AngioDynamics SmartPort Infection Resulted in Removal of Failed Port Catheter: Lawsuit

Florida woman indicates she was forced to have a defective SmartPort device removed only a few months after it was implanted.

A recently filed lawsuit alleges that the defective design of an AngioDynamics SmartPort port catheter led to a severe and life-threatening sepsis infection for a Florida woman, shortly after the device was implanted in her body.

The complaint (PDF) was brought by Lydia Runkel in the U.S. District Court for the Southern District of California on April 10, naming the manufacturers, AngioDynamics, Inc. and Navilyst Medical, Inc., as the defendants. 

AngioDynamics port catheters, including the SmartPort, Vortex Port and Xcela Port, as well as others, 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.

However, Runkel’s complaint joins more than 140 AngioDynamics port catheter lawsuits filed against the manufacturer, each alleging that design defects and the breakdown of barium sulfate used in the devices have led to microfractures, migration and serious infections. These failures have been linked to complications such as device fracturing and bacterial buildup, often requiring surgical removal.

A similar series of Bard PowerPort lawsuits have been filed against C.R. Bard, each indicating that the chemo ports are prone to fracturing, migrating and causing infections, allegedly also due to the breakdown of barium sulfate used during the manufacturing process.

Runkel’s lawsuit indicates that she was implanted with an AngioDynamics SmartPort port catheter in March 2020. However, a few months later, in August 2020, she presented to the hospital with fever, chills, nausea, vomiting, back pain and headaches, which doctors determined were the result of an AngioDynamics SmartPort infection.

According to the complaint, Runkel’s doctors diagnosed her with severe sepsis and Enterobacter bacteremia and indicated that the SmartPort was the source of the infection. Due to the AngioDynamics port infection, doctors surgically removed the device in September 2020, just a few months after implantation.

Like similar claims filed nationwide, Runkel notes that the manufacturer was well aware of AngioDynamics SmartPort infection risks for years, but hid those risks from patients and the medical community.

“Defendants knew or should have known at the time they manufactured, labeled, distributed and sold the SmartPort that was implanted into Plaintiff that the SmartPort posed a significant and higher risk than other similar devices of device failure and resulting serious injuries,” the lawsuit states. “Defendants failed to timely and reasonably warn of material facts regarding the safety and efficacy of the SmartPort; no reasonable health care provider, including Plaintiff’s, or patient would have used the device in the manner directed, had those facts been made known to the prescribing healthcare providers or the consumers of the device.”

The lawsuit presents claims of negligence, failure to warn, design defect, breach of warranty, fraudulent concealment, and violations of Florida deceptive and unfair trade practice laws. She is seeking both compensatory and punitive damages.

AngioDynamics Port Infection Lawsuits

Runkel’s complaint will be consolidated with similar AngioDynamics port catheter lawsuits centralized in the Southern District of California for coordinated pretrial proceedings under U.S. District Judge Jinsook Ohta.

As part of the coordinated management of the growing litigation, Judge Ohta is expected to establish a bellwether trial process, during which a handful of representative cases will be selected for early trial dates. These trials will allow the parties and court 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 infection 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.