SmartPort Infection Lawsuit Alleges AngioDynamics Catheter Defects Forced Surgical Removal

New York woman says her SmartPort was only implanted for a few months before becoming infected due to a defective design and lack of transparency from the manufacturers.

Lorrie Smith claims a SmartPort catheter used for her chemotherapy caused an infection, forcing doctors to remove the device months after implantation.

The complaint (PDF) was filed in the U.S. District Court for the Southern District of California on January 26, naming AngioDynamics Inc. and Navilyst Medical Inc., the manufacturers of the SmartPort, as the defendants.

SmartPort is one of a line of AngioDynamics port catheters, designed to give doctors a way to repeatedly deliver drugs and fluids into a patient’s body without repeated needle sticks. They consist of an injection port and polyurethane silicon catheter. However, a growing number of former patients now say these devices are defectively designed, leaving them with device failures, infections, broken and migrating parts and embolism risks.

These problems have led to intense scrutiny of port catheters from AngioDynamics and other medical device manufacturers, as well as a number of AngioDynamics port catheter lawsuits and Bard PowerPort lawsuits being pursued in the federal court system over the past year.

According to Smith’s SmartPort infection lawsuit, she was implanted with the device in October 2022 to provide her with chemotherapy. However, she says that neither she nor her doctors were made aware of the implant’s high failure and infection rates.

In January 2023, less than four months after implantation, Smith was hospitalized for chest pains and shortness of breath. It was then that doctors discovered she had a SmartPort infection and surgically removed the device, replacing it with another SmartPort.

“Defendants advertised, promoted, marketed, sold, and distributed the SmartPort as a safe medical device when Defendants knew or should have known the SmartPort was not safe for its intended purposes and that the product could cause serious medical problems.”

– Lorrie Smith v. AngioDynamics Inc. et al

According to the SmartPort infection lawsuit, these problems can include:

• Hemorrhage
• Infection
• Sepsis
• Thrombus (blood clots)
• Cardia/Pericardial Tamponade
• Cardiac arrhythmia
• Severe Pain
• Organ and Tissue Perforation
• Death

The complaint argues that AngioDynamics not only failed to design a safe and effective port catheter but also failed to design a safe and effective procedure for removing the port catheter in case of failure. It also alleges the manufacturer gave physicians misleading information in order to maximize sales.

Smith presents claims of negligence, design defect, manufacturing defect, failure to warn, breach of warranty and fraudulent concealment.

AngioDynamics Port Catheter Failure Lawsuits

The complaint will be consolidated with nearly 300 other AngioDynamics port catheter lawsuits filed in federal courts nationwide, which have been centralized for coordinated discovery and pretrial proceedings in the Southern District of California under U.S. District Judge Jinsook Ohta.

Last year, Judge Ohta indicated that she plans to hold a series of AngioDynamics “bellwether” early trials to help the parties see how juries may respond to evidence and testimony that could be repeated throughout the litigation.

Lawyers have been ordered to select 18 cases, including nine chosen by plaintiffs and nine chosen by the manufacturer, representing the range of reported injuries involved in the litigation, including infections, fractures and blood clots. From that group, eight lawsuits will move forward as potential bellwether trials to gauge how juries evaluate the evidence and expert testimony.

While these early trial dates will not be binding on other port catheter claims, they could have significant influence on any potential AngioDynamics port catheter settlement negotiations. However, if the bellwether trials end without a settlement being reached, Judge Ohta may remand the cases back to their original courts for individual trial dates.