Port Catheter Thrombosis Lawsuit Claims Defective AngioDynamics Xcela Device Caused Injury

Lawsuits allege certain AngioDynamics port catheters have been manufactured with barium sulfate, which can weaken the device over time, leading to pits, fissures and cracks linked to serious adverse complications.

A Nevada woman has filed a product liability lawsuit alleging that defects with an AngioDynamics Xcela port catheter caused thrombosis in her jugular vein, requiring removal of the implanted vascular access device.

The complaint (PDF) was brought by Victoria Whiteford in the U.S. District Court for the Southern District of California on May 21, naming AngioDynamics Inc., Navilyst Medical Inc. and PFM Medical Inc. as defendants.

Whiteford claims she received an Xcela Power Injectable port catheter in March 2018 for long-term intravenous access during medical treatment. However, little more than a year later, she developed swelling and clotting in her neck, with imaging studies revealing thrombosis in her right internal jugular vein, which she alleges was caused by the device.

Port Catheter Thrombosis Risks

Implantable port catheter systems are medical devices designed to provide long-term vascular access for patients requiring repeated infusions of medications, fluids, nutrition or blood products. The systems typically consist of a port implanted beneath the skin and a catheter inserted into a major blood vessel.

The AngioDynamics Xcela catheter was manufactured with a polyurethane material combined with barium sulfate, which was intended to make the device visible on imaging scans. However, a series of port catheter lawsuits allege the barium sulfate particles can weaken the structural integrity of the devices over time, creating pits, fissures and cracks on the surface.

Those defects could increase the risk of thrombosis, infections, biofilm buildup and other serious complications by allowing fibrinous blood products to collect on the degraded catheter surface.

As a result, a growing number of AngioDynamics port catheter lawsuits allege the manufacturers were aware for years that the devices were associated with serious failure risks, yet continued marketing the products as safe and effective without adequately warning physicians or patients about the potential dangers.

Xcela Port Catheter Failure Allegations

According to the complaint, Whiteford underwent implantation of the Xcela catheter on March 9, 2018, at MountainView Hospital in Las Vegas for long-term IV access.

The lawsuit alleges that on May 1, 2019, Whiteford returned to the hospital with complaints of swelling and clotting in the right side of her neck. An ultrasound allegedly confirmed thrombosis in the right internal jugular vein, leading physicians to remove the Xcela port two days later.

Whiteford claims the manufacturers knew for years that Xcela devices were linked to increased reports of thrombosis, infections, catheter fractures and migration problems, yet continued to market the products as safe and effective while failing to warn doctors or patients about the potential for complications.

The filing further claims the manufacturers concealed reports of device failures submitted through the FDA’s Alternative Summary Reporting program, which allegedly prevented physicians and patients from learning about the true scope of complications associated with the port catheter systems.

“Defendants provided incomplete, insufficient, and misleading information to physicians in order to increase the number of physicians using the Xcela for the purpose of increasing their sales. By so doing, Defendants caused the dissemination of inadequate and misleading information to patients, including the Plaintiff.”

— Victoria Whiteford v. AngioDynamics Inc. et al.

The complaint raises allegations of negligence, strict product liability, failure to warn, design defect, breach of implied and express warranties, fraudulent concealment and violations of Nevada deceptive trade practices laws. It seeks compensatory and punitive damages for physical injuries, pain and suffering, medical expenses and other losses allegedly caused by the device.

Port Catheter Lawsuits

Whiteford’s lawsuit will move forward as part of an AngioDynamics port catheter multidistrict litigation (MDL), which is centralized in the Southern District of California before U.S. District Judge Jinsook Ohta for coordinated discovery and pretrial proceedings involving similar claims filed throughout the federal court system.

As part of the MDL, the court is expected to establish a bellwether process involving a small group of representative lawsuits selected for early trial dates. Those cases are intended to help the parties assess how juries may respond to evidence and legal arguments expected to recur throughout the litigation.

Similar allegations have been raised in thousands of Bard PowerPort lawsuits consolidated in the District of Arizona, where more than 3,000 plaintiffs claim C.R. Bard and parent company Becton, Dickinson and Company sold implantable port devices made with barium sulfate that were prone to fracture, thrombosis and other serious complications. 

Earlier this month, the first Bard PowerPort bellwether trial ended with a defense verdict after jurors found the manufacturers were not liable for failure-to-warn claims or alleged consumer fraud violations. However, the jury was unable to reach a unanimous decision on whether the PowerPort devices were defectively designed or whether the companies violated unlawful trade practices laws.

The split verdict is expected to place increased focus on future bellwether trials, which may provide additional guidance on how juries evaluate the scientific evidence and competing claims presented in the litigation.

Additional Bard PowerPort bellwether trials are currently scheduled to begin on July 7, August 18, October 13, December 1, and February 2, 2027. If the proceedings do not lead to settlements or other resolutions, the court may eventually begin remanding individual lawsuits back to federal district courts nationwide for separate trial dates.

Sign up for more legal news that could affect you or your family.