• March 13, 2019
• CMZ Law
• no comments

Pharmaceutical Innovations Inc., a New Jersey pharmaceutical company based in Newark, has recently pleaded guilty to selling ultrasound gel contaminated with bacteria. The gel, used in scans, sonograms, EKGs and similar procedures, makes direct contact with the skin.

How the Case Began

The company was originally targeted by the FDA in 2012. At that time a Michigan hospital reported that 16 surgical patients had been infected with a bacterial pathogen associated with a particular batch of ultrasound gel from Pharmaceutical Innovations. It was found that all of the infected patients had undergone transesophageal ultrasounds during heart valve replacement surgeries which led investigators to suspect the gel as the contaminant. The hospital had then tested the gel and confirmed that it was, in fact, the source of the contamination.

The Charges against Pharmaceutical Innovations

Pharmaceutical Innovations was charged with violating the Federal Food, Drug and Cosmetic Act. Prosecutors charged that FDA inspections of the facility indentified multiple breaches in accepted manufacturing practices. The FDA also said in court filings that the company had failed to resolve their manufacturing issues in spite of repeated warnings.

How the Case Was Resolved

Pharmaceutical Innovations entered a guilty plea in U.S. District Court in Newark to two misdemeanor counts of introducing adulterated medical devices into interstate commerce. The firm was fined $50,000 for the crime and forced to forfeit $50,000 (the approximate value of the defective product) to settle a civil lawsuit regarding its distribution. In addition, the company was placed on two years of probation.

Pharmaceutical Innovations also agreed to destroy products that have tested high for infectious bacteria in order to settle the civil suit. Company executives state that they’re now committed to maintaining compliance with all relevant regulations. An injunction has also been issued requiring that the company pay for regular inspections and certifications of its facility by independent experts and auditors.

U.S. Attorney Paul Fishman has stated that “Pharmaceutical Innovations shipped defective products that exposed hospital patients to dangerous bacterial contamination.” He went on to say that the plea agreement and civil settlement indicate that the company has accepted responsibility for the hazardous contamination and is taking steps to prevent any medical missteps in the future.  

Medical mistakes happen all too frequently, not only as a result of medical device failure or product contamination, but because of errors made by hospitals and medical professionals. If you have suffered as a result of a medical, surgical, or medication-related error while in a medical facility or at the hands of a medical professional, you should contact an experienced medical malpractice attorney as soon as possible so that you receive the compensation you deserve.