AngioDynamics Xcela Port Catheter Lawsuit Filed Over Infection, Need for Implant Removal

Lawsuit accuses AngioDynamics of failing to warn the public and doctors about known risk of infection and failure of the Xcela port catheter.

A Kentucky woman has filed an AngioDynamics Xcela lawsuit against the manufacturers of the implantable port catheter, claiming the medical device contains an unreasonably dangerous and defective design, which caused her to develop a severe infection, requiring surgical removal of the port.

The complaint (PDF) was brought by Chaya Caldwell in the U.S. District Court for the Southern District of California on January 22, naming AngioDynamics, Inc., Navilyst Medical, Inc., and PFM Medical, Inc. as defendants.

The AngioDynamics Xcela port catheter is a medical device implanted under the skin to provide long-term access to veins for administering medication or drawing blood. Approved by the FDA in 2008 through the controversial 510(k) premarket notification program, it was cleared based on being “substantially equivalent” to existing port catheters.

However, plaintiffs allege that after a growing number of adverse events linked to the device, the manufacturer knew or should have known that the Xcela was defectively designed and prone to causing infections or failure of the port catheter.

The allegations raised in Caldwells complaint 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.

According to the lawsuit, Caldwell was implanted with the Xcela port catheter in May 2020 for ongoing venous access. However, in October 2021, she was admitted to a hospital following complaints of a fever.

Doctors determined that Caldwell had developed an infection that was originating from her Xcela port catheter. Just days later doctors surgically removed the catheter. However, the complaint indicates that the manufacturer knew of this problem long before the device was implanted in Caldwell, but chose to conceal the risks in order to maximize profits.

“Defendants were aware or should have been aware that the Xcela had a substantially higher failure rate than other similar products on the market, yet Defendants failed to warn consumers of this fact,” the lawsuit states. “Defendants also intentionally concealed the severity of complications caused by the Xcela and the likelihood of these events occurring.”

Caldwell’s complaint indicates the manufacturers should have adequately informed patients and doctors about the risks, should have established an adequate post-market surveillance system to detect problems after the implants were placed on the market, and should have issued an Xcela recall when discovering the failure rates and problems.

She presents claims of negligence, failure to warn, design defect, breach of warranty and fraudulent concealment.

AngioDynamics Port Catheter Lawsuits

Caldwell’s complaint will be consolidated with a growing number of similar AngioDynamics port catheter lawsuits, which are currently centralized for coordinated pretrial proceedings under U.S. District Judge Jinsook Ohta in the Southern District of California.

In November, Judge Ohta held an initial status conference for the litigation, instructing plaintiffs to propose a leadership structure for AngioDynamics port catheter attorneys to ensure fair representation of all plaintiffs’ needs and interests.

As the litigation progresses, it is anticipated that he will establish a bellwether trial process, which will result in the selection of a handful of representative cases for early trial dates. These trials will allow both parties to evaluate how juries may react to evidence and testimony that will be presented repeatedly throughout the courts during 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.