AngioDynamics Xcela Port Catheter Problems Caused Sepsis Infection, Lawsuit Claims

A Georgia woman implanted with an AngioDynamics Xcela port catheter has filed a product liability lawsuit against the manufacturers, claiming that design defects caused her to develop serious and life-threatening infections, including sepsis.

The complaint (PDF) was brought by Destiny Kelly in the U.S. District Court for the Southern District of California earlier this month, naming AngioDynamics Inc., Navilyst Medical Inc. and PFM Medical Inc. as defendants.

It is one of a growing number of port catheter lawsuits filed against AngioDynamics in recent months, each raising similar allegations that the implantable venous access devices used to deliver chemotherapy or other medications directly into a patient’s bloodstream are constructed with materials that are prone to develop microfractures, which may allow dangerous infections to develop.

The AngioDynamics Xcela was approved by the FDA in 2008, through a controversial 510(k) premarket notification program, meaning the manufacturers only had to show it was “substantially equivalent” to previous port catheters to gain approval. However, Kelly and other plaintiffs allege that the manufacturer knew or should have known that the system was defectively designed.

The allegations are similar to those made in a series of Bard PowerPort lawsuits being pursued against C.R. Bard, each indicating that the chemo port is prone to fracturing, migrating and causing infections due to the breakdown of barium sulfate used during the manufacturing process.

Kelly indicates she was implanted with an AngioDynamics Xcela port in March 2019, for ongoing treatment of sickle cell disease.

However, in December 2022, she sought medical treatment for body pain and fever. Kelly tested positive for infection and was diagnosed with severe sepsis, which medical professionals linked to problems with the Angiodynamics Xcela port catheter. As a result, she had the implant removed in early January 2023.

Kelly indicates that AngioDynamics should have known about the risk of problems with the port catheters, specifically due to the high concentrations of barium sulfate particles within the catheter materials.

“Barium sulfate is known to contribute to reduction of the mechanical integrity of polyurethane in vivo as the particles of barium sulfate dissociate from the surface of the catheter over time, leaving microfractures and other alterations of the polymeric structure and degrading the mechanical properties of the polyurethane,” the lawsuit notes. “This defect in the manufacturing process led to a heterogeneous modified polymer which led to an irregular catheter surface replete with fissure, pits and cracks. The roughened catheter surface leads to the collection and proliferation of fibrinous blood products, thereby drastically increasing the risk of biofilm, infection, and sepsis.”

The lawsuit presents claims for negligence, failure to warn, design defect, breach of warranty and fraudulent concealment, seeking both compensatory and punitive damages.

AngioDynamics Port Catheter Litigation

Kelly’s complaint was filed days after the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all AngioDynamics port catheter lawsuits brought in federal courts nationwide, since each of the claims raise similar questions of fact and law.

To help manage the growing litigation, the AngioDynamics lawsuits filed by Kelly and other plaintiffs will be centralized in the Southern District of California under U.S. District Judge Jinsook Ohta, for coordinated discovery and pretrial proceedings.

Now that the courts have established an AngioDynamics port catheter MDL, or multidistrict litigation, it is likely that Judge Ohta will appoint a small group of lawyers to serve in various leadership positions throughout the pretrial proceedings. These attorneys will be charged with conducting discovery into common issues in the litigation and performing other actions that benefit all plaintiffs pursuing a lawsuit.

The MDL judge may then direct the parties to select several representative claims to serve as potential early bellwether trial dates, which would help the parties gauge how juries are likely to respond to evidence and testimony to be repeated throughout the litigation.

Following coordinated discovery and any bellwether trials in the MDL, if the parties are unable to reach any settlement agreements or another resolution on the AngioDymanics port catheter lawsuits, Judge Ohta may remand each case back to the U.S. District Court where it was originally filed for a future trial date. However, pretrial proceedings in the AngioDyamics port catheter MDL will likely take several years.