Angiodynamics LifePort Lawsuit Filed Over Risk of the Port Catheters Failing, Causing Severe Injury

A California woman has filed a product liability lawsuit against the manufacturers of the Angiodynamics LifePort, alleging that one of the implantable port catheters failed and fractured inside her body, requiring surgical removal.

The complaint (PDF) was brought by Laura Schultz in the U.S. District Court Eastern District of California on September 9, pursuing damages from the device manufacturers, Angiodynamics, Inc. and Navilyst Medical, Inc.

The Angiodynamics LifePort is an implantable port catheter that was approved by the U.S. Food and Drug Administration (FDA) in 2005, to allow long-term access to the vascular system to deliver medications, nutrients and treatments such as chemotherapy directly into the bloodstream.

While the LifePort has been marketed as a safe and effective treatment for individuals undergoing chemotherapy or those requiring long term venous access, the devices have been linked to a growing number of port catheter fracture, migration and infection injuries, which lawsuits now claim are caused by the use of defective materials that can weaken the structural integrity of the devices.

According to this Angiodynamics lawsuit, Schultz states she received an implantable LifePort catheter system in February 2009, before receiving chemotherapy treatment for breast cancer.

However, Schultz states that she began to experience irregular heart rate side effects in November 2009, and was later admitted to Stanislaus Surgical Hospital in Modesto, California, where a review of imaging scans determined the LifePort had thrombosed and fractured, allowing pieces of the LifePort to migrate into her right atrium, which is the right upper chamber of the heart that receives deoxygenated blood from the body and pumps it to the lungs for oxygenation.

Following the discovery, Shultz underwent surgical removal of the LifePort catheter system to remove the fractured and thrombosed components of the LifePort reservoir and the parts of the dislodged catheter.

Similar to other Angiodynamics port catheter lawsuits filed to date, Shultz argues that the LifePort’s design, specifically the high concentration of barium sulfate in the catheter material, contributed to the thrombosis and fracturing of the device.

The lawsuit claims the degradation of the barium sulfate used to design the LifePort creates a rough surface within the catheter, promoting the accumulation of fibrinous material from the bloodstream, ultimately leading to clot formation and the fracturing and migrating of the device.

Schultz claims that Angiodynamics knew about the high risk of these port catheter thrombosis and fracturing problems through adverse event reports submitted to the FDA, but failed to warn patients, the medical industry or federal regulators.

“Defendants had sole access to material facts concerning the defective nature of the LifePort product and its propensity to cause serious and dangerous side effects, such as catheter fracture, fracture and migration, and the catheter-related thrombosis,” Schultz’s lawsuit states. “Defendants intentionally underreported the number and nature of adverse events associated with fracture and migration of the devices and the catheter-related thrombosis to the Plaintiff’s health care providers, as well as the FDA.”

She presents claims of negligence, defective design and manufacturing, failure to warn, breach of warranty and fraudulent concealment, seeking both punitive and compensatory damages.

Potential Consolidation of Angiodynamics Port Catheter Lawsuits

Schultz’s LifePort lawsuit against Angiodynamics joins more than 20 separate lawsuits filed against the medical device manufacturer, each raising similar claims that various implantable port catheters made by Angiodynamics such as the Vortex, Xcela and others, contain design defects that make them prone to fracture, migration and infection problems.

Given the growing number of claims being filed in multiple federal courts nationwide, several plaintiffs with pending claims filed a motion to transfer Angiodynamics port catheter lawsuits with the U.S. Judicial Panel on Multidistrict Litigation (JPML) in July 2024.

The plaintiff’s requested that all lawsuits brought over Angiodynamics port catheter defects throughout the federal court system be consolidated and centralized for pretrial proceedings in the U.S. District Court for the Western District of Missouri.

In response to the motion, the JPML is now scheduled to hear oral arguments from both plaintiffs and defendants on September 26, 2024, in which the parties will present evidence to support or challenge consolidating and centralizing the cases before one judge for pretrial proceedings as part of an Angiodynamics Port Catheter multidistrict litigation.

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

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.

Similar to the Bard PowerPort lawsuits, if an MDL is established, complaints filed against Angiodynamics in U.S. District Courts throughout the country will be transferred to one judge for discovery, pretrial proceedings and potentially a series of early bellwether trials. However, if the parties fail to reach an Angiodynamics port catheter settlement agreement or another resolution during the MDL proceedings, each lawsuit may be transferred back to their originating districts for individual trial dates in the future.