SmartPort Lawsuit Filed After AngioDynamics Port Catheter Fracture Requires Surgical Removal

Missouri woman claims she had to undergo additional surgery to have AngioDynamics SmartPort fragments removed after the device shattered inside her body.

As AngioDynamics continues to face a growing number of implantable port catheter lawsuits over device failures, a Missouri woman has filed a lawsuit alleging that the design of the company’s SmartPort implants is defective, leading to one fracturing and shattering inside her body.

Sharon Coggins brought the complaint (PDF) in the U.S. District Court for the Southern District of California on March 24, naming SmartPort’s manufacturers, AngioDynamics, Inc. and Navilyst Medical, Inc., as the defendants.

AngioDynamics port catheters, including the SmartPort, Vortex Port and Xcela Port, as well as others, are implantable venous access devices used to deliver medications, nutrients and other fluids directly into the bloodstream. These devices are often used for cancer patients, consisting of a port for easy access and a catheter that carries the fluid into the body.

Despite being designed for long-term placement under the skin, Coggins’ allegations echo those raised in more than 1,000 AngioDynamics port catheter lawsuits, each claiming that the SmartPort, and other brands made from a polyurethane material high in barium sulfate, are prone to developing microfractures, compromising their durability and safety.

Similar allegations are also being pursued in a series of Bard PowerPort lawsuits against C.R. Bard, each indicating that the similarly designed chemo ports are prone to fracturing, migrating and causing infections, also due to the breakdown of barium sulfate used during the manufacturing process.

In her lawsuit, Coggins indicates she was implanted with an AngioDynamics SmartPort port catheter in March 2013. However, in March 2020, her doctors determined that the port had failed and fractured inside her body.

Just days after the discovery, the fractured port catheter was surgically removed. Although a fragment of the catheter could not be removed at the time, requiring Coggins to undergo an additional surgery to have the fragment removed in April 2020.

Coggins’ lawsuit indicates the manufacturer knew of these problems for years before this incident, but failed to provide adequate warning to patients or doctors about the true failure risks.

“At the time of her operation, Plaintiff was not informed of, and had no knowledge of the complaints, known complications, and risks associated with SmartPort,” the lawsuit states. “Plaintiff was never informed by Defendants of the defective and dangerous nature of the SmartPort.”

Coggins presents claims of fraudulent concealment, negligence, failure to warn, design defect, breach of warranty and violations of Missouri’s Merchandising Practices Act.

AngioDynamics Port Catheter Lawsuits MDL

Given common questions of fact and law raised in complaints filed throughout the federal court system, Coggins’ claim will be consolidated with similar AngioDynamics SmartPort lawsuits centralized as part of a multi-district litigation (MDL), in the Southern District of California for coordinated pretrial proceedings under U.S. District Judge Jinsook Ohta.

As part of the coordinated management of the growing litigation, it is expected that Judge Ohta will want to establish a bellwether trial process, during which a handful of representative cases will be selected for early trial dates.

These trials will allow both parties 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 catheter 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.