Angiodynamics Xcela Lawsuit Alleges Design Port Defects Caused Severe Infection, Surgical Removal

Barium sulfate used in the port catheter tubes cause Xcela infections and failures, according to lawsuit filed by an Arizona woman who required surgical removal of the port.

AngioDynamics faces a product liability lawsuit over Xcela port catheter design defects, indicating that materials used in its construction tend to degrade and cause microfractures, increasing the risk of infections and failure of the port.

The complaint (PDF) was filed by Serena Coleman in the U.S. District Court for the Southern District of California on May 9, indicating that she required surgical removal of an AngioDynamics Xcela port after it failed and led to the development of a severe infection.

Xcela is a port catheter device that is implanted in patients receiving frequent IV or needle injections. The devices are often used to deliver chemotherapy or other recurrent treatments, involving a port component where a needle can be inserted and a catheter that delivers the fluids directly into a patient’s vein. However, in recent years, design problems with AngioDynamics ports and Bard PowerPort products have lead to questions about the safety of materials used in the construction of the catheter tubes.

Coleman now joins a growing number of individuals throughout the United States who are pursuing port catheter lawsuits against the manufacturers, alleging that the use of high concentrations of barium sulphate makes the catheter tubes prone to cracking or fracturing, which can lead to sever and life-threatening injuries, including sepsis.

Coleman indicates that she received an AngioDynamics Xcela port catheter in May 2022. However, in October of that year, she went to a hospital emergency department complaining of central line site pain. Doctors found a lump at the port catheter implant site and determined she suffered from an infection caused by the implant.

In late October 2022, Coleman’s infected Xcela port was surgically removed and she blames the infection on the construction of the port catheter with barium sulfate particles.

“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,” her lawsuit states. “The roughened catheter surface leads to the collection and proliferation of fibrinous blood products, thereby drastically increasing the risk of biofilm, infection, and sepsis.”

Coleman’s complaint indicates she will have to undergo additional surgeries due to the failed port catheter and has suffered permanent injuries as a result. The lawsuit presents claims of negligence, failure to warn, design defect, breach of warranty, fraudulent concealment, and violations of California’s Consumer Legal Remedies Act.

Bard PowerPort Lawsuits

The problems described in Coleman’s AngioDynamics Xcela port lawsuit are similar to those made in a growing number of Bard PowerPort lawsuits currently being pursued, which involve similar allegations of design defects.

With a rapidly growing number of complaints being filed against Bard throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation decided to centralize all Bard Powerport lawsuits in August 2023, transferring the claims to U.S. District Judge David G. Campbell, in the District of Arizona, for coordinated discovery and pretrial proceedings as part of a federal MDL, or multidistrict litigation.

To help manage the claims and gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation, Judge Campbell has established a bellwether trial process, where a group of 24 initial Bard port catheter lawsuits will go through discovery and be prepared for a series of early trial dates.

After the bellwether cases are selected, the parties will conduct further case-specific discovery, including depositions and work up for trial. Those claims will later be reduced down to six Bard PowerPort bellwether trial cases, which will be set to go before juries in late 2025 or early 2026, to help to gauge how they may respond to certain evidence and testimony that will be repeated throughout the litigation.

While the outcomes of these early bellwether trials will not have any binding impact on other claims pending in the MDL, they will likely have a major impact on Bard Power Port settlement negotiations and any attempt to resolve large numbers of claims.