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 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.

“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’s failure to follow important safety requirements is serious and warrants the significant penalties imposed as part of this resolution.”

“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. Pentax filed an MDR about the Advocate Lutheran infections in late September 2013.

In late June 2014, Pentax learned that four patients at Massachusetts General Hospital in Boston were infected with Escherichia coli bacteria after being treated with the same Pentax endoscope. Pentax also failed to file MDRs about this incident within 30 days because its employees misunderstood the reporting requirements. Pentax filed an MDR about the infections at Massachusetts General Hospital in December 2014.

“Americans expect and deserve that the medical devices used on them are safe, effective, and properly labeled with accurate information. When companies subvert FDA’s standards and requirements, they place unsuspecting patients at risk,” said Catherine A. Hermsen, Assistant Commissioner for Criminal Investigations, FDA Office of Criminal Investigations. “FDA will continue to investigate and help bring to justice companies that jeopardize the public health by distributing misbranded products.”

As part of the DPA, Pentax has agreed to, among other actions, conduct a thorough audit of its current instructions for use for endoscopic devices and MDR procedures to determine their compliance with FDA requirements and report to the FDA in writing. It has agreed to enhance its compliance training and maintain an effective compliance program. Pentax’s president and the president of the Lifecare Division of Pentax’s parent, Hoya Corporation, must annually certify that Pentax took the compliance measures required by the DPA, and Hoya’s board of directors must certify annually that Pentax’s compliance program is effective.

The investigation was conducted by special agents from the FDA’s Office of Criminal Investigations, under the direction of Special Agent in Charge Jeffrey J. Ebersole of the New York Field Office, along with special agents of the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert.

The government is represented by Assistant U.S. Attorney R. David Walk Jr. of the U.S. Attorney’s Office for the District of New Jersey and Senior Litigation Counsel Patrick Jasperse of the Civil Division’s Consumer Protection Branch, with the assistance of Senior Counsel Shannon M. Singleton of the FDA’s Office of Chief Counsel.

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of New Jersey, visit its website at https://www.justice.gov/usao-nj.