Bring An Equalizer to the Fight. Choose a Firm That Was Created to Advocate for Victims.

FDA Seeking to Shut Down Medical Device Company Over Patient Infections

Federal regulators are working to shut down a medical device company that produced ultrasound, mammography, and electrocardiogram gels that have been tied to at least 16 infections.

Working with the Department of Justice, the U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Pharmaceutical Innovations Inc. and its principal officer, Gilbert Buchalter. The court order will prohibit them from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.

According to the FDA’s complaint, its inspections at Pharmaceutical Innovations’ New Jersey facility identified numerous and repeated deviations from the manufacturing practices required under the Federal Food, Drug, and Cosmetic Act. The company also allegedly failed to obtain required FDA approval or clearance for several new ultrasound gels it has brought into the market.

Most concerning, 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 notify the FDA after becoming aware of these infections, as required by law. Subsequent FDA testing on gel samples revealed significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca. The bacteria pose serious risks of infection, such as pneumonia.

“Patients should be able to have confidence that the health-care products they use are safe,” U.S. Attorney Paul Fishman said in a statement. “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.”