Severity of Bard PowerPort Complications and Likelihood of Problems Occurring Were Withheld from FDA and Consumers: Lawsuit

Lawsuit indicates that the failure to warn patients and the medical community about the risk of Bard PowerPort complications contributed to the development of a life-threatening infection for an Illinois woman.

According to allegations raised in a recently filed product liability lawsuit, Becton Dickinson and Company, and its C.R. Bard and Bard Access Systems subsidiaries, actively concealed information about the likelihood of patients experiencing Bard PowerPort complications, including life-threatening catheter infections.

Emmali Richmond filed the complaint (PDF) in New Jersey Superior Court on November 16, indicating that her injuries could have been avoided if accurate information had been disclosed to patients, regulators and the medical community.

The Bard PowerPort is a vascular access device, consisting of an injection port, where the needle is inserted to deliver medications, and a polyurethane catheter tube which carries the drug into the blood vessel.

Unlike other implanted port catheters, such as Port-a-cath or Mediport, the Bard PowerPort is marketed as a special type of port catheter, which is intended to withstand higher injection pressures. However, Richmond indicates that the catheter tube is prone to fracture and rupture, leading to serious Bard PowerPort complications, including infections, pulmonary embolism, deep vein thrombosis and other injuries.

According to the complaint, Richmond was implanted with a PowerPort in February 2022 for chemotherapy treatment of breast cancer. However, in May 2022, she was admitted to a hospital due to a suspected infection.

It was determined that she suffered a pseudomonas bacteremia infection caused by the port catheter device. As a result, the Bard PowerPort was surgically removed just days later. However, Richmond remained hospitalized due to life-threatening risks to her vital organs caused by the infection.

The lawsuit indicates her injuries, and similar PowerPort infections which sickened and injured others, could have been avoided if the manufacturers had been honest about the device’s problems. She claims that the manufacturer actively hid adverse event reports from the FDA, instead of making them publicly available, calling the actions “willful, wanton, gross, and outrageous corporate conduct,” which Richmond’s lawsuit says demonstrates a conscious disregard for the safety of patients in order to maximize profits.

“Despite being aware of defects in the PowerPort devices manufactured by Defendants, Defendants intentionally concealed the severity of complications caused by PowerPort and the likelihood of these events occurring from both the FDA and consumers,” her lawsuit states. “Rather than correct the design and manufacturing process of the PowerPort to make it safer, or adequately warn physicians of the dangers associated with the PowerPort, Defendants continued to actively and aggressively market the PowerPort as safe, despite their knowledge of design and manufacturing defects, and despite numerous reports of catheter infection, and related injuries to numerous patients in which the PowerPort had been installed.”

November 2023 Bard PowerPort Lawsuit Update

Days after it was filed, the manufacturer removed Richmond’s claim to the federal court system, where it joins dozens of similar Bard PowerPort lawsuits that are now centralized as part of a federal MDL (multidistrict litigation) before U.S. District Judge David Campbell in the District of Arizona.

Given common questions of fact and law, the litigation has been consolidated to help reduce duplicative discovery into common issues that apply to all cases, avoid conflicting pretrial ruling from different judges and to serve the convenience of common witnesses, parties and the judicial system.

As part of the management of the port catheter lawsuits, it is expected that Judge Campbell will select a small group of representative cases that will be prepared for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. However, if the manufacturer fails to negotiation Bard PowerPort settlements following these MDL proceedings, each case may later be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.