Product Liability: Contaminated Ultrasound Gel

Pharmaceutical Innovations Inc., a Newark-based pharmaceutical company, just pleaded guilty of charges this week in connection with the sale of ultrasound gel that was contaminated with bacteria. The bacteria found in the gel infected an outstanding 16 patients. Along with this, they also agreed to settle a civil lawsuit tied to its distribution of the gel and was ordered to pay $50,000 in fines as well as an additional $50,000 for the products in question.

Product Liability

In the realm of product liability, there are three types of defects: manufacturing, design, and failure to warn. Here are those types of defects further explained for your understanding:

Manufacturing: This type of defect occurs when the product is different than its design because of something that happened in the manufacturing process. This could include contamination of a product, such as with the ultrasound gel.

Design: This means that the actual intended design of the product could be inherently dangerous. Typically with drugs or medical supplies, this means that it could cause severe side effects or worse.

Failure to Warn: These defects occur when a product is not labeled correctly or lacks proper instructions, safety warnings, or usage recommendations.

In any of these cases, a plaintiff must be able to show that negligence was at play to sue for product liability. Was it suspected that the product was unsafe but it was not inspected properly? Were risks discussed somewhere along the line? If the plaintiff can prove that somebody in the chain breached their duty of care, then they can hold them legally liable for damages.

Liability in the Ultrasound Gel Case

U.S. Attorney Paul Fishman said on behalf of the incident, “Pharmaceutical Innovations shipped defective products that exposed hospital patients to dangerous bacterial contamination.” Because of this, the company is being held responsible for their actions and will be taking preventative measures to ensure that it will never happen again. Along with this, all contaminated gel still swimming around will be destructed immediately. The president of the company was noted as saying, “We are pleased to have addressed the concerns of the FDA and to demonstrate our continuing commitment to manufacturing high-quality products for our customers.”

In 2012, 16 patients became infected with Pseudomonas aeruginosa, a bacterial pathogen. They confirmed this contamination through tests and found that these patients had all undergone transesophageal ultrasounds prior. These internal procedures were performed as an alternative to traditional echocardiograms to those who had heart valve replacement surgeries. Luckily, the company is doing everything in its nature to prevent this accident happening again and there were no fatalities relating to the incident.

The pharmaceutical company pleaded guilty before U.S. District Court Judge Esther Salas. They were found guilty with two misdemeanor counts of introducing adultered medical devices into interstate commerce. Not only did they receive their outstanding fines but were also put on two years of probation.

Have you fallen victim to a product that caused you harm? Have you received injuries or illnesses as a result? Call us today for information on your case.