Pentax Medical Company will pay $43 million to resolve criminal charges based on the company’s shipment of four types of endoscopes for 18 months without FDA-cleared instructions for use and the company’s failure to file timely reports of two infections associated with its endoscopes. Pentax was charged in a criminal complaint filed in Newark federal court with distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Pentax has entered into a three-year deferred prosecution agreement (DPA) that will allow it to avoid conviction if it complies with the reform and enhanced compliance requirements outlined in the agreement. As a result of the conduct outlined in the criminal complaint, Pentax has agreed to pay a $40 million criminal fine and to forfeit $3 million. The criminal complaint against Pentax, which Pentax agrees is true, charges that Pentax made a deliberate business decision not to use revised FDA-cleared instructions for cleaning its endoscopes because Pentax feared the new instructions would cause it to lose business. Endoscopes are reusable devices that must be cleaned after each use or else infectious material may remain and be transmitted to subsequent patients. In 2014, the FDA told Pentax to revise its existing cleaning instructions for four types of endoscopes and add cleaning steps. Pentax agreed, and FDA cleared, revised cleaning instructions in April 2014. Pentax was then required to include these revised cleaning instructions when it shipped those four endoscopes.
Instead, for the next 18 months, Pentax shipped the four types of endoscopes with the old instructions for use — not the newly enhanced, FDA-cleared cleaning instructions. Pentax decided not to use the enhanced cleaning instructions because they required customers to spend more time cleaning the endoscopes. One internal email warned that the increase of cleaning time from five minutes to 25 minutes would be “catastrophic,” and another predicted that customers “will be very upset and could switch away from PENTAX because of the extra time, manpower, and cost to perform the new protocol.” Pentax continued shipping the four types of endoscopes without the FDA-cleared cleaning instructions until September 2015. At that time, Pentax started including FDA-cleared instructions for two of the endoscopes and newly validated cleaning instructions for the other two types of endoscopes. Pentax made $18 million in gross profits from selling the four types endoscopes during this 18-month period.
