Are Certain Ultrasound Gels Unsafe to Use?
Just as some pharmaceutical drugs are dangerous, so are some medical devices. One medical device manufacturer of ultrasound, mammography, and electrocardiogram gels and scanning pads is facing scrutiny from the U.S. Food and Drug Administration (FDA) after several violations.
Can the FDA Place an Injunction on Dangerous Companies?
The FDA can forcefully stop a dangerous company from manufacturing its products by requesting an injunction through the courts. It must get court approval before it can do that.
The FDA announced in early October that it is seeking a permanent injunction against Pharmaceutical Innovations Inc. (PII), which is based out of Newark, New Jersey. The FDA wants the injunction in place until the company comes into compliance with current health standards.
The U.S. Department of Justice (DOJ) filed the complaint on behalf of the FDA. It alleges:
- According to the FDA, the company “did not manufacture their devices in conformity with the current good manufacturing practice requirements of the Federal Food, Drug, and Cosmetic Act.”
- The company distributed its products before getting premarket approval or clearance from the FDA.
Have People Been Injured by Products from Pharmaceutical Innovations, Inc.?
This is not the first time PII has been in trouble with the government.
In 2012, the FDA had to seize specific lots of Other-Sonic Generic Ultrasound Transmission Gel. Significant amounts of bacteria were in those lots, and that could cause serious infections.
Before the FDA could stop it, this product infected some people at a hospital in Michigan. The FDA issued an alert to all healthcare facilities to discontinue use of that particular gel.
Zoll & Kranz, LLC – Defective Medical Drug and Device Lawyers