E. Coli Infection Was Caused by AngioDynamics SmartPort Port Catheter, Lawsuit Alleges

Lawsuit claims SmartPort port catheter caused E. coli infections, while the chemotherapy drugs it delivered suppressed cancer patient’s immune system.

A Florida woman has filed an AngioDynamics lawsuit, alleging that the company’s defectively designed SmartPort port catheters caused her to develop an infection that left her hospitalized for several days.

The complaint (PDF) brought by Jessica Malagon in the U.S. District Court for the Southern District of California on February 25, is just one of a growing number of port catheter lawsuits naming AngioDynamics Inc. & Navilyst Medical, Inc. as the defendants.

AngioDynamics port catheters, including the SmartPort, Vortex Port and Xcela Port, are implantable venous access devices used to deliver medications, nutrients and other fluids directly into the bloodstream. These devices, often used for cancer patients, consist of a port for easy access and a catheter that carries the fluid into the body.

Although the implants are designed to be left in place long-term under the skin, individuals like Malagon allege that the material is prone to develop microfractures, due to the use of high levels of barium sulfate in the production of the polyurethane catheter.

Similar allegations are also being pursued in a series of Bard PowerPort lawsuits against C.R. Bard, each indicating that the chemo ports are prone to fracturing, migrating and causing infections, also due to the breakdown of barium sulfate used during the manufacturing process.

According to Malagon’s lawsuit, she was implanted with an AngioDynamics SmartPort in June 2020, for the purpose of providing chemotherapy treatment.

However, in April 2021, Malagon went to an emergency room due to a fever and bilateral hip pain. While the hip pain was determined to be unrelated, Malagon was diagnosed with an E. Coli infection.

E. Coli is a bacteria that lives in the intestines of people and animals. It can become pathogenic, causing severe bowel pain and diarrhea when exposed outside of the intestinal tract. It can cause mild to severe diarrhea and abdominal cramps, bloody stools and fevers lasting between five and 10 days. It can be particularly dangerous to someone who has a compromised immune system, like a chemotherapy patient.

Malagon was hospitalized for five days and was treated with antibiotics. However, her symptoms returned in March 2023, and she suspected her SmartPort had become infected. Doctors confirmed the SmartPort was the source of the infection, and it was surgically removed in December 2023.

“Defendants failed to design and establish a safe, effective procedure for removal of SmartPort; therefore, in the event of a failure, injury, or complications it is difficult to safely remove SmartPort,” the lawsuit states. “Defendants provided incomplete, insufficient, and misleading information to physicians in order to increase the number of physicians using SmartPort for the purpose of increasing their sales. By so doing, Defendants caused the dissemination of inadequate and misleading information to patients, including the Plaintiff.”

Malagon presents claims of negligence, design defect, failure to warn, breach of warranty, fraudulent concealment, and violating the Florida Deceptive and Fair Trade Practices Act.

AngioDynamics Port Catheter Lawsuits

Similar AngioDynamics port catheter lawsuits, like Malagon’s, have been centralized for coordinated pretrial proceedings in the Southern District of California under U.S. District Judge Jinsook Ohta.

It is expected that Judge Ohta will want to establish a bellwether trial process, during which a handful of representative cases will be selected for early trial dates. These trials would allow both parties to evaluate how juries may respond to evidence and expert testimony likely to be repeated throughout the litigation.

While the results of those bellwether trials would not be binding, they could help the parties reach an AngioDynamics port catheter lawsuit settlement agreement. If the parties do not reach an agreement, and no other resolution is found to the litigation, Judge Ohta may then remand each case back to the U.S. District Court where it originated for a future trial date.