Port Catheter Lawsuit Claims Defective Design Led to Fungal Bloodstream Infection

Lawsuit alleges AngioDynamics knew about SmartPort failure risks for years before woman was implanted with the device.

A Texas woman has filed a product liability lawsuit against the makers of the SmartPort port catheter claiming the medical implant caused her to contract a candida fungal infection, which can cause thrush and other adverse health effects.

The complaint (PDF) was brought by Gretchen Wofford in the U.S. District Court for the Southern District of California on October 22, naming AngioDynamics Inc. and Navilyst Medical Inc. as defendants.

Wofford accuses the companies of manufacturing and marketing defective medical implants made of inferior materials. She says AngioDynamics failed in its duty to provide accurate warnings to patients and the medical community about the SmartPort potentially fracturing and allowing infectious material to take root.

Port Catheter Failures

Port catheters are medical implants consisting of a subdermal port and catheter. They are implanted in patients who require regular drug or fluid injections, like chemotherapy patients. Once the port is implanted, doctors do not have to perform a needle stick every time access to a vein is needed.

In recent months, a growing number of port catheter lawsuits have been filed against AngioDynamics and C.R. Bard, both makers of port catheters, following reports from health care providers that devices such as the SmartPort were fracturing post-implantation. These malfunctions have resulted in bleeding, infections, thrombosis, heart rhythm problems, device migration and pieces of fractured catheter entering the blood stream, putting patients at risk of a pulmonary embolism.

According to numerous individuals’ allegations, manufacturers used too much of a substance known as barium sulfate in the design of the catheter hose, which is inserted into the bloodstream. When too much is added to the polyurethane catheter, it allegedly degrades faster than expected, causing device failure.

Port Catheter Infection Allegations

According to the complaint, Wofford was first implanted with an AngioDynamics SmartPort port catheter in January of this year. The device was implanted on the right side of her chest for the purposes of chemotherapy.

In March, Wofford went to the hospital for brachytherapy, when healthcare professionals diagnosed her as suffering from an acute fever over 105 degrees Fahrenheit that included symptoms of chills, confusion, fatigue and weakness. She was admitted to the hospital for a suspected sepsis infection.

Blood cultures revealed Wofford was suffering from Candida, a fungal infection in the bloodstream. Additional tests tracked the infection back to the SmartPort, which was surgically removed later that month as she was treated with broad-spectrum antibiotics, antimicrobial and antifungal medications.

The lawsuit states Wofford was hospitalized for 16 days and suffered serious injuries and medical expenses.

Wofford alleges AngioDynamics knew about the problems with the SmartPort long before it was implanted in her, having received a large number of adverse event reports warning of similar problems in patients who received the port catheter implants for years.

“Soon after the SmartPort was introduced to market, which was years before Plaintiff was implanted with her device, Defendants began receiving large numbers of adverse event reports (‘AERs’) from health care providers reporting that the SmartPort was fracturing post-implantation and that fractured pieces were migrating throughout the human body, including to the heart and lungs. Defendants also received large numbers of AERs reporting that SmartPort was found to have perforated internal vasculature.”

– Gretchen Wofford v. AngioDynamics Inc et al.

The lawsuit presents claims of negligence, design defect, manufacturing defect, failure to warn, breach of warranty, fraudulent concealment and violation of the Texas Deceptive Trade Practices Act. It seeks both compensatory and punitive damages.

Port Catheter Lawsuits

Wofford’s complaint is one of many AngioDynamics port catheter lawsuits filed over the manufacturer’s devices, including the SmartPort, Vortex Port, Xcela and others. All federal claims are currently consolidated in the Southern District of California before U.S. District Judge Jinsook Ohta for coordinated discovery and pretrial proceedings as part of a multidistrict litigation (MDL)

Similar Bard PowerPort lawsuits filed at the federal level have also been consolidated into an MDL in the District of Arizona before U.S. District Judge David G. Campbell, who has already begun to bring early bellwether test cases to trial.

The first Bard PowerPoert lawsuit ended in a defense verdict, which the plaintiff has challenged, seeking a new trial over alleged improper jury instructions. The second trial ended in a $40 million verdict for a New Mexico woman who said her PowerPort fractured inside of her body, causing a pulmonary embolism.

A third PowerPort lawsuit bellwether trial is currently underway, involving claims of port catheter infection by May Lattanzio of Florida.

While none of these trials are binding on other claims, they are being closely watched, as the results could have a significant impact on any port catheter lawsuit settlement negotiations.

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