Lawsuit Claims AngioDynamics BioFlo Port Catheters Defectively Designed

Complaint joins other AngioDynamics port catheter lawsuits arguing that the company knew the implants were problematic, yet took no action to warn or correct the design.

A Texas man’s lawsuit against AngioDynamics alleges that its BioFlo Power Injectable Ports have defectively designed catheters that can fracture and break, which similar lawsuits claim afflict several of the company’s other port catheters as well.

The AngioDynamics BioFlo belongs to a line of port catheters, also known as port-a-caths, that include the SmartPort, Vortex Port and Xcela Port. They are designed to provide doctors a way of giving patients repeated drug and fluid injections through a reusable port that can be implanted in individuals undergoing chemotherapy or similar regular drug treatments.

In recent years a growing number of port catheter lawsuits have been filed against AngioDynamics due to catheter failures, device fractures, infections and other complications, each involving similar allegations that the devices’ flexible catheter tubing was manufactured using too much of a chemical known as barium sulfate, which causes it to be brittle and prone to cracking and fracturing, as well as capturing bacteria.

C.R. Bard faces a similar series of Bard PowerPort lawsuits over its own port catheter design, which plaintiffs say has similar design defects as those by AngioDynamics.

In a complaint (PDF) filed on September 22, Donald Gotcher claims AngioDynamics’ BioFlo Port has the same problem, which led to him suffering an infection and requiring additional surgery to have the implant removed in 2021. However, he says it took years to discover that his infection was a known risk to AngioDynamics Inc. and Navilyst Medical Inc., although this risk was never relayed to patients or the medical community.

Gotcher’s lawsuit claims he was implanted with the BioFlo Port in February 2014 to assist with treatments for chemotherapy. When he was told it had to be removed in March 2021 due to a port-related infection, what neither he nor his doctors were told was that this was a known increased risk linked to the implant’s design.

His complaint claims that while it was not until 2023 that Gotcher learned there was a heightened risk of infections associated with the BioFlo Port, the manufacturer had known for years.

“Soon after the BioFlo Port was introduced to market, Defendants began receiving large numbers of adverse event reports from health care providers reporting that the BioFlo Port was fracturing post-implantation and that fractured pieces were migrating throughout the human body, including to the heart and lungs.”

— Donald Gotcher v. AngioDynamics Inc. et al

The lawsuit alleges AngioDynamics also received reports of the BioFlo port perforations of the internal vasculature, which led to bleeding, infections, sepsis, port erosion, cardia/pericardial tamponade and other complications, many of which can be severe and life-threatening.

Gotcher indicates the manufacturer sought to place profit over patients’ safety by cutting corners, and refusing to update the design once it knew they had a problem and were showing higher rates of failure than anticipated. He presents claims of negligence, negligent failure to warn, negligent -design defect, negligent – manufacturing defect, strict liability – design defect, strict liability – failure to warn, strict liability – manufacturing defect, breach of warranty, common law fraud, fraudulent concealment, neglect misrepresentation and gross negligence.

AngioDynamics Port Catheter Lawsuits

Like other AngioDynamics port catheter lawsuits being filed in federal courts nationwide, Gotcher’s complaint will be consolidated in the Southern District of California under U.S. District Judge Jinsook Ohta for centralized discovery and coordinated pretrial proceedings.

Earlier this month the judge ordered the parties to work on a process for choosing several AngioDynamics port catheter lawsuits, that are representative of the litigation as a whole, to serve as early test cases. These bellwether trials will give the parties and the court the opportunity to see how juries are likely to respond to evidence and testimony likely to be repeated throughout the litigation.

While the results of those bellwether trials will not be binding on other plaintiffs pursuing claims, they could help gauge how juries will respond to similar evidence and testimony likely to be repeated throughout the litigation. In addition, the average AngioDynamics port lawsuit payouts awarded by juries may help lawyers negotiate settlements in other claims.

Following the bellwether trials, if the parties do not reach a resolution for the litigation, Judge Ohta may then remand each case back to the U.S. District Court where it originated for a future trial date.