Port Catheter Infection Lawsuit Claims SmartPort Defects Caused Sepsis, Pulmonary Embolism

Despite hundreds of adverse event reports shortly after the devices hit the market, lawsuit claims AngioDynamics refuses to improve SmartPort’s design.

A lawsuit against AngioDynamics alleges that an infection, sepsis and pulmonary embolism was traced back to a SmartPort port catheter device that was supposed to assist with chemotherapy.

The complaint (PDF) was filed by Malia Hookano in the U.S. District Court for the Southern District of California on March 17, naming AngioDynamics Inc. & Navilyst Medical Inc. as the defendants. It claims Hookano suffered serious injuries as a result of the SmartPort’s allegedly defective design.

The SmartPort is one of a series of port catheter implants manufactured by AngioDynamics, along with the Vertex Port, Xcela Port and others. The devices are designed to allow long-term access to a patient’s bloodstream for repeated injections without the need for a new needlestick each time.

Frequently implanted in patients undergoing chemotherapy, port catheters consist of a small injection port placed beneath the skin that connects to a flexible catheter, allowing medication to be delivered directly into a vein.

However, reports of infections, device migration and implant failures have raised concerns about the design of port catheters, also known as totally implantable vascular access devices (TIVADs), over the last several years. This has led to hundreds of AngioDynamics port catheter lawsuits filed in courts nationwide, and thousands of Bard PowerPort lawsuits brought against its competitor, C.R. Bard.

Each of the claims, like Hookano’s, raise similar allegations that the port catheters were defectively designed and manufactured, making patients susceptible to fractures, migration, infections and premature failure, often requiring additional medical treatment or surgery to remove the device.

Hookano received an AngioDynamics SmartPort port catheter in February 2019 to help in her chemotherapy treatments. Both she and her doctor relied on the company’s representations that the implant was safe and effective.

However, Hookano was experiencing a fever, chills and coughing by late May. She was subsequently diagnosed with sepsis and pulmonary embolism.

It would be several years before she realized that the illnesses and problems with the SmartPort were linked to a potentially defective design, which the lawsuit claims was due to AngioDynamics’ efforts to conceal those problems from the public, medical community and federal regulators.

Shortly after the device was put on the market, AngioDynamics began to receive hundreds of adverse event reports from doctors who were witnessing fractures, infections and pieces migrating into patients’ hearts and bodies, yet the company refused to issue new warnings or change the device’s design, Hookano claims.

“Defendants knew and had reason to know, that the SmartPort was not safe for the patients for whom they were prescribed and implanted, because once implanted the device was prone to infection, thrombosis, fracturing, migrating, perforating internal vasculature and otherwise malfunctioning.”

– Malia Hookano v. AngioDynamics Inc. et al

Hookano’s port catheter infection lawsuit presents claims of negligence, failure to warn, design defect, breach of warranty, fraudulent concealment and violations of Nevada’s Deceptive Trade Practices Act. It seeks both compensatory and punitive damages.

AngioDynamics Port Catheter Lawsuits

Currently, all AngioDynamics port catheter lawsuits are consolidated in the Southern District of California as part of a multidistrict litigation (MDL) before U.S. District Judge Jinsook Ohta. Hookano’s complaint will be centralized with more than 300 similar claims to undergo coordinated discovery and pretrial proceedings.

In addition, Judge Ohta has ordered the parties to prepare to hold a series of early test trials. These “bellwether” trials are designed to see how juries respond to evidence and testimony that would be key factors in claims throughout the litigation.

Judge Ohta has called on parties to select nine AngioDynamics port catheter lawsuits each, for a total of 18, to serve as an initial bellwether pool, from which the first early test cases will be selected. Those selections, meant to be representative of the majority of cases, are due by June 5, 2026.

While the results of these bellwether trials are not binding on other claims, they will be closely watched to see how juries interpret evidence and testimony that would be repeated throughout hundreds of AngioDynamics port catheter lawsuits if they should go to trial.

However, if the parties are unable to reach an AngioDynamics port catheter lawsuit settlement or other resolution, the judge is likely to begin remanding cases back to their originating districts for individual trial dates.