SmartPort Surgery Lawsuit Claims AngioDynamics Catheter Fractured Inside Woman’s Body

Woman alleges a CT scan revealed that the SmartPort catheter fractured and left a broken segment lodged in two major veins near her heart.

A Missouri woman has filed a product liability lawsuit alleging that an AngioDynamics SmartPort catheter required a surgical retrieval procedure to remove a broken piece from out of her left brachiocephalic vein and superior vena cava.

The complaint (PDF) was brought by Sujata Lochmann in the U.S. District Court for the Southern District of California on May 11, naming AngioDynamics Inc. and Navilyst Medical Inc. as defendants.

Lochmann claims the defendants concealed evidence that the AngioDynamics SmartPort catheter had a substantially higher failure rate than comparable devices 

AngioDynamics SmartPort Catheter Concerns

AngioDynamics markets the SmartPort as a totally implantable vascular access device (TIVAD) designed to provide repeated access to the bloodstream for chemotherapy, medications, intravenous fluids, blood products and nutritional solutions. The system consists of an implanted port and a catheter made of silicone or polyurethane that is intended to remain in the body for long-term treatment.

However, many of these catheters contain barium sulfate to make them visible on imaging studies. Some individuals claim this material can degrade over time, causing pits, cracks and microfractures that weaken the catheter and increase the risk of fracture, thrombosis, infection, occlusion and migration.

In light of these findings, a growing number of AngioDynamics lawsuits allege the manufacturers knew for years that their port catheter devices were prone to fracture and other serious complications, yet continued to market the catheters as safe and effective without providing adequate warnings to doctors and patients.

SmartPort Fracture Allegations

According to the complaint, Lochmann underwent implantation of an AngioDynamics SmartPort, model CT80STSD, at University Hospital in Columbia, Missouri, on April 10, 2019.

The lawsuit indicates that during a routine follow-up visit at The University of Texas MD Anderson Cancer Center on October 19, 2021, a CT scan revealed that her previously intact left subclavian port catheter had fractured, with a broken segment lodged in her left brachiocephalic vein and superior vena cava. She underwent a foreign body retrieval procedure the next day to remove the detached catheter fragment.

Lochmann alleges that the SmartPort was defectively designed and manufactured, inadequately tested and sold without sufficient warnings about the risks of catheter fracture, migration, thrombosis, infection and other potentially life-threatening complications. The complaint also claims AngioDynamics concealed adverse event reports and other information indicating the SmartPort had a substantially higher failure rate than similar port catheter systems.

“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 purpose and that the product could cause serious medical problems, including infections.”

— Sujata Lochmann v. AngioDynamics Inc. et al

The lawsuit raises allegations of negligence, strict product liability, failure to warn, design defect, breach of express and implied warranties, fraudulent concealment and punitive damages. It seeks compensation for medical expenses, pain and suffering, permanent injuries and other financial and non-economic losses.

Port Catheter Lawsuits

Lochmann’s complaint will proceed as part of an AngioDynamics SmartPort multidistrict litigation (MDL), which was established in the Southern District of California before U.S. Judge Jinsook Ohta, who is coordinating discovery and pretrial proceedings in all related lawsuits filed throughout the federal court system.

As the litigation moves forward, the court is expected to establish a bellwether process, in which a small group of representative cases will be prepared for early trial dates. The outcomes of those trials are intended to help the parties evaluate how juries may respond to common evidence and legal issues that will be repeated throughout the litigation.

A similar group of Bard PowerPort lawsuits have already been consolidated in the District of Arizona, where more than 3,000 claims allege that C.R. Bard and its parent company, Becton, Dickinson and Company, sold port catheters with many of the same design problems alleged in the AngioDynamics litigation.

The first Bard PowerPort bellwether trial ended in a defense verdict, with the jury finding both that the manufacturer was not liable for failing to warn or instruct about potential PowerPort risks, and rejecting the plaintiffs’ consumer fraud claims. However, jurors were unable to reach a unanimous verdict on whether the PowerPort was defectively designed or whether the manufacturers engaged in unlawful trade practices.

The mixed verdict may increase the significance of future bellwether trials, which are expected to provide additional insight into how juries evaluate the evidence and legal arguments presented in these cases.

Additional Bard PowerPort bellwether trials are scheduled to begin on July 7, August 18, October 13, December 1, and February 2, 2027. If the bellwether trials conclude without a settlement or other resolution, Judge Campbell is expected to begin remanding the cases back to their originating federal districts for individual trial dates.

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