AngioDynamics Vortex Lawsuit Filed Over Infected Port Catheter Device

An Iowa woman has filed a product liability lawsuit against AngioDynamics, alleging that Vortex port catheters implanted in her body were defective and unreasonably dangerous, causing infections and the need for additional surgeries to remove two of the failed devices.

The complaint (PDF) was brought last week by Charmaine Brockway in the U.S. District Court for the Southern District of Iowa, pursuing damages from the device manufacturers, AngioDynamics, Inc. and Navilyst Medical, Inc.

First introduced in 2003, the Angiodynamics Vortex is comprised of a port implant and catheter, which is used to provide healthcare professionals the ability to easily inject medications, nutrients and other fluid products into a patient’s bloodstream. It is designed to be left in place long-term under the skin.

However, according to Brockway’s lawsuit, the Vortex port-a-cath is prone to develop microfractures due to the use of barium sulfate in the production of the polyurethane catheter. This can cause the structure to Angiodynamics Vortex to fail, increasing the risk of infections, device fractures and blood clots, which could break off into the patients’ bloodstream, potentially damaging the heart and other organs.

The complaint raises allegations similar to those presented in hundreds of Bard PowerPort lawsuits currently pending in the federal court system, involving reports of hemorrhage, infections, sepsis, heart rhythm problems, severe pain, perforation of blood vessels and organs, and even death.

According to this Angiodynamics Vortex lawsuit, Brockway was implanted with the port catheter in June 2019. However, in April 2022, she reported to an emergency room suffering from chest pain, and doctors discovered she was suffering from an infection that they traced back to the Vortex implant. The device was then removed during surgery, and another Vortex port was implanted.

However, this device also failed, resulting in more infection problems from the Angiodynamics Vortex in March 2023. After the second device was explanted, Brockway decided to not have another port put into her body.

The lawsuit indicates that Angiodynamics knew about the high risk of these port catheter infection problems through adverse event reports (AERs), but failed to warn patients, the medical industry, or federal regulators.

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

She presents claims of negligence, design defect, failure to warn, breach of warranty, fraudulent concealment and violations of consumer protection laws. Brockway seeks both punitive and compensatory damages.

Bard PowerPort Lawsuits

The allegations are similar to those made in a growing number of product liability lawsuits being pursued against C.R. Bard, each indicating that a Bard PowerPort fractured or degraded over time, causing infections, perforations and other injuries.

Given nearly identical allegations raised in the complaints brought 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 being reduced down to six Bard PowerPort bellwether trial cases, which will be set to go before juries to hel to gauge how they may respond to certain evidence and testimony that will be repeated throughout the litigation.

Following discovery, the parties will attempt to agree on the final six bellwether claims by March 10, 2025, and it is widely expected that the first trials may begin by late 2025 or early 2026.

While the outcomes of these early bellwether trials will not have any binding impact on other claims pending in the MDL, including claims filed after the April 1 deadline, they will likely have a major impact on Bard Power Port settlement negotiations and any attempt to resolve large numbers of claims.