PENTAX Medical deferred prosecution agreement from DOJ
Davis Polk represented PENTAX Medical, a global medical device manufacturer that is a division of HOYA Group, in a criminal investigation into potential misbranding of its endoscope devices. Davis Polk secured a three year deferred prosecution agreement for the company from DOJ, which will allow PENTAX to avoid conviction if it complies with certain reform and enhanced compliance requirements. PENTAX agreed to pay $43 million to resolve the charges, which are based on the company’s shipment of certain types of endoscopes without approved instructions for use and failure to file timely FDA-required reports. The deferred prosecution agreement, secured in April 2020, does not require a monitor for our client.