AngioDynamics Catheter Lawsuit Claims SmartPort Device Embedded in Jugular Vein, Caused Embolism

Complaint joins a growing number of AngioDynamics lawsuits, which claim that barium sulfate in the catheter material may degrade the devices’ structural integrity over time.

A product liability lawsuit alleges that an AngioDynamics SmartPort catheter became embedded in a Michigan woman’s jugular vein, leading to an embolism and other complications following implantation.

The complaint (PDF) was filed by Cassandra Henderson in the U.S. District Court for the Southern District of California on April 20. It names AngioDynamics Inc. and its subsidiary, Navilyst Medical Inc., as defendants.

Henderson claims the AngioDynamics SmartPort port catheter was defectively designed and manufactured, particularly due to the inclusion of barium sulfate in its material, which may degrade over time and cause microfractures, infection risks and overall device failure.

Port Catheter Lawsuits

Often referred to as totally implantable vascular access devices, or TIVADs, port catheters include a small reservoir placed beneath the skin that connects to a flexible tube, allowing medications to be delivered directly into a vein. These devices are intended to provide reliable, long-term access to the bloodstream, reducing the need for repeated needle insertions.

AngioDynamics produces several implantable port catheter systems, including the SmartPort, Vortex and Xcela, which are commonly used in patients receiving chemotherapy.

However, both patients and healthcare providers have raised concerns in recent years about complications associated with these and related devices. Reported issues have included catheter fracture and migrations, as well as infections, prompting hundreds of lawsuits against AngioDynamics. Nearly identical claims have also been raised in thousands of Bard PowerPort lawsuits.

AngioDynamics SmartPort Failure Allegations

According to the lawsuit, Henderson received a SmartPort CT device in September 2017 at Henry Ford Hospital in Detroit, where it was implanted to facilitate chemotherapy treatments.

However, Henderson allegedly returned to the hospital just months later with complaints that the port was malfunctioning and malpositioned. Doctors determined that the catheter had become embedded along her right internal jugular vein, resulting in an embolism linked to the vascular access device.

The lawsuit claims the SmartPort catheter was defectively designed and manufactured, pointing to issues with the device’s polyurethane composition. According to the complaint, the inclusion of barium sulfate may weaken the catheter material over time, creating microfractures and increasing the risk of infection, biofilm buildup and device failure.

Henderson alleges that AngioDynamics failed to adequately test the SmartPort system before bringing it to market and did not properly monitor post-market safety data. The lawsuit further claims the manufacturers withheld critical safety information from physicians and patients, including known risks of catheter failure, infection and embolism.

The complaint also accuses the defendants of using the FDA’s Alternative Summary Reporting (ASR) program to obscure the frequency and severity of adverse events associated with the devices, preventing doctors and patients from fully understanding the risks.

In addition, the lawsuit indicates that neither Henderson nor her healthcare providers were adequately warned about the risk that the catheter could become embedded in a vein or lead to serious vascular complications.

“Moreover, Defendants concealed—and continue to conceal—their knowledge of the SmartPort CT’s dangerous propensity to precipitate infection.”

— Cassandra Henderson v. AngioDynamics Inc. et al

The case raises allegations of negligence, strict products liability, design defect, failure to warn, breach of implied warranty, breach of express warranty, fraudulent concealment and violations of Michigan’s Consumer Protection Act. It seeks exemplary and general damages.

AngioDynamics Catheter Lawsuits

Henderson’s case is one of more than 300 similar AngioDynamics claims that have been centralized in a multidistrict litigation (MDL) in the Southern District of California, where coordinated discovery and pretrial proceedings are underway before U.S. District Judge Jinsook Ohta.

As part of the litigation, Judge Ohta has directed both sides to identify nine AngioDynamics port catheter cases each by June 5, to create a pool of 18 lawsuits that will be prepared for early “bellwether” trials. These initial trials are intended to gauge how juries may evaluate common evidence and testimony presented across the broader litigation.

Although the outcomes will not directly determine the result of other cases, they are expected to provide important insight into potential jury verdicts and damage awards, which may shape future settlement discussions.

If the parties are unable to reach a resolution, cases that remain unresolved will likely be sent back to their original courts for individual trial proceedings.

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