Xcela Chemo Port Lawsuit Alleges Defective Catheter Device Caused Strep, Sepsis Infections

The lawsuit indicates that, in addition to the need for hospitalization and removal of the port catheter, the design defects also delayed the plaintiff’s breast cancer chemotherapy treatment.

A woman implanted with an AngioDynamics Xcela port catheter indicates in a recently filed lawsuit that design defects caused the device to fail, requiring additional surgery to remove the chemo port after she began to suffer symptoms of serious infections that could have been life-threatening.

Daun Reed, of Missouri, brought the complaint (PDF) in the U.S. District Court for the Southern District of California on November 11, indicating that AngioDynamics Inc., Navilyst Medical Inc. and PFM Medical Inc. sold an unreasonably dangerous and defective medical device, which left her with permanent injuries and delayed her critical breast cancer chemotherapy treatments.

The Xcela chemo port is part of a line of AngioDynamics port catheters, which also includes the SmartPort and Vortex Port. These implants are designed to give doctors a way to administer drugs and fluids to patients repeatedly as part of some medical treatments, such as chemotherapy. The device consists of an injection port and a polyurethane or silicon catheter.

Reed’s claim joins hundreds of similar AngioDynamics chemo port lawsuits filed over the last year. C.R. Bard also faces a number of similar Bard PowerPort lawsuits, which all raise nearly identical allegations that design defects cause the catheters to degrade over time, developing microfractures that lead to infections, blood clots, device migration, and the need for corrective surgery.

The lawsuit indicates Reed was implanted with an AngioDynamics Xcela Plus Port in her left chest wall in December 2018. The device was meant to help her doctor provide ongoing vein access for the delivery of chemotherapy drugs to treat Reed’s breast cancer.

In April of this year, Reed went to the hospital, after symptoms including coughing and congestion evolved into nausea and vomiting over just a few days. She was admitted to a hospital’s intensive care unit once doctors determined she was suffering from both sepsis and group B strep bacteremia.

Two days after presenting to the hospital with her symptoms, doctors determined the source of the infection was her Xcela chemo port and surgically removed it. Strep B bacteria was detected on the catheter tip.

According to the complaint, not only did the implant endanger Reed’s life, but also interrupted her breast cancer treatment.

“Following the removal of the Xcela port, Plaintiff did not wish to be implanted with another port. Therefore, she was required to stop her chemotherapy treatment and was placed on immunotherapy to continue treatment for her breast cancer.”

– Daun Reed v. AngioDynamics Inc. et al

Reed presents claims of negligence, failure to warn, design defect, breach of warranty, fraudulent concealment, and violations of the Missouri Merchandising Practices Act. She seeks both compensatory and punitive damages.

AngioDynamics Chemo Port Lawsuits

The complaint will be centralized with other AngioDynamics chemo port lawsuits in the Southern District of California under U.S. District Judge Jinsook Ohta, who is overseeing coordinated discovery and pretrial proceedings.

The manufacturer already faces at least 252 similar claims alleging that problems with the design of the port catheters can lead to fracturing, device migration, infections and thrombosis injuries.

Last month, Judge Ohta approved a bellwether trial process meant to test how juries respond to these allegations. Both sides will select nine cases each, creating a pool of 18 lawsuits representing the range of reported injuries, including infections, fractures and blood clots.

While not binding on other claims, these early trials are expected to influence any potential AngioDynamics port catheter settlement negotiations. If no agreement is reached, Judge Ohta may send unresolved cases back to their original courts for individual trials, a process that could take several years to complete.