Lawsuit Alleges AngioDynamics SmartPort Fractured, Migrated Out of Position, Resulting in Surgery To Remove Port Catheter Fragments

Faulty materials used in constructing the implantable port catheter led to the device’s failure, lawsuit claims.

An AngioDynamics SmartPort port catheter shattered inside of an Illinois woman’s body, resulting in injuries and the need for revision surgery, according to a recently filed lawsuit.

The complaint (PDF) was brought by Janna Nicholson in the U.S. District Court for the Northern District of California on May 7, alleging that AngioDynamics, Inc. and Navilyst Medical, Inc. manufactured a defectively designed port catheter that caused her injuries.

The SmartPort is part of a line of port catheters manufactured by AngioDynamics, which also includes the Vortex Port, Xcela Port and others. They are implantable venous access devices used to deliver medications, nutrients and other fluids directly into the patient’s bloodstream. The implants are used to give doctors a consistent port to easily inject medications and other fluids into the body.

However, the manufacturer now faces more than 150 AngioDynamics port catheter lawsuits filed in courts nationwide, each alleging that the implants are made with barium sulfate, which is prone to breaking down, leading to fractures, migration and serious infections. The resulting complications often require surgical removal of the implant and frequently disrupt or delay the routine treatments the ports are designed to support.

In addition to the growing number of AngioDynamics port catheter lawsuits being filed, C.R. Bard also faces a series of similar Bard PowerPort lawsuits, each indicating that the chemo ports are defectively manufactured with barium sulfate that makes the devices prone to fracturing, infections and failures.

Nicholson’s lawsuit indicates she was implanted with a SmartPort in April 2011. However, when doctors went to remove the implant in August 2017, they discovered that the device had fractured and fragmented.

Doctors found that the debris had migrated to her right atrium and had to perform additional surgery to recover the fragments. The lawsuit indicates that it took Nicholson until 2023 to learn about the potential defective design elements that caused her injuries.

“Defendants advertised, promoted, marketed, sold, and distributed the SmartPort as a safe medical device when Defendants knew or should have known the SmartPort was not safe for its intended purposes and that the product could cause serious medical problems,” the lawsuit states. “Defendants had sole access to material facts concerning the defective nature of the products and their propensity to cause serious and dangerous side effects.”

The lawsuit indicates that the catheter portion of the device is made of a polymeric mixture of polyurethane and barium sulfate. However, the latter is known to reduce the integrity of polyurethane in certain concentrations, leading to an increased risk of fracturing, Nicholson’s lawsuit claims.

“This defect in the manufacturing process led to a heterogeneous modified polymer which led to an irregular catheter surface replete with fissures, pits and cracks,” Nicholson’s claim states, presenting claims of negligence, failure to warn, design defect, breach of warranty, fraudulent concealment and violations of the Illinois Consumer Fraud and Deceptive Business Practices Act. She seeks both punitive and compensatory damages.

AngioDynamics Port Catheter Lawsuits

All federal AngioDynamics port catheter lawsuits, like Nicholson’s, have been centralized under U.S. District Judge Jinsook Ohta in the Southern District of California for coordinated pretrial proceedings.

As part of the coordinated management of the growing litigation, Judge Ohta is expected to establish a bellwether trial process, during which a handful of representative cases will be selected for early trial dates. These trials will allow the parties and court to evaluate how juries may respond to evidence and expert testimony likely to be repeated throughout the litigation.

While the results of those bellwether trials would not be binding, they could help the parties reach an AngioDynamics port infection lawsuit settlement agreement. If the parties do not reach an agreement, and no other resolution is found to the litigation, Judge Ohta may then remand each case back to the U.S. District Court where it originated for a future trial date.