Pentax Medical Company Agrees to Pay $43 Million to Resolve Criminal Investigation Concerning Misbranded Endoscopes
Company Shipped Medical Devices Without Approved Instructions for Use and Failed to File FDA-Required Adverse Event Reports of Serious Infections
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, the Department of Justice announced today.
Pentax was charged in a criminal complaint filed today 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. 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.
-“In carrying out its responsibilities to protect the health and safety of patients treated with medical devices, the FDA relies on manufacturers to provide health care professionals with the correct, approved or cleared instructions for safe use of the devices, and to report promptly to the FDA potential product safety issues,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division.
-“Pentax made a decision to ignore the cleared instructions for use of its endoscopes, believing that doing so would increase its sales, putting profits over patient safety,” said U.S. Attorney Craig Carpenito for the District of New Jersey. “In doing so, and by failing to report to the FDA certain adverse events relating to those endoscopes, it broke the law, jeopardized the health of patients, and, ultimately, cost itself $43 million on fines and forfeiture.”
-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.
-Pentax was also charged with and admitted failing to file timely reports of two infection incidents associated with its endoscope. To enable FDA and others to identify and monitor adverse events, the FDCA requires medical device manufacturers to file adverse event reports – known as Medical Device Reports (MDRs) – within 30 days of becoming aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury.
-In June 2013, Pentax learned that four patients at Advocate Lutheran General Hospital in Chicago were infected with drug-resistant bacteria after being treated with the same Pentax endoscope. Pentax failed to file MDRs within 30 days because its employees did not understand the reporting requirements.
-In late June 2014, Pentax learned that four patients at Massachusetts General Hospital in Boston were infected with Escherichia coli bacteria
This seems like a sneaky way to infect a lot more people. I checked the Parent company named HOYA in Japan
https://www.justice.gov/opa/pr/pentax-medical-company-agrees-pay-43-million-resolve-criminal-investigation-concerning