AngioDynamics SmartPort Infection Lawsuit Alleges Defective Port Caused Sepsis

Lawsuit claims SmartPort catheter defects promoted bacterial growth that required hospitalization and surgical removal of the entire port system.

A Pennsylvania man has filed an AngioDynamics SmartPort lawsuit alleging defects in an implanted port used to administer chemotherapy caused a severe infection that spread and resulted in sepsis only weeks after the device was implanted.

Mark Richard Stevens brought the complaint (PDF) in the U.S. District Court for the Southern District of California on July 28, naming AngioDynamics Inc. and Navilyst Medical Inc. as defendants. .

Stevens argues the companies knew or should have known that defects affecting their SmartPort catheters could increase the risk of bacterial growth, infection and other serious complications. He goes on to claim those problems caused him to develop a Pseudomonas infection, cellulitis, severe neutropenia and sepsis, requiring hospitalization and surgical removal of the entire SmartPort system.

AngioDynamics SmartPort Infection Concerns

Implantable port catheters are surgically positioned beneath the skin to provide repeated access to the bloodstream for patients who require chemotherapy, medications, blood transfusions or other intravenous treatments. Products such as the AngioDynamics SmartPort, Vortex Port and Xcela generally feature a small reservoir connected to a catheter that carries medications and fluids into a vein.

However, AngioDynamics and other port manufacturers, including C.R. Bard, have faced hundreds of port catheter lawsuits in recent years involving bloodstream infections, blood clots, catheter fractures, vascular damage and other serious complications. Lawsuits allege defects in certain port catheter systems can cause the material to deteriorate after implantation, creating irregular surfaces where bacteria and blood products may collect and contribute to infections and other problems.

Individuals pursuing AngioDynamics port catheter lawsuits maintain the company was aware, or should have been aware, of the potential for these complications but continued selling and promoting the devices without providing adequate warnings to patients and the medical community about the alleged risks.

SmartPort Infection Lawsuit

In the complaint, Stevens indicates he underwent surgery on June 7, 2021, to have an AngioDynamics SmartPort implanted through his left internal jugular vein. The device was intended to provide vascular access for chemotherapy treatments he was receiving for lymphoma.

Only two weeks later, on June 21, Stevens went to Indiana Regional Medical Center in Pennsylvania complaining of pain around the SmartPort site that radiated into his neck, along with symptoms consistent with an infection.

Wound cultures taken from the port site subsequently tested positive for Pseudomonas, according to the lawsuit. Stevens was diagnosed with cellulitis, severe neutropenia and sepsis. Two days later, doctors surgically removed the entire SmartPort and catheter because of the infection, cellulitis, sepsis and positive Pseudomonas cultures.

Stevens alleges the SmartPort had been implanted and used as intended and had not been improperly altered or misused before the infection developed.

The complaint maintains AngioDynamics knew or should have known its SmartPort devices were susceptible to infection, thrombosis, fractures, migration and other failures, but continued to market the products as safe and reliable vascular access devices.

“As a direct and proximate result of the defective SmartPort and the wrongful acts and omissions of the Defendants as alleged herein, Plaintiff was injured due to the use of the SmartPort, which caused Plaintiff various physical, mental, and emotional injuries and damages.”

— Mark Richard Stevens v. AngioDynamics Inc. et al.

Stevens also alleges AngioDynamics received adverse event reports involving SmartPort infections and other serious complications, yet failed to adequately warn patients or doctors about the risks.

According to the lawsuit, some adverse events involving AngioDynamics implanted port products were submitted through the FDA’s former Alternative Summary Reporting program, which allowed certain medical device incidents to be reported in a manner that was not readily visible to doctors and the public.

Stevens claims he was unaware that a defect in the SmartPort may have contributed to his infection and sepsis until late 2025, when he encountered information concerning recently identified risks involving SmartPort and similar port catheter devices.

The lawsuit raises allegations of negligence, failure to warn, design defect, breach of implied and express warranties, fraudulent concealment and violations of Pennsylvania consumer protection laws. It seeks compensatory and punitive damages, maintaining the SmartPort infection caused substantial physical and mental pain, permanent injuries, additional surgery, medical expenses and other economic losses.

AngioDynamics Port Catheter Lawsuits

Stevens’ complaint joins hundreds of other AngioDynamics port catheter claims consolidated before U.S. District Judge Jinsook Ohta in the Southern District of California, where the parties are conducting coordinated discovery and addressing common pretrial issues involving allegations that the company marketed defective implantable port systems.

As the litigation moves forward, the court is expected to identify a limited number of representative claims for early bellwether trials. Although those verdicts will not determine the outcome of other cases, they may provide insight into how juries view recurring evidence and allegations, potentially shaping future AngioDynamics port catheter settlement negotiations.

Thousands of similar Bard PowerPort lawsuits are also pending in a separate federal multidistrict litigation before U.S. District Judge David G. Campbell in the District of Arizona. Those lawsuits allege design and manufacturing problems make the implanted catheters prone to fractures, blood clots, infections and other potentially serious injuries.

The first Bard PowerPort bellwether case went before a jury earlier this year, ending in a mixed result in May. Jurors ruled against the plaintiff on failure-to-warn and consumer fraud claims but were unable to reach a unanimous decision on allegations involving a defective design. The plaintiff subsequently asked the court for a new trial, maintaining that improper jury instructions affected the deliberations.

More Bard PowerPort bellwether trials are planned throughout 2027. If the test cases and settlement negotiations fail to produce a broader resolution, individual claims could eventually be sent back to their originating federal courts for separate trials.

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