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5 Shocking Medical Device Crimes—Pharmaceutical Innovations Inc.

Pharmaceutical Innovations Inc.

Pharmaceutical Innovations Inc.

In July 2016, Pharmaceutical Innovations Inc. of Newark, NJ, pleaded guilty to criminal charges around its distribution of ultrasound gel contaminated with bacteria, according to a U.S. Department of Justice press release

According to court documents and statements, 16 surgical patients at a Michigan hospital were reported in February 2012 to be infected with the bacteria Pseudomonas aeruginosa. That hospital believed these patients' infections were linked to a specific lot of the company's ultrasound gel. A sample from that lot did test positive for the bacteria. Another lot shipped in April 2012 was determined contaminated with two types of bacteria, P. aeruginosa and Klebsiella oxytoca.

A related civil lawsuit was resolved in July too, with the company agreeing to allow gel products that tested for very high levels of infectious bacteria to be destroyed. The company is also subject to a permanent injunction for which it must undergo and pay for regular inspections and certifications.

After its guilty plea to the two misdemeanor criminal charges of "introducing adulterated medical devices into interstate commerce," the company was ordered to pay a $50,000 criminal fine, to forfeit another $50,000, and was placed on two years probation, according to the DOJ release.



Learn about "Developing Devices That Generate Data for Evidence-Based Medicine" at the MD&M Minneapolis Conference, September 21-22.

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