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The Department of Justice announced today that the department, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the District of New Jersey against Pharmaceutical Innovations Inc. and Gilbert Buchalter, who is the company’s founder, owner, and chairman of the board.
According to the complaint, the defendants violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing adulterated and misbranded medical devices. The devices at issue are gels that hospitals and other caregivers use to take ultrasound scans. Under the FDCA, a device manufacturer must: comply with current good manufacturing practice requirements; obtain required premarket approval or clearance before distributing its devices and notify the FDA and follow-up on any reports of serious injuries or deaths associated with its devices. The government alleges that the company violated each of these requirements.
“This action furthers the FDA’s mission of ensuring that all medical devices sold to hospitals and other caregivers are produced in conformance with current good manufacturing practice requirements,” said Acting Assistant Attorney General for the Civil Division Joyce R. Branda. “Device manufacturers who undermine this mission will be held accountable.”
“Patients should be able to have confidence that the healthcare products they use are safe,” said U.S. Attorney Paul J. Fishman for the District of New Jersey. “Actions like the one we are taking here reinforce the law that manufacturers adhere to strict approval and production requirements. We are committed to stopping those who don’t.”
The complaint alleges that FDA inspections at Pharmaceutical Innovations’ Newark, New Jersey, facility have identified numerous and repeated deviations from current good manufacturing practices, including that the company has failed to show that it: validated its dry heat sterilization and dry heat treatment processes; routinely monitors its water systems to ensure that the water is suitable for manufacturing medical devices and routinely sanitizes the tubing and connections of its water systems to ensure objectionable microorganisms do not reside in the inner piping surface. The complaint further alleges that Pharmaceutical Innovations has not sought FDA approval or clearance for the new ultrasound gels it has brought into the market. As a result, according to the complaint, the defendants’ products are adulterated and misbranded devices under the FDCA.
The complaint alleges that, in February 2012, a Michigan hospital reported that it had traced infections among 16 surgical patients to a specific gel made by Pharmaceutical Innovations. However, the company failed to submit a medical device report to the FDA after becoming aware of these infections as required by law. FDA testing on samples of that gel identified bacterial contamination. The relevant lots of Pharmaceutical Innovations’ ultrasound gel were seized by the U.S. Marshals Service, following a seizure lawsuit filed by the United States.
The complaint alleges that, despite numerous warnings from FDA, the defendants have failed to bring their operations into compliance with the law. The Justice Department will seek a permanent injunction requiring the defendants to cease manufacturing, processing, packing, labeling, holding and distributing devices until they comply with the FDCA and applicable FDA regulations.
The FDA referred this matter to the Justice Department. The Consumer Protection Branch of the Civil Division filed this case on behalf of the United States.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.