversight in addition to the fines that the company will be required to pay.
The FDA and the DOJ are Aggressive When Enforcing Safety Measure
Criminal resolutions are rare in cases where companies neglect to file required adverse event reports. However, the actions taken by the government are consistent with the policy to the FDA and the Department of Justice (DOJ), which are to enforce regulations when patients’ safety is at stake aggressively.
The DOJ is most concerned with “consumer harm, the threat of harm and fraud,” when they look into investigating a company or bringing about an indictment. The DOJ does not concern itself with matters that do not involve any harm or fraud, but merely “one-off technical, regulatory violations.”
When the public’s attention is brought to an issue of medical device quality and safety, the chances of the government pursuing a criminal solution are greater.
Companies that violate the FDA’s regulations are placing themselves at risk of being found legally liable and even criminally liable for their actions. The United States government believes that patients and medical providers should have confidence in the quality of the products manufactured for medical use.
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