October 3, 2014 — The Food and Drug Administration (FDA) and the Department of Justice (DOJ) are teaming up to keep a New Jersey-based manufacturer of surgical gel from selling products that are contaminated with bacteria.
In 2012, Other-Sonic Ultrasound Gel manufactured by Pharmaceutical Innovations, Inc., was linked to an outbreak of 16 infections at one hospital in Michigan.
The company failed to notify the FDA despite receiving the reports. After FDA testing discovered “significant amounts” of bacteria in the products, U.S. Marshals seized lots of Other-Sonic Generic Ultrasound Transmission Gel.
The FDA says the owners of Pharmaceutical Innovations have failed to act on promises to fix quality-control issues, in violation of federal law, putting patient safety at risk.
As a result, the FDA have filed a lawsuit (PDF) in the U.S. District Court for the District of New Jersey. Prosecutors are seeking a permanent injunction against the owners of Pharmaceutical Innovations.
Safety officials are concerned about a number of severe side effects. Applying contaminated gel to the skin could cause inflammatory dermatitis, even on intact skin. Using the product in invasive biopsies could spread bacteria into deeper tissues, resulting in sepsis (blood poisoning) or abscesses.
In June 2012, the FDA warned about possible life-threatening risks:
“For example, if Pseudomonas aeruginosa is introduced into the upper airway through a transesophageal echocardiography (TEE) procedure and begins to grow, it may cause no symptoms. However, if it is accidentally aspirated into the lower airway, it could cause tracheobronchitis or pneumonia.”
Do I have a Surgical Gel Infection Lawsuit?
The Schmidt Firm, PLLC is currently accepting surgical gel and ultrasound gel induced injury cases in all 50 states. If you or somebody you know has been diagnosed with an infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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