Chemo Port Fracture Lawsuit Alleges SmartPort Problems Led to Removal Surgery

Lawsuit claims improper concentrations and mixing of barium sulfate weakened the SmartPort catheter, causing it to fracture.

A South Carolina woman has filed a product liability lawsuit alleging a defective AngioDynamics SmartPort catheter fractured while implanted in her late husband, requiring an additional surgical procedure to remove the device.

The complaint (PDF) was brought by Vicki L. Chiappini on behalf of herself and the estate of her deceased husband, Albert Peter Chiappini Jr., in the U.S. District Court for the Southern District of California on October 8. It names AngioDynamics Inc. and Navilyst Medical Inc. as defendants.

Chiappini maintains AngioDynamics and Navilyst knew or should have known about reports of SmartPort fractures and other complications that could result in additional surgeries, yet continued selling the devices anyway.

Port Catheter Risks

Port catheters are medical devices implanted beneath the skin to provide ongoing access to a patient’s bloodstream for chemotherapy, blood transfusions, medications and other intravenous treatments. They typically feature an access port connected to a flexible polyurethane catheter that delivers fluids directly into a vein.

Medical manufacturers AngioDynamics and C.R. Bard face hundreds of port catheter lawsuits nationwide, alleging that defects in the devices have caused bloodstream infections, blood clots, vascular damage and other potentially life-threatening complications.

The lawsuits claim that defects in the catheter materials can create irregular surfaces where bacteria and blood products accumulate, increasing the likelihood of serious injuries. Plaintiffs also allege that manufacturers failed to adequately test the devices or address known safety concerns.

AngioDynamics port catheter lawsuits specifically claim the manufacturer knew or should have known about these risks but continued selling the implants without providing adequate warnings to patients and medical professionals.

Chemo Port Fracture Allegations

According to the complaint, Albert Chiappini Jr. underwent surgery to have an AngioDynamics SmartPort implanted on March 31, 2020, at Conway Medical Center in Conway, South Carolina. The device was implanted by Dr. Aaron M. Epstein to provide vascular access for chemotherapy.

On October 9, 2023, medical providers discovered that Chiappini’s SmartPort had fractured and recommended removing it. Dr. Epstein removed the fractured device at CMC Surgical Associates on November 22, 2023. The complaint alleges the failure caused physical and emotional suffering, additional medical expenses and other financial losses.

Chiappini’s wife attributes the fracture to problems involving the concentration and distribution of barium sulfate within the catheter’s polymer material. The lawsuit claims these manufacturing problems weakened the tubing, while safer alternative designs were available that could have reduced or prevented deterioration.

The complaint maintains that neither Chiappini nor his physicians would have agreed to use the device if the manufacturers had disclosed the risks.

“Defendants’ design decision of how it chose to utilize barium sulfate and its specific process for mixing it with polyurethane/silicone leads to a structurally compromised catheter, thereby creating a defective condition and heightened risk to the user or consumer.”

— Vicki L. Chiappini et al. v. AngioDynamics Inc. et al.

Vicki Chiappini raises allegations of negligence, design defect, manufacturing defect, failure to warn, breach of implied warranty, breach of express warranty, fraudulent concealment, survival action and violation of South Carolina’s Unfair Trade Practices Act. She seeks general and punitive damages.

Port Catheter Lawsuits

The case joins hundreds of AngioDynamics port catheter lawsuits being handled by U.S. District Judge Jinsook Ohta in the Southern District of California, where the claims have been centralized for coordinated discovery and pretrial proceedings. As the litigation progresses, the court is expected to select a small group of representative cases for early bellwether trials.

Meanwhile, U.S. District Judge David G. Campbell is overseeing a separate multidistrict litigation (MDL) in the District of Arizona involving federal Bard PowerPort lawsuits. The first bellwether trial ended without a complete verdict, prompting the plaintiff to seek a new trial over allegations that improper jury instructions affected the outcome.

A second bellwether trial resulted in a $40 million verdict for a New Mexico woman who claimed her Bard PowerPort fractured after implantation, allowing pieces of the catheter to migrate to her heart and causing a pulmonary embolism.

Judge Campbell has scheduled additional Bard PowerPort bellwether trials throughout the year. Although these verdicts do not determine the outcomes of other lawsuits, they may provide insight into how juries respond to the evidence and help guide potential port catheter settlement negotiations.

If attorneys cannot reach settlements or otherwise resolve the litigation, individual cases may eventually be returned to the federal courts where they originated for separate trials.

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