scales of justice in court room

More than 200 lawsuits claim that AngioDynamics port catheters are responsible for serious injuries. A federal panel has consolidated AngioDynamic port lawsuits into federal multidistrict litigation (MDL) — a process designed to expedite the resolution of many lawsuits claiming similar injuries.

AngioDynamics port catheters are devices that provide patients with long-term access to their veins, often for treatments such as chemotherapy. However, the U.S. Food and Drug Administration has received hundreds of reported failures.

Lawsuits claim the company used excessive amounts of barium sulfate in the devices, causing them to degrade, pit or crack. This made the devices prone to fracture, causing perforation in blood vessels or organs, along with infections, blood clots and other injuries.

Attorneys anticipate that more AngioDynamic port lawsuits will be added to the MDL in the coming months.

Types of Injuries and Complications

A review of complications reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database since 2020 found nearly 300 reports of AndioDynamic port failures. Those problems included 62 reports of fractures and 31 reports of part detachments, with some overlapping.

Select AngioDynamic Port Injuries Reported to MAUDE Since 2020

  • Foreign object in the patient’s body (43 reported)
  • Infection (42 reported)
  • Component embedded in tissue (26 reported)
  • Pulmonary embolism (11 reported)

In a report to the FDA from the manufacturer, one patient claimed they received an AngioDynamics SmartPort device for chemotherapy, but the catheter fractured and broke inside their body. This caused serious complications, including bleeding and heart rhythm problems. The patient required surgery to remove the device, experienced significant pain and suffering and now faces ongoing medical treatments, corrective surgery and financial losses from medical bills and lost wages.

In its report to the FDA, AngioDynamics was unable to confirm the problem because the broken device was not returned for review. The company claimed it found no defects in the product’s history or quality checks. The instructions warn that improper use — like using the wrong syringe size or placing the catheter in risky areas — can cause the device to break and harm patients.

Researchers Examine Port Catheter Injuries

While port catheter placements are overwhelmingly successful, researchers have estimated that more than 10% of people receiving one of the devices may experience complications. Reports of injuries surrounding another manufacturer’s device have resulted in more than 2,000 Bard PowerPort lawsuits.

A 2022 study in Cureus examined over 800 cases of port placements using devices manufactured by various companies. The study included AngioDynamic’s SmartPort, but not Bard PowerPort devices.

Port Catheter Injuries Found in 2022 Cureus Study

  • Thrombosis
  • Infection
  • Mechanical failure
  • Fracture and/or migration
  • Tissue damage

These issues occurred at different times, with some happening within 30 days after the procedure, but more than 70% arose later.